Qsymia for Weight Loss
Over the past couple of years, there has been a transformation in mindset on the part of doctors and their treatment of weight problems. They have found such terrible difficulties—outbreaks of diabetes, heart attacks and strokes— and they are ready to try other modes of treatment. Just look at the expanding number of gastric bypass operations in the past few years. The Food and Drug Administration has authorized two completely new medicines in 2012: Qsymia and Belviq, to help overweight and obese individuals lose weight. Qsymia is available with a doctor's prescription. Listed below are some guidelines for its use. See if it might be suitable for you. Qsymia is a class IV controlled prescription treatment that consists of phentermine and Topamax (topiramate extended-release) that may well help some obese or overweight adults with weight-related medical problems lose weight and keep the weight off. The phentermine (the reason for the controlled drug classification) is the appetite reducer and is comparable to the phentermine in Adipex and Fastin, which have been in the marketplace since the middle of the 1970s. Topamax has been available for a decade and is commonly used for seizures and headaches. So Qsymia is not really new. It's two older prescription drugs combined in a special delivery method, with four different dosing levels. Qsymia should be utilized with a reduced calorie diet and increased physical exercise. It is not known if Qsymia shifts your risk of heart difficulties, cerebrovascular accidents, or death due to heart problems or stroke. It is not known if Qsymia is safe and productive when taken with other prescribed over-the-counter or organic weight-loss items, so be watchful.So what has triggered people to think about using medications for weight loss?It is the frustrating disappointment of all kinds of weight loss plans and the fact that the medical community fails to see obesity as an illness. Often doctors believe that their obese patients simply have no will power and control and thus they hold back medications that could assist them with weight loss. Other doctors believe, frequently without vocalizing it, that dropping weight and sustaining fat loss is a hopeless situation anyway so why try? While other people associate all diet prescription drugs with phen/fen.Over the previous few years, there has been a shift in perspective on the part of doctors and their therapy of obesity. They have seen such horrible complications: epidemics of diabetes and its complications, strokes, and coronary heart disorders that they are prepared to try various other modes of treatment. Just look at the escalating number of gastric bypass surgical procedures in the previous several years. The FDA has authorized two brand new drugs in 2012 - Qsymia and Belviq.The first, Qsymia is readily available now with a doctors prescription. Below are a few guidelines for its use. Qsymia is a prescription treatment that is made up of phentermine and Topamax (topiramate extended-release) that may help some obese adults or some over weight adults who also have weight-related medical conditions lose weight and keep the weight off. The phentermine is the appetite reducer and is similar to the phentermine in Adipex and Fastin that's been on the market since the mid 1970’s. The Topamax has been available for a decade and is used for seizures and headaches. So Qsymia is not really new—it’s 2 older drugs blended in a distinctive delivery method with 4 different dosing levels that stretched over months. A titrated dose delivery system was developed to lessen the side effects.
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Qsymia: New FDA Approved Diet Medication- Is It For You?
Richard L. Lipman M.D.
www.qsymiaMD.com
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Chapter 1: Is the Qsymia Weight Loss Plan for You?
The Qsymia Weight Loss Plan is designed to help you get rid of that extra weight now and forever. It is not for the individual that has 10 to 20 pounds to lose. It is for the 75 million Americans who have 30, 50, or 100 pounds or more to lose, who feel they have tried everything and failed. It is for the millions more with diabetes and other medical problems whose obesity has been impossible to reverse. It is for those 100,000 or more Americans thinking about drastic actions such as gastric bypass surgery. This revolutionary weight loss plan combines a effortless, easy-to-remember food plan with the first of a new class of prescription medications that puts you in control of your hunger and cravings, perhaps for the very first time in your life. The breakthrough drug is Qsymia-a combination of Phentermine and Topiramate. These two medications have been on the market for decades. More than 30 million people have taken Phentermine and 4 million people have been treated with Topiramate around the world. The Qsymia Weight Loss Plan is new arsenal in the battle against obesity. The powerful forces that tell you when to eat and when not to eat—forces that easily overwhelm the normal control mechanisms of overweight individuals—are revealed in groundbreaking new research. For decades, even centuries, lack of willpower has been misidentified as a psychological weakness in most obese individuals. We now know that, through no fault of their own, obese individuals’ brains are actually biochemically different from those of thin people. Obese people lack the normal internal signals to stop eating. They are either missing the chemicals or are not responding normally to those chemicals, and they end up eating the wrong foods or simply too much food. In the past decade, researchers have returned to older medications and have discovered new answers to complex human health problems. The results of this research have just begun to reach the public—and the first of a new class of miracle medical drugs for obesity is here now. The Qsymia Weight Loss Plan—the breakthrough plan for long-term weight loss and maintenance, is based on a sensible food and medication plan created to decrease hunger and eliminate cravings. Just as new prescription drugs for depression have changed the face of psychiatry, so too will new anti-obesity medications change the way the medical profession treats overweight individuals. This new plan is built on the simplest, easiest-to-remember food plan. There are no complicated food preparations. In fact, there are no recipes at all! There is no shopping for unusual foods, there’s no counting calories, carbohydrates, fat, protein, or points. By understanding what makes you hungry and what makes you full, you will eat normal food and eliminate most of your hunger and cravings even before you take medication. You and your doctor are about to learn that there is a long-term solution to losing weight and keeping it off. It is never about counting anything. It is about controlling hunger and cravings— not through willpower, but by using the power of your body’s own chemicals (mimicked by Qsymia and other drugs to come) along with a simple, personalized food plan designed to eliminate a few trigger foods causing weight gain to prevent hunger and satisfy cravings.
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For the millions of overweight individuals who have or are at substantial risk for medical problems as a consequence of obesity, I believe that The Qsymia Weight Loss Plan will be the last diet book you will ever need. Follow along as more information is accumulated on Qsymia on my website at: http://www.qsymiaMD.com.
Chapter 2: Qsymia: What It is and How to Take It
Over the past couple of years, there has been a transformation in mindset on the part of doctors and their treatment of weight problems. They have found such terrible difficulties—outbreaks of diabetes, heart attacks and strokes— and they are ready to try other modes of treatment. Just look at the expanding number of gastric bypass operations in the past few years. The Food and Drug Administration has authorized two completely new medicines in 2012: Qsymia and Belviq, to help overweight and obese individuals lose weight. Qsymia is available with a doctor's prescription. Listed below are some guidelines for its use. See if it might be suitable for you. Qsymia is a class IV controlled prescription treatment that consists of Phentermine and topiramate (topiramate extended-release) that may well help some obese or overweight adults with weight-related medical problems lose weight and keep the weight off. The Phentermine (the reason for the controlled drug classification) is the appetite reducer and is comparable to the Phentermine in Adipex and Fastin, which have been in the marketplace since the middle of the 1970s. Topiramate has been available for a decade and is commonly used for seizures and headaches. So Qsymia is not really new. It's two older prescription drugs combined in a special delivery method, with four different dosing levels. Qsymia should be utilized with a reduced calorie diet and increased physical exercise. It is not known if Qsymia shifts your risk of heart difficulties, cerebrovascular accidents, or death due to heart problems or stroke. It is not known if Qsymia is safe and productive when taken with other prescribed over-the-counter or organic weight-loss items, so be watchful.
Mechanisms of Action in Qsymia
One would think that since phentermine and topiramate have been on the market for a long time, the mechanism of action would be clear. Unfortunately they are not. Both act on different areas of the brain to release substances that eventually produce feelings of fullness, reduce appetite and decrease cravings. Phentermine is a sympathomimetic amine( which means the chemical structure is similar to amphetamine). The effect of phentermine on chronic weight management is likely due to the release of catecholamines (hormones such as norepinephrine) in the brain which decrease appetite. Topiramate acts by causing fullness and disinterest in food. The interesting issue for users of Qsymia is that there appears to be a synergistic effect of these two drugs. As you will see, the doses used in the titration are very, very low, starting with 3.75 mg of phentermine (the usual starting dose of phentermine is 15 mg) and 23 mg of topiramate (the usual starting dose of topiramate is 50 mg.) The maximal dose is 15 mg of phentermine and 96 mg of topiramate. This compares to the usual and customary dose of phentermine (37.5 mg) and the dose of topiramate usually between 100 and 400 mg per day).
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How this synergistic effect comes about is unclear. Topiramate used in this preparation is timereleased and is not the same form of topiramate used clinically for headaches and seizures. Therefore, it would not be possible (as some websites have suggested) to mix small doses of generic phentermine and topiramate together and produce the same medication. Many physicians treating overweight patients (myself included) have tried this off-label use and were not able to arrive at an effective drug with low side effects. To overcome the side effects of topiramate, the manufacturer has developed a time-released topiramate and then titrated the dose, starting at 23 mg, slowly increasing it over 6 to 8 weeks to 92 mg. They have employed two treatment dose levels and two starter dose levels to help. As the topiramate is slowly increased, so is the phentermine, from 3.75 mg to 15 mg. To any dieter who has taken phentermine before, these would appear to be very, very low and probably ineffective doses. (See “How to Take Qsymia and What to Expect” for additional information). Remember, there is a synergistic effect between the two components of the drugs. Here are the four doses of Qsymia. The first number on the label is the phentermine dose and the second number is the topiramate dose. Each one of the bottles below is the supplied bottle from the manufacturer containing 30 days of capsules. Note the color change on the labels and the corresponding color change of the capsules.
Results of the Qsymia Studies
Qsymia has been tested in more than 4500 subjects over more than 2 years. Two large groups participated each for a year. Before they began the study, patients in the first study group had an average BMI of 42 and an average weight of 256 lbs. Up to a quarter of patients had been diagnosed with obesity-related medical problems such as hypertension or abnormal blood lipids, but these conditions were well-controlled on up to 1 or 2 medications. None of the patients in study #1 had diabetes and 83% were female. Before they began the study, patients in the second study group had an average BMI of 37 and an average weight of 227 lbs. They also had a least 2 obesity-related medical problems such as hypertension, diabetes, enlarged waist or abnormal blood lipids which were not as well controlled as in the patients from the first study group. 70% of patients in study #2 were female. The studies were double-blind and placebo-controlled, so neither the subject nor the physicians or the company knew who was taking the medications. The results of the studies are given below. Note there was a progressive dose-related reduction in body weight until the about the 40th week—then the weight loss seemed to level off for the next 16 weeks. The reason for this is unclear. The average weight loss in study #1 at 8 weeks was about 6% of body weight. The average starting weight in study #1 was 256 lb. so the actual average weight loss was 15 lbs at 8 weeks. The FDA’s criterion for a successful weight loss drug is a 5% weight reduction at the end of 12 months. Qsymia appears to greatly exceed that. The
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average weight reduction overall was about 13-15% of body weight after 40 weeks. This would be an average of about 38 lbs over the first 40 weeks. You need to notice there was a significant weight loss even with the lowest dose. I think this dose might be very appropriate for older patients. Losing 10% of your body weight is all that is needed to improve metabolic abnormalities such as lowering blood sugar if you are diabetic, reducing your blood pressure, and lowering your cholesterol. You don’t have to be as thin as a popular Hollywood celebrity to be healthy and reverse the metabolic abnormalities caused by obesity. You also need to remember that the subjects were given a very general low-calorie diet that reduced their caloric intake by only 500 kcal/day. Whether this was personalized and how much time was spent with each individual is unknown. One would only expect about a 1 lb per week weight loss if there were a reduction of 500 calories per day. (7 days x 500 calorie/day reduction = 3500 calorie reduction/week = 1 lb weight loss/week). No specific exercise program was prescribed. Note that in study #2 there was less weight loss. Was this due to the fact that initial weights were lower or to the fact that these subjects had related medical problems and they were taking many medications?
This observation may have significant impact on many patients who elect to use Qsymia and do not have the weight loss seen in Study #1. Please keep that in mind if your weight loss is much less than seen in study #1 there are many factors to explain it. This includes age, thyroid status and even gender. The graph below shows the average weight loss in patients from study 2 who took the study drugs for the full 56 weeks. The patients in this study had a least 2 weight-related medical complications that were poorly controlled or required at least 2 medications to control them.
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The unwanted effects are linked to the two unique medicines. Considering these prescription drugs have been on the marketplace for a prolonged period, we are familiar with what to expect. Anybody who has used Phentermine or Phendimetrazine has experience some of these side effects. These include a dry mouth, mild anxiety (similar to drinking a cup of espresso), insomnia, increased sweating, and mild constipation.
Possible Side Effects of Phentermine Taken Alone (from the phentermine literature)
Sleeplessness, nervousness, agitation, mania, mood changes, dry mouth, increase heart rate, palpitations, panic attacks, hostility, blurred eyesight, increase in eye pressure, bowel problems.
Possible Topiramate Side Effects (from the Topiramate Literature):
Numbness in fingers, feet, sleepiness, thoughts of committing suicide, depressive disorders, anxiousness, concentration and memory difficulties, mood variations, attention deficit, metabolic acidosis, tiredness, no hunger, low blood sugar, seizures if you quit drug too quickly, kidney stones, increased sweating, and warmth.
Actual Side Effects Observed in the Qsymia Studies:
In the Qsymia clinical studies, they did not discover any unexpected side effects that have not been reported in patients taking either phentermine or topiramate alone. The most common side effects reported in the Qsymia studies were paraesthesias (described as tingling in the hands, feet or face), dizziness, dysgeusia ( a metallic taste in mouth associated with carbonated drinks), insomnia, constipation and a dry mouth. Most of the side effects were dose related, meaning that the more Qsymia that is taken, the greater the side effects. In table 3 below, you will see a list of all side effects that were reported at a rate of at least 2%. It is also important to note that most side effects were minor and transient (meaning that they went away on their own), and should be acceptable for most patients. In table 3 you can see that only 1% of patients stopped the study due to the paraesthesias. In table 4 you can see that close to 20% of patients taking Qsymia 15/92
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experienced paraesthesias. Remember, the two components of Qsymia have been on the market for more than 20 years so physicians should know what to expect and the doses are much less when the drugs are given alone for their original condition.
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Women of Childbearing Age: Birth Defects
The FDA and the manufacturer are very concerned with possible birth defects, such as cleft palate, from their prior experience with topiramate. Any women of child-bearing age need to have an initial negative pregnancy test and a monthly negative pregnancy test. In addition, unless she is in menopause, has had surgical removal of the uterus or ovaries, or has a partner with a vasectomy, she must use effective birth control. If the woman does not have an IUD or progesterin implant, she will need to use TWO different forms of birth control. Women should not get pregnant taking Qsymia. Please see www.drugs.com/pro/qsymia.html for much more on this issue.
Heart Rate Rise:
Although blood pressures decreased with Qsymia, there was an average increase of heart rate of 1-2 beats per minute in patients taking Qsymia 15/92. Table 5 below shows the percentage of patients who had a heart rate elevation of 5, 10, 15 or 20 beats per minute at single time point during the year long studies. Heart rate needs to be checked by the prescribing physician, and it is important to tell your physician if you have any palpitations or feelings of a racing heartbeat while at rest during Qsymia treatment.
Who Cannot Take Qsymia
Do not take Qsymia if you are pregnant, planning to become pregnant or become pregnant during Qsymia treatment; have glaucoma; have thyroid problems (hyperthyroidism); are taking certain medications called monomaine oxidase inhibitors (MAOI’s) or have taken MAOI’s in the past 14
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days, are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in Qsymia.
Who Can Take Qsymia?
To qualify for Qsymia, you must have a BMI of at least 27, with weight-related medical problems or a BMI of 30 or more either with or without co-morbidities. The FDA defines comorbidities as a hypertension, high blood lipids, diabetes mellitus or a waistline above 105 cm. Table 5 lists the BMI’s.
You can also obtain your BMI from an on line calculator at this CDC web site: http://nhlbisupport.com/bmi/bminojs.htm. Once you have your BMI, you will need to see you physician for a prescription. Due to the risk of oral clefts in the first trimester of pregnancy, Qsymia is only available through certain home deliver pharmacies. You cannot buy Qsymia at your local pharmacy or through an online pharmacy, even with your doctor’s prescription. After a history and physical examination, your physician will fax the prescription and a form to an approved pharmacy—currently these include CVS, Walgreen’s, Express Scripts and Walmart online. You will need to provide your credit card information to the pharmacy for payment before they can mail you your medication. If you do not receive a call within a few days, you may need to call the pharmacy yourself. You will receive the medications in the mail and cannot pick them up at your local pharmacy.
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Chapter 3: How to Take Qsymia (from the FDA) and What to Expect
Once you have received your Qsymia pills, the dosing is very easy. Regardless of the dose level, Qsymia should be taken once a day in the morning without or with food. Most people take it right before breakfast. For individuals who stay up or eat late in the evening , the medication can be taken at 10 or 11 AM. You will receive two bottles—the starter dose of 3.75/23 for 14 days and the first treatment dose 7.5 /46mg for 30 days. Once the dose is established, you can order 3 months at a time. (The first number is the mg of phentermine and the second number is the mg of topiramate.) The starter dose is very, very low and the side effects are almost non-existent. A few people who are sensitive to topiramate have complained of fatigue. The phentermine component is 1/10 of the standard dose and therefore has few side effects, such as anxiety or insomnia. The second bottle in your first shipment is the “low” treating dose of 7.5/46. This is taken daily in the morning for a month or more after you have completed the 14 days on the starter dose. If you find the drug to be effective, I see no reason to increase the dose further. In my experience more than 50% of individuals find they lose weight easily without significant side effects. About 4050% of patients need a higher dose. What you should notice is a lack of hunger, a reduction in cravings, a feeling of fullness and a disinterest in food, especially from 3-4 PM to bedtime. Remember, a lot of eating is social and habitual, so you must make some effort not to end up with 3 pieces of pizza sitting in front of you. You must not pull up to the drive-thru at McDonald’s and order a #2 or #3 as usual, or go to Outback and order a 10 oz. steak with fries. Have one piece of pizza in front of you. Order the salad at the drive-thru and chicken and veggies at Outback. You won’t be hungry and you will be surprised how full you will quickly become. But you need to give the pill a chance to work. Remember it takes about 20 minutes to feel full from eating just about anything. That’s why I like starting with a cup of soup or an appetizer. The side effects of this dose are variable among individuals. Some people will notice a dry mouth, others a little bit of anxiety. More will notice a little bit of drowsiness and others may experience some mild pins and needles in their fingertips. All of these are mild symptoms and they usually disappear in 3-7 days. My observations early on during the first month of treatment with 7.5/46 dosage found more than ½ of the dieters had almost no side effects, 25% noticed a few side effects they could put up with, and about 15% noticed some side effects that bothered them but would not stop them from taking the medication. Side effects for most people disappear as the drug is taken. In addition, some effects are minimized when the drug is titrated slowly. The remaining individuals were so bothered by one side effect or another that they stopped the medication. I have treated overweight people with medications for weight loss for over 40 years. I have seen medications come and go. What I have observed is that there is no medication that is effective for weight loss that will have absolutely NO side effects. It’s just part of the trade-off. If you cannot tolerate side effects, you should not be taking these medications. After you have completed the third week of your first treatment bottle (7.5/46—the yellow bottle with the purple and yellow capsule), you will need to make an important decision with your physician: should you continue with this dose or should you escalate to the next higher dose? I believe that you should always take the lowest effective dose. If you are doing well on this dose, losing weight without much hunger or cravings, then why not continue with the same dose for another month? On my food plan (that I describe in the next chapter), most of my patients would
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have lost about 10-15 lbs at the end of 6 weeks. (Remember, it’s 6 weeks if you add the starter dose.) Everyone is different, so weight loss depends upon how old you are, whether you are a man or a women, your starting weight, and if you have medical problems, or if you are taking other medications. A man in his 20’s or 30’s that weighs 250 lbs would lose weight faster than a 60-year-old woman who is 160 lbs with diabetes. If you are happy with your progress and you need to lose more weight, then you can visit your physician again, or refill the 7.5/46 if you have been given a refill for another month. If you have not lost 3% of your body weight after three months on the 7.5/46 dose, either discontinue the medication or escalate the dose.
Escalating the Dose of Qsymia to Reach Maximal Weight Loss
If you noticed the graphs under the results section of this chapter, there was a difference in average weight loss between the 7.5/46 and the 15/92 dose of Qsymia. The former group lost about 9-10% of their body weight and the high dose lost 13-15% of their body weight. Along with this increased weight loss was a slight increase in side effects (See table 4). The 15/92 dose of Qsymia contains a full half dose of phentermine. In phentermine-sensitive patients, care should be taken to avoid caffeine and other stimulants. If you have not lost the weight you wanted to lose or if you are still hungry and are having trouble sticking to the weight loss plan, you might need to escalate the dose of Qsymia. If you are a woman of childbearing age, make sure you are taking two forms of effective birth control and that your pregnancy test is negative. On the third week of the 7.5/46, you should order you next two bottles for the next 6 weeks: the starter dose of 11.25/69 for 14 days and the treatment dose of 15/96mg. The latter dose is the highest dose of Qsymia. When the bottles arrive, take the starter dose of 11.25/69, which is in the bottle with the green label. Take that capsule every morning for 14 days. When completed, start taking the 15/92 capsule on the 15th day. For the next 30 days, take that capsule every morning. This is the highest dose capsule and it may have some of the side effects of drowsiness, anxiety, insomnia, constipation, dry mouth, tingling in the fingers, and the metallic taste in the mouth. Again, most of these side effects wear off. You can avoid caffeine and take the pill earlier if you are experiencing insomnia and anxiety. You can add caffeine if you are bothered by the drowsiness. You can add a stool softener if you are constipated. There are multiple over-thecounter mouth sprays and gels for dry mouth. These are all minor side effects, and for people with diabetes or other metabolic abnormalities, the benefits far outweigh any brief discomfort because losing weight can be lifesaving for people with obesity-related medical conditions. You can take Qsymia as long as you need to. The Qsymia label states that it is indicated for “chronic weight management.”) And up to two years of efficacy and safety data are available from the Qsymia clinical studies.
Follow along with me as I relate my personal experiences treating my overweight patients in my office in Miami, Florida at www.QsymiaMD.com.
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Qsymia Drug Interactions
Pregnancy and Breast Feeding Pregnancy Category X: Contraindicated in Breast Feeding because toprimate and phentermine are excreted in human milk. MAOs: Use of Qsymia with MAOs should be avoided. Oral Contraceptives: When Qsymia was taken along with oral contraceptives, there was a slight reduction in exposure to estrogen and a slight increase in progestin exposure. This might lead to spotting, but is not expected to decrease contraceptive efficacy since this is a primarily determined by the progestin component. However, this study did not address contraceptive efficacy. Non-Potassium-Sparing Diuretics: There was a slight increase in potassium loss with nonsparing diuretics with Qsymia.
Antiepileptic drugs
Concomitant administration of Dilantin with Topiramate decreased Topiramate concentrations by 40%.
Early Experiences with Qsymia: Jeff H., a Diabetic with Heart Disease Loses Weight on Qsymia
Jeff H., a 55-year-old marketing executive, had made it through two heart attacks and was a type 2 diabetic when he came to see me. He ran his own public relations company, a high stress job with significant travel. He was on the road every week. Married for 34 years, he had two very health-conscious sons, one in college and one in high school. Jeff’s wife suffered from a terminal and terrible disease. Jeff weighed 331 lbs and was scared to death. We began by examining a typical day of eating, both at home and on the road. Two bowls of cereal at midnight. Eating the last piece of pizza. Nibbling at the food, while clearing the table. When he was stressed—he ate. When he was happy—he ate. When he was upset or angry—he ate. He knew he was killing himself. In addition, he felt terribly guilty because of the feeling that he was being irresponsible to his wife and sons. He had no sense of portion control—he ate what was put in front of him and then sought more. His snacks were fast food drive-thru or high fat, high calorie snacks from convenience stores. A climb up a flight of stairs would leave him out of breath. He had tried every diet from Atkins to South Beach, from Jenny Craig to shakes and bars, and nothing seemed to work. He had tried every diet pill on the market without much success. His problems were not so much hunger as a lack of fullness and impulse eating. His diabetic medications made it impossible for him to lose weight. Qsymia is changing Jeff’s life. With the prescription, he was simply not able to eat the 3700 or so calories he had been consuming every day for years. We made small changes to his food choices: subs instead of burgers, soup before lunch, low-calorie snacks. Qsymia literally took away his constant hunger and cravings. His blood sugars fell to normal within three weeks of taking the medication. Today, Jeff has already lost 20 lbs and continues with a single dose of 7.5/46 at 10
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AM. Of course he has to watch his food and make better choices. However, this is much easier when he is not "hungry" all day long.
Algorithm for Dosing Qsymia from the Manufacturer and the FDA
As mention earlier, when you order Qsymia for the first time you will receive 2 weeks of the starter dose of 3.75/23 and 30 days of 7.5/46. The graph below outlines how the manufacturer believes the drug should be taken. The studies suggest that the increases in dosages were faster than this outline. The table below is the algorithm developed by the FDA and the manufacturer.
Dr. Lipman’s Alternate Faster Algorithm for Dosing Qsymia
After treating 25 patients when the drug first was available in the fall of 2012, I realized that this algorithm was too slow and expensive for many people. They were purchasing too many bottles of medications that proved to be ineffective and thus the dieting experience became much too expensive for many patients. For other patients, it took them too long to reach their effective dose level and they simply quit the medication in the middle of their diet. Others became very frustrated with the long process of ordering and receiving the medication via the current mail order system. I then put together another dosing algorithm that helps people reach their effective dose level faster and with less expense. The only problem with this system is that the rapid increase of topiramate doses sometimes does not leave some individuals with enough time to become comfortable with the side effects of the topiramate (sleepiness, moodiness, tingling in the fingers etc.) In the clinical studies the doses were increased only after 30 days leaving much more time for the dieter to acclimate to the medication. Each dieter along with his doctor really needs to decide which dosing pattern is best. Here is the rapid dosing schedule from my office. It’s based on discovering the effective dose of Qsymia over 30 days:
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You will order the 3.75/23 (14 capsules) and the 7.5/46(30 capsules) of Qsymia as your initial order. This will last you a month and give you a chance to try all 4 dose levels so you can determine your effective dose level. Week 1: Begin taking the 3.75/23 Qsymia (the lowest dose) mid - morning for 7 days. This very low dose may be appropriate for a few people sensitive to the medication or for older individuals. The vast majority of dieters will need to take higher doses. Week 2: 7.5/46 Qsymia dose: If you feel well with no side effects, but are still hungry after 7 days, then go to the 7.5/46 dose daily. Take the 7.5/46 capsules for a week. If this is working for you (your appetite and cravings are controlled and you are losing weight without significant side effects) then this is probably your effective dose. Then you should ask your doctor to order you an additional 30 or 60 days supply of the 7.5/46 Qsymia dose capsules which you can take for as long as you need. If however, you are still hungry and not losing as much weight as you think you should go to the next dose level. Week 3: 3.75/23 plus 7.5/46 Qsymia dose: Take the 3.75/23 capsules left over from the first days (the purple capsules) together with the 7.5/46 capsule in the morning. You will be taking the equivalent of the 11.25/69 dose. You should have enough 3.75/23 capsules to take for this week. At this point you will have experienced taking the third dosage equivalent of Qsymia-- the 11.25/69 dose. It’s possible that this dose will be the best for you. If it is, then have you doctor order 30 or 60 days of the 11.25/69 dosage of Qsymia. This is your effective dosage. On the other hand, if you are still hungry, you have a chance to try the strongest dosage of Qsymia in the 4th week of your Qsymia trial without having to order any more medication. Week 4: 7.5/46 x 2 capsules per day: You can try the equivalent 15/92 Qsymia dosage by taking two of the 7.5/46 capsules together at once in the mid-morning. This is same as taking one of the 15/92 capsules. You should have enough for 7 days left. At this point you have tried all of the doses of Qsymia and should have a good idea what dose of Qsymia will control your hunger and cravings with the least side effects. Whatever the effective dose is, you can take it until you have lost the weight you need to. You will need to see you physician to order the correct dosage at least once a month at which time he/she will check your blood pressure, pulse rate as well as your weight. Do no forget to have your blood chemistries done before you start the medication and after a month or two. Woman of child bearing age please be extra careful about contraception! Whether you stay on the 7.5/46, the 11.25/69 or the 15/92 Qsymia dosages will depend on your rate of weight loss and your side effects. Most people will probably want the higher dose since the rate of weight loss seen in the studies was faster with this dosage. Note the side effects were somewhat higher as well.
Frequently Asked Questions About Qsymia
16 Will Insurance Pay for Qsymia?
I have had several insurance companies pay for part or all of a Qsymia prescription. You will have to have a BMI greater than 30, probably greater than 34 or 35 (morbid obesity). Some companies will require the presence of co-morbidities. Some companies require letters from your physicians, similar to gastric bypass requirements. Other companies will not pay at all. Remember, Qsymia is new, so be patient. Once insurance companies learn about this great drug, things will change.
How Long Can I take Qsymia?
There were two phase three studies that went on for 56 weeks, and one of them was extended for an additional 52 weeks (for a total of 2 years of continuous treatment.) I tell my patients you should take the drug as long as you need it and as long as you are losing weight. The label states that you should not continue to take Qsymia if you have not lost at least 5% of your body weight after taking Qsymia after taking Qsymia 15/92 for 12 weeks.
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Qsymia: New FDA Approved Diet Medication- Is It For You?
Richard L. Lipman M.D.
www.qsymiaMD.com
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Chapter 1: Is the Qsymia Weight Loss Plan for You?
The Qsymia Weight Loss Plan is designed to help you get rid of that extra weight now and forever. It is not for the individual that has 10 to 20 pounds to lose. It is for the 75 million Americans who have 30, 50, or 100 pounds or more to lose, who feel they have tried everything and failed. It is for the millions more with diabetes and other medical problems whose obesity has been impossible to reverse. It is for those 100,000 or more Americans thinking about drastic actions such as gastric bypass surgery. This revolutionary weight loss plan combines a effortless, easy-to-remember food plan with the first of a new class of prescription medications that puts you in control of your hunger and cravings, perhaps for the very first time in your life. The breakthrough drug is Qsymia-a combination of Phentermine and Topiramate. These two medications have been on the market for decades. More than 30 million people have taken Phentermine and 4 million people have been treated with Topiramate around the world. The Qsymia Weight Loss Plan is new arsenal in the battle against obesity. The powerful forces that tell you when to eat and when not to eat—forces that easily overwhelm the normal control mechanisms of overweight individuals—are revealed in groundbreaking new research. For decades, even centuries, lack of willpower has been misidentified as a psychological weakness in most obese individuals. We now know that, through no fault of their own, obese individuals’ brains are actually biochemically different from those of thin people. Obese people lack the normal internal signals to stop eating. They are either missing the chemicals or are not responding normally to those chemicals, and they end up eating the wrong foods or simply too much food. In the past decade, researchers have returned to older medications and have discovered new answers to complex human health problems. The results of this research have just begun to reach the public—and the first of a new class of miracle medical drugs for obesity is here now. The Qsymia Weight Loss Plan—the breakthrough plan for long-term weight loss and maintenance, is based on a sensible food and medication plan created to decrease hunger and eliminate cravings. Just as new prescription drugs for depression have changed the face of psychiatry, so too will new anti-obesity medications change the way the medical profession treats overweight individuals. This new plan is built on the simplest, easiest-to-remember food plan. There are no complicated food preparations. In fact, there are no recipes at all! There is no shopping for unusual foods, there’s no counting calories, carbohydrates, fat, protein, or points. By understanding what makes you hungry and what makes you full, you will eat normal food and eliminate most of your hunger and cravings even before you take medication. You and your doctor are about to learn that there is a long-term solution to losing weight and keeping it off. It is never about counting anything. It is about controlling hunger and cravings— not through willpower, but by using the power of your body’s own chemicals (mimicked by Qsymia and other drugs to come) along with a simple, personalized food plan designed to eliminate a few trigger foods causing weight gain to prevent hunger and satisfy cravings.
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For the millions of overweight individuals who have or are at substantial risk for medical problems as a consequence of obesity, I believe that The Qsymia Weight Loss Plan will be the last diet book you will ever need. Follow along as more information is accumulated on Qsymia on my website at: http://www.qsymiaMD.com.
Chapter 2: Qsymia: What It is and How to Take It
Over the past couple of years, there has been a transformation in mindset on the part of doctors and their treatment of weight problems. They have found such terrible difficulties—outbreaks of diabetes, heart attacks and strokes— and they are ready to try other modes of treatment. Just look at the expanding number of gastric bypass operations in the past few years. The Food and Drug Administration has authorized two completely new medicines in 2012: Qsymia and Belviq, to help overweight and obese individuals lose weight. Qsymia is available with a doctor's prescription. Listed below are some guidelines for its use. See if it might be suitable for you. Qsymia is a class IV controlled prescription treatment that consists of Phentermine and topiramate (topiramate extended-release) that may well help some obese or overweight adults with weight-related medical problems lose weight and keep the weight off. The Phentermine (the reason for the controlled drug classification) is the appetite reducer and is comparable to the Phentermine in Adipex and Fastin, which have been in the marketplace since the middle of the 1970s. Topiramate has been available for a decade and is commonly used for seizures and headaches. So Qsymia is not really new. It's two older prescription drugs combined in a special delivery method, with four different dosing levels. Qsymia should be utilized with a reduced calorie diet and increased physical exercise. It is not known if Qsymia shifts your risk of heart difficulties, cerebrovascular accidents, or death due to heart problems or stroke. It is not known if Qsymia is safe and productive when taken with other prescribed over-the-counter or organic weight-loss items, so be watchful.
Mechanisms of Action in Qsymia
One would think that since phentermine and topiramate have been on the market for a long time, the mechanism of action would be clear. Unfortunately they are not. Both act on different areas of the brain to release substances that eventually produce feelings of fullness, reduce appetite and decrease cravings. Phentermine is a sympathomimetic amine( which means the chemical structure is similar to amphetamine). The effect of phentermine on chronic weight management is likely due to the release of catecholamines (hormones such as norepinephrine) in the brain which decrease appetite. Topiramate acts by causing fullness and disinterest in food. The interesting issue for users of Qsymia is that there appears to be a synergistic effect of these two drugs. As you will see, the doses used in the titration are very, very low, starting with 3.75 mg of phentermine (the usual starting dose of phentermine is 15 mg) and 23 mg of topiramate (the usual starting dose of topiramate is 50 mg.) The maximal dose is 15 mg of phentermine and 96 mg of topiramate. This compares to the usual and customary dose of phentermine (37.5 mg) and the dose of topiramate usually between 100 and 400 mg per day).
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How this synergistic effect comes about is unclear. Topiramate used in this preparation is timereleased and is not the same form of topiramate used clinically for headaches and seizures. Therefore, it would not be possible (as some websites have suggested) to mix small doses of generic phentermine and topiramate together and produce the same medication. Many physicians treating overweight patients (myself included) have tried this off-label use and were not able to arrive at an effective drug with low side effects. To overcome the side effects of topiramate, the manufacturer has developed a time-released topiramate and then titrated the dose, starting at 23 mg, slowly increasing it over 6 to 8 weeks to 92 mg. They have employed two treatment dose levels and two starter dose levels to help. As the topiramate is slowly increased, so is the phentermine, from 3.75 mg to 15 mg. To any dieter who has taken phentermine before, these would appear to be very, very low and probably ineffective doses. (See “How to Take Qsymia and What to Expect” for additional information). Remember, there is a synergistic effect between the two components of the drugs. Here are the four doses of Qsymia. The first number on the label is the phentermine dose and the second number is the topiramate dose. Each one of the bottles below is the supplied bottle from the manufacturer containing 30 days of capsules. Note the color change on the labels and the corresponding color change of the capsules.
Results of the Qsymia Studies
Qsymia has been tested in more than 4500 subjects over more than 2 years. Two large groups participated each for a year. Before they began the study, patients in the first study group had an average BMI of 42 and an average weight of 256 lbs. Up to a quarter of patients had been diagnosed with obesity-related medical problems such as hypertension or abnormal blood lipids, but these conditions were well-controlled on up to 1 or 2 medications. None of the patients in study #1 had diabetes and 83% were female. Before they began the study, patients in the second study group had an average BMI of 37 and an average weight of 227 lbs. They also had a least 2 obesity-related medical problems such as hypertension, diabetes, enlarged waist or abnormal blood lipids which were not as well controlled as in the patients from the first study group. 70% of patients in study #2 were female. The studies were double-blind and placebo-controlled, so neither the subject nor the physicians or the company knew who was taking the medications. The results of the studies are given below. Note there was a progressive dose-related reduction in body weight until the about the 40th week—then the weight loss seemed to level off for the next 16 weeks. The reason for this is unclear. The average weight loss in study #1 at 8 weeks was about 6% of body weight. The average starting weight in study #1 was 256 lb. so the actual average weight loss was 15 lbs at 8 weeks. The FDA’s criterion for a successful weight loss drug is a 5% weight reduction at the end of 12 months. Qsymia appears to greatly exceed that. The
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average weight reduction overall was about 13-15% of body weight after 40 weeks. This would be an average of about 38 lbs over the first 40 weeks. You need to notice there was a significant weight loss even with the lowest dose. I think this dose might be very appropriate for older patients. Losing 10% of your body weight is all that is needed to improve metabolic abnormalities such as lowering blood sugar if you are diabetic, reducing your blood pressure, and lowering your cholesterol. You don’t have to be as thin as a popular Hollywood celebrity to be healthy and reverse the metabolic abnormalities caused by obesity. You also need to remember that the subjects were given a very general low-calorie diet that reduced their caloric intake by only 500 kcal/day. Whether this was personalized and how much time was spent with each individual is unknown. One would only expect about a 1 lb per week weight loss if there were a reduction of 500 calories per day. (7 days x 500 calorie/day reduction = 3500 calorie reduction/week = 1 lb weight loss/week). No specific exercise program was prescribed. Note that in study #2 there was less weight loss. Was this due to the fact that initial weights were lower or to the fact that these subjects had related medical problems and they were taking many medications?
This observation may have significant impact on many patients who elect to use Qsymia and do not have the weight loss seen in Study #1. Please keep that in mind if your weight loss is much less than seen in study #1 there are many factors to explain it. This includes age, thyroid status and even gender. The graph below shows the average weight loss in patients from study 2 who took the study drugs for the full 56 weeks. The patients in this study had a least 2 weight-related medical complications that were poorly controlled or required at least 2 medications to control them.
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The unwanted effects are linked to the two unique medicines. Considering these prescription drugs have been on the marketplace for a prolonged period, we are familiar with what to expect. Anybody who has used Phentermine or Phendimetrazine has experience some of these side effects. These include a dry mouth, mild anxiety (similar to drinking a cup of espresso), insomnia, increased sweating, and mild constipation.
Possible Side Effects of Phentermine Taken Alone (from the phentermine literature)
Sleeplessness, nervousness, agitation, mania, mood changes, dry mouth, increase heart rate, palpitations, panic attacks, hostility, blurred eyesight, increase in eye pressure, bowel problems.
Possible Topiramate Side Effects (from the Topiramate Literature):
Numbness in fingers, feet, sleepiness, thoughts of committing suicide, depressive disorders, anxiousness, concentration and memory difficulties, mood variations, attention deficit, metabolic acidosis, tiredness, no hunger, low blood sugar, seizures if you quit drug too quickly, kidney stones, increased sweating, and warmth.
Actual Side Effects Observed in the Qsymia Studies:
In the Qsymia clinical studies, they did not discover any unexpected side effects that have not been reported in patients taking either phentermine or topiramate alone. The most common side effects reported in the Qsymia studies were paraesthesias (described as tingling in the hands, feet or face), dizziness, dysgeusia ( a metallic taste in mouth associated with carbonated drinks), insomnia, constipation and a dry mouth. Most of the side effects were dose related, meaning that the more Qsymia that is taken, the greater the side effects. In table 3 below, you will see a list of all side effects that were reported at a rate of at least 2%. It is also important to note that most side effects were minor and transient (meaning that they went away on their own), and should be acceptable for most patients. In table 3 you can see that only 1% of patients stopped the study due to the paraesthesias. In table 4 you can see that close to 20% of patients taking Qsymia 15/92
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experienced paraesthesias. Remember, the two components of Qsymia have been on the market for more than 20 years so physicians should know what to expect and the doses are much less when the drugs are given alone for their original condition.
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Women of Childbearing Age: Birth Defects
The FDA and the manufacturer are very concerned with possible birth defects, such as cleft palate, from their prior experience with topiramate. Any women of child-bearing age need to have an initial negative pregnancy test and a monthly negative pregnancy test. In addition, unless she is in menopause, has had surgical removal of the uterus or ovaries, or has a partner with a vasectomy, she must use effective birth control. If the woman does not have an IUD or progesterin implant, she will need to use TWO different forms of birth control. Women should not get pregnant taking Qsymia. Please see www.drugs.com/pro/qsymia.html for much more on this issue.
Heart Rate Rise:
Although blood pressures decreased with Qsymia, there was an average increase of heart rate of 1-2 beats per minute in patients taking Qsymia 15/92. Table 5 below shows the percentage of patients who had a heart rate elevation of 5, 10, 15 or 20 beats per minute at single time point during the year long studies. Heart rate needs to be checked by the prescribing physician, and it is important to tell your physician if you have any palpitations or feelings of a racing heartbeat while at rest during Qsymia treatment.
Who Cannot Take Qsymia
Do not take Qsymia if you are pregnant, planning to become pregnant or become pregnant during Qsymia treatment; have glaucoma; have thyroid problems (hyperthyroidism); are taking certain medications called monomaine oxidase inhibitors (MAOI’s) or have taken MAOI’s in the past 14
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days, are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in Qsymia.
Who Can Take Qsymia?
To qualify for Qsymia, you must have a BMI of at least 27, with weight-related medical problems or a BMI of 30 or more either with or without co-morbidities. The FDA defines comorbidities as a hypertension, high blood lipids, diabetes mellitus or a waistline above 105 cm. Table 5 lists the BMI’s.
You can also obtain your BMI from an on line calculator at this CDC web site: http://nhlbisupport.com/bmi/bminojs.htm. Once you have your BMI, you will need to see you physician for a prescription. Due to the risk of oral clefts in the first trimester of pregnancy, Qsymia is only available through certain home deliver pharmacies. You cannot buy Qsymia at your local pharmacy or through an online pharmacy, even with your doctor’s prescription. After a history and physical examination, your physician will fax the prescription and a form to an approved pharmacy—currently these include CVS, Walgreen’s, Express Scripts and Walmart online. You will need to provide your credit card information to the pharmacy for payment before they can mail you your medication. If you do not receive a call within a few days, you may need to call the pharmacy yourself. You will receive the medications in the mail and cannot pick them up at your local pharmacy.
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Chapter 3: How to Take Qsymia (from the FDA) and What to Expect
Once you have received your Qsymia pills, the dosing is very easy. Regardless of the dose level, Qsymia should be taken once a day in the morning without or with food. Most people take it right before breakfast. For individuals who stay up or eat late in the evening , the medication can be taken at 10 or 11 AM. You will receive two bottles—the starter dose of 3.75/23 for 14 days and the first treatment dose 7.5 /46mg for 30 days. Once the dose is established, you can order 3 months at a time. (The first number is the mg of phentermine and the second number is the mg of topiramate.) The starter dose is very, very low and the side effects are almost non-existent. A few people who are sensitive to topiramate have complained of fatigue. The phentermine component is 1/10 of the standard dose and therefore has few side effects, such as anxiety or insomnia. The second bottle in your first shipment is the “low” treating dose of 7.5/46. This is taken daily in the morning for a month or more after you have completed the 14 days on the starter dose. If you find the drug to be effective, I see no reason to increase the dose further. In my experience more than 50% of individuals find they lose weight easily without significant side effects. About 4050% of patients need a higher dose. What you should notice is a lack of hunger, a reduction in cravings, a feeling of fullness and a disinterest in food, especially from 3-4 PM to bedtime. Remember, a lot of eating is social and habitual, so you must make some effort not to end up with 3 pieces of pizza sitting in front of you. You must not pull up to the drive-thru at McDonald’s and order a #2 or #3 as usual, or go to Outback and order a 10 oz. steak with fries. Have one piece of pizza in front of you. Order the salad at the drive-thru and chicken and veggies at Outback. You won’t be hungry and you will be surprised how full you will quickly become. But you need to give the pill a chance to work. Remember it takes about 20 minutes to feel full from eating just about anything. That’s why I like starting with a cup of soup or an appetizer. The side effects of this dose are variable among individuals. Some people will notice a dry mouth, others a little bit of anxiety. More will notice a little bit of drowsiness and others may experience some mild pins and needles in their fingertips. All of these are mild symptoms and they usually disappear in 3-7 days. My observations early on during the first month of treatment with 7.5/46 dosage found more than ½ of the dieters had almost no side effects, 25% noticed a few side effects they could put up with, and about 15% noticed some side effects that bothered them but would not stop them from taking the medication. Side effects for most people disappear as the drug is taken. In addition, some effects are minimized when the drug is titrated slowly. The remaining individuals were so bothered by one side effect or another that they stopped the medication. I have treated overweight people with medications for weight loss for over 40 years. I have seen medications come and go. What I have observed is that there is no medication that is effective for weight loss that will have absolutely NO side effects. It’s just part of the trade-off. If you cannot tolerate side effects, you should not be taking these medications. After you have completed the third week of your first treatment bottle (7.5/46—the yellow bottle with the purple and yellow capsule), you will need to make an important decision with your physician: should you continue with this dose or should you escalate to the next higher dose? I believe that you should always take the lowest effective dose. If you are doing well on this dose, losing weight without much hunger or cravings, then why not continue with the same dose for another month? On my food plan (that I describe in the next chapter), most of my patients would
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have lost about 10-15 lbs at the end of 6 weeks. (Remember, it’s 6 weeks if you add the starter dose.) Everyone is different, so weight loss depends upon how old you are, whether you are a man or a women, your starting weight, and if you have medical problems, or if you are taking other medications. A man in his 20’s or 30’s that weighs 250 lbs would lose weight faster than a 60-year-old woman who is 160 lbs with diabetes. If you are happy with your progress and you need to lose more weight, then you can visit your physician again, or refill the 7.5/46 if you have been given a refill for another month. If you have not lost 3% of your body weight after three months on the 7.5/46 dose, either discontinue the medication or escalate the dose.
Escalating the Dose of Qsymia to Reach Maximal Weight Loss
If you noticed the graphs under the results section of this chapter, there was a difference in average weight loss between the 7.5/46 and the 15/92 dose of Qsymia. The former group lost about 9-10% of their body weight and the high dose lost 13-15% of their body weight. Along with this increased weight loss was a slight increase in side effects (See table 4). The 15/92 dose of Qsymia contains a full half dose of phentermine. In phentermine-sensitive patients, care should be taken to avoid caffeine and other stimulants. If you have not lost the weight you wanted to lose or if you are still hungry and are having trouble sticking to the weight loss plan, you might need to escalate the dose of Qsymia. If you are a woman of childbearing age, make sure you are taking two forms of effective birth control and that your pregnancy test is negative. On the third week of the 7.5/46, you should order you next two bottles for the next 6 weeks: the starter dose of 11.25/69 for 14 days and the treatment dose of 15/96mg. The latter dose is the highest dose of Qsymia. When the bottles arrive, take the starter dose of 11.25/69, which is in the bottle with the green label. Take that capsule every morning for 14 days. When completed, start taking the 15/92 capsule on the 15th day. For the next 30 days, take that capsule every morning. This is the highest dose capsule and it may have some of the side effects of drowsiness, anxiety, insomnia, constipation, dry mouth, tingling in the fingers, and the metallic taste in the mouth. Again, most of these side effects wear off. You can avoid caffeine and take the pill earlier if you are experiencing insomnia and anxiety. You can add caffeine if you are bothered by the drowsiness. You can add a stool softener if you are constipated. There are multiple over-thecounter mouth sprays and gels for dry mouth. These are all minor side effects, and for people with diabetes or other metabolic abnormalities, the benefits far outweigh any brief discomfort because losing weight can be lifesaving for people with obesity-related medical conditions. You can take Qsymia as long as you need to. The Qsymia label states that it is indicated for “chronic weight management.”) And up to two years of efficacy and safety data are available from the Qsymia clinical studies.
Follow along with me as I relate my personal experiences treating my overweight patients in my office in Miami, Florida at www.QsymiaMD.com.
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Qsymia Drug Interactions
Pregnancy and Breast Feeding Pregnancy Category X: Contraindicated in Breast Feeding because toprimate and phentermine are excreted in human milk. MAOs: Use of Qsymia with MAOs should be avoided. Oral Contraceptives: When Qsymia was taken along with oral contraceptives, there was a slight reduction in exposure to estrogen and a slight increase in progestin exposure. This might lead to spotting, but is not expected to decrease contraceptive efficacy since this is a primarily determined by the progestin component. However, this study did not address contraceptive efficacy. Non-Potassium-Sparing Diuretics: There was a slight increase in potassium loss with nonsparing diuretics with Qsymia.
Antiepileptic drugs
Concomitant administration of Dilantin with Topiramate decreased Topiramate concentrations by 40%.
Early Experiences with Qsymia: Jeff H., a Diabetic with Heart Disease Loses Weight on Qsymia
Jeff H., a 55-year-old marketing executive, had made it through two heart attacks and was a type 2 diabetic when he came to see me. He ran his own public relations company, a high stress job with significant travel. He was on the road every week. Married for 34 years, he had two very health-conscious sons, one in college and one in high school. Jeff’s wife suffered from a terminal and terrible disease. Jeff weighed 331 lbs and was scared to death. We began by examining a typical day of eating, both at home and on the road. Two bowls of cereal at midnight. Eating the last piece of pizza. Nibbling at the food, while clearing the table. When he was stressed—he ate. When he was happy—he ate. When he was upset or angry—he ate. He knew he was killing himself. In addition, he felt terribly guilty because of the feeling that he was being irresponsible to his wife and sons. He had no sense of portion control—he ate what was put in front of him and then sought more. His snacks were fast food drive-thru or high fat, high calorie snacks from convenience stores. A climb up a flight of stairs would leave him out of breath. He had tried every diet from Atkins to South Beach, from Jenny Craig to shakes and bars, and nothing seemed to work. He had tried every diet pill on the market without much success. His problems were not so much hunger as a lack of fullness and impulse eating. His diabetic medications made it impossible for him to lose weight. Qsymia is changing Jeff’s life. With the prescription, he was simply not able to eat the 3700 or so calories he had been consuming every day for years. We made small changes to his food choices: subs instead of burgers, soup before lunch, low-calorie snacks. Qsymia literally took away his constant hunger and cravings. His blood sugars fell to normal within three weeks of taking the medication. Today, Jeff has already lost 20 lbs and continues with a single dose of 7.5/46 at 10
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AM. Of course he has to watch his food and make better choices. However, this is much easier when he is not "hungry" all day long.
Algorithm for Dosing Qsymia from the Manufacturer and the FDA
As mention earlier, when you order Qsymia for the first time you will receive 2 weeks of the starter dose of 3.75/23 and 30 days of 7.5/46. The graph below outlines how the manufacturer believes the drug should be taken. The studies suggest that the increases in dosages were faster than this outline. The table below is the algorithm developed by the FDA and the manufacturer.
Dr. Lipman’s Alternate Faster Algorithm for Dosing Qsymia
After treating 25 patients when the drug first was available in the fall of 2012, I realized that this algorithm was too slow and expensive for many people. They were purchasing too many bottles of medications that proved to be ineffective and thus the dieting experience became much too expensive for many patients. For other patients, it took them too long to reach their effective dose level and they simply quit the medication in the middle of their diet. Others became very frustrated with the long process of ordering and receiving the medication via the current mail order system. I then put together another dosing algorithm that helps people reach their effective dose level faster and with less expense. The only problem with this system is that the rapid increase of topiramate doses sometimes does not leave some individuals with enough time to become comfortable with the side effects of the topiramate (sleepiness, moodiness, tingling in the fingers etc.) In the clinical studies the doses were increased only after 30 days leaving much more time for the dieter to acclimate to the medication. Each dieter along with his doctor really needs to decide which dosing pattern is best. Here is the rapid dosing schedule from my office. It’s based on discovering the effective dose of Qsymia over 30 days:
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You will order the 3.75/23 (14 capsules) and the 7.5/46(30 capsules) of Qsymia as your initial order. This will last you a month and give you a chance to try all 4 dose levels so you can determine your effective dose level. Week 1: Begin taking the 3.75/23 Qsymia (the lowest dose) mid - morning for 7 days. This very low dose may be appropriate for a few people sensitive to the medication or for older individuals. The vast majority of dieters will need to take higher doses. Week 2: 7.5/46 Qsymia dose: If you feel well with no side effects, but are still hungry after 7 days, then go to the 7.5/46 dose daily. Take the 7.5/46 capsules for a week. If this is working for you (your appetite and cravings are controlled and you are losing weight without significant side effects) then this is probably your effective dose. Then you should ask your doctor to order you an additional 30 or 60 days supply of the 7.5/46 Qsymia dose capsules which you can take for as long as you need. If however, you are still hungry and not losing as much weight as you think you should go to the next dose level. Week 3: 3.75/23 plus 7.5/46 Qsymia dose: Take the 3.75/23 capsules left over from the first days (the purple capsules) together with the 7.5/46 capsule in the morning. You will be taking the equivalent of the 11.25/69 dose. You should have enough 3.75/23 capsules to take for this week. At this point you will have experienced taking the third dosage equivalent of Qsymia-- the 11.25/69 dose. It’s possible that this dose will be the best for you. If it is, then have you doctor order 30 or 60 days of the 11.25/69 dosage of Qsymia. This is your effective dosage. On the other hand, if you are still hungry, you have a chance to try the strongest dosage of Qsymia in the 4th week of your Qsymia trial without having to order any more medication. Week 4: 7.5/46 x 2 capsules per day: You can try the equivalent 15/92 Qsymia dosage by taking two of the 7.5/46 capsules together at once in the mid-morning. This is same as taking one of the 15/92 capsules. You should have enough for 7 days left. At this point you have tried all of the doses of Qsymia and should have a good idea what dose of Qsymia will control your hunger and cravings with the least side effects. Whatever the effective dose is, you can take it until you have lost the weight you need to. You will need to see you physician to order the correct dosage at least once a month at which time he/she will check your blood pressure, pulse rate as well as your weight. Do no forget to have your blood chemistries done before you start the medication and after a month or two. Woman of child bearing age please be extra careful about contraception! Whether you stay on the 7.5/46, the 11.25/69 or the 15/92 Qsymia dosages will depend on your rate of weight loss and your side effects. Most people will probably want the higher dose since the rate of weight loss seen in the studies was faster with this dosage. Note the side effects were somewhat higher as well.
Frequently Asked Questions About Qsymia
16 Will Insurance Pay for Qsymia?
I have had several insurance companies pay for part or all of a Qsymia prescription. You will have to have a BMI greater than 30, probably greater than 34 or 35 (morbid obesity). Some companies will require the presence of co-morbidities. Some companies require letters from your physicians, similar to gastric bypass requirements. Other companies will not pay at all. Remember, Qsymia is new, so be patient. Once insurance companies learn about this great drug, things will change.
How Long Can I take Qsymia?
There were two phase three studies that went on for 56 weeks, and one of them was extended for an additional 52 weeks (for a total of 2 years of continuous treatment.) I tell my patients you should take the drug as long as you need it and as long as you are losing weight. The label states that you should not continue to take Qsymia if you have not lost at least 5% of your body weight after taking Qsymia after taking Qsymia 15/92 for 12 weeks.
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