is qulipta a peptide FAQ

No. Qulipta is approved to help prevent migraine episodes. The drug hasn’t been studied for treating migraine headaches while they’re happening. It is unknown whether Qulipta is effective for this use. Talk with your doctor about how to treat migraine headaches that may still occur while you’re taking Qulipta. For examples of medications that your doctor may recommend, see the “Qulipta use with other drugs” section.

It’s possible that you might lose weight while taking Qulipta. The medication can cause a decreased appetite in some people. Over time, this could lead to weight loss. However, it’s important to note that Qulipta is not FDA approved for weight loss. If you’re concerned about weight loss while taking Qulipta, talk with your doctor. They can recommend ways to maintain a weight that’s healthy for you.

Qulipta starts to work soon after you start taking it. However, it may take a few weeks before you notice fewer migraine episodes. Qulipta can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Qulipta. These lists do not include all possible side effects. For more information about the possible side effects of Qulipta, you can talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may concern or bother you. Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while taking Qulipta and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Qulipta is meant to be swallowed whole. The manufacturer does not indicate whether you can crush, split, or chew these tablets. If you have trouble swallowing Qulipta tablets whole, talk with your doctor or pharmacist. If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

If you miss a dose of Qulipta, take it as soon as possible. However, if it’s nearly time for your next dose, skip the missed dose and take your next scheduled dose as usual. You should not take extra doses to make up for a missed dose.

Qulipta is meant to be used as a long-term treatment. If you and your doctor determine that Qulipta is safe and effective for you, you’ll likely take it long term. Here are answers to some frequently asked questions about Qulipta.

Older people can likely take Qulipta. The drug is not expected to cause any specific problems in older people. However, clinical trials did not include enough people ages 65 years and older. So it is unknown whether older people respond to Qulipta differently from younger people. Older people are more likely to have decreased kidney function, which can affect dosing. If you’re age 65 years or older, your doctor will likely prescribe a low dose of Qulipta to start. If this does not cause any bothersome side effects, they may increase your dose if needed. Your doctor can answer any questions you have about taking Qulipta. Qulipta is not known to interact with alcohol. However, if you have certain side effects with Qulipta, these could be made worse by drinking alcohol. Examples of these side effects include fatigue, tiredness, and nausea. It’s important to note that drinking alcohol can trigger migraine episodes in some people. Qulipta helps prevent migraine episodes. If you drink alcohol and know that it’s one of your migraine episode triggers, you should avoid drinking it during treatment with Qulipta. If you’re not sure what triggers your migraine episodes, talk with your doctor about keeping a migraine diary. This can help you work out potential triggers to avoid. You’ll typically take Qulipta by itself to help prevent migraine episodes. However, you may still experience migraine episodes while taking this medication. If you have a migraine episode while taking Qulipta, your doctor may recommend taking certain other drugs to treat your symptoms. These drugs may include:

Allergies to Ingredients. People who are allergic to any of the following should not take Qulipta.

You will need a prescription from a health care provider. Your primary care provider, neurologist, or a headache specialist may prescribe it, and you can get it at any pharmacy. There is a copay card available from the drugmaker that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance, and what type of insurance you have. You can find out more at https://www.qulipta.com/savings-support/qulipta-complete-savings-program.

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. In particular, make sure that you discuss if you are using any of the following before taking Qulipta.

Qulipta works by blocking a substance in the brain called calcitonin gene-related peptide (CGRP), which is involved in headache pain and can make headaches last longer. By blocking CGRP, Qulipta helps prevent migraine.

Do not take Qulipta unless it has been prescribed to you by a healthcare provider. Take it as prescribed. Do not share Qulipta with other people, even if they have the same condition as you. It may harm them. Keep Qulipta out of the reach of children. Qulipta can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Qulipta affects you.

Avoid grapefruit, grapefruit juice, and any products that contain grapefruit while taking Qulipta. There are no known interactions between Qulipta and alcohol. However, alcohol can trigger migraine attacks in some people. Also, the risk of sleepiness may be increased if you drink alcohol while taking Qulipta. Consult your healthcare provider for more information and medical advice.

Qulipta should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

For preventing episodic migraine, two studies were done to see if Qulipta was effective, compared to a placebo containing no medicine. People in the studies did not know if they were getting Qulipta or the placebo. Both studies included people who had a history of migraine with or without aura for at least a year. People could take medicines to treat an acute headache (including acetaminophen, ibuprofen, or a triptan) as needed. They could not take other medicines that affected CGRP, and they could not take other medicines to prevent migraine (such as topiramate, propranolol, or amitriptyline). In these studies, people took a placebo or Qulipta at a dose of 10 milligrams, 30 milligrams, or 60 milligrams once daily for 3 months. Efficacy was measured by the change in the average number of monthly migraine days during that time frame. People in these studies had an average of about 8 migraine days per month before the study started. Most people in the studies were female (over 85%) and White (over 76%). The average age of people in the studies was 40 to 42 years. People in the studies who took Qulipta to prevent episodic migraine had fewer migraine days per month than people who took the placebo. The people who took Qulipta had 3.6 to 4.2 fewer migraine days per month over 3 months, depending on their daily dose of Qulipta. People who took the placebo had about 2.5 fewer migraine days per month. For preventing chronic migraine, a study was done to see if 60 milligrams of Qulipta once daily was effective, compared to a placebo containing no medicine. Again, people in the studies did not know if they were getting Qulipta or the placebo. Everyone in the study had a history of chronic migraine for at least a year. People in the study could take medicines to treat an acute headache (including acetaminophen, ibuprofen, or a triptan) as needed. About 11% of people in the study were allowed to use one other medicine to prevent migraine (such as topiramate, propranolol, or amitriptyline). They could not take other medicines that affected CGRP. People in this study had an average of about 19 migraine days per month before the study started. Most people in this study were female (87%) and White (60%). The average age of people in the study was 42 years. Efficacy was measured by the change in the average number of monthly migraine days during the 3 months the study lasted. The people who took 60 milligrams of Qulipta once daily to prevent chronic migraine had about 7 fewer migraine days per month, while people who took the placebo had about 5 fewer migraine days per month. Your results may differ from what was seen in clinical studies.

If you or someone else has used too much Qulipta, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

Qulipta comes as a 10-milligram, 30-milligram, and 60-milligram tablet that you take by mouth, with or without food. The dosage differs, depending on whether you are taking it to prevent episodic or chronic migraine. For episodic migraine, the recommended dosage is 10 milligrams, 30 milligrams, or 60 milligrams once daily. For chronic migraine, the recommended dosage is 60 milligrams once daily. If you have severe liver or kidney problems or you are on dialysis, you may need to avoid Qulipta or your health care provider may prescribe a lower dose. You may also need a lower dose or to avoid Qulipta if you are taking certain other medicines. For more details, see the section about interactions below.

Several medicines can affect the blood levels of Qulipta. Your body has enzymes and proteins that process and remove many types of medicines from the body. Other medicines can affect this process, which may slow down or speed up how Qulipta is broken down or cleared from your body. For example, taking Qulipta with medicines that inhibit certain enzymes or proteins could increase the amount of Qulipta in your body. This may lead to excessive or dangerous side effects. Grapefruit juice can also inhibit some of these enzymes. On the other hand, taking Qulipta with medicines that induce certain enzymes could decrease the amount of Qulipta in your body. This may cause it to work less well or not work at all. If you are taking certain medicines that inhibit or induce these enzymes or proteins, you may not be able to take Qulipta at all, or your health care provider may need to prescribe a lower dose. Ask your pharmacist or other health care provider if any of your medicines interact with Qulipta. Tell your health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. Also tell them if you eat grapefruit or drink grapefruit juice. This will help them determine if there are any interactions with Qulipta, or if you need a dosage adjustment. Do not start or stop other medicines while taking Qulipta without talking to your health care provider.

The most common side effects are nausea, constipation, tiredness, and drowsiness. Nausea is a common symptom that can happen with migraine in general. To help limit nausea, you can try simple steps, like eating bland foods, such as toast or crackers, and avoiding strong smells, such as from cooking, perfume, or smoke. Your health care provider may also prescribe medicine to help manage nausea if you commonly have nausea during a migraine. If you have constipation, there are strategies you can use to help prevent and manage it. For example, you can drink more fluids, add high-fiber fruits and vegetables to your diet, and exercise most days of the week, if possible. You could also try adjusting how you sit on the toilet to make it easier to poop, such as by leaning back, raising your feet, or squatting. Because Qulipta can cause tiredness and drowsiness, do not drive or do other activities that require alertness or coordination until you know how it affects you. While not common, a severe allergic reaction may happen with Qulipta. Stop taking Qulipta and get medical help right away if you have symptoms of an allergic reaction, such as trouble breathing or a severe rash. An allergic reaction can happen right away or days after taking the medicine. These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

While less common, the most serious side effects of Qulipta are described below, along with what to do if they happen. Severe Allergic Reactions. Qulipta may cause allergic reactions, which can be serious. Allergic reactions can occur at any time, and may occur several days after you take Qulipta. Stop taking Qulipta and get help right away if you have any of the following symptoms of a serious allergic reaction.