Indication and Important Safety Information
Juxtapid® (lomitapide) capsules is a prescription medicine used along with diet and other lipid lowering treatments, including low-density lipoprotein (LDL) apheresis where available, in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL (“bad”) cholesterol, total cholesterol, a protein that carries bad cholesterol in the blood (apolipoprotein B), and non-high-density lipoprotein cholesterol (non-HDL-C).
Studies have not been conducted to tell us whether Juxtapid can help prevent problems from high cholesterol, such as heart attack, stroke, death, or other health problems. Studies have also not been conducted to tell us whether Juxtapid is safe for use in people with high cholesterol but who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).
Juxtapid is available only through certified pharmacies that are enrolled in the Juxtapid REMS Program. Your doctor must be enrolled and certified in the program in order to prescribe Juxtapid.
Juxtapid may cause serious side effects, including:
- Juxtapid can cause liver problems such as increased liver enzymes or increased fat in the liver. For this reason, your doctor should do blood tests to check your liver before you start Juxtapid and while you are taking Juxtapid (especially if your dose is increased). If your tests show signs of liver problems, your doctor may lower your dose of Juxtapid or stop it altogether.
- You should tell your doctor if you have had liver problems in the past, including liver problems while taking other medicines.
- Stomach problems can also be a symptom of liver problems. Tell your doctor right away if you have nausea; vomiting or stomach pain that gets worse, does not go away, or changes; fever; yellowing of your eyes or skin; feeling more tired than usual; or having flu-like symptoms while taking Juxtapid because these may be signs of liver problems.
- Do not drink more than 1 alcoholic drink per day while taking Juxtapid.
Harm to your unborn baby:
- Do not take Juxtapid if you are pregnant, think you may be pregnant, or are planning to become pregnant.
- You should have a negative pregnancy test result before you can start on Juxtapid. Use effective birth control while taking Juxtapid. If you become pregnant while taking Juxtapid, stop taking Juxtapid and call your doctor right away.
You should not take Juxtapid if you:
- Are taking medications known as moderate or strong CYP3A4 inhibitors (for example, certain medications used to treat bacterial, fungal, or viral infections, as well as certain medications used to treat depression, high blood pressure, or angina). These medications may affect how your body breaks down Juxtapid.
- Have moderate to severe liver problems or active liver disease, including abnormal liver function tests.
Other possible side effects of Juxtapid:
- The most common side effects of Juxtapid are stomach problems including diarrhea, nausea, vomiting, cramps/pain, indigestion, and/or gas. You may be able to reduce your chance of stomach problems by following an eating plan consisting of less than 20% of calories from fat.
- Juxtapid makes it harder for some fat-soluble nutrients, such as vitamin E and fatty acids, to get into your body. Take supplements that contain fat-soluble vitamins each day while you take Juxtapid. Ask your doctor, nurse, or dietitian how to take them.
Tell your doctor if you have any side effect that bothers you or that does not go away. Stop taking Juxtapid and tell your doctor if you have severe diarrhea, especially if you also have lightheadedness, decreased urine output, or tiredness. These are not all the possible side effects of Juxtapid. For more information, speak with your doctor or pharmacist.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Juxtapid may affect the way other medicines work, and other medicines may affect how Juxtapid works.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
This is the most important information about Juxtapid. For more detailed information, Please see the Medication Guide and full Prescribing Information including Box Warning.