What is Juxtapid?
Juxtapid® (lomitapide) capsules is a prescription medicine used along with a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, in people 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 decrease 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.
Important Safety Information
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 liver problems. 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.
You should not take Juxtapid if you:
- Are pregnant, think you may be pregnant, or are planning to become pregnant
- Are taking medications known as moderate or strong CYP3A4 which may affect how your body breaks down Juxtapid (e.g. medications intended to treat bacterial, fungal or viral infections, and medications to treat depression, high blood pressure or angina)
- Have moderate to severe liver problems or active liver disease, including abnormal liver function tests
Juxtapid may cause harm to your unborn baby. Use effective birth control while taking Juxtapid. If you become pregnant while taking Juxtapid, stop taking Juxtapid and call your doctor right away.
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.
Stomach problems can also be symptoms 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 as these may be signs of liver problems.
Juxtapid makes it harder for some nutrients to get into your body. Take vitamin E and fatty acids each day while you take Juxtapid so you are sure you are getting the nutrients you need. Ask your doctor, nurse, or dietitian how to add them to your diet.
Tell your doctor if you have any side effect that bothers you or that does not go away. 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 should not drink grapefruit juice while on Juxtapid, as it 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.