Lomitapide Observational Worldwide Evaluation Registry (LOWER)

LOWER is a “registry” that will gather information on the long-term safety and effectiveness of Juxtapid® (lomitapide) capsules in patients taking Juxtapid as part of usual medical care. A registry is an observational study where routine data is collected as part of your usual doctor visits. There are no study-required procedures or tests and no study medication is provided. All decisions about your health and treatment will be made by your regular doctor and other healthcare providers. The registry will collect information concerning your health, medications, and other therapies, as well as procedures or tests you have had performed. The study period for data collection will be a minimum of 10 years.     

If you stop taking Juxtapid for any reason, this does not affect your participation in the registry. Your health information will still be collected as part of your usual care for a minimum of 10 years. Before you join LOWER, you will be asked to read and sign an informed consent form. This form will describe the study in more detail and also discusses how privacy of participants will be protected and how medical information is kept confidential. 

Who can participate in LOWER?

If the healthcare provider that prescribed you Juxtapid is participating in LOWER you may be eligible to participate. Your decision to participate in this study is voluntary. Full detailed information about the study is described in the informed consent form.

To participate in LOWER, you must be 18 years of age or older and meet 1 of the following 2 criteria:

  1. Starting treatment with Juxtapid at the time of registry enrollment, or
  2. Started treatment with Juxtapid within 36 months before joining LOWER

Learn more about LOWER

To learn more about LOWER, talk to your healthcare provider who prescribed Juxtapid for you or call our Registry Call Center at our toll-free number, 1-877-902-4099.

Pregnancy exposure registry

The purpose of this registry is to collect information on pregnancies and babies whose mothers were treated with Juxtapid during pregnancy or within 30 days prior to the first day of their last menstrual period before a positive pregnancy test. Juxtapid should not be used in women who are pregnant, possibly pregnant or are planning to become pregnant because it may harm the unborn baby. Women who are capable of becoming pregnant should have a negative pregnancy test before starting Juxtapid and should use an effective method of birth control during therapy with Juxtapid. However, any woman who becomes pregnant while taking Juxtapid will be asked to enroll into this pregnancy exposure registry. If you become pregnant while taking Juxtapid, stop taking Juxtapid and call your doctor right away. You are also encouraged to volunteer to participate in the pregnancy exposure registry.

Learn more about the pregnancy exposure registry

To learn more about the pregnancy exposure registry, call the Registry Call Center at our toll-free number, 1-877-902-4099.

Compass | 1-85-JUXTAPID

Juxtapid may cause liver problems.

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

  • 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.