Juxtapid works from a different angle

What is Juxtapid?

Juxtapid is a prescription medication used along with a low-fat diet and other cholesterol-lowering therapies in adults with HoFH to help lower bad (LDL) cholesterol. People with HoFH have trouble removing unused bad cholesterol from the bloodstream because the mechanism for removing bad cholesterol from the bloodstream does not work properly.

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 decrease problems from high cholesterol, such as heart attack, stroke, death, or other health problems.

Medications such as statins rely on a well-functioning mechanism to remove cholesterol—which is why they may not be enough to help people with HoFH reach their target cholesterol level set with their doctor.

Since your liver’s mechanism to remove cholesterol isn’t working properly, Juxtapid helps limit the amount of bad cholesterol your liver makes in the first place. This way, your body has less bad cholesterol to remove from the bloodstream.

Juxtapid works from a different angle—by helping to limit the amount of bad (LDL) cholesterol your liver makes.

Select Important Safety Information

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.
In people with HoFH, our livers don’t work right and so statins may not work as well for us. With Juxtapid, our livers make less bad cholesterol, so there’s less to get rid of.
Stacee, Diagnosed with HoFH
Individual results may vary.

Potential liver problems and why they can happen

Because of the way Juxtapid works in the liver, liver problems can happen in some people. Your doctor will monitor your liver through regular blood tests.

What your doctor will do

Your doctor should perform blood tests to check your liver before you start Juxtapid, if your dose is increased, and while you are taking Juxtapid.

Blood test results will tell your doctor if certain liver enzyme levels are higher than usual. Higher enzyme levels can be an early sign of liver problems. If your tests show signs of liver problems, your doctor may reduce your dose or stop Juxtapid altogether. In Juxtapid clinical studies, elevated liver enzyme levels typically went down after either stopping or reducing the dose of Juxtapid.

Always speak with your doctor about any questions you may have about taking Juxtapid.

What you can do

Keep track of all the medications you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure to keep your doctor and your pharmacist informed. Some medications, when taken together, can overwork the liver and cause problems.

Tell your doctor if you have had liver problems, including liver problems while taking other medicines. Tell your doctor right away if you have any of the following symptoms, as these may be signs of liver problems: 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.

Limit the amount of alcohol you drink (no more than 1 drink per day). One drink can be either a 12-ounce beer, a 5-ounce glass of wine, or 1.5 ounces of liquor.

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, Instructions for Use and full Prescribing Information including Box Warning.