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Frequently Asked Questions About Juxtapid

Juxtapid was approved by the FDA in 2012 for adults with HoFH (homozygous familial hypercholesterolemia) to be used along with a low-fat eating plan and other cholesterol-lowering therapies. Many people who started Juxtapid years ago continue to take it because it helps manage their condition.

Juxtapid is prescribed to lower LDL (“bad”) cholesterol, total cholesterol, apolipoprotein B (a protein that carries bad cholesterol in the blood), and non–HDL cholesterol. It can be used along with diet, other cholesterol-lowering medications, and LDL apheresis (if available).

Juxtapid has not been studied to determine if it lowers the risk of heart attack, stroke, or other serious health problems. It has also not been studied in people with other types of high cholesterol, such as heterozygous familial hypercholesterolemia (HeFH).

At this time, there is no cure for HoFH. Because Juxtapid works by decreasing the amount of cholesterol your body produces, you need to take it regularly to maintain the effect. Learn more about taking Juxtapid here

Juxtapid is not available at regular retail pharmacies. It is available only through certified pharmacies that are enrolled in the Juxtapid REMS (Risk Evaluation and Mitigation Strategy) Program. Juxtapid is delivered directly to your home by Accredo, our specialty pharmacy partner.

The REMS Program also includes a registry to track how patients respond to treatment. For more information, talk to your doctor or call 1-877-902-4099.

In the beginning, you’ll speak with each member of the patient support team to make sure that your insurance and Juxtapid questions are answered, you’re on track with your eating plan, and your prescription is filled properly. Ongoing support will be personalized based on your needs. Learn more about the support program here.

Nutritional supplements are part of your Juxtapid treatment plan. Because Juxtapid can affect how your body absorbs certain nutrients, your doctor will likely recommend you take supplements with essential fatty acids and vitamin E.

You should take one of each supplement in the morning with food. Avoid taking them at night with Juxtapid, since they contain a small amount of fat. Learn more about what to expect with Juxtapid.

The low-fat eating plan recommended with Juxtapid is different from a traditional heart-healthy diet—because all fats count. While taking Juxtapid, you should aim for less than 20% of your daily calories from fat. This may help reduce the chance of stomach problems, like diarrhea or bloating. Your Patient Education Liaison (PEL)* can help you personalize the plan to fit your lifestyle and make it easier to follow.

*PELs are employed by Chiesi USA, Inc.
Because of the way Juxtapid works in the liver, it can cause liver problems, such as increased liver enzymes or increased fat in the liver. Your doctor should perform blood tests to check your liver before you start Juxtapid, if your dose is increased, and while you take Juxtapid, to ensure that you aren’t showing elevated enzyme levels, which can be an early sign of liver problems. If you do show signs of liver problems, your doctor will either lower your dose or stop Juxtapid altogether. Learn more about what to expect with Juxtapid.
In clinical studies, elevated liver enzymes typically went back down after patients either reduced the dose or stopped taking Juxtapid. Your doctor will help interpret your liver test results and guide you on the best next steps based on your health and treatment goals.

Important Safety Information

INDICATION

Juxtapid 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 who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).

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 Boxed Warning for the risk of liver toxicity.

Important Safety Information

INDICATION

Juxtapid 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 who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).

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 Boxed Warning for the risk of liver toxicity.