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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.

USE and IMPORTANT SAFETY INFORMATION

JUXTAPID (lomitapide) is a prescription medicine used along with a low-fat diet, exercise and other low-density lipoprotein (LDL) lowering medicines to reduce LDL-C in adults and children 2 years of age and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).

It is not known if JUXTAPID is safe and effective in people with kidney problems including people with end-stage kidney disease who are not on dialysis.

It is not known if JUXTAPID is safe and effective when used in children under the age of 2.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about JUXTAPID?

  • JUXTAPID is available only through certified pharmacies that are enrolled in the JUXTAPID REMS Program. Your healthcare provider must be enrolled in the program in order for you to be prescribed JUXTAPID.
  • There is a registry that collects information about the effects of taking JUXTAPID over time. Ask your healthcare provider for more information about this registry or visit www.JUXTAPID.com or call 1-877-902-4099.

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 healthcare provider should do blood tests to check your liver before you start JUXTAPID, if your dose is increased, and while you take JUXTAPID. 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.
  • JUXTAPID may cause nausea, vomiting and stomach pain, especially if you do not eat a low-fat diet. These side effects can also be symptoms of liver problems. Tell your healthcare provider right away if you have nausea; vomiting or stomach pain that gets worse, does not go away, or changes; fever; flu-like symptoms; yellowing of your eyes or skin; or are feeling more tired than usual while taking JUXTAPID.
  • 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.
  • If you are a female who can get pregnant, you should have a negative pregnancy test result before you start on JUXTAPID. Use effective birth control while taking JUXTAPID and for 2 weeks after your last dose of JUXTAPID. If you become pregnant while taking JUXTAPID, stop taking JUXTAPID and call your healthcare provider right away.

Do not take JUXTAPID if you:

  • Are taking medicines that are strong or moderate CYP34A inhibitors (for example, certain medicines used to treat bacterial, fungal, or viral infections, and medicines used to treat depression, high blood pressure or chest pain). These medicines may affect how your body breaks down JUXTAPID.
  • Drink grapefruit juice.
  • Have moderate to severe liver problems or active liver disease, including abnormal liver function tests.

Before you take JUXTAPID, tell your healthcare provider about all of your medical conditions, including if you have liver problems; have kidney problems; have intestine or bowel problems; drink alcohol; are breastfeeding or plan to breastfeed. It is not known if JUXTAPID passes into your breastmilk. You and your healthcare provider should decide if you will take JUXTAPID or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. JUXTAPID may affect the way other medicines work, and other medicines may affect how JUXTAPID works.

Other possible side effects of JUXTAPID include:

  • Problems absorbing certain nutrients. 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.
  • Gastrointestinal symptoms. Diarrhea, nausea, vomiting, and stomach pain or discomfort are very common when taking JUXTAPID. Strictly following a low-fat diet may help lower the chance of having these symptoms. Stop taking JUXTAPID and tell your healthcare provider if you have severe diarrhea, especially if you also have lightheadedness, decreased urine output, or tiredness.
  • Muscle pain, tenderness and weakness (myopathy). This can happen when JUXTAPID is taken with certain doses of simvastatin and lovastatin. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual while taking JUXTAPID.
  • Increased levels of certain blood thinners. JUXTAPID can increase the level of the blood thinner, warfarin. If you take warfarin, your healthcare provider should check your blood clotting times frequently, especially after your dose of JUXTAPID changes.
  • Liver problems caused by certain drugs. Certain medicines can cause liver problems, including isotretinoin, acetaminophen, methotrexate, tetracyclines, and tamoxifen. If you take these medicines with JUXTAPID your healthcare provider may do blood tests more often to check your liver.
  • The most common side effects of JUXTAPID in adults and children 5 years of age and older include: diarrhea, nausea, stomach (abdominal) pain, indigestion, vomiting, and increases in liver enzymes.

Tell your healthcare provider 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, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

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.

For additional information, please see the Medication Guide and Full Prescribing Information, including BOXED WARNING.

USE and IMPORTANT SAFETY INFORMATION

JUXTAPID (lomitapide) is a prescription medicine used along with a low-fat diet, exercise and other low-density lipoprotein (LDL) lowering medicines to reduce LDL-C in adults and children 2 years of age and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).

It is not known if JUXTAPID is safe and effective in people with kidney problems including people with end-stage kidney disease who are not on dialysis.

It is not known if JUXTAPID is safe and effective when used in children under the age of 2.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about JUXTAPID?

  • JUXTAPID is available only through certified pharmacies that are enrolled in the JUXTAPID REMS Program. Your healthcare provider must be enrolled in the program in order for you to be prescribed JUXTAPID.
  • There is a registry that collects information about the effects of taking JUXTAPID over time. Ask your healthcare provider for more information about this registry or visit www.JUXTAPID.com or call 1-877-902-4099.

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 healthcare provider should do blood tests to check your liver before you start JUXTAPID, if your dose is increased, and while you take JUXTAPID. 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.
  • JUXTAPID may cause nausea, vomiting and stomach pain, especially if you do not eat a low-fat diet. These side effects can also be symptoms of liver problems. Tell your healthcare provider right away if you have nausea; vomiting or stomach pain that gets worse, does not go away, or changes; fever; flu-like symptoms; yellowing of your eyes or skin; or are feeling more tired than usual while taking JUXTAPID.
  • 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.
  • If you are a female who can get pregnant, you should have a negative pregnancy test result before you start on JUXTAPID. Use effective birth control while taking JUXTAPID and for 2 weeks after your last dose of JUXTAPID. If you become pregnant while taking JUXTAPID, stop taking JUXTAPID and call your healthcare provider right away.

Do not take JUXTAPID if you:

  • Are taking medicines that are strong or moderate CYP34A inhibitors (for example, certain medicines used to treat bacterial, fungal, or viral infections, and medicines used to treat depression, high blood pressure or chest pain). These medicines may affect how your body breaks down JUXTAPID.
  • Drink grapefruit juice.
  • Have moderate to severe liver problems or active liver disease, including abnormal liver function tests.

Before you take JUXTAPID, tell your healthcare provider about all of your medical conditions, including if you have liver problems; have kidney problems; have intestine or bowel problems; drink alcohol; are breastfeeding or plan to breastfeed. It is not known if JUXTAPID passes into your breastmilk. You and your healthcare provider should decide if you will take JUXTAPID or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. JUXTAPID may affect the way other medicines work, and other medicines may affect how JUXTAPID works.

Other possible side effects of JUXTAPID include:

  • Problems absorbing certain nutrients. 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.
  • Gastrointestinal symptoms. Diarrhea, nausea, vomiting, and stomach pain or discomfort are very common when taking JUXTAPID. Strictly following a low-fat diet may help lower the chance of having these symptoms. Stop taking JUXTAPID and tell your healthcare provider if you have severe diarrhea, especially if you also have lightheadedness, decreased urine output, or tiredness.
  • Muscle pain, tenderness and weakness (myopathy). This can happen when JUXTAPID is taken with certain doses of simvastatin and lovastatin. Tell your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual while taking JUXTAPID.
  • Increased levels of certain blood thinners. JUXTAPID can increase the level of the blood thinner, warfarin. If you take warfarin, your healthcare provider should check your blood clotting times frequently, especially after your dose of JUXTAPID changes.
  • Liver problems caused by certain drugs. Certain medicines can cause liver problems, including isotretinoin, acetaminophen, methotrexate, tetracyclines, and tamoxifen. If you take these medicines with JUXTAPID your healthcare provider may do blood tests more often to check your liver.
  • The most common side effects of JUXTAPID in adults and children 5 years of age and older include: diarrhea, nausea, stomach (abdominal) pain, indigestion, vomiting, and increases in liver enzymes.

Tell your healthcare provider 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, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

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.

For additional information, please see the Medication Guide and Full Prescribing Information, including BOXED WARNING.