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Is Juxtapid FDA-approved as a high cholesterol treatment?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Jan 27, 2023.

Official answer

by Drugs.com

Yes, Juxtapid is an oral treatment approved by the FDA to treat a rare, inherited cholesterol disorder known as Homozygous Familial Hypercholesterolemia (HoFH). In HoFH, patients cannot remove unwanted LDL (“bad cholesterol”) from their body, and often die from a heart attack before the age of thirty.

Juxtapid is used with diet and other lipid-lowering treatments to reduce:

  • LDL (“bad”) cholesterol. In patients with HoFH, LDL-C levels may be over 400 mg/dL
  • total cholesterol
  • apolipoprotein B, a protein that carries “bad” cholesterol in the blood
  • non-high-density lipoprotein cholesterol (non-HDL-C).

How well does Juxtapid work?

Juxtapid was evaluated in a 26-week clinical trial of 29 patients taking other cholesterol-lowering medicines and also taking Juxtapid up to a maximum dose of 60 mg. LDL cholesterol fell by an average of 40% and total cholesterol fell by 36% during the first 26 weeks. These results were maintained over the next 12 months.

It is not known if this medicine can decrease serious health problems from high cholesterol, such as heart attack, stroke, or death. It is also not known if this medicine can be used in people with high cholesterol who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).

How do I take Juxtapid?

Juxtapid (generic name: lomitapide) is given as an oral capsule you take once in the evening on an empty stomach (at least 2 hours after dinner or evening snack). Don’t take Juxtapid with food, but DO take each dose with a glass of water.

Do not drink grapefruit juice or eat grapefruit while taking Juxtapid. Also, do not have more than 1 alcoholic drink per day, as this may cause liver damage.

Your doctor will also recommend that you take nutritional supplements to replace the essential fatty acids and vitamin E that are not absorbed by your body while taking Juxtapid. Take the supplements in the morning with food. Do not take them at night with Juxtapid as they do contain limited amounts of fat.

Juxtapid can cause harm to your unborn baby. Do not use this medicine if you are pregnant, think you are pregnant, or trying to get pregnant. Talk to your doctor about the best method for birth control before you start treatment.

Take all medicines exactly as prescribed by your doctor.

Common side effects with Juxtapid

The most common side effects (that occur in at least 28 out of every 100 people) are:

  • diarrhea
  • nausea
  • vomiting
  • dyspepsia (heartburn)
  • abdominal (stomach) pain

When you first start treatment, you will start at a lower dose to help minimize the risk for stomach side effects.

Learn more: Juxtapid Warnings and Side Effects (in detail)

Related questions

What drug classification is Juxtapid?

Juxtapid is classified as a microsomal triglyceride transfer protein (MTP) inhibitor. It binds directly to the MTP protein, preventing the assembly of apo-B containing lipoproteins in the intestine and liver cells.

This mechanism blocks the synthesis of chylomicrons and very low density lipoprotein (VLDL), which are triglyceride-rich lipoproteins. Blocking the synthesis of VLDL leads to reduced levels of plasma LDL (“bad cholesterol”) in Homozygous Familial Hypercholesterolemia (HoFH).

How do I get Juxtapid and how much does it cost?

Juxtapid is mailed to you from a specialty pharmacy, it is not available from your local pharmacy. Juxtapid costs about $53,471 per month for 28 capsules, but most people do not pay this price.

It is considered a specialty medicine and is only available through certified pharmacies enrolled in a special program called the Juxtapid REMS (Risk Evaluation and Mitigation Strategy) Program. Your doctor must also be enrolled in the program in order to prescribe Juxtapid.

The specialty pharmacy will deliver Juxtapid through the mail to you, answer any questions, and help you get the needed nutritional supplements for therapy.

Juxtapid costs about $53,471 per month for 28 capsules, a month's supply. It is available as a 5 mg, 10 mg and 20 mg oral capsule. This price can vary depending on which pharmacy you visit, where you live, any discounts and if you have private or government-sponsored insurance.

Does Juxtapid have a copay card?

Yes, Amryt Pharma offers a Copay Card for Juxtapid if you qualify. Contact the manufacturer at 1-855-898-2743 to learn more about the Juxtapid Compass Support Team and financial assistance.

The Juxtapid Copay Card Program can help to cover the costs of copayments or co-insurance at 100%, up to the program maximum, if you are eligible.

Is there a generic for Juxtapid?

At this time, Juxtapid is only available as a brand name drug. A generic version is not yet available in the U.S.

This is not all the information you need to know about Juxtapid (lomitapide) for safe and effective use and does not take the place of your doctor’s directions. Review the full xxx information and discuss this information and any questions you have with your doctor or other health care provider.

References

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