TM Owner Chiesi USA, Inc.
Juxtapid 20mg Capsule
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Indications & Clinical Uses
- Juxtapid 20 mg capsules contain lomitapide, a microsomal triglyceride transfer protein (MTP) inhibitor.
- Juxtapid is approved in the United States to reduce LDL cholesterol, total cholesterol, apolipoprotein B and non-HDL cholesterol in people with homozygous familial hypercholesterolaemia (HoFH), as an add-on to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where that is available.
- It was first approved in December 2012 for adults, and the indication was extended in March 2026 to children aged 2 years and over, with lower maximum doses in younger age groups.
- Juxtapid is still marketed; the current US label (revised February 2026) is held by Chiesi USA, Inc., which took the product over from Amryt and Aegerion.
- It is not for other forms of raised cholesterol, and an effect on heart attacks or strokes has not been established.
- Juxtapid is supplied only through a restricted programme, the JUXTAPID REMS Program.
Side Effects
- Juxtapid carries a BOXED WARNING for hepatotoxicity.
- It raises liver transaminases and causes fat to build up in the liver (hepatic steatosis), which may progress to steatohepatitis and cirrhosis; 34 percent of adults in the pivotal trial had transaminases at least three times the upper limit of normal, and liver fat rose by a median of about 6 percent in adults and 4 percent in children, with unknown long-term consequences.
- The commonest side effects are gastrointestinal: diarrhoea, nausea, indigestion, vomiting, abdominal pain or discomfort, constipation, flatulence, weight loss and reduced appetite.
- These are worse when you eat more fat than the prescribed diet allows.
- Chest pain, influenza-like symptoms and back pain are also reported.
- Get urgent medical advice for yellowing of the skin or eyes, dark urine, pain under the right ribs, persistent nausea or vomiting, unusual tiredness, fever or loss of appetite.
Precautions & Warnings
- Liver tests (ALT, AST, bilirubin and alkaline phosphatase) are required before starting Juxtapid, before every dose increase, and regularly during treatment; the dose must be reduced or stopped if enzymes rise beyond the label limits.
- In the United States Juxtapid is dispensed only through the JUXTAPID REMS Program, with certified prescribers, enrolled patients and certified pharmacies.
- You must follow a diet supplying less than 20 percent of calories from fat and take daily supplements of vitamin E and the essential fatty acids linoleic acid, alpha-linolenic acid, EPA and DHA, because Juxtapid reduces absorption of fat-soluble nutrients.
- Juxtapid is contraindicated in pregnancy, in moderate or severe hepatic impairment or active liver disease including unexplained persistent abnormal liver tests, and with moderate or strong CYP3A4 inhibitors.
- Women who can become pregnant need a negative pregnancy test before starting and effective contraception throughout.
- Avoid alcohol.
- Capsules are swallowed whole and must not be opened, crushed or chewed.
Avoid Interactions
- Blood levels of Juxtapid, and therefore the risk of liver injury, are increased by CYP3A4 inhibitors.
- Moderate and strong inhibitors such as ketoconazole, itraconazole, posaconazole, clarithromycin, erythromycin, telithromycin, ritonavir and other HIV protease inhibitors, verapamil, diltiazem and fluconazole are contraindicated with Juxtapid, and weak inhibitors including atorvastatin, oral contraceptives, alprazolam and ranitidine require a dose limit.
- Grapefruit and grapefruit juice must be avoided completely.
- Juxtapid roughly doubles simvastatin exposure, so the simvastatin dose must be capped, and it increases the effect of warfarin, so INR must be monitored closely whenever the Juxtapid dose changes.
- Alcohol and other liver-toxic medicines add to the risk of fatty liver and liver injury.
- Bile-acid sequestrants such as colesevelam or colestyramine should be taken at least 4 hours apart from Juxtapid so they do not reduce its absorption.
- Tell your healthcare provider about every medicine, herbal remedy and supplement before starting.
References
Frequently Asked Questions
Juxtapid (lomitapide) lowers LDL cholesterol in people with homozygous familial hypercholesterolaemia, a rare inherited condition. It is added to a low-fat diet and other cholesterol-lowering treatments, including apheresis. Approved for adults in 2012, the indication was extended in March 2026 to children aged 2 years and over.
Juxtapid (lomitapide) capsules are swallowed whole once a day with a glass of water, at least 2 hours after the evening meal. Do not open, crush or chew them. Adults start at 5 mg daily and the dose is raised in steps, guided by liver tests, to a maximum of 60 mg.
Juxtapid (lomitapide) most often causes diarrhoea, nausea, indigestion, vomiting, abdominal pain and weight loss, which get worse if you eat too much fat. It carries a boxed warning for liver toxicity: raised liver enzymes and fat build-up in the liver. Report yellow skin or eyes, dark urine or right-sided pain urgently.
Avoid grapefruit and grapefruit juice completely, and avoid moderate or strong CYP3A4 inhibitors such as ketoconazole, itraconazole, clarithromycin and ritonavir, which are contraindicated with Juxtapid (lomitapide). Avoid alcohol, which adds to liver damage. Keep fat below 20 percent of daily calories and separate bile-acid binders by 4 hours.
Liver tests (ALT, AST, bilirubin and alkaline phosphatase) are done before you start Juxtapid (lomitapide), before every dose increase, and regularly afterwards. The dose is reduced or stopped if enzymes rise too far. In the United States these checks are enforced through the JUXTAPID REMS Program using certified prescribers and pharmacies.
No. Juxtapid (lomitapide) is contraindicated in pregnancy because it may harm the unborn baby. You need a negative pregnancy test before starting and effective contraception throughout treatment. Tell your prescriber at once if you become pregnant. Daily vitamin E and essential fatty acid supplements are also required during treatment.
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