Lomitapide
Lomitapide (sold as Juxtapid capsules) is a cholesterol-lowering medicine used with diet and other treatments for homozygous familial hypercholesterolemia (HoFH), a rare inherited form of very high LDL cholesterol.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Lomitapide (Juxtapid) is a specialist medicine for homozygous familial hypercholesterolemia (HoFH), a rare inherited form of very high LDL cholesterol, used with a low-fat diet and other cholesterol treatments since about 2013; it blocks a protein called MTP in the liver and intestine, so fewer fat-carrying particles are made and LDL falls. Diarrhea, nausea, indigestion and belly pain are very common and can be severe enough to cause dehydration. The thing to watch is your liver, since lomitapide carries a boxed warning for liver toxicity (it can raise liver enzymes and build fat in the liver), so it comes only through the restricted Juxtapid REMS program and every liver test counts.
Clinical pearls
- Never combine it with grapefruit juice or drugs that block its breakdown, such as clarithromycin, fluconazole, diltiazem or verapamil.
- Take the daily vitamin E and essential fatty acid supplements, since lomitapide cuts absorption of fat-soluble vitamins and fatty acids.
- Lomitapide raises simvastatin and lovastatin levels, so those statin doses are capped to limit the risk of muscle injury.
- Vomiting or diarrhea can stop birth control pills working, so ask about backup contraception, since lomitapide can harm an unborn baby.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Juxtapid can cause liver damage. It can raise liver enzymes and increase fat in the liver. Over time, that fat buildup may be a risk factor for serious liver disease such as steatohepatitis and cirrhosis (scarring).
In trials, about 1 in 3 adults and about 1 in 7 children had liver enzyme rises of at least three times the upper limit of normal. Your doctor will check your liver tests before and during treatment, adjust the dose if they rise, and stop the medicine if there is significant liver toxicity.
Because of this risk, Juxtapid is available only through a restricted program (the Juxtapid REMS Program). It should be prescribed only for people with HoFH.
Patient information guide A plain-language walkthrough of Lomitapide, written from its FDA label.
What Lomitapide is used for
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Lomitapide is used for one rare inherited condition.
- Juxtapid capsules are used with a low-fat diet and other lipid-lowering treatments (including LDL apheresis where available) to lower LDL cholesterol, total cholesterol, apolipoprotein B and non-HDL cholesterol in homozygous familial hypercholesterolemia (HoFH).
- Not established for high cholesterol without HoFH, including heterozygous familial hypercholesterolemia.
- Its effect on heart disease and death has not been determined.
How Lomitapide works
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Lomitapide binds to and blocks microsomal triglyceride transfer protein (MTP), found inside liver and intestinal cells. This protein is needed to assemble particles that carry fat and cholesterol, including chylomicrons and VLDL.
With less VLDL made, less LDL cholesterol ends up in the blood.
Lomitapide dosage
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Juxtapid is a capsule taken by mouth. Your prescriber chooses the dose and adjusts it based on liver tests, tolerability and cholesterol response.
- Follow a low-fat diet as directed, which also helps limit stomach side effects.
- Take the vitamin E and essential fatty acid supplements your prescriber recommends.
- Avoid grapefruit juice.
- Follow your prescriber’s and the label’s directions for timing and missed doses.
Dosing details from the FDA-approved label
From the Lomitapide prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Before treatment, measure ALT, AST, alkaline phosphatase, and total bilirubin; obtain a negative pregnancy test in females of reproductive potential; initiate a low-fat diet supplying <20% of energy from fat or less than 30 grams of fat, whichever is less. ( 2.1 ). The recommended initiation dosage is ( 2.2 ): 2 mg for patients aged 2 to 15 years. 5 mg for patients aged 16 years and older. Follow the titration schedule presented in Table 1 according to the patient's age. Select the dosage based on the recommended target LDL-C, safety, and tolerability ( 2.2 ). For pediatric patients, if a patient crosses over into the next age category, escalate the dose of JUXTAPID up to the maximum recommended dose applicable for the new age group ( 2.2 ). Measure transaminases prior to any dosage increase. If transaminases are abnormal, reduce or withhold dosing of JUXTAPID and monitor as recommended ( 5.1 ). Table 1: Recommended JUXTAPID Dosage and Titration Schedule Age group (years) JUXTAPID Dose 2 mg 5 mg 10 mg 20 mg 40 mg 60 mg W:Weeks; ---: Not a recommended dosage; 1 Maximum recommended dosage. 2 to 10 W 0 to 8 W 9 to 12 W 13 to 16 W 17 and beyond 1 --- --- 11 to 15 W 0 to 4 W 5 to 8 W 9 to 12 W 13 to 16 17 and beyond 1 --- 16 to 17 --- W 0 to 4 W 5 to 8 W 9 to 12 13 and beyond 1 --- 18 and older --- W 0 to 2 W 3 to 6 W 7 to 10 W 11 to 14 15 and beyond 1 Due to reduced absorption of fat-soluble vitamins/fatty acids: Take daily vitamin E [400 international units (IU) for patients aged 9 years and older, or 200 IU for patients aged 2 to 8 years old] and linoleic acid (200 mg), alpha-linolenic acid (210 mg), eicosapentaenoic acid (110 mg), and docosahexaenoic acid (80 mg) supplements ( 2.2 ). Take orally once daily, whole, with water and without food, at least 2 hours after evening meal. If unable to swallow intact capsule, patients may sprinkle capsule contents onto a tablespoon of apple sauce or mashed banana ( 2.3 ). Refer to the Full PI for dosage modifications based on elevated transaminases ( 2.5 ); in patients with end-stage renal disease on dialysis require dose adjustment ( 2.6 ), and in patients with baseline mild hepatic impairment require dose adjustment ( 2.7 ).
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Lomitapide side effects
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Stomach and bowel effects are the most common, and they affect most people who take it.
Common side effects
- Diarrhea
- Nausea
- Indigestion (dyspepsia)
- Vomiting
- Abdominal pain
- Weight loss
- Raised liver tests (ALT/AST)
- Decreased appetite (in children)
When to get medical help
- Call your doctor right away if you have severe diarrhea, or signs of dehydration such as lightheadedness, less urine or unusual tiredness. Stop the medicine and contact your provider.
- Tell your doctor promptly about any signs of liver problems, since lomitapide can raise liver enzymes and cause fat buildup in the liver.
- Call your doctor if you become pregnant or think you might be. The medicine must be stopped.
- If you take birth control pills and have vomiting or diarrhea, contact your provider about backup contraception.
- Report chronic stomach or bowel problems, since they may raise the risk of vitamin and fatty acid deficiencies.
Call your provider for severe diarrhea, signs of dehydration (lightheadedness, less urine, tiredness) or liver concerns.
Lomitapide warnings and precautions
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- Liver toxicity (boxed warning): raised liver enzymes and liver fat; can lead to steatohepatitis and cirrhosis. Regular testing is required.
- Restricted program: available only through the Juxtapid REMS Program with certified prescribers and pharmacies.
- Pregnancy: may cause fetal harm; stop if pregnancy is detected.
- Severe diarrhea: can cause dehydration and may affect absorption of other oral medicines.
- Nutrient absorption: may reduce fat-soluble vitamins and fatty acids, so daily supplements are needed.
Lomitapide interactions
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Several medicines and foods change how much lomitapide is in your body or how other drugs behave.
- Strong or moderate CYP3A4 inhibitors: not allowed, as they can greatly raise lomitapide levels.
- Grapefruit juice: avoid for the same reason.
- Weak CYP3A4 inhibitors: dose is reduced by half.
- Warfarin: levels and INR rise; regular INR checks needed.
- Simvastatin and lovastatin: levels rise, increasing muscle injury risk, so doses are limited or reduced.
- P-glycoprotein substrates (such as digoxin): may be absorbed more, so a lower dose may be needed.
- Bile acid sequestrants: separate by at least 4 hours.
- Oral contraceptives: may work less well if vomiting or diarrhea occurs.
Interactions listed in the FDA-approved label
From the Lomitapide prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inhibitors (such as boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, tipranavir/ritonavir, voriconazole): A strong CYP3A4 inhibitor has been shown to increase lomitapide exposure approximately 27-fold. Concomitant use with lomitapide is contraindicated.
- Moderate CYP3A4 inhibitors (such as amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil): Use has not been studied, but lomitapide exposure will likely increase significantly in the presence of these inhibitors. Concomitant use with lomitapide is contraindicated.
- Grapefruit juice: CYP3A4 inhibitors increase exposure to lomitapide; the label lists grapefruit juice with this interaction. Patients must avoid grapefruit juice while taking JUXTAPID.
- Weak CYP3A4 inhibitors (such as alprazolam, amiodarone, amlodipine, atorvastatin, bicalutamide, cilostazol, cimetidine, cyclosporine, fluoxetine, fluvoxamine, ginkgo, goldenseal, isoniazid, lapatinib, nilotinib, pazopanib, ranitidine, ranolazine, ticagrelor, zileuton): Weak CYP3A4 inhibitors can increase lomitapide exposure approximately 2-fold. Decrease the JUXTAPID dose by half; careful titration may then be considered based on LDL-C response and safety/tolerability to a maximum recommended dosage of 30 mg daily, except when coadministered with oral contraceptives, in which case the maximum is 40 mg daily.
- Warfarin: Lomitapide increases plasma concentrations of both R(+)-warfarin and S(-)-warfarin by approximately 30% and increased the INR 22%. Undergo regular monitoring of INR, particularly after any changes in lomitapide dosage; adjust the warfarin dose as clinically indicated.
- Simvastatin: Lomitapide approximately doubles the exposure of simvastatin; the risk of myopathy, including rhabdomyolysis, is dose related. Reduce the simvastatin dose by 50% when initiating JUXTAPID; limit simvastatin to 20 mg daily (or 40 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity).
- Lovastatin: Interaction has not been studied, but JUXTAPID may increase the exposure of lovastatin. Consider reducing the lovastatin dose when initiating JUXTAPID.
- P-glycoprotein (P-gp) substrates (such as aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, imatinib, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, saxagliptin, sirolimus, sitagliptin, talinolol, tolvaptan, topotecan): Lomitapide is a P-gp inhibitor and may increase the absorption of P-gp substrates. Consider dose reduction of the P-gp substrate when used concomitantly with lomitapide.
- Bile acid sequestrants: JUXTAPID has not been tested for interaction with bile acid sequestrants; they can interfere with the absorption of oral medications. Separate administration of JUXTAPID and bile acid sequestrants by at least 4 hours.
Read the label’s full interactions text
7 DRUG INTERACTIONS CYP3A4 inhibitors increase exposure to lomitapide. Strong and moderate CYP3A4 inhibitors are contraindicated with JUXTAPID. Patients must avoid grapefruit juice ( 4 , 5.6 , 7.1 ). When administered with weak CYP3A4 inhibitors, the dose of JUXTAPID should be decreased by half. The dosage of JUXTAPID may then be up-titrated to a maximum recommended dosage of 30 mg daily ( 2.3 , 5.6 , 7.2 ). Warfarin: Lomitapide increases plasma concentrations of warfarin. Monitor international normalized ratio (INR) regularly, especially with JUXTAPID dose adjustment ( 5.8 , 7.3 ). Simvastatin and lovastatin exposure increase with JUXTAPID. Limit dose when co-administered with JUXTAPID due to myopathy risk ( 5.7 , 7.4 ). P-glycoprotein (P-gp) Substrates: Consider dose reduction of P-gp substrate because of possible increased absorption with JUXTAPID ( 7.5 ). Bile Acid Sequestrants: Separate JUXTAPID dosing by at least 4 hours ( 7.6 ). 7.1 Moderate and Strong CYP3A4 Inhibitors A strong CYP3A4 inhibitor has been shown to increase lomitapide exposure approximately 27-fold [see Clinical Pharmacology (12.3) ] . Concomitant use of strong CYP3A4 inhibitors (such as boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, tipranavir/ritonavir, voriconazole) with lomitapide is contraindicated. Concomitant use of moderate CYP3A4 inhibitors (such as amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil) has not been studied, but concomitant use with lomitapide is contraindicated since lomitapide exposure will likely increase significantly in the presence of these inhibitors. Patients must avoid grapefruit juice while taking JUXTAPID [see Contraindications (4) , Warnings and Precautions (5.6) , and Clinical Pharmacology (12.3) ] .
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Lomitapide
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- Do not take if pregnant; a negative pregnancy test and effective contraception are needed for women who could become pregnant.
- Not for people with moderate or severe liver impairment or active liver disease.
- Not recommended while breastfeeding.
- Children 2 years and older with HoFH have been studied.
- Older adults: dosing should be cautious.
- End-stage kidney disease on dialysis: exposure was higher in a study.
- Chronic bowel or pancreatic disease may raise the risk of nutrient deficiencies.
Lomitapide overdose
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There is no specific treatment for lomitapide overdose. Care is symptom-based and supportive, and liver tests should be monitored. Dialysis is unlikely to help because the drug is highly protein-bound.
What Lomitapide does in the body
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Lomitapide lowers LDL cholesterol by reducing VLDL production. It also increases fat in the liver. At concentrations 23 times the peak level from the maximum recommended dose, it did not prolong the QT interval (a heart rhythm measure) to any clinically relevant extent.
How your body processes Lomitapide
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Only about 7% of an oral dose reaches the bloodstream, with peak levels around 6 hours after a dose. The liver breaks it down extensively, mainly through the CYP3A4 enzyme. It leaves the body through urine (as metabolites) and feces. Its half-life is about 40 hours. Levels are higher in people with moderate liver impairment.
How to store Lomitapide
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F). protect from moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Lomitapide
168 supplements and herbal products have documented interactions with Lomitapide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 124
- Minor · 38
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Lomitapide: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Lomitapide — the kind of thing our pharmacy team would talk through with you at the counter.
What is lomitapide for?
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How should I take it?
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What side effects should I expect?
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Why do I need so many blood tests?
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Can I take other medicines with it?
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What if I might become pregnant?
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Is Lomitapide available over the counter?
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When was Lomitapide first available?
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Who makes Lomitapide?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Lomitapide on HelloPharmacist
Lomitapide forms and strengths (how it comes)
Lomitapide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Juxtapid is used with a low-fat diet and other lipid-lowering treatments to lower LDL cholesterol in people with HoFH.
- Juxtapid is not established for high cholesterol without HoFH.
- Juxtapid is taken by mouth as a capsule.
- Juxtapid is given with a low-fat diet plus daily vitamin E and essential fatty acid supplements.
- Juxtapid requires liver tests before starting and regularly during treatment.
- Juxtapid is dispensed only through the Juxtapid REMS Program.
Lomitapide on the U.S. market: products, makers and brands
How Lomitapide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
2 companies list 7 Lomitapide product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2012. Brand names on the directory include Juxtapid; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Compare Lomitapide products
A representative set of FDA-listed product records for Lomitapide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 10 mg | Oral | Amryt Pharmaceuticals DAC | NDA | View NDC → |
| 20 mg | Oral | Amryt Pharmaceuticals DAC | NDA | View NDC → |
| 2 mg | Oral | Chiesi USA, Inc. | NDA | View NDC → |
| 5 mg | Oral | Chiesi USA, Inc. | NDA | View NDC → |
| 10 mg | Oral | Chiesi USA, Inc. | NDA | View NDC → |
| 20 mg | Oral | Chiesi USA, Inc. | NDA | View NDC → |
| 30 mg | Oral | Chiesi USA, Inc. | NDA | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Lomitapide NDCs →
Lomitapide side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Lomitapide — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Lomitapide in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Lomitapide FDA approval history
How Lomitapide went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Lomitapide recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Lomitapide recalls since July 2021.
✅No Lomitapide recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1364479 1 dose form · 7 strengths
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Dose form (SCDF) Oral Capsule RxCUI 1364483In current FDA listings
Look up RxCUI 1364479 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Lomitapide supply and shortage status
Whether Lomitapide is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Lomitapide brand names
Lomitapide is sold under one brand name in the FDA directory — Juxtapid. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Lomitapide: manufacturers and labelers
2 companies list Lomitapide products with the FDA. By number of product records, the largest are Chiesi USA, Inc., Amryt Pharmaceuticals DAC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Lomitapide drug class (RxNorm)
Lomitapide belongs to the Microsomal Triglyceride Transfer Protein Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Lomitapide page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Chiesi USA, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →