Lomitapide Dosage

This dosage information may not include all the information needed to use Lomitapide safely and effectively. See additional information for Lomitapide.

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Hyperlipidemia

Lomitapide should be taken with a glass of water on an empty stomach at least 2 hours after the evening meal.

Initial dose: 5 mg orally once daily. Dose should be escalated gradually based on acceptable safety and tolerability.

Dosing escalation: 5 mg orally daily for at least 2 weeks; then 10 mg orally daily for at least 4 weeks; then 20 mg orally daily for at least 4 weeks, then 40 mg orally daily for at least 4 weeks; then 60 mg orally daily

Maintenance dose: Should be individualized, taking into account the goal of therapy and the response to treatment

Maximum dose: 60 mg orally daily

Usual Adult Dose for Homozygous Familial Hypercholesterolemia

Lomitapide should be taken with a glass of water on an empty stomach at least 2 hours after the evening meal.

Initial dose: 5 mg orally once daily. Dose should be escalated gradually based on acceptable safety and tolerability.

Dosing escalation: 5 mg orally daily for at least 2 weeks; then 10 mg orally daily for at least 4 weeks; then 20 mg orally daily for at least 4 weeks, then 40 mg orally daily for at least 4 weeks; then 60 mg orally daily

Maintenance dose: Should be individualized, taking into account the goal of therapy and the response to treatment

Maximum dose: 60 mg orally daily

Renal Dose Adjustments

Mild, moderate, and severe renal impairment, including end-stage renal disease not yet receiving dialysis: Data not available (It is possible that patients with renal impairment who are not yet receiving dialysis may experience increases in lomitapide exposure exceeding 50%)

End-stage renal disease receiving dialysis: Maximum dose should not exceed 40 mg daily since lomitapide exposure in these patients increased approximately 50%.

Liver Dose Adjustments

Mild liver impairment (Child-Pugh A): Maximum dose is 40 mg daily (lomitapide exposure is increased approximately 50% in these patients)

Moderate or severe hepatic impairment (Child-Pugh B or C) or active liver disease including unexplained persistent abnormal liver function tests: Contraindicated

Dose Adjustments

Transaminases should be measured prior to any increase in dose.

Weak CYP450 3A4 inhibitors (such as alprazolam, amiodarone, amlodipine, atorvastatin, bicalutamide, cilostazol, cimetidine, cyclosporine, fluoxetine, fluvoxamine, ginkgo, goldenseal, isoniazid, lapatinib, nilotinib, oral contraceptives, pazopanib, ranitidine, ranolazine, tipranavir/ritonavir, ticagrelor, zileuton) increase the exposure of lomitapide approximately 2-fold. Therefore, lomitapide dosage should not exceed 30 mg daily when it is used concomitantly with these inhibitors.

Patients should follow a low-fat diet supplying less than 20% of energy from fat and the dosage of lomitapide should be increased gradually to reduce the risk of gastrointestinal adverse events.

Dialysis

Maximum dose should not exceed 40 mg daily since lomitapide exposure in these patients increased approximately 50%.

Other Comments

Before initiating therapy with lomitapide:
-Measure transaminases (ALT, AST), alkaline phosphatase, and total bilirubin.
-Obtain a negative pregnancy test in females of reproductive potential.
-Initiate a low-fat diet supplying less than 20% of energy from fat.

Lomitapide should be taken with a glass of water on an empty stomach at least 2 hours after the evening meal. Food may increase gastrointestinal adverse reactions.

Lomitapide should be swallowed whole; not opened, crushed, dissolved, or chewed.

Patients treated with lomitapide should take daily supplements that contain 400 IU vitamin E and at least 200 mg linoleic acid, 210 mg ALA, 110 mg EPA, and 80 mg DHA.

Patients should be advised not to drink more than one alcoholic beverage daily because alcohol may increase levels of hepatic fat and induce or exacerbate liver injury.

Grapefruit juice must be eliminated from the diet while being treated with lomitapide.

The safety and effectiveness of lomitapide have not been established in patients with hypercholesterolemia who do not have HoFH.

Patients may enroll in a voluntary registration program to monitor long term effects at www.JUXTAPID.com.

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