Names and pronunciation
(loe-mi′ta-pide) Juxtapid
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Drug reference
(loe-mi′ta-pide) Juxtapid
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Func. class.: Antilipemic
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Chem. class.: Microsomal triglyceride transfer protein (MTP) inhibitor
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ACTION: Directly binds to and in- hibits MTP, which is located in the lu- men of the endoplasmic reticulum. MTP inhibition prevents the assembly of apo-B–containing lipoproteins in enterocytes and hepatocytes resulting in reduced production of chylomi- crons and VLDL and subsequently re- duces plasma LDL-C concentrations
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USES: Homozygous familial hypercholesterolemia
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CONTRAINDICATIONS Hyper- sensitivity, pregnancy, breastfeeding
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Black Box Warning: Hepatotoxicity, re- quires an experienced clinician Precautions: Contraception require- ments, dialysis, ethanol ingestion, hepatic disease, lactase deficiency, malabsorp- tion syndrome, pancreatic insufficiency, renal impairment, requires an experi- enced clinician Black Box Warning: Available only through the Juxtapid REMS program at www.Juxtapid.com Black Box Warning: Hepatotoxicity: Monitor LFTs baseline and periodically, if L 3 × ULN, discontinue; contraindicated in moderate or severe hepatic impair- ment (based on Child-Pugh category B or C) or active hepatic disease • Monitor serum alkaline phosphatase, serum bilirubin, serum cholesterol pro- file baseline and periodically • Dialysis: Do not exceed a dose of lo- mitapide 40 mg PO • Pregnancy/breastfeeding: Do not use in pregnancy, rule out before starting treatment, if pregnancy occurs, discon tinue immediately and enroll in Global Lomitapide Pregnancy Exposure Registry 1-877-902-4099, do not breastfeed
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SIDE EFFECTS CV: Chest pain, angina pectoris, palpitations CNS: Fatigue, dizziness, headache GI: Diarrhea, nausea, dyspepsia, vomit- ing, abdominal pain, weight loss, abdom- inal distention, constipation, flatulence, gastroenteritis, liver steatosis, increased LFTs, GERD, tenesmus, bowel urgency, hepatotoxicity MS: Back pain RESP: Nasopharyngitis, nasal congestion MISC: Fever, infection
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DOSAGE AND ROUTES Adult: PO Initial: 5 mg daily; after ≥2 wk, may increase to 10 mg daily; then ≥4-wk intervals, may increase to 20 mg daily, then to 40 mg daily, max 60 mg/day
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Available forms: Capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 60 mg
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Administer: • Give with water only • Give ≥2 hr after the evening meal to lessen GI adverse effects • Avoid grapefruit and grapefruit juice • Swallow capsules whole (do not open, crush, chew) • To take supplements of vitamin E 400 IU, linoleic acid 200 mg, ALA 210 mg, EPA 110 mg, DHA 80 mg; take ≥2 hr of product • Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture
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Assess:
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Evaluate: • Therapeutic response: Reduction in LDL cholesterol
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Patient and caregiver information: • To notify provider of chest pain, change in heartbeat, flulike symptoms, severe/ persistent nausea/vomiting/abdominal pain/diarrhea, dry skin/mouth/eyes, in- creased thirst, dizziness, confusion • To notify provider of dark urine, fa- tigue, lack of appetite, light-colored stools, yellow skin/eyes • To continue with a low-fat diet and to take product ≥2 hr after evening meal to prevent GI upset • To not consume more than 1 alcoholic drink per day • Allergic reaction: Rash, itching; red, swollen, blistered, peeling skin; wheez- ing; tightness in the chest or throat; trouble breathing, swallowing, talking; swelling of the mouth, face, lips, tongue, throat • Not to double dose if missed, take at next scheduled time • Pregnancy/breastfeeding: To notify provider if pregnancy is planned or sus- pected, if using hormonal contraceptives or if breastfeeding. Additional contracep- tive measures are required HIGH ALERT
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PHARMACOKINETICS Onset and duration unknown, peak 6 hr; half-life 40 hr Interactions Increase: lomitapide effect—CYP3A4 inhibitors Increase: myopathy—lovastatin, simva statin, decrease dose of statin Increase: substrate level—P-gp sub- strates, decrease dose of substrate Increase: hepatotoxicity—acetamino- phen, monitor LFTs Increase: bleeding risk—warfarin, mon- itor INR Decrease: lomitapide effect—bile acid sequestrants Drug/Herb Increase: lomitapide effect—Ginkgo biloba Drug/Food Do not use with grapefruit juice NURSING CONSIDERATIONS
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