JUXTAPID 10 MG — DIN 02420376

What is JUXTAPID?

JUXTAPID 10 MG contains LOMITAPIDE (LOMITAPIDE MESYLATE) : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02420376, held by CHIESI FARMACEUTICI S.P.A., supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 23-Feb-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is JUXTAPID used for?

JUXTAPID® (lomitapide capsules) is indicated as an adjunct to a low-fat diet and other lipid-lowering drugs, with or without LDL apheresis, to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolemia (HoFH). Due to its benefit-risk profile, the prescribing of JUXTAPID should be limited to physicians experienced in the diagnosis and treatment of familial hypercholesterolemia. The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Treatment with JUXTAPID (lomitapide) should be initiated and monitored by a physician experienced in the treatment of familial hypercholesterolemia. JUXTAPID should be used as an adjunct to a low-fat diet and other lipid-lowering drugs, in the treatment of HoFH. Appropriate control of the fat content in the diet is essential to reduce the occurrence and severity of gastrointestinal side effects associated with the use of JUXTAPID. Patients should follow a diet supplying less than 20% of energy from fat prior to initiating JUXTAPID treatment, and should continue this diet during treatment. Dietary counseling should be provided. To reduce the risk of developing a fat-soluble nutrient deficiency due to JUXTAPID's mechanism of action in the small intestine, patients treated with JUXTAPID should take daily dietary supplements that contain 400 international units vitamin E and at least 200 mg linoleic acid, 210 mg alpha linoleic acid (ALA), 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA). These dietary supplements should not be taken within a two hour window of JUXTAPID administration. For example, it may be convenient for dietary supplements to be taken in the morning. JUXTAPID should be taken without food (see 4.4 Administration). JUXTAPID administration with food increases systemic exposure to lomitapide (see 10.3 Pharmacokinetics). JUXTAPID administration with food may also increase the incidence of gastrointestinal adverse events, and so should be avoided. The dose of JUXTAPID should be escalated gradually to minimize the incidence and severity of gastrointestinal side effects. The recommended starting dose is 5 mg once daily. After 2 weeks, the dose may be increased, based on acceptable safety and tolerability, to 10 mg, and then, at a minimum of 4-week intervals, to 20 mg, 40 mg, and the maximum recommended dose of 60 mg as described in Table 1. Modify dosing for patients taking concomitant CYP 3A4 inhibitors, renal impairment, or baseline hepatic impairment. During the first year, measure liver-related tests, especially ALT and/or AST, prior to each increase in dose or monthly, whichever occurs first. JUXTAPID should be taken once a day with a glass of water, without food, at least 2 hours after the evening meal. Patients should swallow JUXTAPID capsules whole. Capsules should not be opened, crushed dissolved, or chewed. If a dose of JUXTAPID is missed, the normal dose should be taken at the usual time the next day. If dosing is interrupted for more than a week, the healthcare provider should be contacted before restarting treatment.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Patients with moderate or severe hepatic impairment, including those with unexplained persistent abnormal liver function tests. Patients with a known significant, chronic bowel disease, such as inflammatory bowel disease or malabsorption. Concomitant administration of >20 mg daily simvastatin (40 mg daily is allowed for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity). Concomitant use of JUXTAPID (lomitapide) with strong or moderate CYP 3A4 inhibitors. Pregnancy. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency, or glucose-galactose malabsorption. Patients who are hypersensitive to JUXTAPID, or to any ingredient in the formulation or component of the container.

Warnings and precautions

Concomitant Use of CYP 3A4 Inhibitors: JUXTAPID is contraindicated with concomitant use of strong and moderate CYP 3A4 inhibitors. If treatment with strong or moderate CYP 3A4 inhibitors is unavoidable, JUXTAPID should be stopped during the course of treatment. Grapefruit juice must be omitted from the diet during treatment with JUXTAPID. Concomitant Use with HMG-CoA Reductase Inhibitors: JUXTAPID increases plasma concentrations of statins. The risk of myopathy, including rhabdomyolysis, is dose related with use of statins. Lomitapide approximately doubles the exposure to simvastatin. It is recommended to reduce the dose of simvastatin by 50% when initiating JUXTAPID. While taking JUXTAPID, limit simvastatin dosage 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). Risk of Severe Diarrhea and Dehydration: Use of lomitapide has been associated with severe diarrhea and dehydration. Caution should be exercised in vulnerable patients (e.g., geriatric patients, or patients taking diuretics) due to the subsequent risk of hypovolemia and hypotension. Hepatic Steatosis: Consistent with the mechanism of action of JUXTAPID, most treated patients exhibited increases in hepatic triglyceride content, with or without concomitant increases in hepatic transaminases. The long term consequences of hepatic steatosis associated with JUXTAPID treatment are unknown, including risk of progression to steatohepatitis, fibrosis and cirrhosis. Use with Hepatotoxic Agents: Caution should be exercised when JUXTAPID is co-administered with agents known to have a potential for hepatotoxicity. Alcohol Consumption: JUXTAPID should be used with caution in patients who consume alcohol because of its potential to induce or exacerbate hepatic injury, including steatosis. Limitation of alcohol use is warranted with JUXTAPID treatment, e.g., a limit of no more than one drink daily. Elevations in Hepatic Transaminases: Elevations in alanine and/or aspartate transaminases (ALT and/or AST) associated with JUXTAPID treatment are generally dose-dependent, asymptomatic, and reversible. Liver enzyme changes occur most often during dose escalation, but may occur at any time during therapy. Patients should be advised that JUXTAPID may cause birth defects based on animal studies. Before initiating treatment in women of child-bearing potential, the absence of pregnancy should be confirmed, appropriate advice on effective methods of contraception provided, and effective contraception initiated. Patients taking estrogen-based oral contraceptives should be advised about possible loss of effectiveness due to diarrhea and/or vomiting. If the patient becomes pregnant while taking JUXTAPID, the patient should immediately stop taking JUXTAPID and contact their health professional.