• Hyperlipoproteinemias

Hyperlipoproteinemias:

Indications for EZALLOR SPRINKLE:

Adjunct to diet in hypertriglyceridemia. Adjunct to diet in primary dysbetalipoproteinemia (Type III hyperlipoproteinemia). Adjunct to other lipid-lowering treatments (or if these treatments are unavailable), in homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB.

Limitations of Use:

Not studied in Fredrickson Type I and V dyslipidemias.

Adult:

Swallow whole. If unable to swallow caps, can open and sprinkle contents onto applesauce; consume immediately. May be given via NG tube. Take once daily. Dose range 5–40mg. HoFH: initially 20mg. All others: usual starting dose 10–20mg. Use max 40mg dose only if 20mg is insufficient. Asian patients: consider 5mg initially (see full labeling). Concomitant cyclosporine: max 5mg. Concomitant simeprevir, atazanavir/ritonavir, or lopinavir/ritonavir: initially 5mg; max 10mg. Concomitant gemfibrozil: avoid; if needed, max 10mg. Severe renal impairment (CrCl <30mL/min) not on hemodialysis: initially 5mg; max 10mg.

Children:

<18yrs: not established.

Contraindications:

Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy. Nursing mothers.

Warnings/Precautions:

Discontinue if myopathy or elevated CK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Monitor liver function before starting therapy and as clinically indicated. Interrupt therapy if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs; do not restart if alternate etiology not found. History of liver disease or heavy alcohol ingestion. Severe renal impairment. Hypothyroidism (if inadequately treated). Asian patients. Elderly. Advise females of reproductive potential to use effective contraception during treatment.

Pharmacologic Class:

HMG-CoA reductase inhibitor.

Interactions:

See Adults. Avoid gemfibrozil. Increased risk of myopathy with niacin (≥1g/day), fibrates, inhibitors of certain transporter proteins including OATP1B1 and BCRP (eg, cyclosporine, simeprevir, atazanavir/ritonavir, lopinavir/ritonavir), colchicine; use caution. Monitor with anticoagulants. Caution with drugs that decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine). Separate dosing of antacids (give ≥2hrs after rosuvastatin).

Adverse Reactions:

Headache, myalgia, abdominal pain, asthenia, nausea; myopathy, rhabdomyolysis with renal dysfunction, elevated liver enzymes, proteinuria and hematuria (consider dose reduction if persistent), increased HbA1c and fasting serum glucose, rare: cognitive impairment, hepatic failure, immune-mediated necrotizing myopathy.

Generic Availability:

NO

How Supplied:

Caps 5mg, 10mg, 20mg, 40mg—30, 90