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 Dosage:

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, darolutamide: max 5mg. Concomitant regorafenib: max 10mg. Concomitant atazanavir/ritonavir, lopinavir/ritonavir, simeprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir: initially 5mg; max 10mg. Concomitant gemfibrozil (if unavoidable): initially 5mg; max 10mg. Severe renal impairment (CrCl <30mL/min) not on hemodialysis: initially 5mg; max 10mg.

Children Dosage:

<18yrs: not established.

EZALLOR SPRINKLE Contraindications:

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

EZALLOR SPRINKLE Warnings/Precautions:

Discontinue if myopathy or elevated CK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Immune-mediated necrotizing myopathy; monitor. 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 (≥65yrs). Advise females of reproductive potential to use effective contraception during treatment.

EZALLOR SPRINKLE Classification:

HMG-CoA reductase inhibitor.

EZALLOR SPRINKLE Interactions:

See Adults. Avoid gemfibrozil. Increased risk of myopathy with niacin (≥1g/day), fenofibrates, cyclosporine, darolutamide, regorafenib, atazanavir/ritonavir, lopinavir/ritonavir, simeprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, colchicine; use caution. Concomitant with sofosbuvir/velpatasvir/voxilaprevir, ledipasvir/sofosbuvir: not recommended. Monitor INR 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.

Generic Drug Availability:

NO

How Supplied:

Caps 5mg, 10mg, 20mg, 40mg—30, 90