Ezallor Sprinkle
(Rosuvastatin)Ezallor Sprinkle Prescribing Information
Indications and Usage (1) 02/2025
EZALLOR SPRINKLE is indicated:
• To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor.
• As an adjunct to diet to:
o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
o Reduce LDL-C and slow the progression of atherosclerosis in adults.
o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
• As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).
• As an adjunct to diet for the treatment of adults with:
o Primary dysbetalipoproteinemia.
o Hypertriglyceridemia.
- Take orally with or without food, at any time of day. (2.1)
- Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating EZALLOR SPRINKLE, and adjust dosage if necessary. (2.1)
- Adults:Recommended dosage range is 5 to 40 mg once daily. (2.1)
- Pediatric Patients with HeFH:Recommended dosage range is 5 to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 to 20 mg once daily for patients aged 10 years and older. (2.2)
- Pediatric Patients with HoFH:Recommended dosage is 20 mg once daily for patients aged 7 years and older. (2.2)
- Asian Patients:Initiate at 5 mg once daily. Consider risks and benefits of treatment if not adequately controlled at doses up to 20 mg once daily. (2.4)
- Patients with Severe Renal Impairment (not on hemodialysis):Initiate at 5 mg once daily; do not exceed 10 mg once daily. (2.5)
- See full prescribing information for EZALLOR SPRINKLE dosage and administration modifications due to drug interactions. (2.6)
Hard gelatin capsules:
- 5 mg: Size “3” pink cap/off white body, imprinted axially with “984” on cap and body in black ink filled with yellow colored granules.
- 10 mg: Size “3” purple cap/off white body, imprinted axially with “985” on cap and body in black ink filled with yellow colored granules.
- 20 mg: Size “1” blue cap/off white body, imprinted axially with “986” on cap and body in black ink filled with yellow colored granules.
- 40 mg: Size “0el” green cap/white body, imprinted axially with “987” on cap and body in black ink filled with yellow colored granules.
- Pregnancy: May cause fetal harm. (8.1)
- Lactation: Breastfeeding not recommended during treatment with EZALLOR SPRINKLE. (8.2)
EZALLOR SPRINKLE is contraindicated in patients with:
- Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)].
- Hypersensitivity to rosuvastatin or any excipients in EZALLOR SPRINKLE. Hypersensitivity reactions, including rash, pruritus, urticaria, and angioedema, have been reported with EZALLOR SPRINKLE [see Adverse Reactions (6.1)].