EZALLOR SPRINKLE

EZALLOR SPRINKLE — rosuvastatin calcium capsule
Sun Pharmaceutical Industries, Inc.

1 INDICATIONS AND USAGE

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

1.1 Hypertriglyceridemia

EZALLOR Sprinkle is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.

1.2 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)


EZALLOR Sprinkle is indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).

1.3 Adult Patients with Homozygous Familial Hypercholesterolemia

EZALLOR Sprinkle is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.

1.4 Limitations of Use

EZALLOR Sprinkle has not been studied in Fredrickson Type I and V dyslipidemias.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

The dose range for EZALLOR Sprinkle in adults is 5 mg to 40 mg orally once daily. The usual starting dose is 10 mg to 20 mg once daily. The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily. The maximum EZALLOR Sprinkle dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose [see Warnings and Precautions (5.1)].

EZALLOR Sprinkle can be administered as a single dose at any time of day, with or without food. Swallow capsules whole. Do not crush or chew. For patients who cannot swallow capsules, the capsules can be opened for administration [see Dosage and Administration (2.5)].

When initiating EZALLOR Sprinkle therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate EZALLOR Sprinkle starting dose should first be utilized, and only then titrated according to the patient’s response and individualized goal of therapy.

After initiation or upon titration of EZALLOR Sprinkle, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.2 Dosing in Asian Patients

In Asian patients, consider initiation of EZALLOR Sprinkle therapy with 5 mg once daily due to increased rosuvastatin plasma concentrations. The increased systemic exposure should be taken into consideration when treating Asian patients not adequately controlled at doses up to 20 mg once daily [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

2.3 Use with Concomitant Therapy

Patients taking cyclosporine and darolutamide

The dose of EZALLOR Sprinkle should not exceed 5 mg once daily [see Warnings and Precautions (5.1), Drug Interactions (7.1), Drug Interactions (7.4) and Clinical Pharmacology (12.3)].

Patients taking gemfibrozil

Avoid concomitant use of EZALLOR Sprinkle with gemfibrozil. If concomitant use cannot be avoided, initiate EZALLOR Sprinkle at 5 mg once daily. The dose of EZALLOR Sprinkle should not exceed 10 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.5) and Clinical Pharmacology (12.3)].

Patients taking regorafenib

Concomitant use of EZALLOR Sprinkle and regorafenib, the dose of EZALLOR Sprinkle should not exceed 10 mg once daily. [see Warnings and Precautions (5.1), Drug Interactions (7.5) and Clinical Pharmacology (12.3)].

Patients taking atazanavir and ritonavir, lopinavir and ritonavir, simeprevir or c ombination of dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir and glecaprevir/pibrentasvir

Initiate EZALLOR Sprinkle therapy with 5 mg once daily. The dose of EZALLOR Sprinkle should not exceed 10 mg once daily [see Warnings and Precautions (5.1), Drug Interactions (7.3) and Clinical Pharmacology (12.3)].

2.4 Dosing in Patients with Severe Renal Impairment

For patients with severe renal impairment (CLcr < 30 mL/min/1.73 m2) not on hemodialysis, dosing of EZALLOR Sprinkle should be started at 5 mg once daily and not exceed 10 mg once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.5 Administration Options


EZALLOR Sprinkle capsule should be swallowed whole. For patients unable to swallow an intact capsule, alternative administration options are available.

Oral Administration

Directions for use with soft food (applesauce or pudding)

For patients with swallowing difficulty, EZALLOR Sprinkle capsule can be opened and contents can be sprinkled over soft food. The contents of the capsules should be swallowed along with a small amount (teaspoonful) of soft food (such as applesauce or chocolate/vanilla flavored pudding). The drug/food mixture should be swallowed within 60 minutes and not be stored for future use. If it is not used in its entirety, the remaining contents should be discarded immediately.

Nasogastric Tube (≥16 French) Administration

For patients who have a nasogastric tube in place, the EZALLOR Sprinkle capsule can be opened and the intact granules emptied into a 60 mL catheter tipped syringe and add 40 mL of water. Replace the plunger and shake the syringe vigorously for 15 seconds. The granules in EZALLOR Sprinkle capsule may start dissolving which is acceptable. Attach the syringe to a nasogastric tube (≥16-French) and deliver the contents of the syringe through the nasogastric tube into the stomach. After administering the granules, the nasogastric tube should be flushed with 20 mL of additional water. The mixture must be used immediately after preparation and not be stored for future use. If it is not used in its entirety, the remaining mixture should be discarded immediately. Use with any other liquids is not recommended.

3 DOSAGE FORMS AND STRENGTHS

5 mg: Hard gelatin capsule, 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: Hard gelatin capsule, 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: Hard gelatin capsule, 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: Hard gelatin capsule, Size “0el” green cap/white body, imprinted axially with “987” on cap and body in black ink filled with yellow colored granules.

4 CONTRAINDICATIONS

EZALLOR Sprinkle is contraindicated in the following conditions:

  • Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin [see Adverse Reactions (6.1)].
  • Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [see Warnings and Precautions (5.3)].
  • Pregnancy [see Use in Specific Populations (8.1, 8.3)].
  • Lactation. Limited data indicate that rosuvastatin is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require EZALLOR Sprinkle treatment should not breastfeed their infants [see Use in Specific Populations (8.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Skeletal Muscle Effects

Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including rosuvastatin . These risks can occur at any dose level, but are increased at the highest dose (40 mg).

EZALLOR Sprinkle should be prescribed with caution in patients with predisposing factors for myopathy (e.g., age ≥ 65 years, inadequately treated hypothyroidism, renal impairment).

The risk of myopathy during treatment with EZALLOR Sprinkle may be increased with concurrent administration of gemfibrozil, some other lipid-lowering therapies (other fibrates or niacin), cyclosporine, darolutamide, regorafenib, atazanavir/ritonavir, lopinavir/ritonavir, simeprevir or combination of sofosbuvir/velpatasvir/voxilaprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, all combinations with ledipasvir (including ledipasvir/sofosbuvir) [see Dosage and Administration (2) and Drug Interactions (7)]. Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors, including rosuvastatin, coadministered with colchicine, and caution should be exercised when prescribing EZALLOR Sprinkle with colchicine [see Drug Interactions (7.9)].

EZALLOR Sprinkle therapy should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. EZALLOR Sprinkle therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).

All patients should be advised to promptly report to their physician unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing EZALLOR Sprinkle.

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