Rosuvastatin

ROSUVASTATIN- rosuvastatin tablet, film coated
Aphena Pharma Solutions — Tennessee, LLC

1 INDICATIONS AND USAGE

Rosuvastatin tablets are indicated:

  • To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor.
  • As an adjunct to diet to:
    • Reduce LDL-C in adults with primary hyperlipidemia.
    • Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.
    • 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:
    • Primary dysbetalipoproteinemia.
    • Hypertriglyceridemia.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration Information

  • Administer rosuvastatin tablets orally as a single dose at any time of day, with or without food. The tablet should be swallowed whole.
  • Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets and adjust the dosage if necessary.
  • If a dose is missed, advise patients not take an extra dose. Resume treatment with the next dose.

2.2 Recommended Dosage in Adult Patients

  • The dosage range for rosuvastatin tablets is 5 mg to 40 mg orally once daily.
  • The recommended dose of rosuvastatin tablets depends on a patient’s indication for usage, LDL-C, and individual risk for cardiovascular events.

2.3 Recommended Dosage in Pediatric Patients

Dosage in Pediatric Patients 8 Years of Age and Older with HeFH

The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10 years and older.

Dosage in Pediatric Patients 7 Years of Age and Older with HoFH

The recommended dosage is 20 mg orally once daily.

2.4 Dosing in Asian Patients

Initiate rosuvastatin tablets at 5 mg once daily due to increased rosuvastatin plasma concentrations. Consider the risks and benefits of rosuvastatin tablets when treating Asian patients not adequately controlled at doses up to 20 mg once daily [see Warnings and Precautions (5.1), Use in Specific Populations (8.8), and Clinical Pharmacology (12.3)].

2.5 Recommended Dosage in Patients with Renal Impairment

In patients with severe renal impairment (CL cr less than 30 mL/min/1.73 m 2) not on hemodialysis, the recommended starting dosage is 5 mg once daily and should not exceed 10 mg once daily [see Warnings and Precautions (5.1)and Use in Specific Populations (8.6)] .

There are no dosage adjustment recommendations for patients with mild and moderate renal impairment.

2.6 Dosage and Administration Modifications Due to Drug Interactions

Rosuvastatin tablets Dosage Modifications Due to Drug Interactions

Table 1 displays dosage modifications for rosuvastatin tablets due to drug interactions [see Warnings and Precautions (5.1)and Drug Interactions (7.1)].

Table 1: Rosuvastatin tablets Dosage Modifications Due to Drug Interactions
Concomitantly Used Drug Rosuvastatin tablets Dosage Modifications
Cyclosporine Do not exceed 5 mg once daily.
Teriflunomide Do not exceed 10 mg once daily.
Enasidenib Do not exceed 10 mg once daily.
Capmatinib Do not exceed 10 mg once daily.
Fostamatinib Do not exceed 20 mg once daily.
Febuxostat Do not exceed 20 mg once daily.
Gemfibrozil Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 10 mg once daily.
Tafamidis Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 20 mg once daily.
Antiviral Medications
  • Sofbuvir/velpatasvir/voxilaprevir
  • Ledipasvir/sofosbuvir
Concomitant use not recommended.
  • Simeprevir
  • Dasabuvir/ombitasvir/paritaprevir/ritonavir
  • Elbasvir/Grazoprevir
  • Sofosbuvir/Velpatasvir
  • Glecaprevir/Pibrentasvir
  • Atazanavir/Ritonavir
  • Lopinavir/Ritonavir
Initiate at 5 mg once daily. Do not exceed 10 mg once daily.
Darolutamide Do not exceed 5 mg once daily.
Regorafenib Do not exceed 10 mg once daily.

Rosuvastatin tablets Administration Modifications Due to Drug Interactions

When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, administer Rosuvastatin at least 2 hours before the antacid [see Drug Interactions (7.2)] .

3 DOSAGE FORMS AND STRENGTHS

Rosuvastatin tablets, USP:

  • 5 mg of rosuvastatin: pink colored, oval shaped, biconvex, film coated tablets, debossed with SG on one side and 116 other side.
  • 10 mg of rosuvastatin: pink colored, round, biconvex, film coated tablets, debossed with SG on one side and 117 other side.
  • 20 mg of rosuvastatin: pink colored, round, biconvex, film coated tablets, debossed with SG on one side and 118 other side.
  • 40 mg of rosuvastatin: pink colored, oval shaped, biconvex, film coated tablets debossed with SG on one side and 119 other side.

4 CONTRAINDICATIONS

Rosuvastatin tablets are contraindicated in the following conditions:

  • Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)] .
  • Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets [see Adverse Reactions (6.1)] .

5 WARNINGS AND PRECAUTIONS

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