Fluvastatin

ATC code

C10AA04

Therapeutic class

Statin (HMG-CoA reductase inhibitor) · HMG-CoA reductase inhibitor

Forms

oral capsule, prolonged-release tablet

Brand names

Digaril Prolib (ES) · Lescol (US) · Lescol XL (US) · Fluvastatine Sandoz (FR)

Overall confidence

medium

Regulatory sources consulted

AEMPS CIMA FT 64692: https://cima.aemps.es/cima/dochtml/ft/64692/FT_64692.html
Standard Clinical Pharmacology Reference
Flockhart Table (CYP P450 Drug Interaction Table)
AEMPS CIMA · nº registro 64692 ↗
RxNorm rxcui 41127 ↗

Approved indications

Primary hypercholesterolemia and mixed dyslipidemia, as an adjunct to diet to reduce elevated total cholesterol, LDL-C, Apo B, and triglycerides.
Secondary prevention of major adverse cardiac events in patients with coronary heart disease after percutaneous coronary intervention.

Contraindications

Absolute

Hypersensitivity to fluvastatin or to any of the excipients.
Active liver disease or unexplained persistent elevations of serum transaminases.
Pregnancy and lactation.
Myopathy.

Clinical warnings

Major warning · Musculoskeletal Effects: Cases of myopathy, myositis, and rhabdomyolysis have been reported. Patients should be advised to promptly report any unexplained muscle pain, tenderness, or weakness. — AEMPS CIMA
Major warning · Hepatic Effects: Liver function tests are recommended before initiating treatment and periodically thereafter. If transaminase levels exceed 3 times the upper limit of normal, treatment should be discontinued. — AEMPS CIMA

Drug interactions

HighCyclosporineL04AD01
Mechanism: Inhibition of hepatic uptake transporters (OATP1B1) and CYP2C9, leading to a significant increase in fluvastatin exposure.
Recommendation: Concomitant use is not recommended. If considered necessary, the dose of fluvastatin should not exceed 20 mg twice daily.
AEMPS CIMA FT 64692
ModerateFluconazoleJ02AC01
Mechanism: Potent inhibition of CYP2C9, the main metabolizing enzyme for fluvastatin, increasing fluvastatin AUC and Cmax.
Recommendation: Administer with caution. The dose of fluvastatin should not exceed 20 mg twice daily if given with fluconazole.
AEMPS CIMA FT 64692
HighGemfibrozilC10AB04
Mechanism: Pharmacodynamic interaction with increased risk of muscle toxicity (myopathy and rhabdomyolysis). Possible inhibition of fluvastatin metabolism.
Recommendation: Avoid concomitant use due to a significant increase in the risk of myopathy/rhabdomyolysis.
AEMPS CIMA FT 64692

Adverse events

Common (≥1%)

headache · insomnia · abdominal pain · nausea · dyspepsia · myalgia

Rare but serious

rhabdomyolysis · myopathy · hepatitis · pancreatitis · thrombocytopenia

Pregnancy and lactation

FDA category: X

Contraindicated during pregnancy and lactation. There is a potential for serious fetal harm. Women of childbearing potential should use effective contraception.