fluvastatin sodium: clinical use

Prescribing considerations

• Continue appropriate dietary and lifestyle measures during treatment.
• Assess muscle-toxicity risk factors, including renal impairment, hypothyroidism, personal or family muscle disorders, previous statin or fibrate toxicity, heavy alcohol use and interacting medicines.
• Use caution with previous liver disease, substantial alcohol intake or severe renal impairment.
• Paediatric evidence is limited to heterozygous familial hypercholesterolaemia in children aged at least nine years; long-term developmental and outcome data are limited.

Contraindications and cautions

• Hypersensitivity to fluvastatin or a formulation excipient
• Active liver disease
• Unexplained persistent elevation of serum transaminases
• Pregnancy
• Breastfeeding

Monitoring

• Check liver function before treatment, following relevant treatment changes and periodically; discontinue for persistent marked transaminase elevation.
• Routine creatine kinase monitoring is unnecessary in asymptomatic patients. Check it before treatment in patients with important risk factors and when muscle symptoms develop.
• Monitor glucose clinically and biochemically in people at increased risk of diabetes.
• With warfarin or another coumarin, monitor coagulation when fluvastatin is started, stopped or otherwise changed.

Clinical pharmacology

Fluvastatin is a synthetic, hepatically acting competitive HMG-CoA reductase inhibitor. It is highly protein-bound, predominantly metabolised in the liver through multiple CYP pathways including CYP2C9, and mainly eliminated through the faeces.

Formulation and product differences

• Hard capsules are immediate-release formulations.
• Prolonged-release tablets absorb more slowly and retain fluvastatin in the body longer than capsules.
• Both selected formulations may be taken with or without food and should be swallowed whole.

Capsule

Route: Oral

Strengths: 20 mg

Modified-release tablet

Route: Oral

Strengths: 80 mg