Pitavastatin

ATC code

C10AA08

Therapeutic class

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

Forms

oral tablet

Brand names

Livalo (US) · Alipza (MX) · Livazo (ES)

Overall confidence

medium

Regulatory sources consulted

Reduction of elevated total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) in adults, adolescents, and children aged 6 years and older with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia, and mixed (combined) dyslipidemia, when response to diet and other non-pharmacological measures is inadequate.

Hypersensitivity to the active substance or to any of the excipients.
Severe hepatic impairment, active liver disease, or persistent unexplained elevations of serum transaminases (>3x ULN).
Myopathy.
Concomitant treatment with cyclosporine.
Pregnancy, lactation or women of childbearing potential not using adequate contraceptive measures.

Major warning · Muscle effects: Cases of myalgia, myopathy, and, rarely, rhabdomyolysis have been reported. Patients should be advised to promptly report any unexplained muscle pain, tenderness, or weakness. — EMA SPC

HighCyclosporineL04AD01
Mechanism: Inhibition of the OATP1B1 transporter, resulting in a 4.6-fold increase in pitavastatin AUC.
Recommendation: Concomitant use is contraindicated due to the high risk of myopathy and rhabdomyolysis.
AEMPS SPC
HighErythromycinJ01FA01
Mechanism: Inhibition of the OATP1B1 transporter, resulting in a 2.8-fold increase in pitavastatin AUC.
Recommendation: If concomitant use is unavoidable, limit the pitavastatin dose to a maximum of 1 mg/day.
AEMPS SPC

headache · myalgia · arthralgia

rhabdomyolysis · myopathy · hepatotoxicity · pancreatitis

FDA category: X

Contraindicated during pregnancy and lactation. Women of childbearing potential must use effective contraceptive methods during treatment.