Abemaciclib

What it is and how it works

Selectively inhibits CDK4 and CDK6, preventing phosphorylation of the retinoblastoma protein and blocking progression from the G1 to the S phase of the cell cycle in hormone receptor-positive breast cancer cells.

Indications

HR-positive, HER2-negative locally advanced or metastatic breast cancer with an aromatase inhibitor or fulvestrant; adjuvant treatment of HR-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence, with endocrine therapy.

Dosage and administration (summary)

150 mg orally twice daily in combination with endocrine therapy, continued until disease progression or unacceptable toxicity (2 years in the adjuvant setting); dose reductions for toxicity.

Contraindications

Hypersensitivity to abemaciclib or excipients.

Warnings and precautions

Diarrhoea is very common and requires early antidiarrhoeal treatment and fluids; neutropenia, hepatotoxicity, venous thromboembolism and interstitial lung disease may occur. Monitor blood counts and liver function; avoid strong CYP3A4 inhibitors and inducers.

Pregnancy

Contraindicated in practice; may cause fetal harm and effective contraception is required.

Storage and supply

Store below 30 °C in the original package.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.