Recommended dose: abemaciclib 150 mg orally twice daily in combination with endocrine therapy. For early breast cancer, treatment is continued for two years or until recurrence or unacceptable toxicity; for advanced or metastatic breast cancer, treatment continues as long as clinical benefit is maintained or until unacceptable toxicity. Dose reductions for adverse reactions are 100 mg twice daily first, then 50 mg twice daily second. If strong CYP3A4 inhibitors cannot be avoided, reduce to 100 mg twice daily; severe hepatic impairment requires once-daily dosing.

Reduce to 100 mg twice daily if strong CYP3A4 inhibitors cannot be avoided; use once daily in severe hepatic impairment. Abemaciclib is contraindicated in patients with hypersensitivity to the active substance or its excipients.

Most commonly occurring adverse reactions were diarrhoea, infections, neutropenia, leukopenia, anaemia, fatigue, nausea, vomiting, alopecia and decreased appetite. Other very common reactions included thrombocytopenia, lymphopenia, headache, dysgeusia, dizziness, stomatitis, dyspepsia, pruritus, rash, and alanine/aspartate aminotransferase increased. Clinically important reported reactions included febrile neutropenia, venous thromboembolism, and ILD/pneumonitis. Grade 3 or higher events were generally under 5% except neutropenia, leukopenia, and diarrhoea.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

The safety and efficacy were evaluated in three randomized Phase 3 studies in HR-positive, HER2-negative early or advanced/metastatic breast cancer. monarchE: n=5,637 randomized; median age approximately 51 years; 99% women. MONARCH 3: n=493; median age 63 years; 100% women. MONARCH 2: n=669; median age 60 years; 100% women.

Recommended dose: abemaciclib 150 mg orally twice daily in combination with endocrine therapy. For early breast cancer, treatment is continued for two years or until recurrence or unacceptable toxicity; for advanced or metastatic breast cancer, treatment continues as long as clinical benefit is maintained or until unacceptable toxicity. Dose reductions for adverse reactions are 100 mg twice daily first, then 50 mg twice daily second. If strong CYP3A4 inhibitors cannot be avoided, reduce to 100 mg twice daily; severe hepatic impairment requires once-daily dosing.

Reduce to 100 mg twice daily if strong CYP3A4 inhibitors cannot be avoided; use once daily in severe hepatic impairment. Abemaciclib is contraindicated in patients with hypersensitivity to the active substance or its excipients.

Most commonly occurring adverse reactions were diarrhoea, infections, neutropenia, leukopenia, anaemia, fatigue, nausea, vomiting, alopecia and decreased appetite. Other very common reactions included thrombocytopenia, lymphopenia, headache, dysgeusia, dizziness, stomatitis, dyspepsia, pruritus, rash, and alanine/aspartate aminotransferase increased. Clinically important reported reactions included febrile neutropenia, venous thromboembolism, and ILD/pneumonitis. Grade 3 or higher events were generally under 5% except neutropenia, leukopenia, and diarrhoea.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

The safety and efficacy were evaluated in three randomized Phase 3 studies in HR-positive, HER2-negative early or advanced/metastatic breast cancer. monarchE: n=5,637 randomized; median age approximately 51 years; 99% women. MONARCH 3: n=493; median age 63 years; 100% women. MONARCH 2: n=669; median age 60 years; 100% women.