Neutropenia: Neutropenia was reported in patients receiving abemaciclib. Dose modification is recommended for patients who develop Grade 3 or 4 neutropenia (see Dosage & Administration). Fatal events occurred in <1% of patients. Patients should be instructed to report any episode of fever to their healthcare provider.
Infections/infestations: Infections were reported in patients receiving abemaciclib plus endocrine therapy at a higher rate than in patients treated with placebo plus endocrine therapy. Lung infection was reported in patients receiving abemaciclib without concurrent neutropenia. Fatal events occurred in <1% of patients. Patients should be monitored for signs and symptoms of infection and treated as medically appropriate.
Venous thromboembolism: Venous thromboembolic events were reported in 5.3% of patients treated with abemaciclib plus fulvestrant or aromatase inhibitors, compared to 0.8% of patients treated with placebo plus fulvestrant or aromatase inhibitors. Patients should be monitored for signs and symptoms of deep vein thrombosis and pulmonary embolism and treated as medically appropriate.
Increased aminotransferases: Increases in ALT and AST were reported in patients receiving abemaciclib. Based on the level of ALT or AST elevation, abemaciclib may require dose modification (see Dosage & Administration).
Diarrhoea: Diarrhoea is the most common adverse reaction. Across clinical studies, median time to onset of the first diarrhoea event was approximately 6 to 8 days, and median duration of diarrhoea was 9 to 12 days (Grade 2) and 6 to 8 days (Grade 3). Diarrhoea can be associated with dehydration. Patients should start treatment with antidiarrhoeal agents such as loperamide at the first sign of loose stools, increase oral fluids and notify their healthcare provider. Dose modification is recommended for patients who develop ≥ Grade 2 diarrhoea (see Dosage & Administration).
Concomitant use of inducers of CYP3A4: Concomitant use of CYP3A4 inducers should be avoided due to the risk of decreased efficacy of abemaciclib (see Interactions).
Visceral crisis: There are no data on the efficacy and safety of abemaciclib in patients with visceral crisis.
Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium-free".
Effects on ability to drive and use machines: Verzenio has minor influence on the ability to drive and use machines. Patients should be advised to be cautious when driving or using machines in case they experience fatigue or dizziness during treatment with Verzenio (see Adverse Reactions).