Calcent 100

Mantle Cell Lymphoma (after at least one prior therapy) Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL)

Acalabrutinib inhibits BTK, blocking signalling pathways essential for malignant B-cell growth, survival and migration.

Recommended dose: 100 mg twice daily (every 12 hours). Continue until disease progression or unacceptable toxicity.

Anaemia Neutropenia Thrombocytopenia Upper respiratory tract infection Headache Diarrhoea Musculoskeletal pain

Pregnancy Based on findings in animals, may cause fetal harm when administered to pregnant women There are no available data in pregnant women to inform the drug-associated risk In animal reproduction studies, administration of acalabrutinib to pregnant rabbits during organogenesis resulted in reduced fetal growth; rabbit maternal exposures (AUC) were ~4 times that of humans given a dose of 100 mg twice daily Advise pregnant women of the potential risk to a fetus Lactation No data are available regarding the presence of acalabrutinib or its active metabolite in human milk, its effects on the breastfed child, or on milk production Acalabrutinib and its active metabolite were present in the milk of lactating rats Owing to the potential for adverse reactions in a breastfed child, advise lactating women not to breastfeed while taking acalabrutinib and for at least 2 weeks after the final dose

Serious hemorrhagic events, including fatal events, reported; the mechanism for the bleeding events is not well understood; acalabrutinib may further increase hemorrhage risk in patients receiving antiplatelet or anticoagulant therapies, and patients should be monitored for signs of bleeding; consider the benefit-risk of withholding acalabrutinib for 3-7 days presurgery and postsurgery depending on the type of surgery and the risk of bleeding Serious infections (bacterial, viral, or fungal), including fatal events and opportunistic infections, reported; monitor for infection and consider prophylaxis in patients who are at increased risk for opportunistic infections Cytopenias reported, including neutropenia, anemia, and thrombocytopenia; assess complete blood cell counts monthly during treatment Second primary malignancies, including nonskin carcinomas, have occurred in patients with hematologic malignancies treated with acalabrutinib; the most frequent was skin cancer; advise patients regarding need for protection from sun exposure Atrial fibrillation and flutter occurred (rare) during clinical trials; monitor patients and manage as appropriate

There is no specific antidote. Provide supportive treatment and seek immediate medical attention.

Store below 30°C. Protect from light. Keep out of reach of children.