Calcent 100

Acalabrutinib is a targeted anticancer medicine that inhibits Bruton's Tyrosine Kinase (BTK), helping reduce abnormal B-cell growth. It is mainly used to treat certain blood cancers.

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

Tyrosine Kinase Inhibitor

Bruton's Tyrosine Kinase (BTK) Inhibitor

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

Irreversibly binds to BTK. Blocks B-cell receptor signalling. Reduces proliferation of malignant B-cells. Slows tumour progression.

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

Swallow the capsule whole with water. Do not chew, crush or open. Can be taken with or without food.

Skip the missed dose if more than 3 hours have passed. Take the next scheduled dose. Do not take a double dose.

Anaemia Neutropenia Thrombocytopenia Upper respiratory tract infection Headache Diarrhoea Musculoskeletal pain

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

Hypersensitivity to Acalabrutinib or any component of the formulation.

Strong CYP3A inhibitors increase drug levels. CYP3A inducers reduce effectiveness. PPIs and antacids decrease absorption. May increase exposure to BCRP substrates.

Can be taken with or without food. Avoid grapefruit and Seville oranges.

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

Avoid breastfeeding during treatment and for at least 2 weeks after the last dose.

Safety and efficacy have not been established in children.

Generally no dose adjustment is required in elderly patients, but close monitoring is recommended.

No adjustment is generally required in mild to moderate renal impairment. Limited data in severe renal impairment. Avoid in severe hepatic impairment.

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.

Molecular Formula: C₂₆H₂₃N₇O₂ Molecular Weight: 465.51 g/mol

Question: What is Acalabrutinib? Answer: Acalabrutinib is a targeted anticancer medicine that belongs to the Bruton's Tyrosine Kinase (BTK) inhibitor class. Question: What conditions is Acalabrutinib used to treat? Answer: It is used to treat Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL), and Small Lymphocytic Lymphoma (SLL). Question: Should Acalabrutinib be taken with food? Answer: It can be taken with or without food. Question: Can the capsule be crushed or chewed? Answer: No. The capsule should be swallowed whole with water. Do not crush, chew, or open it. Question: What should I do if I miss a dose? Answer: If more than 3 hours have passed since the scheduled dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose. Question: Is Acalabrutinib safe during pregnancy? Answer: No. Acalabrutinib may harm the unborn baby and should generally be avoided during pregnancy unless specifically advised by a healthcare provider. Question: Can I breastfeed while taking Acalabrutinib? Answer: No. Breastfeeding should be avoided during treatment and for at least 2 weeks after the last dose. Question: What are the most common side effects of Acalabrutinib? Answer: Common side effects include anaemia, headache, diarrhoea, infections, neutropenia, thrombocytopenia, and musculoskeletal pain.