Calquence

Monotherapy for patients w/ mantle cell lymphoma (MCL) & chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least 1 prior therapy. In combination w/ bendamustine & rituximab (BR) for adult patients w/ previously untreated MCL who are ineligible for autologous stem cell transplant. In combination w/ obinutuzumab or as monotherapy for patients w/ previously untreated CLL/SLL. In combination w/ venetoclax w/ or w/o obinutuzumab for patients w/ previously untreated CLL/SLL.

MCL 100 mg bd as monotherapy or in combination w/ other medicinal products. In combination w/ BR: Administer on day 1 on cycle 1 (each cycle is 28 days) until disease progression or unacceptable toxicity. Bendamustine 90 mg/m² on days 1 & 2 of each cycle for total of 6 cycles & rituximab 375 mg/m² on day 1 each cycle for total of 6 cycles. Patient achieving a partial or complete response after the 1st 6 cycles Maintenance: Rituximab 375 mg/m² on day 1 of every other cycle for max of 12 additional doses, starting on cycle 8 up to cycle 30. CLL/SLL 100 mg bd as monotherapy or in combination. Separate doses by approx 12 hr. In combination w/ obinutuzumab: Continue until disease progression or unacceptable toxicity. In combination w/ venetoclax w/ or w/o obinutuzumab: Continue until disease progression, unacceptable toxicity or completion of 14 cycles of treatment (each cycle is 28 days).

May be taken with or without food: Take at the same time each day. Swallow whole w/ water, do not chew/crush/dissolve/divide.

Hypersensitivity.

May increase risk of haemorrhage in patients receiving antithrombotics; consider additional monitoring for bleeding signs when concomitant use is medically necessary; consider w/holding treatment for at least 3 days pre- & post-surgery. Consider prophylaxis in patients who are at increased risk for opportunistic infections. Monitor for signs & symptoms of infection & treat as medically appropriate; CBC (for possible cytopenias including neutropenia, anaemia & thrombocytopenia) as medically appropriate; symptoms (eg, palpitations, dizziness, syncope, chest pain, dyspnoea) of atrial fibrillation & atrial flutter & obtain an ECG as appropriate. Possible 2nd primary malignancies including non-skin cancers; monitor appearance of skin cancers. Assess patients considered at risk for tumour lysis syndrome (TLS) for possible TLS risk & closely monitored as clinically indicated. Possible interstitial lung disease (ILD)/pneumonitis; monitor patients for pulmonary symptoms (eg, cough, dyspnoea or hypoxia) & manage ILD/pneumonitis as clinically indicated. Patients w/ severe CV disease. May affect ability to drive or use machines due to potential fatigue & dizziness. Severe renal impairment (eGFR <29 mL/min/1.73 m²) or ESRD. Avoid use in patients w/ severe hepatic impairment (Child-Pugh C or total bilirubin >3x ULN & any AST). Women of childbearing potential should avoid becoming pregnant during treatment. Not to be used during pregnancy. Do not breastfeed during treatment & for 2 days after receiving the last dose. Childn & adolescents <18 yr.

Infection, diarrhoea, headache, musculoskeletal pain, bruising, arthralgia, fatigue, nausea, leukopenia & rash.

Increased C_max & AUC w/ strong CYP3A inhibitors (eg, ketoconazole, conivaptan, clarithromycin, indinavir, itraconazole, ritonavir, telaprevir, posaconazole, voriconazole). Decreased C_max & AUC w/ strong CYP3A inducers (eg, phenytoin, rifampin, carbamazepine). Decreased total AUC w/ moderate CYP3A inducer (eg, efavirenz). May unpredictably decrease plasma conc w/ St. John's wort. May increase exposure w/ BCRP (eg, MTX) & MATE1 (eg, metformin) substrates.

Targeted Cancer Therapy

L01EL02 - acalabrutinib ; Belongs to the class of Bruton's tyrosine kinase (BTK) inhibitors. Used in the treatment of cancer.

POM