Generic Details

Indications

Mantle Cell Lymphoma

Adult Dose

Mantle Cell Lymphoma Indicated for mantle cell lymphoma (MCL) in patients who have received ?1 prior therapy 100 mg PO every twelve hours Continue until disease progression or unacceptable toxicity   Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Indicated for treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)   Monotherapy 100 mg PO every twelve hours Continue until disease progression or unacceptable toxicity   Combination with obinutuzumab Indicated for patients with previously untreated CLL or SLL Start acalabrutinib at Cycle 1 (each cycle is 28 days) Start obinutuzumab at Cycle 2 for a total of 6 cycles Refer to obinutuzumab for infusion rates Cycle 1 Days 1-28: Acalabrutinib 100 mg PO q12hr   Cycle 2 Days 1-28: Acalabrutinib 100 mg PO q12hr Day 1: Obinutuzumab 100 mg IV infusion Day 2: Obinutuzumab 900 mg IV infusion Days 8 and 15: Obinutuzumab 1000 mg IV infusion   Cycles 3-7 Day 1-28: Acalabrutinib 100 mg PO q12hr Day 1: Obinutuzumab 1000 mg IV infusion Cycle 8 and subsequent cycles Day 1-28: Acalabrutinib 100 mg PO q12hr Continue until disease progression or unacceptable toxicity Mantle Cell Lymphoma Indicated for mantle cell lymphoma (MCL) in patients who have received ?1 prior therapy 100 mg PO every twelve hours Continue until disease progression or unacceptable toxicity   Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Indicated for treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Monotherapy 100 mg PO every twelve hours Continue until disease progression or unacceptable toxicity   Combination with obinutuzumab Indicated for patients with previously untreated CLL or SLL Start acalabrutinib at Cycle 1 (each cycle is 28 days) Start obinutuzumab at Cycle 2 for a total of 6 cycles Refer to obinutuzumab for infusion rates Cycle 1 Days 1-28: Acalabrutinib 100 mg PO q12hr   Cycle 2 Days 1-28: Acalabrutinib 100 mg PO q12hr Day 1: Obinutuzumab 100 mg IV infusion Day 2: Obinutuzumab 900 mg IV infusion Days 8 and 15: Obinutuzumab 1000 mg IV infusion   Cycles 3-7 Day 1-28: Acalabrutinib 100 mg PO q12hr Day 1: Obinutuzumab 1000 mg IV infusion Cycle 8 and subsequent cycles Day 1-28: Acalabrutinib 100 mg PO q12hr Continue until disease progression or unacceptable toxicity

Renal Dose

Renal impairment Mild-to-moderate (eGFR >30 mL/min/1.73m²): No clinically relevant pharmacokinetics (PK) difference observed Severe (eGFR <30 mL/min/1.73m²) or patients on dialysis: Acalabrutinib PK has not been evaluated

Pregnancy-Lactation

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 Pregnancy testing is recommended for females of reproductive potential before initiating therapy   Animal data 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 BID Advise pregnant women of the potential risk to a fetus   Contraception Embryofetal harm and dystocia may occur when administered to pregnant women Females of reproductive potential: Use effective contraception during treatment and for at least 1 week following the last dose; if used during pregnancy, or if the patient becomes pregnant while taking drug, inform patient of the potential hazard 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

Testing generic

Indications

Adult Dose

Renal Dose

Pregnancy-Lactation

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