Leukemias, lymphomas, and other hematologic cancers:

Indications for CALQUENCE:

Mantle cell lymphoma (MCL) in adults who have received at least one prior therapy. Chronic lymphocytic leukemia (CLL). Small lymphocytic lymphoma (SLL).

Adult:

Swallow whole with water. 100mg approx. every 12hrs until disease progression or unacceptable toxicity. In combination with obinutuzumab (CLL/SLL): initiate acalabrutinib at Cycle 1 of each 28-day cycle, then initiate obinutuzumab at Cycle 2 for a total of 6 cycles; give acalabrutinib prior to obinutuzumab if given on same day. Concomitant moderate CYP3A inhibitors: 100mg once daily. Concomitant strong CYP3A inducers: avoid; if needed, increase dose to 200mg every 12hrs. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

Risk of serious hemorrhagic events (monitor); consider the benefit/risk of withholding treatment for 3–7 days pre-and post-surgery. Monitor for infections; consider prophylaxis if at risk for opportunistic infections. Monitor for cytopenias; obtain CBCs regularly. Risk of second primary malignancies (eg, skin cancer or other carcinomas); advise patients to protect from sun exposure. Monitor for atrial fibrillation/flutter; manage appropriately. Severe hepatic impairment: not recommended. Advise females of reproductive potential to use effective contraception during and for ≥1 week after the last dose. Pregnancy: exclude status prior to initiation (potential risk of fetal harm and dystocia). Nursing mothers: not recommended (during and for ≥2 weeks after the last dose).

Pharmacologic Class:

Bruton tyrosine kinase (BTK) inhibitor.

Interactions:

Avoid concomitant strong CYP3A inhibitors (eg, itraconazole); if short-term use (eg, anti-infectives for ≤7days), interrupt acalabrutinib therapy. Concomitant moderate CYP3A inhibitors, strong CYP3A inducers (eg, rifampin): see Adults. Increased risk of hemorrhage with concomitant antithrombotics; consider benefit/risk. Antagonized by gastric acid reducing agents (eg, PPI [avoid], H2-receptor antagonist, or antacid); if needed, consider ranitidine, famotidine, or calcium carbonate. Separate dosing by at least 2hrs with antacids. Take acalabrutinib 2hrs before H2-receptor antagonist use.

Adverse Reactions:

Anemia, neutropenia, thrombocytopenia, upper RTI, headache, diarrhea, musculoskeletal pain; hemorrhage, infections, second primary malignancy, atrial fibrillation/flutter.

Generic Availability:

NO

How Supplied:

Caps—60

Pricing for CALQUENCE

100mg capsule (Qty: 60)
Appx. price $15520
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