Generic Name and Formulations:
Venetoclax 10mg, 50mg, 100mg; tabs.
AbbVie and Genentech
Indications for VENCLEXTA:
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, in patients who have received at least one prior therapy, alone or in combination with rituximab. Newly-diagnosed acute myeloid leukemia (AML) in adults ≥75yrs or who have comorbidities that preclude use of intensive induction chemotherapy, in combination with azacitidine, or decitabine, or low-dose cytarabine.
Assess for level of tumor lysis syndrome risk; provide prophylactic hydration and anti-hyperuricemics prior to 1st dose. Swallow whole. Take with food and water. CLL/SLL (initiate with 5-week ramp-up): 20mg once daily for Week 1, then 50mg once daily for Week 2, then 100mg once daily for Week 3, then 200mg once daily for Week 4, then 400mg once daily for Week 5. Monotherapy: continue 400mg once daily until disease progression or unacceptable toxicity. In combination with rituximab: initiate rituximab after 5-week ramp-up phase and has received venetoclax 400mg for 7 days; give rituximab on Day 1 of each 28-day cycle for 6 cycles and continue venetoclax 400mg once daily for 24 months from Cycle 1 Day 1 of rituximab (see full labeling). AML: confirm WBC is <25×109/L prior to initiation; initiate combination therapy on Day 1. Ramp-up phase: 100mg on Day 1, then 200mg on Day 2, followed by 400mg on Day 3; on Day 4 and beyond, continue 400mg once daily (in combination with azacitidine or decitabine) or 600mg once daily (in combination with low-dose cytarabine) until disease progression or unacceptable toxicity. Concomitant strong or moderate CYP3A inhibitors or P-gp inhibitors, dose modifications for toxicities, TLS prophylaxis: see full labeling.
Concomitant strong CYP3A inhibitors at initiation or during dose ramp-up phase in CLL/SLL patients.
Risk of tumor lysis syndrome (esp. with high tumor burden, comorbidities, CrCl <80mL/min); perform tumor burden assessment, radiographic evaluation, blood chemistry; correct pre-existing abnormalities prior to initiation. Risk of neutropenia; monitor CBCs during therapy; interrupt or reduce dose if severe. Severe renal impairment or on dialysis. Embryo-fetal toxicity. Pregnancy: avoid; exclude status prior to initiation. Females of reproductive potential should use effective contraception during and for ≥30 days after final dose. Nursing mothers: not recommended.
See Contraindications. Potentiated by strong CYP3A or P-gp inhibitors (eg, ketoconazole, ritonavir, posaconazole); adjust doses and monitor. Concomitant moderate CYP3A inhibitors or P-gp inhibitors (eg, rifampin); consider alternatives; if inhibitor necessary, reduce venetoclax dose by ≥50% and monitor closely. Resume at prior venetoclax dose 2–3 days after discontinuing the inhibitor. Avoid concomitant strong CYP3A inducers (eg, rifampin) or moderate CYP3A inducers. Avoid live attenuated vaccines until B-cell recovery. Avoid grapefruit, Seville oranges, and starfruit during treatment. Avoid concomitant P-gp substrates (eg, digoxin); if unavoidable, separate dosing by ≥6hrs before venetoclax. Monitor INR closely with concomitant warfarin.
Neutropenia, diarrhea, nausea, upper RTI, anemia, fatigue, thrombocytopenia, musculoskeletal pain, edema, cough, constipation, vomiting, pyrexia, pneumonia, dyspnea, hemorrhage, rash, abdominal pain, sepsis, back pain, myalgia, dizziness, oropharyngeal pain, hypotension; tumor lysis syndrome.
Starting Packs—1; Wallets 10mg—14; 50mg—7; Tabs 100mg—120, 180