Leukemias, lymphomas, and other hematologic cancers:
Indications for DARZALEX:
Treatment of multiple myeloma: as combination therapy with lenalidomide and dexamethasone or bortezomib, melphalan, and prednisone, in newly-diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); as combination therapy with lenalidomide and dexamethasone or bortezomib and dexamethasone, in patients with relapsed/refractory multiple myeloma who have received ≥1 prior therapy; or as combination therapy with bortezomib, thalidomide, and dexamethasone, in newly-diagnosed patients who are eligible for ASCT; as combination therapy with pomalidomide and dexamethasone in patients who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor (PI); as monotherapy in patients who have received ≥3 prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
Pre-medicate with corticosteroids (long- or intermediate-acting), oral antipyretics, oral or IV antihistamines 1–3 hours prior to every infusion and administer oral corticosteroids post-infusion. Give only as IV infusion. Initially infuse at 50mL/hr for Week 1 and 2 infusions, then 100mL/hr for subsequent infusions (Week 3 onwards); may increase by 50mL/hr every hour; max 200mL/hr. Week 1 infusion (Option 1): single dose given in 1 day (16mg/kg on Day 1); or, (Option 2): split dose over 2 consecutive days (8mg/kg on Days 1 and 2). Monotherapy and combination therapy with lenalidomide or pomalidomide and dexamethasone: 16mg/kg weekly at Weeks 1–8, every 2 weeks at Weeks 9–24, then every 4 weeks at Week 25 onwards until disease progression. Combination therapy with bortezomib, melphalan and prednisone: 16mg/kg weekly at Weeks 1–6, every three weeks at Weeks 7–54, then every four weeks at Week 55 onwards until disease progression. Combination therapy with bortezomib, thalidomide, and dexamethasone (Induction): 16mg/kg weekly at Weeks 1–8, every 2 weeks at Weeks 9–16, then stop for high dose chemotherapy and ASCT; (Consolidation): 16mg/kg every 2 weeks at Weeks 1–8. Combination therapy with bortezomib and dexamethasone: 16mg/kg weekly at Weeks 1–9, every three weeks at Weeks 10–24, then every four weeks at Week 25 onwards until disease progression. Management of infusion reactions, pre- and post-infusion medications, others: see full labeling. Prophylaxis for herpes zoster reactivation: initiate antiviral prophylaxis within 1 week after starting therapy and continue for 3 months after treatment.
Should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support. Monitor frequently for infusion reactions; interrupt treatment for infusion reactions of any severity. Permanently discontinue if an anaphylactic reaction, life-threatening (Grade 4) or upon 3rd occurrence of ≥Grade 3 infusion reaction occurs; for Grade 1, 2, or 3 reactions, reduce the infusion rate when restarting. History of COPD: may require additional post-infusion drugs; consider prescribing short- or long-acting bronchodilators and inhaled corticosteroids. Interference with cross-matching and RBC antibody screening; type/screen patients prior to initiating treatment. Increased neutropenia (monitor for infections) and thrombocytopenia: obtain CBCs during therapy; dose delay may be required to allow recovery of neutrophils and platelets. Neonates/infants: defer live vaccines if exposed to drug in utero until hematology evaluation. Pregnancy. Advise females of reproductive potential to use effective contraception during treatment and for 3 months after cessation. Nursing mothers.
CD38-directed monoclonal antibody.
Interferes with Indirect Antiglobulin (Coombs) Test, serum protein electrophoresis and immunofixation assays leading to false (+) results.
Infusion reactions, neutropenia, thrombocytopenia, fatigue, asthenia, nausea, diarrhea, constipation, decreased appetite, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, upper respiratory tract infection.
Half-life: 18 ± 9 days.