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 carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma who have received ≥1 prior therapy; or as combination therapy with bortezomib and dexamethasone in patients who have received ≥1 prior therapy; 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.

Adult Dosage:

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. Combination therapy with carfilzomib and dexamethasone: 8mg/kg on Days 1 and 2 at Week 1; followed by 16mg/kg weekly at Weeks 2–8, every 2 weeks at Weeks 9–24, then every 4 weeks at Week 25 onwards until disease progression. Management of infusion-related 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.

Children Dosage:

Not established.

DARZALEX Warnings/Precautions:

Should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support. Monitor frequently for infusion-related reactions; interrupt infusion for reactions of any severity. Permanently discontinue if an anaphylactic reaction, life-threatening (Grade 4) or upon 3rd occurrence of ≥Grade 3 infusion-related 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 initiation. Increased neutropenia (monitor for infections) and thrombocytopenia: obtain CBCs during therapy; consider withholding until recovery of neutrophils and platelets. Neonates/infants: defer live vaccines if exposed to drug in utero until hematology evaluation. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended.

DARZALEX Classification:

CD38-directed monoclonal antibody.

DARZALEX Interactions:

Interferes with Indirect Antiglobulin (Coombs) Test, serum protein electrophoresis and immunofixation assays leading to false (+) results.

Adverse Reactions:

Upper respiratory infection, neutropenia, infusion-related reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, asthenia.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1