Generic Name and Formulations:
Daratumumab 100mg/5mL, 400mg/20mL; per vial; soln for IV infusion after dilution; contains mannitol; preservative-free.
Janssen Biotech, Inc.
- FDA Expands Daratumumab Approval for Multiple Myeloma
- Bristol-Myers Squibb and Janssen Announce Nivolumab / Daratumumab Collaboration
- FDA Approves 2 New Daratumumab Combination Regimens for Relapsed Multiple Myeloma
- Non-Hodgkin Lymphoma (NHL) Treatment Regimens: Extranodal NK/T-cell Lymphoma
- Non-Hodgkin Lymphoma (NHL) Treatment Regimens: Adult T-Cell Leukemia/Lymphoma
- Leukemia Treatment Regimens: Acute Myeloid Leukemia (AML)
Indications for DARZALEX:
Treatment of multiple myeloma: as combination therapy with lenalidomide and dexamethasone, or bortezomib and dexamethasone, in patients who have received ≥1 prior therapy; as combination therapy with pomalidomide and dexamethasone in patients who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor (PI); or 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 first two infusions, then 100mL/hr for subsequent infusions; may increase by 50mL/hr every hour; max 200mL/hr. 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 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 life-threatening (Grade 4) or upon 3rd recurrence of Grade 3 infusion reactions occur; 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. Females of reproductive potential should use effective contraception during treatment and for 3 months after cessation. Nursing mothers.
Interferes with Indirect Antiglobulin (Coombs) Test, serum protein electrophoresis and immunofixation assays leading to false (+) results.
CD38-directed monoclonal antibody.
Infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, upper respiratory tract infection.
Sign Up for Free e-newsletters
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
|Head and Neck Cancer||Regimens||Drugs|
|Renal Cell Carcinoma||Regimens||Drugs|
Cancer Therapy Advisor Articles
- Clostridium Difficile Infection in Patients With Cancer — In the Clinic
- Targeted and Immunotherapies for Metastatic Renal Cell Carcinoma
- Atezolizumab, Carboplatin, Nab-Paclitaxel Combination Prolongs PFS in NSCLC
- FDA Approves Front-Line Brentuximab Vedotin Plus Chemotherapy for Hodgkin Lymphoma
- Confronting Racial Disparities in Prostate Cancer Survival Outcomes
- Everolimus Plus Letrozole: An Effective First-Line Therapy for Advanced Breast Cancer
- FDA Approves Nilotinib for Pediatric Patients With CML
- Nicotinamide and Cancer
- Nivolumab Plus Ipilimumab Improves Overall Survival, ORR in Renal Cell Carcinoma
- Encorafenib, Binimetinib May Be Effective in BRAF-Mutant Melanoma