Leukemias, lymphomas, and other hematologic cancers:

Indications for DARZALEX FASPRO:

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 in patients with relapsed/refractory multiple myeloma who have received ≥1 prior therapy; as combination therapy with bortezomib and dexamethasone in patients who have received ≥1 prior therapy; as monotherapy in patients who have received ≥3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

Adult:

Pre-medicate with corticosteroids (long- or intermediate-acting), acetaminophen, oral or IV antihistamines 1–3 hours prior to every inj and administer oral corticosteroids post inj. Give by SC inj into abdomen over approx. 3–5mins; rotate inj sites. Combination therapy with lenalidomide and dexamethasone (4-week cycle) or as monotherapy: 1800mg/30000units weekly at Weeks 1–8 (8 doses), every 2 weeks at Weeks 9–24 (8 doses), then every 4 weeks at Week 25 onwards until disease progression. Combination therapy with bortezomib, melphalan and prednisone (6-week cycle): 1800mg/30000units weekly at Weeks 1–6 (6 doses), every three weeks at Weeks 7–54 (16 doses), then every four weeks at Week 55 onwards until disease progression. Combination therapy with bortezomib and dexamethasone (3-week cycle): 1800mg/30000units weekly at Weeks 1–9 (9 doses), every three weeks at Weeks 10–24 (5 doses), then every four weeks at Week 25 onwards until disease progression. Pre- and post-injection 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:

Not established.

Warnings/Precautions:

Should be administered by a healthcare professional. Monitor for systemic and local administration-related reactions; permanently discontinue if anaphylaxis or life-threatening (Grade 4) reactions occur. History of COPD: 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 periodically 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. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 3 months after last dose. Pregnancy: also refer to lenalidomide labeling when used in combination. Nursing mothers: not recommended.

Pharmacologic Class:

CD38-directed monoclonal antibody + endoglycosidase.

Interactions:

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

Adverse Reactions:

Upper respiratory tract infection, lab abnormalities (eg, decreased in leukocytes, lymphocytes, neutrophils, platelets and hemoglobin). In combination therapy: also constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, back pain, muscle spasms, pneumonia, dyspnea; hypersensitivity reactions.

Generic Availability:

NO

How Supplied:

Single-dose vial (15mL)—1

Pricing for DARZALEX FASPRO

1800mg of 30000 units/15ml vial (Qty: 1)
Appx. price $525
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