Select therapeutic use:

Leukemias, lymphomas, and other hematologic cancers:

Indications for: DARZALEX FASPRO

Treatment of multiple myeloma: in combination with lenalidomide and dexamethasone or bortezomib, melphalan, and prednisone, in newly-diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma who have received ≥1 prior therapy; in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib and dexamethasone in patients who have received ≥1 prior therapy; in combination with pomalidomide and dexamethasone in patients who have received ≥1 prior therapy 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), 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. In combination with lenalidomide and dexamethasone (4-week cycle), in combination with pomalidomide 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. In combination 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. In combination with bortezomib, thalidomide, and dexamethasone (4-week cycle): 1800mg/30000units weekly at Weeks 1–8 (8 doses), every 2 weeks at Weeks 9–16 (4 doses), stop for high dose chemotherapy and ASCT, then re-initiate every 2 weeks at Weeks 1–8 (4 doses). In combination 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 Dosage:

Not established.

DARZALEX FASPRO Warnings/Precautions:

Should be administered by a healthcare provider. Monitor for systemic and local administration-related reactions; permanently discontinue if anaphylaxis or life-threatening (Grade 4) reactions occur. AL amyloidosis: cardiac toxicity (esp. with NYHA Class IIIA or Mayo Stage IIIA disease); monitor more frequently. 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 the last dose. Pregnancy: contraindicated in combination with lenalidomide, thalidomide, or pomalidomide; refer to their respective labeling. Nursing mothers: not recommended.

DARZALEX FASPRO Classification:

CD38-directed monoclonal antibody + endoglycosidase.

DARZALEX FASPRO 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 Drug Availability:

NO

How Supplied:

Single-dose vial (15mL)—1

Pricing for DARZALEX FASPRO

1800mg of 30000 units/15ml vial (Qty: 1)
Appx. price $549
GoodRx

Miscellaneous hematological agents:

Indications for: DARZALEX FASPRO

Adults with newly diagnosed light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone.

Limitations of Use:

Not indicated and not recommended for treatment of patients with AL amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

Adult Dosage:

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. In combination with bortezomib, cyclophosphamide, and dexamethasone (4-week cycle): 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 or a max of 2yrs. 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 Dosage:

Not established.

DARZALEX FASPRO Warnings/Precautions:

Should be administered by a healthcare provider. Monitor for systemic and local administration-related reactions; permanently discontinue if anaphylaxis or life-threatening (Grade 4) reactions occur. AL amyloidosis: cardiac toxicity (esp. with NYHA Class IIIA or Mayo Stage IIIA disease); monitor more frequently. 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 the last dose. Pregnancy: contraindicated in combination with lenalidomide, thalidomide, or pomalidomide; refer to their respective labeling. Nursing mothers: not recommended.

DARZALEX FASPRO Classification:

CD38-directed monoclonal antibody + endoglycosidase.

DARZALEX FASPRO 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 Drug Availability:

NO

How Supplied:

Single-dose vial (15mL)—1

Pricing for DARZALEX FASPRO

1800mg of 30000 units/15ml vial (Qty: 1)
Appx. price $549
GoodRx