Darzalex Faspro (daratumumab [a CD38-directed cytolytic antibody] and hyaluronidase-fihj [an endoglycosidase]) is indicated for the treatment of adults with mutiple myeloma, high-risk smoldering multiple myeloma, and light chain (AL) amyloidosis. Darzalez Faspro was first approved in 2020, for the treatment of patients with multiple myeloma.
Read on to learn more about Darzalex Faspro’s approved indications, warnings and precautions, adverse effects, and more.
Medication Overview:
- Brand Name: Darzalex Faspro
- Generic Name: Daratumumab and Hyaluronidase-fihj
- Treatment for: Multiple Myeloma, High-Risk Smoldering Multiple Myeloma, Light Chain (AL) Amyloidosis
- Manufacturer(s): Johnson & Johnson
- Initial FDA Approval: May 2020
| Indicated Condition | Indication(s) | Age | Initial Date Approved |
|---|---|---|---|
| Multiple Myeloma | In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant. In combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. As monotherapy, in patients who have received at least three 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. | Adults | May 2020 |
| High-Risk Smoldering Multiple Myeloma | As monotherapy. | Adults | November 2025 |
| Light Chain (AL) Amyloidosis | In combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients. | Adults | January 2021 |
Warnings and Precautions:
Hypersensitivity and Administration Reactions: Permanently discontinue Darzalex Faspro in patients who experience life-threatening hypersensitivity or administration-related reactions.
Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis: Patients with cardiac involvement should be monitored more frequently for cardiac adverse reactions. Supportive care should be administered as appropriate.
Infections: Darzalex Faspro may cause serious or fatal infections. Patients should be monitored for signs and symptoms of infection and treated promptly when necessary.
Neutropenia: Complete blood cell counts should be monitored periodically during treatment. Patients with neutropenia should be observed for signs of infection. Consider withholding Darzalex Faspro to allow neutrophil recovery.
Thrombocytopenia: Monitor complete blood cell counts periodically throughout treatment. Consider withholding Darzalex Faspro to allow platelet recovery.
Embryo-Fetal Toxicity: Darzalex Faspro can cause fetal harm. Pregnant women should be advised of the potential risk to the fetus, and females of reproductive potential should use effective contraception during treatment.
Interference with Blood Compatibility Testing: Darzalex Faspro may interfere with cross-matching and red blood cell antibody screening. Patients should undergo type and screen testing prior to starting treatment, and blood banks should be informed if a patient has received Darzalex Faspro.
Dosage and Administration:
For subcutaneous use only.
- Pre-medicate with a corticosteroid, acetaminophen and histamine-1 receptor antagonist.
- The recommended dosage of Darzalex Faspro is (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously into the abdomen over approximately 3 to 5 minutes according to recommended schedule.
- Administer post-medications as recommended.
Contraindications:
Patients with a history of severe hypersensitivity to daratumumab, hyaluronidase or any of the components of the formulation.
Adverse Reactions:
- The most common adverse reactions (≥20%) in patients with multiple myeloma eligible for autologous stem cell transplant who received Darzalex Faspro-VRd are peripheral neuropathy, fatigue, upper respiratory infection, constipation, musculoskeletal pain, insomnia, rash, diarrhea, edema, and pyrexia.
- The most common adverse reactions (≥20%) in patients with multiple myeloma who were ineligible for autologous stem cell transplant who received Darzalex Faspro-VRd are upper respiratory tract infection, sensory neuropathy, musculoskeletal pain, diarrhea, fatigue, edema, rash, motor dysfunction, COVID-19, constipation, sleep disorder, cough, pneumonia, renal impairment, dizziness, nausea, urinary tract infection, pyrexia, abdominal pain, dyspnea, decreased appetite, and bruising.
- The most common adverse reaction (≥20%) in patients with multiple myeloma who received Darzalex Faspro monotherapy is upper respiratory tract infection.
- The most common adverse reactions (≥20%) in patients with multiple myeloma who received Darzalex Faspro-VMP are upper respiratory tract infection, constipation, nausea, fatigue, pyrexia, peripheral sensory neuropathy, diarrhea, cough, insomnia, vomiting, and back pain.
- The most common adverse reactions (≥20%) in patients with multiple myeloma who received Darzalex Faspro-Rd are fatigue, diarrhea, upper respiratory tract infection, muscle spasms, constipation, pyrexia, pneumonia, and dyspnea.
- The most common adverse reactions (≥20%) in patients with multiple myeloma who received Darzalex Faspro-Pd are fatigue, pneumonia, upper respiratory tract infection, and diarrhea.
- The most common adverse reactions (≥20%) in patients with multiple myeloma who received Darzalex Faspro-Kd are upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.
- The most common adverse reactions (≥20%) in patients with high-risk smoldering multiple myeloma who received Darzalex Faspro monotherapy are upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy, and injection site reactions.
- The most common adverse reactions (≥20%) in patients with light chain (AL) amyloidosis are upper respiratory tract infection, diarrhea, peripheral edema, constipation, fatigue, peripheral sensory neuropathy, nausea, insomnia, dyspnea, and cough.
- The most common (≥40%) hematology laboratory abnormalities with Darzalex Faspro are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.
Examples of Daratumumab in Clinical Guidance
- Treatment of Multiple Myeloma
- American Society of Clinical Oncology (ASCO), Cancer Care Ontario (CCO)
- January 2026
- “Daratumumab therapy may be offered to patients with high-risk smoldering myeloma. Quadruplet therapy with daratumumab or isatuximab, combined with bortezomib, lenalidomide, and dexamethasone, should be offered as initial therapy for transplant eligible patients.”
- Immunotherapy for the Treatment of Multiple Myeloma
- Society for Immunotherapy of Cancer (SITC)
- July 2020
- “[Daratumumab] is FDA-approved and the panel recommends its use in the following settings…”
Please note: This article is current as of May 15, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.
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