Darzalex Faspro Daratumumab and Hyaluronidase-fihj Injection

1. Indications and Usage
Daratumumab and hyaluronidase-fihj is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, or who have demonstrated intolerance to such agents.
2. Dosage and Administration
Recommended Dosage: The recommended dosage is 1800 mg administered subcutaneously once weekly for four doses, followed by once every three weeks.
Administration: The solution should be administered subcutaneously by a healthcare professional. It should not be administered intravenously.
Premedication: Premedication with antihistamines and analgesics is recommended to reduce the risk of infusion-related reactions.
Rate: The injection should be administered at a rate not exceeding 30 mL/min.
3. Mechanism of Action
Daratumumab: A human monoclonal antibody that targets CD38, a cell-surface enzyme and receptor. It induces cell death through antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, and apoptosis.
Hyaluronidase: An enzyme that temporarily disrupts the extracellular matrix of the subcutaneous tissue, allowing for the rapid absorption of the larger daratumumab molecule through subcutaneous administration.
4. Safety and Warnings
Infusion-Related Reactions: Severe and fatal infusion-related reactions, including anaphylaxis and bronchospasm, can occur.
Neutropenia and Infections: Neutropenia and other infections, including viral reactivations, are common adverse reactions.
Hemolytic Transfusion Reaction: Daratumumab binds to CD38 on red blood cells, which can interfere with blood typing and crossmatching.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most frequent adverse reactions include fatigue, pyrexia, upper respiratory tract infections, diarrhea, nausea, and musculoskeletal pain.
Clinical Research: Clinical trials have demonstrated that this combination significantly improves response rates and progression-free survival in heavily pre-treated patients with multiple myeloma.
6. Drug Interactions
Vaccines: Live or live-attenuated vaccines should be avoided during treatment with daratumumab.
Blood Transfusions: Special precautions are required for blood typing and crossmatching to prevent hemolytic transfusion reactions.
7. Pharmaceutical Information
Composition: The active ingredients are daratumumab and recombinant human hyaluronidase.
Appearance: The solution is clear to slightly opalescent and colorless.
Storage: Store refrigerated at 2°C to 8°C. Do not freeze. Protect from light.