Daratumumab/hyaluronidase
Daratumumab/hyaluronidase | |
---|---|
[[File:|frameless|220px|alt=|]] | |
INN | |
Drug class | Monoclonal antibody + Enzyme |
Routes of administration | Subcutaneous injection |
Pregnancy category | |
Bioavailability | |
Metabolism | |
Elimination half-life | |
Excretion | |
Legal status | Rx-only |
CAS Number | 1909107-80-7 |
PubChem | |
DrugBank | DB15181 |
ChemSpider | |
KEGG | D11930 |
Daratumumab/hyaluronidase (brand name Darzalex Faspro) is a combination medication used for the treatment of multiple myeloma. It consists of daratumumab, a monoclonal antibody, and hyaluronidase, an enzyme that enhances drug absorption when administered subcutaneously.
Mechanism of Action[edit | edit source]
Daratumumab[edit | edit source]
Daratumumab is a CD38-targeting monoclonal antibody that works by binding to the CD38 protein found on the surface of multiple myeloma cells. This leads to:
- Complement-dependent cytotoxicity (CDC)
- Antibody-dependent cell-mediated cytotoxicity (ADCC)
- Apoptosis (programmed cell death)
Hyaluronidase[edit | edit source]
Hyaluronidase-fihj is an enzyme that breaks down hyaluronic acid, a component of the extracellular matrix. This:
- Increases permeability of subcutaneous tissues, allowing better absorption of daratumumab.
- Reduces infusion time, making administration more convenient compared to intravenous daratumumab.
Indications[edit | edit source]
Daratumumab/hyaluronidase is approved for the treatment of:
- Multiple myeloma, in combination with:
Lenalidomide and Dexamethasone Bortezomib and Dexamethasone Carfilzomib and Dexamethasone
- Light chain amyloidosis (AL amyloidosis) – as a first-line treatment.
Administration[edit | edit source]
- Route: Subcutaneous injection (SC) in the abdominal region.
- Advantages over IV daratumumab:
Faster administration (5 minutes vs. several hours for IV infusion). Lower risk of infusion-related reactions.
Side Effects[edit | edit source]
Common adverse effects include:
- Infusion-related reactions (less frequent than IV formulation)
- Fatigue
- Nausea
- Back pain
- Cytopenias (low blood cell counts)
Neutropenia (risk of infection) Thrombocytopenia (risk of bleeding) Anemia
- Respiratory infections
- Peripheral edema (fluid retention)
Contraindications and Precautions[edit | edit source]
- Hypersensitivity to daratumumab or hyaluronidase.
- Increased risk of respiratory infections requires monitoring.
- Interference with blood typing – Daratumumab binds to CD38 on red blood cells, which can interfere with compatibility testing.
- Pregnancy and lactation – Limited data; use with caution.
Drug Interactions[edit | edit source]
- Immunomodulatory agents (e.g., Lenalidomide) – Used in combination for synergistic effect.
- Corticosteroids (e.g., Dexamethasone) – Used to reduce infusion reactions.
- Live vaccines – Avoid due to potential immunosuppression.
Comparison with IV Daratumumab[edit | edit source]
Feature | IV Daratumumab | SC Daratumumab/Hyaluronidase |
---|---|---|
Route | Intravenous (IV) | Subcutaneous (SC) |
Administration Time | 3–7 hours | 5 minutes |
Infusion-related Reactions | More common | Less frequent |
Convenience | Requires IV access | No IV required |
Hospital Visits | More frequent | Less frequent |
Regulatory Approval[edit | edit source]
- Approved by the U.S. Food and Drug Administration (FDA) in 2020.
- Approved by the European Medicines Agency (EMA) and other regulatory bodies.
- Included in National Comprehensive Cancer Network (NCCN) guidelines for multiple myeloma.
See Also[edit | edit source]
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