Daratumumab/hyaluronidase

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Daratumumab/hyaluronidase
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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]

Comparison of IV vs. Subcutaneous Daratumumab
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]

See Also[edit | edit source]

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