Darzalex (Daratumumab) – Multiple Myeloma | HongKong DengYue Medicine

Darzalex Application Scope

Darzalex is a monoclonal antibody targeting CD38, used in adults to treat multiple myeloma by killing cancer cells and enhancing the immune response.

Characteristics

• Ingredients: Daratumumab

• Properties:

  • Clear to pale yellow solution

  • Monoclonal IgG1 kappa antibody targeting CD38 on multiple myeloma cells

• Packaging Specification: Injection vials: 100 mg/5 mL and 400 mg/20 mL (20 mg/mL)

• Storage: Store as directed (commonly 2–8 °C); follow vial labeling and local protocols

• Expiry Date: ​Labeled on vial; discard after expiration

• Executive Standard:

  • FDA-reviewed prescribing information (PI)

  • EMA Summary of Product Characteristics (SmPC) reflects standards for oncology biologics

• Approval Number:

  • U.S. monoclonal antibody;

  • FDA approval for initial indication in November 2015;

  • Combination approval Nov 21, 2016

• Date of Revision: U.S. PI last revised April 2025

• Manufacturer: Janssen Biotech, Inc.

Guidelines for the Use of Darzalex

• Dosage and Administration:

  • IV infusion: 16 mg/kg body weight, often weekly initially, then spaced (e.g., weekly → biweekly → monthly);

  • Detailed schedules are available per combination regimen

  • Must premedicate with antihistamines, antipyretics, corticosteroids; monitor closely for infusion reactions

 

• Adverse Reactions:

  • Common (≥20%): infusion reactions, neutropenia, thrombocytopenia, upper respiratory infection, diarrhea, fatigue, anemia, edema

  • Serious risks include severe infusion reactions (bronchospasm, hypoxia), neutropenia, thrombocytopenia, ocular events

• Contraindications: Known hypersensitivity to daratumumab or excipients

• Precautions:

  • Monitor CBC, manage neutropenia/thrombocytopenia

  • Inform blood banks (may cause positive Coombs test; RBC compatibility issues)

  • Use contraception during and up to 3 months after treatment due to embryo-fetal risks

  • Monitor for infusion complications, especially in COPD patients (bronchodilator consideration)

Darzalex Interactions

• Drug Interactions:

  • Interferes with indirect Coombs test and serum protein electrophoresis/immunofixation assays

  • Hepatitis B virus reactivation risk reported; monitor accordingly

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.