DARZALEX 400mg - Daratumumab by Janssen

    DARZALEX

    400mg
    Oncology Medications

    DARZALEX400mg

    DARZALEX (daratumumab) 400mg is the first CD38-targeting monoclonal antibody for multiple myeloma, offering deep and durable responses across all disease stages.

    Generic Name:Daratumumab
    Manufacturer:Janssen

    Key Benefits

    • First-in-class CD38-targeting antibody
    • Multiple mechanisms of myeloma cell killing
    • High response rates across all disease stages
    • Deep responses including MRD-negativity possible
    • IV and subcutaneous (FASPRO) options
    • Authentic Janssen product

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    How DARZALEX Works

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    DARZALEX targets CD38, a glycoprotein highly and uniformly expressed on myeloma cells:

    2

    1. **Complement-Dependent Cytotoxicity (CDC):** DARZALEX activates the complement system to directly lyse myeloma cells.

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    2. **Antibody-Dependent Cellular Cytotoxicity (ADCC):** Natural killer cells and other effector cells are recruited to destroy myeloma cells through Fc receptor engagement.

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    3. **Antibody-Dependent Cellular Phagocytosis (ADCP):** Macrophages are activated to engulf and eliminate myeloma cells.

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    4. **Direct Apoptosis:** DARZALEX can trigger programmed cell death in myeloma cells through Fc receptor crosslinking.

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    5. **Immunomodulation:** DARZALEX depletes CD38-positive immunosuppressive cells (regulatory T-cells, B-cells, and myeloid-derived suppressor cells), enhancing anti-tumor immune responses.

    About DARZALEX 400mg

    DARZALEX (daratumumab) 400mg/20mL and 100mg/5mL by Janssen is a groundbreaking CD38-directed monoclonal antibody that has transformed the treatment landscape for multiple myeloma. As the first CD38-targeting therapy approved for this blood cancer, DARZALEX works through multiple mechanisms to eliminate myeloma cells. DARZALEX is FDA-approved for newly diagnosed multiple myeloma in transplant-eligible and transplant-ineligible patients, as well as relapsed/refractory multiple myeloma after one or more prior therapies. It can be used as monotherapy or in combination with standard myeloma regimens including proteasome inhibitors, immunomodulatory drugs, and steroids. Additionally, DARZALEX is approved for light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide, and dexamethasone. We provide authentic Janssen DARZALEX with proper cold chain handling and competitive wholesale pricing for healthcare providers worldwide.

    Common Uses

    • Newly diagnosed multiple myeloma (transplant-eligible)
    • Newly diagnosed multiple myeloma (transplant-ineligible)
    • Relapsed/refractory multiple myeloma
    • Light chain (AL) amyloidosis
    • Combination with bortezomib-based regimens
    • Combination with lenalidomide-based regimens

    Dosage Information

    DARZALEX dosing follows a step-down schedule based on treatment phase:

    Standard IV Dosing:

  1. Weeks 1-8: 16 mg/kg weekly
  2. Weeks 9-24: 16 mg/kg every 2 weeks
  3. Week 25 onwards: 16 mg/kg every 4 weeks
  4. Pre-Infusion Medications (required):

  5. Corticosteroid (methylprednisolone or equivalent)
  6. Antipyretic (acetaminophen)
  7. Antihistamine (diphenhydramine or equivalent)
  8. Post-Infusion:

  9. Oral corticosteroid post-infusion on days 1-2
  10. **First Infusion:** May require 7+ hours due to rate titration

    **Subsequent Infusions:** 3-4 hours if tolerated

    DARZALEX FASPRO (subcutaneous formulation) offers faster administration (3-5 minutes injection).

    Always consult with a qualified healthcare professional for proper dosing. This information is for reference only.

    Storage & Handling

    Store DARZALEX vials in the original carton at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake. Protect from light.

    Diluted Solution:

  11. Dilute in 0.9% Sodium Chloride Injection
  12. Diluted solution stable for up to 15 hours at room temperature (up to 25°C) and room light
  13. Diluted solution stable for up to 24 hours if refrigerated at 2-8°C and protected from light
  14. Do not freeze diluted solution
  15. DARZALEX does not contain preservatives. Any unused product or waste material should be disposed of according to local requirements.

    We ensure proper cold chain handling during shipping to maintain product integrity.

    Frequently Asked Questions About DARZALEX

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