Daratumumab 100mg Injection - Darzalex Injection Uses, Warning

Daratumumab 100 mg Injection

  • Medicine Name – Darzalex
  • API – Daratumumab
  • Pack Size – 1 Single-use vial
  • Strength – 100 mg
  • Manufactured by – Janssen Pharmaceuticals
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Description

Daratumumab 100 mg injection is indicated: 

  • In combination with lenalidomide and dexamethasone, or Bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. 

  • As monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

Dosage and Side Effects

  • Administer pre-infusion and post-infusion medications.

  • Administer only as an intravenous infusion after dilution in 0.9% Sodium Chloride Injection

  • Daratumumab 100 mg Injection should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage infusion reactions if they occur.

The common side-effects of Daratumumab injection are infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, muscle spasms, back pain, pyrexia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy and upper respiratory tract infection.

Warning and Precautions

  • Infusion reactions: Interrupt Daratumumab injection infusion for infusion reactions of any severity. Permanently discontinue the infusion in case of life threatening infusion reactions. 

  • Interference with cross-matching and red blood cell antibody screening: Type and screen patients prior to starting treatment. Inform blood banks that a patient has received Daratumumab injection.

  • Neutropenia: Monitor complete blood cell counts periodically during treatment. Monitor patients with neutropenia for signs of infection. Dose delay may be required to allow recovery of neutrophils.

  • Thrombocytopenia: Monitor complete blood cell counts periodically during treatment. Dose delay may be required to allow recovery of platelets.

FAQ's

Is daratumumab injection FDA approved?

Daratumumab Injection was approved by the FDA in 2015.

What is the action of Daratumumab Injection?

CD38, a transmembrane glycoprotein expressed on hematopoietic cells, plays various roles, including receptor-mediated adhesion and modulation of cyclase and hydrolase activity. Daratumumab Injection, an IgG1κ human monoclonal antibody, binds to CD38. It inhibits the growth of CD38-expressing tumor cells by inducing apoptosis directly through Fc-mediated cross-linking. Additionally, it promotes immune-mediated tumor cell lysis through complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). Daratumumab reduces specific immune cell subsets, including myeloid-derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs), and B cells (CD38+Bregs).

Is daratumumab Injection a chemotherapy?

Daratumumab injection is not classified as chemotherapy. It is a targeted monoclonal antibody designed to treat multiple myeloma, a type of blood cancer. Rather than a traditional chemotherapy approach, daratumumab operates by specifically targeting CD38-expressing cells, slowing or halting the progression of multiple myeloma in distinct ways.

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