Daratumumab 400mg (Daratumumab)

Daratumumab
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Brand nameDarzalexInternational trade nameDarzalexActive substanceDaratumumabStrength400mgCategoryAnti Cancer

Description of Darzalex 400mg (Daratumumab 400mg)

Darzalex 400mg (Daratumumab 400mg) is a type of antineoplastic Medicine.
Darzalex 400mg (Daratumumab 400mg)  belongs to human CD38-directed monoclonal antibody necessary for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, contain a proteasome inhibitor (PI) and an immunomodulatory agent or who are twice refractory to a PI and an immunomodulatory agent.

Medical use /Indication of Darzalex 400mg (Daratumumab 400mg)

Darzalex in combination with the medicines bortezomib, melphalan and prednisone, is indicated for the treatment in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)

Darzalex in combination with the medicines lenalidomide and dexamethasone or bortezomib and dexamethasone, is indicated for the treatment in people who have received at least one prior medicine to treat multiple myeloma Darzalex in combination with the medicines pomalidomide and dexamethasone, is indicated for the treatment in people who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor

Darzalex indicated alone in people who have received at least three prior medicines to treat multiple myeloma, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent

Mechanism of Action Darzalex 400mg (Daratumumab 400mg)

Daratumumab belongs to immunoglobulin G1 kappa monoclonal antibody against CD38 antigen. CD38 is a transmembrane glycoprotein of various functions, involving receptor mediated adhesion, indicating, and modulation of cyclase and hydrolase activity. CD38 is termed on many cell types and tissues, and highly convey in haematological malignancies containing multiple myeloma tumor cells. By binding CD38, daratumumab leads prohibition of tumor cell growth and induces broad-spectrum apoptosis in multiple ways: by Fc-mediated cross linking, by immune-mediate tumor cell lysis via complement dependent cytotoxicity, antibody dependent cell cytotoxicity, and antibody dependent cellular phagocytosis.

ADME of Darzalex 400mg (Daratumumab 400mg)

Absorption of Darzalex 400mg (Daratumumab 400mg)

peak plasma concentration is 915 mcg/mL (weekly dosing)

Distribution of Darzalex 400mg (Daratumumab 400mg)

Monotherapy volume of distribution in steady-state is 4.7 L and in combination

Elimination of Darzalex 400mg (Daratumumab 400mg)

the half-life of Darzalex monotherapy is 18 days and combination therapy 22-23 days

Side effects of Darzalex 400mg (Daratumumab 400mg)

Darzalex 400mg (Daratumumab 400mg) may causes some common and serious side effects as follows;

  • Loss of appetite
  • Diarrhae
  • High blood pressure
  • Muscular chest pain
  • Low blood counts
  • Fatigue
  • Nasal congestion
  • Throat irritation
  • Cough
  • Shortness of breath
  • Chills vomiting
  • Back pain
  • Joint pain.

Precautions of Darzalex 400mg (Daratumumab 400mg)

While treatment with Darzalex 400mg (Daratumumab 400mg) will cause increased neutropenia and/or thrombocytopenia induced by background therapy; during treatment periodically check CBC counts;monitor patients with neutropenia for signs of infection; dose delay may be needed to allow recovery of neutrophils; no dose decrease is recommended, consider supportive care with growth factors and/or transfusions

Darzalex 400mg (Daratumumab 400mg) willlink to CD38 on RBCs and may leads in a positive indirect antiglobulin test (Coombs test)

Darzalex 400mg (Daratumumab 400mg) resulted in false-positive reports with plasma protein electrophoresis (SPE) and immunofixation (IFE) assays

Drug interaction of Darzalex 400mg (Daratumumab 400mg)

The Medicine Darzalex 400mg (Daratumumab 400mg) has no Medicine interaction studies have been performed

Contraindication of Darzalex 400mg (Daratumumab 400mg)

The Medicine Darzalex 400mg (Daratumumab 400mg) is contraindicated patients with hypersensitivity to the active substance or to any of the excipients

Pregnancy of Darzalex 400mg (Daratumumab 400mg)

Using of Medicine Darzalex 400mg (Daratumumab 400mg) during pregnancyis not advisable due to Medicine mechanism of action, may cause fetal myeloid or lymphoid-cell depletion and reduced bone density.

Lactation of Darzalex 400mg (Daratumumab 400mg)

Excretion into human milk is unknown. May be possible adverse reaction on the breast-fed child from Darzalex 400mg (Daratumumab 400mg)

Dosage of Darzalex 400mg (Daratumumab 400mg)

Darzalex is indicated for the treatment of multiple myeloma the dosage for therapy as follows;

RECENTLY DIAGNOSED MULTIPLE MYELOMA :

  • The usual dose given in patients for weeks 1-6 is 16mg/kg infusion once weekly (total of 6 doses);
  • The usual dose given in patients for Weeks 7-54 is 16 mg/kg IV infusion every 3 weeks (total of 16 doses)
  • The usual dose given in patients for Week 55 onwards until disease progression is 16mg/kg IV infusion every 4 weeks.

RELAPSED/REFRACTORY MULTIPLE MYELOMA :

Monotherapy :

  • The usual dose given in patients for weeks 1-8 is 16mg/kg IV infusion every 2 weeks (total of 8 doses)
  • The usual dose given in patients for Weeks 9-24 is 16mg/kg IV infusion every 2 weeks (total of 8 doses)
  • The usual dose given in patients for Weeks 25 onward until disease progression is 16 mg/kg IV infusion every 4 weeks.

Combination with bortezomib and dexamethasone :

  • The usual dose given in patients for Weeks 1-9 is 16 mg/kg IV infusion once weekly (total of 9 doses)
  • The usual dose given in patients for Weeks 10-24 is 16 mg/kg IV infusion every 3 weeks (total of 5 doses)
  • The usual dose given in patients for Week 25 onwards until disease progression is 16 mg/kg IV infusion every 4 weeks

Combination treatment with lenalidomide and dexamethasone :

  • The usual dose given in patients for Weeks 1-8 is 16 mg/kg IV infusion once weekly (total of 8 doses)
  • The usual dose given in patients for Weeks 9-24 is 16 mg/kg IV infusion every 2 weeks (total of 8 doses)
  • The usual dose given in patients for Week 25 onwards until disease progression is 16 mg/kg IV infusion every 4 weeks

Combination treatment with pomalidomide and dexamethasone :

  • The usual dose given in patients for Weeks 1-8 is 16 mg/kg IV infusion once weekly
  • The usual dose given in patients for Weeks 9-24 is 16 mg/kg IV infusion every 2 weeks
  • The usual dose given in patients for Week 25 onwards until disease progression is 16 mg/kg IV infusion every 4 weeks

Storage of Darzalex 400mg (Daratumumab 400mg)

Store the Medicine at 2 ℃ – 8 ℃

Avoid freezing or shake

Protect from light

Missed dose of Darzalex 400mg (Daratumumab 400mg)

If dose is missed then take it immediately soon, if time reach for next dose, then skip missed dose and continue regular schedule. Avoid taking two doses at a time.

Brand name:
Darzalex
International trade name:
Darzalex
Active substance:
Daratumumab
Strength:
400mg
Category:
Anti Cancer
Packaging:
1 Vial
Product form:
Injection

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