Darzalex 400mg

Darzalex 400mg is used in concomitant use with bortezomib, melphalan and prednisone for the therapies of patients with recently diagnosed multiple myeloma who are unsuitable for autologous stem cell transplant (ASCT)
Darzalex 400mg is used as monotherapy for multiple myeloma in patients who have getting at least 3 lines of therapy, contain a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD).
Darzalex 400mg is used in concomitant use with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 prior therapy
Darzalex 400mg is used in concomitant use with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at 1 prior therapy
Darzalex 400mg is used in concomitant use with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor

Daratumumab

Darzalex

400mg

Janssen Biotech




DESCRIPTION

Darzalex 400mg belongs to anti-cancer drug needed for multiple myeloma in patients who have received at least 3 prior treatments.
Darzalex 400mg is the type of first monoclonal antibody injection approved for this indication and provides another option for patients with multiple myeloma resistant to other treatment.
Darzalex 400mg induces apoptosis of cancer cells by targeting and attaches to CD38 epitope, which is mainly expressed on haematological malignancies.

Mechanism of action

Daratumumab is a Monoclonal antibody which binds with maximum affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab targets and attaches to a protein is called CD38 is believed to induce fast tumor cell death through programmed cell death, or apoptosis, and multiple immune-mediated mechanisms, involving complement-dependent cytotoxicity, antibody-dependent cellular phagocytosis, and antibody-dependent cellular cytotoxicity



Pharmacokinetic

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

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

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



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drug
Brand Darzalex
Ingredients Daratumumab
Strength 400mg
Manufactured Janssen Biotech
Rating

Darzalex is indicated for the treatment of multiple myeloma the dosage for therapy as follows :
NEWLY DIAGNOSED MULTIPLE MYELOMA :
The prescribed dose for weeks 1-6 is 16mg/kg infusion once weekly (total of 6 doses) :
The prescribed dose for Weeks 7-54 is 16 mg/kg IV infusion every 3 weeks (total of 16 doses)
The prescribed dose for Week 55 onwards until disease progression is 16mg/kg IV infusion every 4 weeks.
RELAPSED/REFRACTORY MULTIPLE MYELOMA:
Monotherapy :
The prescribed dose for weeks 1-8 is 16mg/kg IV infusion every 2 weeks (total of 8 doses)
The prescribed dose for Weeks 9-24 is 16mg/kg IV infusion every 2 weeks (total of 8 doses)
The prescribed dose for Weeks 25 onward until disease progression is 16 mg/kg IV infusion every 4 weeks.
Combination with bortezomib and dexamethasone :
• The prescribed dose for Weeks 1-9 is 16 mg/kg IV infusion once weekly (total of 9 doses)
• The prescribed dose for Weeks 10-24 is 16 mg/kg IV infusion every 3 weeks (total of 5 doses)
• The prescribed dose for Week 25 onwards until disease progression is 16 mg/kg IV infusion every 4 weeks
Combination treatment with lenalidomide and dexamethasone :
• The prescribed dose for Weeks 1-8 is 16 mg/kg IV infusion once weekly (total of 8 doses)
• The prescribed dose for Weeks 9-24 is 16 mg/kg IV infusion every 2 weeks (total of 8 doses)
• The prescribed dose for Week 25 onwards until disease progression is 16 mg/kg IV infusion every 4 weeks
Combination treatment with pomalidomide and dexamethasone :
• The prescribed dose for Weeks 1-8 is 16 mg/kg IV infusion once weekly
• The prescribed dose for Weeks 9-24 is 16 mg/kg IV infusion every 2 weeks
• The prescribed dose for Week 25 onwards until disease progression is 16 mg/kg IV infusion every 4 weeks

Side effects

Darzalex 400mg may causes some common and serious side effects as follows :
• Low blood counts
• Fatigue
• Nasal congestion
• Throat irritation
• Cough
• Shortness of breath
• Chills vomiting
• Back pain
• Joint pain
• Loss of appetite
• Diarrhae
• High blood pressure
• Muscular chest pain.

Precautions

Darzalex 400mg mayhave high neutropenia and/or thrombocytopenia induced by background therapy; check CBC counts periodically during treatment; control patients with neutropenia for signs of infection; dose delay may be needed to allow recovery of neutrophils; no dose reduction is recommended, consider supportive care with growth factors and/or transfusions
Darzalex 400mg will Binds to CD38 on RBCs and may reports in a positive indirect antiglobulin test (Coombs test)
Darzalex 400mg will cause false-positive results with serum protein electrophoresis (SPE) and immunofixation (IFE) assays

DRUG – DRUG INTERACTION

  • The drug Darzalex 400mg has no drug interaction studies have been performed

Contraindications

The drug Darzalex 400mg is contraindicated patients with hypersensitivity to the active substance or to any of the excipients




During pregnancy using of drug Darzalex 400mg is not advisable due to drug mechanism of action, may cause fetal myeloid or lymphoid-cell depletion and reduced bone density.

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

Store the drug at 2°C to 8°C .
Avoid freezing or shake
Protect from light

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.


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