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PRODUCT DETAILS

Brand Name : Darzalex
Composition : Daratumumab
Strength availability : 400mg/20ml
Manufactured by : Janssen Biotech
Pack : 20ml injection in a vial
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Darzalex 400mg is a type of antineoplastic drug.
Darzalex 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.

INDICATION

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

ADME

Absorption:
peak plasma concentration is 915 mcg/mL (weekly dosing)
Distribution:
Monotherapy volume of distribution in steady-state is 4.7 L and in combination
Elimination:
the half-life of Darzalex monotherapy is 18 days and combination therapy 22-23 days

DOSAGE

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

MECHANISM

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.

PRECAUTION

While treatment with Darzalex 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 willlink to CD38 on RBCs and may leads in a positive indirect antiglobulin test (Coombs test)
Darzalex 400mg resulted in false-positive reports with plasma protein electrophoresis (SPE) and immunofixation (IFE) assays

DRUG INTERACTION

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

CONTRAINDICATION

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

MISSED DOSE

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.

STORAGE

Store the drug at 2 ℃ – 8 ℃
Avoid freezing or shake
Protect from light

SIDE EFFECTS

Darzalex 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.

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