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Darzalex 100mg/5ml (Daratumumab)

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DARZALEX 100MG

Description

Darzalex 100mg belongs to antineoplastic drug required for multiple myeloma in patients who have getting at least 3 prior treatments.

Darzalex 100mg which is a human CD38-directed monoclonal antibody containing a proteasome inhibitor (PI) and an immunomodulatory agent or who are twice refractory to a PI and an immunomodulatory agent.

Indication

  • Darzalex 100mg is indicated in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 prior therapy
  • Darzalex 100mg is indicated in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are unsuitable for autologous stem cell transplant (ASCT)
  • Darzalex 100mg is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at 1 prior therapy
  • Darzalex 100mg is indicated 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 100mg is indicated in combination 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

Mechanism of action

Daratumumab belongs to a monoclonal antibody whichaction by producing certain cells in the immune system aggression these cancer cells. One of the antigens signify on the surface of multiple myeloma cells is called CD38. Anti-CD38 antibodies, like daratumumab, aims multiple myeloma cells by binding to the CD38 antigen and then indicating the patient’s immune system to attack the tumour.

ADME Properties

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

Single treatment the 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

Dosage and administration

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

RECENTLY DIAGNOSED MULTIPLE MYELOMA

The Darzalex usual dose for weeks 1-6 is 16mg/kg infusion once weekly (total of 6 doses);

The Darzalex usual dose for Weeks 7-54 is 16 mg/kg IV infusion every 3 weeks (total of 16 doses)

The Darzalex usual dose for Week 55 onwards until disease progression is 16mg/kg IV infusion every 4 weeks.

RECURRENT/REFRACTORY MULTIPLE MYELOMA

Monotherapy

The Darzalex usual dose for weeks 1-8 is 16mg/kg IV infusion every 2 weeks (total of 8 doses)

The Darzalex usual dose for Weeks 9-24 is 16mg/kg IV infusion every 2 weeks (total of 8 doses)

The Darzalex usual dose for Weeks 25 onward until disease progression is 16 mg/kg IV infusion every 4 weeks.

Combination with bortezomib and dexamethasone

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

Combination treatment with lenalidomide and dexamethasone

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

Combination treatment with pomalidomide and dexamethasone

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

Side effects

Darzalex 100mg may causes some common and serious side effects as follows

Diarrhae

Throat irritation

Cough

Shortness of breath

Chills vomiting

Back pain

Joint pain

Loss of appetite

Low blood counts

Fatigue

Nasal congestion

High blood pressure

Muscular chest pain

Drug interaction

The drug Darzalex 100mg has no drug interaction studies have been performed

Contraindication

The drug Darzalex 100mg is contraindicated patients with hypersensitivity to the active substance or to any of the excipients

Precautions

Darzalex 100mg may have increased neutropenia and/or thrombocytopenia induced by background therapy; monitor CBC counts periodically during treatment; regulate patients with neutropenia for signs of infection; dose delay may be necessary to allow recovery of neutrophils; no dose reduction is recommended, consider supportive care with growth factors and/or transfusion

Darzalex 100mg willconnect to CD38 on RBCs and may results in a positive indirect antiglobulin test (Coombs test)

Darzalex 100mg will cause false-positive results with serum protein electrophoresis (SPE) and immunofixation (IFE) assays

Pregnancy

During pregnancy using of drug Darzalex100mg is not advisable due to drug mechanism of action, may cause fetal myeloid or lymphoid-cell depletion and reduced bone density.

Lactation

Excretion into human milk is unknown. May be possible adverse reaction on the breast-fed child from Darzalex100mg

Storage

Store the drug at 20C – 80C

Avoid freezing or shake

Protect from light

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.

  • Trade name Darzalex 100mg/5ml
  • Substance Daratumumab
  • Manufacturer Janssen Biotech
  • Packaging 5ml injection in a vial
  • Country of origin India
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