• Home
  • A-B index
  • Pharmacological Index
  • Drug Classes
  • Active Ingredients
  • Companies
  • News
  • Darzalex
    / Janssen


    Active Ingredient
    Daratumumab 20 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 5 ml

    not in the basket chart 60534

    Vial

    1 X 20 ml

    60535

    Related information


    Dosage

    The recommended dose is 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule:
    Weekly: 1st – 8th week.
    Every two weeks:  9th -24th week.
    Every four weeks: 25th week  onwards until disease progression.


    Indications

    Daratumumab as monotherapy is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Infusion‑related reactions: Infusion‑related reactions (IRRs) were reported in approximately half of all patients treated with Daratumumab. Monitor such patients throughout the infusion and the post‑infusion period.
    Interference with Indirect Antiglobulin Test (Indirect Coombs Test): Daratumumab binds to CD38 found at low levels on red blood cells (RBCs) and may result in a positive indirect Coombs test. Daratumumab‑mediated positive indirect Coombs test may persist for up to 6 months after the last daratumumab infusion. It should be recognised that daratumumab bound to RBCs may mask detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type are not impacted. Patients should be typed and screened prior to starting daratumumab treatment. Phenotyping may be considered prior to starting daratumumab treatment as per local practice. Red blood cell genotyping is not impacted by daratumumab and may be performed at any time.
    Interference with determination of Complete Response: Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both, the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M‑protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
    Excipients: Each 5 mL and 20 mL vial of the drug contains 0.4 mmol and 1.6 mmol (9.3 mg and 37.3 mg) sodium, respectively. This should be taken into consideration by patients on a controlled sodium diet.
    See prescribing information for full details.


    Side Effects

    The most frequently reported adverse reactions were IRRs. Other frequently reported adverse reactions  were fatigue, pyrexia, cough, nausea, back pain, upper respiratory tract infection, anaemia, neutropenia  and thrombocytopenia.
    See prescribing information for full details.


    Drug interactions

    No interaction studies have been performed.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Women of child-bearing potential should use effective contraception during, and for 3 months. There are no human or animal data to assess the risk of daratumumab use during pregnancy.
    See prescribing information for full details.
    Lactation: It is not known whether daratumumab is excreted into human or animal milk.  


    Overdose

    Symptoms and signs: There has been no experience of overdosage in clinical studies. Doses up to 24 mg/kg have been administered intravenously in a clinical study.
    Treatment: There is no known specific antidote for daratumumab overdose. In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment should be instituted immediately.


    Important notes

    Storage: Store in a refrigerator (2 °C-8 °C). Do not freeze or shake. Store in the original package in order to protect from light.  


    Manufacturer
    Cilag AG
    Licence holder
    CLOSE