Darzalex

Darzalex

daratumumab

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Daratumumab
Indications/Uses
In combination w/ bortezomib, melphalan & prednisone for the treatment of adult patients w/ newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. As monotherapy for the treatment of adult patients w/ relapsed & refractory multiple myeloma, whose prior therapy included a proteasome inhibitor & an immunomodulatory agent & who have demonstrated disease progression on the last therapy. In combination w/ lenalidomide & dexamethasone, or bortezomib & dexamethasone, for the treatment of adult patients w/ multiple myeloma who have received at least 1 prior therapy.
Dosage/Direction for Use
IV infusion Newly diagnosed multiple myeloma in combination w/ bortezomib, melphalan & prednisolone ([VMP], 6-wk cycle dosing regimen) Recommended dose: 16 mg/kg wkly on wk 1-6, every 3 wk on wk 7-54, every 4 wk on wk 55 onwards until disease progression. Relapased/refractory multiple myeloma as monotherapy & in combination w/ lenalidomide (4-wk cycle dosing regimen) Recommended dose: 16 mg/kg wkly on wk 1-8, every 2 wk on wk 9-24, every 4 wk on wk 25 onwards until disease progression. Relapased/refractory multiple myeloma in combination w/ bortezomib (3-wk cycle dosing regimen) Recommended dose: 16 mg/kg wkly on wk 1-9, every 3 wk on wk 10-24, every 4 wk on wk 25 onwards until disease progression.
Contraindications
Special Precautions
Monitor for infusion-related reactions (IRRs). Permanently discontinue in the event of life-threatening IRRs. May increase neutropenia & thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment. Monitor patients w/ neutropenia for signs of infection. Interference w/ indirect antiglobulin test (indirect Coombs test); w/ serum protein electrophoresis (SPE) & immunofixation (IFE) assays. Patients on a controlled Na diet. Women of child-bearing potential should use effective contraception during & for 3 mth after cessation of treatment. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Infusion reactions, fatigue, nausea, diarrhoea, muscle spasms, pyrexia, cough, neutropenia, thrombocytopenia, anaemia, peripheral sensory, neuropathy, upper resp tract infection.
ATC Classification
L01XC24 - daratumumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Darzalex conc for soln for infusion 100 mg/5 mL
Packing/Price
1's
Form
Darzalex conc for soln for infusion 400 mg/20 mL
Packing/Price
1's
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