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Darzalex

Darzalex

daratumumab

Manufacturer:

Johnson & Johnson

Distributor:

Zuellig
Concise Prescribing Info
Contents
Daratumumab
Indications/Uses
Dosage/Direction for Use
IV Adult ≥18 yr 16 mg/kg. Dosing schedule: Monotherapy &/or in combination w/ lenalidomide & low-dose dexamethasone (4-wk cycle regimen) Wk 1-8: wkly (total: 8 doses); wk 9-24 (1st dose of every 2-wk-dosing schedule at wk 9): every 2 wk (total: 8 doses); wk 25 onwards until disease progression (1st dose of every 4-wk-dosing schedule at wk 25): every 4 wk. In combination w/ bortezomib, melphalan & prednisone (VMP) (6-wk cycle dosing regimen) Wk 1-6: wkly (total: 6 doses); wk 7-54 (1st dose of every 3-wk dosing schedule at wk 7): every 3 wk (total 16 doses); wk 55 onwards until disease progression (1st dose of every 4-wk dosing schedule at 55): every 4 wk. Bortezomib is given bid wkly at wk 1, 2, 4 & 5 for the 1st 6-wk cycle followed by once wkly at wk 1, 2, 4 & 5 for 8 more 6-wk cycles. In combination w/ bortezomib (3-wk cycle regimen) Wk 1-9: wkly (total: 9 doses); wk 10-24 (1st dose of every 3-wk-dosing schedule at wk 10): every 2 wk (total: 5 doses); wk 25 onwards until disease progression (1st dose of every 4-wk dosing schedule at wk 25): every 4 wk.
Contraindications
Special Precautions
Perform HBV screening prior to treatment. Discontinue use if HBV reactivation develops; monitor patients evident of +ve HBV serology. Anaphylactic & infusion-related reactions. Interference w/ indirect antiglobulin test (indirect Coombs' test) & serum protein electrophoresis & immunofixation tests. Women of reproductive potential should use effective contraception 3 mth after treatment. Pregnancy & lactation.
Adverse Reactions
Infusion reactions, upper resp tract infection, peripheral edema, diarrhea & peripheral sensory neuropathy, cough, dyspnea. Constipation, nausea, fatigue, back pain, asthenia, pyrexia, bronchitis, pneumonia, decreased appetite & muscle spasms.
ATC Classification
L01XC24 - daratumumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Darzalex soln for infusion 20 mg/mL
Packing/Price
20 mL x 1's;5 mL x 1's
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