Darzalex

Darzalex

daratumumab

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Daratumumab
Indications/Uses
In combination w/ lenalidomide & dexamethasone for patients w/ newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT) & in patients w/ relapsed or refractory multiple myeloma who have received at least 1 prior therapy. In combination w/ bortezomib, melphalan, prednisone for patients w/ newly diagnosed multiple myeloma who are ineligible for ASCT. In combination w/ bortezomib, thalidomide & dexamethasone in newly diagnosed patients who are eligible for ASCT. In combination w/ bortezomib & dexamethasone for patients w/ multiple myeloma who have received at least 1 prior therapy. In combination w/ carfilzomib & dexamethasone for patients w/ relapsed or refractory multiple myeloma who have received 1-3 prior lines of therapy. Monotherapy for patients w/ multiple myeloma who have received at least 3 prior lines of therapy including proteasome inhibitor (PI) & immunomodulatory agent or who are double-refractory to PI & immunomodulatory agent.
Dosage/Direction for Use
Adult ≥18 yr Monotherapy & in combination w/ lenalidomide & low-dose dexamethasone 16 mg/kg IV infusion as 4-wk cycle regimen. Wk 1-8: Wkly (total: 8 doses). Wk 9-24: Every 2 wk, 1st dose to be given at wk 9 (total: 8 doses). Wk 25 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 25. In combination w/ bortezomib, melphalan & prednisone 16 mg/kg IV infusion as 6-wk cycle regimen. Wk 1-6: Wkly (total: 6 doses). Wk 7-54: Every 3 wk, 1st dose to be given at wk 7 (total: 16 doses). Wk 55 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 55. Bortezomib is given twice wkly at Wk 1, 2, 4 & 5 for 1st 6-wk cycle, followed by once wkly at Wk 1, 2, 4 & 5 for 8 more 6-wk cycles. In combination w/ carfilzomib & dexamethasone 4-wk cycle regimen: Wk 1: 8 mg/kg on days 1 & 2 (total: 2 doses). Wk 2-8: 16 mg/kg wkly (total: 7 doses). Wk 9-24: 16 mg/kg every 2 wk, 1st dose to be given at wk 9 (total: 8 doses). Wk 25 onwards until disease progression: 16 mg/kg every 4 wk, 1st dose to be given at wk 25 (dose based on actual body wt). In combination w/ bortezomib & dexamethasone 16 mg/kg IV infusion as 3-wk cycle regimen. Wk 1-9: Wkly (total: 9 doses). Wk 10-24: Every 3 wk, 1st dose to be given at wk 10 (total: 5 doses). Wk 25 onwards until disease progression: Every 4 wk, 1st dose to be given at wk 25. In combination w/ bortezomib, thalidomide & dexamethasone 16 mg/kg IV infusion as 4-wk cycle regimen. Induction phase: Wk 1-8: Wkly (total: 8 doses). Wk 9-16: Every 2 wk, 1st dose to be given at wk 9 (total: 4 doses). Stop for high-dose chemotherapy & ASCT. Consolidation phase: Wk 1-8: Every 2 wk, 1st dose to be given at wk 1 upon re-initiation of treatment following ASCT (total: 4 doses).
Contraindications
History of severe hypersensitivity.
Special Precautions
Infusion-related reactions (IRRs), monitor patients throughout the infusion & post-infusion period, premed patients w/ antihistamines, antipyretics & corticosteroids to reduce risk of IRRs prior to treatment. Permanently discontinue if anaphylactic or life-threatening (Grade 4) infusion-related reactions (IRR) occurs, administer oral corticosteroids following all infusions to reduce risk of delayed IRRs, consider post-infusion medications for patients w/ history of COPD to manage resp complications. Interrupt infusion & seek immediate ophth evaluation prior to restarting if ocular symptoms occur. Neutropenia/thrombocytopenia, periodically monitor CBC during treatment & in patients w/ neutropenia for signs of infection. Inteference w/ indirect antiglobulin test (indirect Coombs test), type & screen prior to starting. HBV reactivation, perform HBV screening in all patients before initiation. Monitor for clinical & lab signs of HBV reactivation during & for at least 6 mth of treatment. May affect ability to drive & use machines. Women of reproductive potential should use effective contraception during & for 3 mth after treatment. Not to be used during pregnancy. Lactation. Ped patients ≤17 yr.
Adverse Reactions
Infusion reactions, diarrhea, constipation, nausea, peripheral edema, fatigue, back pain, asthenia, pyrexia, URTI, bronchitis, pneumonia, decreased appetite, muscle spasms, peripheral sensory neuropathy, dyspnea, cough, back pain, anemia, neutropenia, thrombocytopenia.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FC01 - daratumumab ; Belongs to the class of CD38 (Clusters of Differentiation 38) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Darzalex infusion conc (single-use vial) 100 mg/5 mL
Packing/Price
1's
Form
Darzalex infusion conc (single-use vial) 400 mg/20 mL
Packing/Price
1's
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