All the Active Ingredient Drugs
Monoclonal Antibody. Daratumumab 20 mg/ml. Vial(Concentr. for sol. for IV infus.): 1 × 5, 20ml.
16 mg/kg body weight admin. as an IV infuse. accord. to the follow. dosing schedule: Wkly.: 1st – 8th week. Every 2 wks.: 9th -24th week. Every 4 wks.: 25th week onwards until dis. progres.
As monother. is indic. for the tmt. of adult pts. with relapsed and refract. multiple myeloma, whose prior ther. includ. a proteasome inhib. and an immunomodulat. agent and who have demonstrated dis.progres. on the last ther.
C/I:Hypersens.
Monoclonal Antibody. Daratumumab 120 mg/ml. Vial (sol. for SC inj.): 1 X 15 ml (1800 mg).
1800 mg of sol. for SC inject. over approx. 3-5 minutes accord. to the follow.
1st – 8th week: once/week.
9th -24th week :every two weeks
25th week onwards until dis. progress.: every 4 weeks
Multiple Myeloma: in combin. with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for adults with newly diagn. multiple myeloma who are ineligible for autologous stem cell transplant.• in combin. with bortezomib, thalidomide and dexamethasone for adults with newly diagn. multiple myeloma who are eligible for autologous stem cell transplant.• in combin. with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for adults with multiple myeloma who have received at least one prior ther.• as monother. for adults with relapsed and refractory multiple myeloma, whose prior ther. included a proteasome inhib. and an immunomodul. agent and who have demonstrated disease progress. on the last ther.•for adults with multiple myeloma in combin. with pomalidomide and dexamethasone in pts. who have received at least one prior line of ther. incl. lenalidomide and a proteasome inhib. • Light chain (AL) amyloidosis: in combin. with cyclophosphamide, bortezomib and dexamethasone for adults with newly diagn. syst. AL amyloidosis.
C/I:Hypersens.