Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - daratumumab, quantity: 400 mg - injection, concentrated - excipient ingredients: glacial acetic acid; sodium acetate trihydrate; sodium chloride; mannitol; polysorbate 20; water for injections - darzalex is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. for use in combination with:,? bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. for use in combination with:,? bortezomib, melphalan and prednisone, or,? lenalidomide and dexamethasone.,? with multiple myeloma who have received:,- at least one prior therapy. for use in combination with:,? bortezomib and dexamethasone, or,? lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent. for use as:,? monotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - daratumumab, quantity: 100 mg - injection, concentrated - excipient ingredients: glacial acetic acid; sodium acetate trihydrate; sodium chloride; mannitol; polysorbate 20; water for injections - darzalex is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. for use in combination with:,? bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. for use in combination with:,? bortezomib, melphalan and prednisone, or,? lenalidomide and dexamethasone.,? with multiple myeloma who have received:,- at least one prior therapy. for use in combination with:,? bortezomib and dexamethasone, or,? lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent. for use as:,? monotherapy.

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

ethnor del istmo, s.a. - daratumumab - daratumumab....400mg/20ml / daratumumab....100mg/5ml

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

ethnor del istmo, s.a. - daratumumab - daratumumab....20mg/ml

Israel - English - Ministry of Health

j-c health care ltd - daratumumab - concentrate for solution for infusion - daratumumab 20 mg / 1 ml - daratumumab - darzalex is indicated:• in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.• in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous st em cell transplant.• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.• as monotherapy 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

Australia - English - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - daratumumab, quantity: 1800 mg - injection, solution - excipient ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride monohydrate; sorbitol; methionine; polysorbate 20; water for injections - darzalex sc is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. for use in combination with:-bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. for use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone.,? with multiple myeloma who have received: - at least one prior therapy. for use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent. for use as: - monotherapy.,darzalex sc in combination with bortezomib, cyclophosphamide and dexamethasone, is indicated for the treatment of patients with light chain al amyloidosis.

Israel - English - Ministry of Health

j-c health care ltd - daratumumab - solution for injection - daratumumab 120 mg / 1 ml - daratumumab - darzalex is indicated:• in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.• in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.• as monotherapy 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.

United States - English - NLM (National Library of Medicine)

janssen biotech, inc. - daratumumab (unii: 4z63yk6e0e) (daratumumab - unii:4z63yk6e0e), hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - darzalex faspro is indicated for the treatment of adult patients with multiple myeloma: - in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. - in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. - in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. - in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. - in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. - in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have receive

European Union - English - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - multiple myeloma - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1).as monotherapy 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.al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

United States - English - NLM (National Library of Medicine)

janssen biotech, inc. - daratumumab (unii: 4z63yk6e0e) (daratumumab - unii:4z63yk6e0e) - daratumumab 100 mg in 5 ml - darzalex is indicated for the treatment of adult patients with multiple myeloma: - in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. - in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. - in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. - in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. - in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. - in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. - as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are double-refractory to a pi and an immunomodulatory agent. darzalex is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylactic reactions) to daratumumab or any of the components of the formulation [see warnings and precautions (5.1)] . risk summary darzalex can cause fetal harm when administered to a pregnant woman. the assessment of associated risks with daratumumab products is based on the mechanism of action and data from target antigen cd38 knockout animal models (see data) . there are no available data on the use of darzalex in pregnant women to evaluate drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the combination of darzalex and lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women, because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. lenalidomide, pomalidomide, and thalidomide are only available through a rems program. refer to the lenalidomide, pomalidomide, or thalidomide prescribing information on use during pregnancy. clinical considerations fetal/neonatal adverse reactions immunoglobulin g1 (igg1) monoclonal antibodies are transferred across the placenta. based on its mechanism of action, darzalex may cause depletion of fetal cd38 positive immune cells and decreased bone density. defer administering live vaccines to neonates and infants exposed to darzalex in utero until a hematology evaluation is completed. data animal data mice that were genetically modified to eliminate all cd38 expression (cd38 knockout mice) had reduced bone density at birth that recovered by 5 months of age. data from studies using cd38 knockout animal models also suggest the involvement of cd38 in regulating humoral immune responses (mice), feto-maternal immune tolerance (mice), and early embryonic development (frogs). risk summary there is no data on the presence of daratumumab in human milk, the effects on the breastfed child, or the effects on milk production. maternal immunoglobulin g is known to be present in human milk. published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts. because of the potential for serious adverse reactions in the breastfed child when darzalex is administered with lenalidomide, pomalidomide, or thalidomide, advise women not to breastfeed during treatment with darzalex. refer to lenalidomide, pomalidomide, or thalidomide prescribing information for additional information. darzalex can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing with the combination of darzalex with lenalidomide, pomalidomide, or thalidomide, refer to the lenalidomide, pomalidomide, or thalidomide labeling for pregnancy testing requirements prior to initiating treatment in females of reproductive potential. contraception advise females of reproductive potential to use effective contraception during treatment with darzalex and for 3 months after the last dose. additionally, refer to the lenalidomide, pomalidomide, or thalidomide labeling for additional recommendations for contraception. safety and effectiveness of darzalex in pediatric patients have not been established. of the 2,459 patients who received darzalex at the recommended dose, 38% were 65 to 74 years of age, and 15% were 75 years of age or older. no overall differences in effectiveness were observed between these patients and younger patients. the incidence of serious adverse reactions was higher in older than in younger patients [see adverse reactions (6.1)] . among patients with relapsed and refractory multiple myeloma (n=1,213), the serious adverse reactions that occurred more frequently in patients 65 years and older were pneumonia and sepsis. within the dkd group in candor, fatal adverse reactions occurred in 14% of patients 65 years and older compared to 6% of patients less than 65 years. among patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (n=710), the serious adverse reaction that occurred more frequently in patients 75 years and older was pneumonia.