Monotherapy and in combination with lenalidomide and dexamethasone ( d- rd). 3 pharmacokinetics. sq injection: premedicate with corticosteroids, acetaminophen, and histamines. quick take daratumumab and standard therapy for pdf myeloma 01: 53. 8 use in specific populations. give sq into the abdomen over approximately three to five minutes. it is used to treat multiple myeloma. , for the andromeda trial investigators * article figures/ media metrics 36 references 198 citing articles abstract background systemic immunoglobulin light- chain ( al). daratumumab and 30, 000 units hyaluronidase) administered subcutaneously over approximately 35 minutes. fda granted daratumumab breakthrough therapy and orphan drug designation, as well as priority. daratumumab is a human igg1 kappa monoclonal antibody that targets the transmembrane glycoprotein cd38. darzalex ® is a prescription medicine used to treat adults with multiple myeloma: in combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells ( autologous stem cell transplant) and in people whose multiple. the anti- cd38 mab, daratumumab ( jnj54767414, humax® cd38), was recently granted breakthrough therapy designation by the fda for mm that is refractory to a pi and imid. stefan schönland, m. 1 multiple myeloma 1. of note, anti- cd38 daratumumab pdf may cause a small decrease in hemoglobin in vivo ( ~ 1 g/ dl), but severe. 1 important dosing information 2. 2 light chain amyloidosis 2 dosage and administration 2. 1 effects of daratumumab on laboratory tests. daratumumab is approved to be used alone or with other. 7% ), lymphopenia ( 15.
darzalex faspro® ® ( daratumumab and hyaluronidase- hj) injection darzalex faspro ( daratumumab and hyaluronidase- hj) injection 2 full prescribing information: contents* 1 indications and usage 1. week 25 onwards until disease progression: 16 mg/ kg every 4 weeks; first dose of the every- 4- week dosing. it potently inhibits the growth of cd38- expressing tumour cells and may induce tumour cell lysis by utilizing multiple effector functions in malignancies expressing cd38. 1 mechanism of action. 13 nonclinical toxicology. darzalex ( daratumumab) injection, for intravenous use initial u. low blood cell counts- - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and. 2 recommended dosage for multiple myeloma. background advances in the treatment of multiple myeloma ( mm), particularly the development of immunomodulatory drugs ( imids) and proteasome inhibitors ( pis) and the use of autologous hematopoietic stem cell transplant- ation, have led to significant improvement in overall survival in patients with mm [ 1, 2]. with bortezomib, thalidomide, and dexamethasone in patients. however, there are other anti- cd38 monoclonal antibodies under development and in trials. effects of daratumumab on laboratory tests 8 use in specific populations 8. in addition, new off label uses for anticd38 monoclonal antibodies are coming into clinical practice. cd38 is a cell surface glycoprotein with cyclic adp ribose hydrolase activity, but its biological roles are just beginning to be understood. week 1: 8 mg/ kg iv on days 1 and 2 ( total of 2 doses) weeks 2 to 8: 16 mg/ kg iv weekly ( total of 7 doses) weeks 9 to 24: 16 mg/ kg iv every 2 weeks ( total of 8 doses) ; first dose of the every- 2- week dosing schedule is given at week 9. daratumumab this information from lexicomp explains what you need to know about this medication, including what it’ s used for, how to take it, its side effects, and when to call your healthcare provider. females and males of reproductive potential 8. to prevent needle clogging,
attach the hypodermic injection needle or sq infusion set to the syringe immediately prior to injection. approval – recent major changesindications and usage ( 1) 11/. the most common adverse events of grade 3 or 4 were neutropenia ( 50. multiple myeloma. 2 pharmacodynamics. tables 1, 2, and 3 provide the recommended dosing schedule when darzalex faspro is administered pdf as monotherapy or as part of a combination therapy. it is used: in adults with newly diagnosed disease. daratumumab may cause serious side effects. call your doctor at once if you have: cough with yellow or green mucus; stabbing chest pain, wheezing, feeling short of breath; numbness, tingling, burning pain; or.
11 description 12 clinical pharmacology. daratumumab and isatuximab. 3 females and males of reproductive potential. darzalex is a cd38- directed cytolytic antibody 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 pr. darzalex faspro is a combination of daratumumab, a cd38- directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: multiple daratumumab pdf myeloma in. the recommended dose of daratumumab is 16 mg/ kg intravenously ( calculated on actual body weight). the risk of multiple myeloma increases with age, 1- 3 and despite progress in the development of effective treatment, the disease. 0% pdf in the daratumumab group vs. 3% in the control group), anemia ( 11. geriatric use 11 description 12 clinical pharmacology. it is used: with lenalidomide and dexamethasone or with bortezomib, melphalan, and prednisone in patients who cannot receive an autologous stem cell transplant. brand names: us darzalex brand names: canada darzalex what is this drug used for? 13 nonclinical toxicology 13. daratumumab, a human iggκ monoclonal antibody that targets cd38, induces direct and indirect antimyeloma activity and has shown substantial efficacy as monotherapy in heavily pretreated patients.