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8 use in specific populations. Darzalex ( daratumumab) injection, for intravenous use initial u. Geriatric use 11 description 12 clinical pharmacology. Approval – recent major changesindications and usage ( 1) 11/. 11 description 12 clinical pharmacology. Tables 1, 2, and 3 provide the recommended dosing schedule when darzalex faspro is administered as monotherapy or as part of a combination therapy.
Of note, anti- cd38 may cause a small decrease in hemoglobin in vivo ( ~ 1 g/ dl), but severe. 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. Effects of daratumumab on laboratory tests 8 use in specific populations 8. 1 effects of daratumumab on laboratory tests.
3 females and males of reproductive potential. 13 nonclinical toxicology. 13 nonclinical toxicology 13. To prevent needle clogging, attach the hypodermic injection needle or sq infusion set to the syringe immediately prior to injection. , for the andromeda trial investigators * article figures/ media metrics 36 references 198 citing articles abstract background systemic immunoglobulin light- chain ( al). Sq injection: premedicate with corticosteroids, acetaminophen, and histamines. Fda granted daratumumab breakthrough therapy and orphan drug designation, as well as priority. Multiple myeloma. 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. It is used: with lenalidomide and dexamethasone or with bortezomib, melphalan, and prednisone in patients who cannot receive an autologous stem cell transplant. 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.
Cd38 is a cell surface glycoprotein with cyclic adp ribose hydrolase activity, but its biological roles are just beginning to be understood. 1 important dosing information 2. Week 25 onwards until disease progression: 16 mg/ kg every 4 weeks; first dose of the every- 4- week dosing. 2 recommended dosage for multiple myeloma. The recommended dose of daratumumab is 16 mg/ kg intravenously ( calculated on actual body weight). Monotherapy and in combination with lenalidomide and dexamethasone ( d- rd). 2 pharmacodynamics. Daratumumab is approved to be used alone or with other. 7% ), lymphopenia ( 15. 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.
Daratumumab and isatuximab. Daratumumab and 30, 000 units hyaluronidase) administered subcutaneously over approximately 3- 5 minutes. Darzalex faspro® ® ( daratumumab and hyaluronidase- hj) injection darzalex faspro ( daratumumab and hyaluronidase- hj) injection 2 full prescribing information: contents* 1 indications and usage 1. 1 mechanism of action. In addition, new off label uses for anti- cd38 monoclonal antibodies are coming into clinical practice. Quick take daratumumab and standard therapy for myeloma 01: 53. With bortezomib, thalidomide, and dexamethasone in patients.
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. Daratumumab may cause serious side effects. Stefan schönland, m. 3 pharmacokinetics.
However, there are other anti- cd38 monoclonal antibodies under development and in trials. Low blood cell counts- - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and. Brand names: us darzalex brand names: canada darzalex what is this drug used for? 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. 2 light chain amyloidosis 2 dosage and administration 2. It is used to treat multiple myeloma.
It is used: in adults with newly diagnosed disease. Females and males of reproductive potential 8. The most common adverse events of grade 3 or 4 were neutropenia ( 50. 0% in the daratumumab group vs. Give sq into the abdomen over approximately three to five minutes. 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.
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 myeloma in. The risk of multiple myeloma increases with age, 1- 3 and despite progress in the development of effective treatment, the disease. 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]. 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. 3% in the control group), anemia ( 11. 1 multiple myeloma 1. Daratumumab is a human igg1 kappa monoclonal antibody that targets the transmembrane glycoprotein cd38.