Advise pregnant womenof the potential risk to a fetus. The ninlaro ixazomib regimen extended pfs by 6 months median. The recommended dose of darzalex is 16 mgkg actual body weight administered as an. Darzalex daratumumab injection, for intravenous use. Full prescribing information 1 indications and usage ocrevus is indicated for the treatment of. Information for the patient darzalex 20 mgml concentrate for solution for infusion daratumumab this medicine is subject to additional monitoring. Prior authorization is required to ensure the safe, clinically appropriate and costeffective use of darzalex while maintaining optimal therapeutic outcomes. Infed iron dextran injection usp is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Oct 29, 2019 droperidol should be administered with extreme caution in the presence of risk factors for development of prolonged qt syndrome, such as. Limited postmarketing cases report preterm births and early pregnancy loss in womentreated with lysodren during pregnancy. Highlights of prescribing information these highlights do not. Darzalex is indicated for use in combination with lenalidomide and. Daratumumab, bortezomib, cyclophosphamide and dexamethasone.
Darzalex is a cd38directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma 1. Studies 14 and manufacturers prescribing information. Darzalex, see manufacturers prescribing information. For sc administration, preferably using a 1ml polypropylene syringe fitted with a disposable 21 to 27gauge x 0. Darzalex daratumumabinjection, for intravenous use initial u. Highlightsof prescribing information kyprolis safely. Mozobil plerixafor injection is a sterile, preservativefree, clear, colorless to paleyellow, isotonic solution for subcutaneous injection. Darzalex faspro is a prescription medicine used to treat adult patients with multiple myeloma. Darzalex dosing schedule with bortezomib 3week cycle dosing regimen weeks schedule. Estimate based on projected patients, calculations on demand, and duration of treatment. Worldwide since approval 2 1530 patients treated with darzalex in clinical trials 1. Darzalex may be considered medically necessary if one of the below conditions are met and use is consistent with the medical necessity criteria that follows. Advise pregnant women of the potential risk to a fetus.
For dosing instructions of combination agents administered with darzalex, see clinical studies 14 and manufacturers prescribing information the darzalex dosing schedule in table 2 is for combination therapy with bortezomib, melphalan and prednisone 6week cycle regimen for patients with newly diagnosed multiple myeloma ineligible for asct. Darzalex is used to treat multiple myeloma bone marrow cancer. Eighteen percent 18% of patients were refractory to a pi only, and 21% were. Bortezomib is administered by subcutaneous or iv injection on days 1, 4, 8, and 11 of each cycle for a total of 8 cycles. This booklet discusses darzalex also known by its generic drug name, daratumumab. Darzalex faspro daratumumab and hyaluronidasefihj is contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase or any of the components of the formulation warnings and precautions. Calculate the dose mg, total volume ml of solution required and the darzalex number of darzalex vials needed based on patient actual body weight. Approval 2015 recent major changesindications and usage 1 062019 dosage and administration 2. You can ask your healthcare provider or pharmacist for. 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. Lyra study habte yimer,1 jason melear,2 edward faber,3 william i. Monitor patients with neutropenia for signs of infection. The darzalex dosing schedule in table 2 is for combination therapy with bortezomib, melphalan and prednisone 6week cycle regimen for patients with newly diagnosed multiple myeloma ineligible for asct. Darzalex daratumumab injection, for intravenous use initial u.
Darzalex, inndaratumumab european medicines agency. Dailymed darzalex daratumumab injection, solution, concentrate. Ninlaro ixazomib healthcare professional information. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. Both systemic administrationrelated reactions, including severe or life. Aliqopa copanlisib for injection, for intravenous use. Highlights of prescribing information these highlights do not include all the information needed to use revlimid safely and effectively. Highlightsof prescribing information kyprolis safely and. Highlights of prescribing information these highlights do not include all the information needed to use promacta safely and effectively.
Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention 1 indications and usage 1. Official hcp website darzalex faspro daratumumab and. Promacta eltrombopag tablets, for oral use promacta eltrombopag for oral suspension initial u. Mitigating the anticd38 interference with serologic testing. Highlights of prescribing information these highlights do not include all the information needed to use darzalex safely and effectively. You can help by reporting any side effects you may get. Prepare the solution for infusion using aseptic technique as follows. Discontinue aliqopa if lifethreatening aliqoparelated toxicity occurs. Calculate the dose mg, total volume ml of darzalex solution required and the number of darzalex vials needed based on patient actual body weight. Twice weekly 2056mgm2 regimen by 30minute infusion kyprolis is administered intravenously as a 30minute infusion on two consecutive days, each week for threeweeks followed by a 12day rest period as shown in table2. Darzalex 20 mgml concentrate for solution for infusion daratumumab. Pdf patients with multiple myeloma mm are typically of an. 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 who have received at least one prior medicine to treat multiple myeloma.
This will allow quick identification of new safety information. Darzalex fda prescribing information, side effects and uses. Darzalex daratumumab dosing, indications, interactions. Darzalex is indicated for the treatment of adult patients with multiple myeloma. Darzalex dosing schedule in combination with lenalidomide or pomalidomide 4. Safety and effectiveness of darzalex have not been established in pediatric patients 1. The recommended dose of darzalex is 16 mgkg actual body weight administered as an intravenous infusion according to the following dosing schedule in table 2. Member has disease progression to at least 3 prior therapies and. Pi and an immunomodulatory agent or who are doublerefractory to a pi and an. Weeks 1 to 9 weekly total of 9 doses weeks 10 to 24. Darzalex is a prescription medicine used to treat adults with multiple myeloma. Darzalex daratumumab is being used as a single agent for all of the following. In preclinical studies in mice and rats, decitabine caused adverse developmental outcomes includingembryofetal lethality and malformations. Each ml contains the equivalent of 50 mg of elemental iron as an iron dextran complex, approximately 0.
Check that the darzalex solution is colorless to yellow. Hypersensitivity and other administration reactions. Welcome to the darzalex faspro daratumumab and hyaluronidasefihj and darzalex daratumumab patient website. Risk for hepatic decompensationin patients with chronic hepatitis candrisk of hepatotoxicity in patients with chronic hepatitis c, promacta in combination with interferon and ribavirin may increase the risk of hepatic decompensationsee warnings and precautions 5. Pdf best practice for the administration of daratumumab in. It is a targeted monoclonal antibody that helps slow or stop the progression of multiple myeloma in several ways. One way is by attaching itself to multiple myeloma cells in your body.
Desferal is supplied as vials containing 500 mg of deferoxamine mesylate usp in sterile. Refer to the dexamethasone prescribing information for other information on that product. If lenalidomide is used during pregnancy, it may cause birth defects or embryofetal death. Indicated in combination with lenalidomide and lowdose dexamethasone for multiple myeloma in patients who have received at least 1 prior therapy. Each ml of the sterile solution contains 20 mg of plerixafor. Pregnancy must be excluded before start of treatment. Animal reproduction studies have not been conducted with mitotane. See the end of section 4 for how to report side effects. Kleo pharmaceuticals receives ind authorization to proceed. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Infusion bagscontainers must be made of polyvinylchloride pvc, polypropylene pp.
Mozobil plerixafor injection, for subcutaneous use. Burke,5 mohit narang,6 don stevens,7 sriya gunawardena,8 yana lutska,8 keqin qi,9 jon ukropec,10 ming qi,11 thomas s. The recommended dose of darzalex is 16 mgkg actual body weight administered as an intravenous infusion according to the following dosing schedule. Withhold or discontinue imfinzi to manage adverse reactions as described in table 2. Check that the darzalex solution is colorless to pale yellow. Highlights of prescribing information initiate promacta at. This may help to protect healthy cells from damage. Darzalex 20 mgml concentrate for solution for infusion. Daratumumab, bortezomib, cyclophosphamide and dexamethasone in newly diagnosed and relapsed multiple myeloma. Advise females of reproductive potential to use effective contraception while receiving dacogenand for 6 months following the last. Do not use if opaque pale particles, discoloration or other foreign particles are present. May 29, 2020 kp1237, a cd38targeting antibody recruiting molecule arm, to be tested in combination with nk cells to treat posttransplant multiple myeloma patients. Darzalex has extensive clinical experience in multiple myeloma 1,2.
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