Prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives. Dacarbazine for injection usp is reconstituted and administered intravenously ph 3. Each vial also contains anhydrous citric acid and mannitol. Busulfex busulfan injection is intended for intravenous administration.
It should be administered under the supervision of a qualified physician who is experienced in allogeneic hematopoietic stem cell transplantation, the use of cancer chemotherapeutic drugs and the management of patients with severe pancytopenia. Triumeq abacavir, dolutegravir, and lamivudine tablets, for oral use. Seizures have been reported in patients receiving highdose oral busulfan at doses producing plasma drug levels similar to those achieved following the recommended dosage of busulfex. Firstline acute lymphoblastic leukemia all all and hypersensitivity to native forms of lasparaginase.
To prepare the final solution for infusion, add a ml of busilvex to b ml of. It is usually given every 6 hours for 4 days for a total of 16 doses before bone marrow transplant. Highlights of prescribing information these highlights do not include all the information needed to use busulfex. Busulfex fda prescribing information, side effects and uses. Busulfan can cause a severe decrease in the number of blood cells in your bone marrow. The resulting solution contains 10 mgml of dacarbazine having a ph of 3. The diluent quantity should be 10 times the volume of busulfan injection, so that the final concentration of. Busulfan injection may cause seizures during therapy with the medication. Highlights of prescribing information palmarplantar. These carbonium ions alkylate dna, which results in the interference of dna replication and rna transcription. Sandimmune soft gelatin capsules cyclosporine capsules, usp and sandimmune oral solution. Prescribing information myleran busulfan 2mg scored tablets warning myleran is a potent drug.
Busulfan injection must be diluted prior to intravenous infusion with either 0. Tell your doctor and pharmacist about all the medications you are taking. Pdr drug summaries are concise pointofcare prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice pdr s drug summaries are available free of charge and serve as a great resource for us based mds, dos, nps and pas in patient practice. For instructions on dilution of the medicinal product before administration, see. Immune globulin intravenous human, 10% liquid privigen. Cellcept mycophenolate mofetil mmf is indicated for the prophylaxis of organ rejection,in recipients of allogeneic kidneysee clinical studies 14. See full prescribing information for complete boxed warning. Busulfan comes as a solution liquid to be given intravenously into a vein over 2 hours by a doctor or nurse in a medical facility. Highlights of prescribing information these highlights do not include all the information needed to use votrient safely and effectively. It is supplied as a clear, colorless, sterile, solution in 10 ml singledose vials. Once busulfan is hydrolyzed, the methanesulfonate groups are released and carbonium ions are produced. Nexavar tablets are round, biconvex, red filmcoated tablets, debossed with the bayer cross on one side and 200 on the other side. Usage should be limited to these areas of involvement.
In patients taking lysodren, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. Unlike other alkylating agents, it has little effect on lymphocytes and exhibits much less immunosuppressive ability. Information for the user busulfan 6 mgml concentrate for solution for infusion busulfan read all of this leaflet carefully before you start using this medicine because it contains important information for you. Administer hydrocortisone, monitor for escalating signs of shock and discontinue. Myleran busulfan dose, indications, adverse effects. Busulfan is an alkylating agent originally given qid by mouth, generally with cyclophosphamide in the socalled bucy regimens.
Highlights of prescribing information these highlights do. Despite prophylactic therapy with phenytoin, one seizure 142 patients was reported during an autologous transplantation clinical trial of busulfex. The current suggested dosing regimen for busulfan use in children was determined based on the results of a single clinical trial of only 24 children undergoing hct receiving busulfan in combination with cyclophosphamide. Each ml contains the equivalent of 50 mg of elemental iron as an iron dextran complex, approximately 0. Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively.
Busulfan injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. It is not known whether other progestinonly contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy. The calculated dose of the resulting solution is drawn into a syringe and administered only intravenously. Population pharmacokinetics of busulfan in pediatric and. These highlights do not include all the information needed to use triumeq safely and effectively. Front side fludarabine phosphate injection, usp rx only for intravenous use only warning fludarabine phosphate injection should be administered under the supervision of a qualified physician. Busulfex busulfan injection is a potent cytotoxic drug that results in profound myelosuppression at the recommended dosage. Busulfan selectively alkylates position n 7 of guanine, and also alkylates the sulfhydryl group of glutathione and cysteine. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Dailymed dacarbazine injection, powder, for solution. Busulfan is an alkylating agent that contains 2 labile methanesulfonate groups attached to opposite ends of a 4carbon alkyl chain.
Mozobil plerixafor injection is a sterile, preservativefree, clear, colorless to paleyellow, isotonic solution for subcutaneous injection. See 17 for patient counseling information and fdaapproved patient labeling. Busulfex busulfan dose, indications, adverse effects. Busulfan is a bifunctional alkylating agent that weakly binds to dna. Busulfan is dissolved in n,ndimethylacetamide dma, 3. Hematopoietic progenitor cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppresion see warnings and precautions 5. Busulfan is an anticancer antineoplastic or cytotoxic chemotherapy drug. If you take busulfan with other medications that may cause a low blood count, the side effects of the medications may be more severe. Find patient medical information for busulfan oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. It should not be used unless a diagnosis of chronic myelogenous leukemia has been adequately established and the responsible physician is knowledgeable in assessing response to chemotherapy. Dacarbazine for injection 200 mgvial is reconstituted with 19. In some cases, health care professionals may use the trade name bulsufex or other names myleran when referring to the generic drug name busulfan. It should be administered under the supervision of a qualified physician who is experienced in allogeneic hematopoietic stem cell transplantation, the use of cancer chemotherapeutic drugs and the management of patients with.
Sandimmune cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Read all of this leaflet carefully before you start using. Busulfan was considered by previous iarc working groups in 1973 and 1987 iarc, 1974, 1987a. Infed iron dextran injection usp is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Since that time, new data have become available, these have been incorporated into the monograph, and taken into consideration in the present evaluation. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. Each ml of the sterile solution contains 20 mg of plerixafor. Busulfan is a bifunctional alkylating agent known chemically as 1,4butanediol, dimethanesulfonate. Busulfan injection causes severe and prolonged myelosuppresion at the recommended dosage. Busulfex busulfan injection is a potent cytotoxic drug that causes profound myelosuppression at the recommended dosage. Clinical trials results of topical dermal studies for contact sensitization. The pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug.
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