Highlights of prescribing information these highlights do not include all the information needed to use effientsafely and effectively. The nervous system has also been reported as affected by means of insomnia, anxiety and dizziness, and shortness of breath has also. Within the first year of life, agerelated developmental changes in physiological and metabolic processes can lead to significantly altered drug disposition 1, 4. For current full prescribing information, please visit lab038212. Women must use birth control while taking busulfex busulfan injection and for some time after the last dose. The recommended starting and target dose for abilify is 10 or 15 mgday administered on a onceaday schedule without regard to meals. Only the preservative free formulation of methotrexate injection, usp may be administered by the intrathecal route. Lovaza omega3acid ethyl esters capsules are supplied as 1gram transparent, softgelatin capsules filled with lightyellow oil and bearing the designation gs fh2. Busulfan all licensing, eu ctd dossiers, formulation. Evaluation of the pharmacokinetics and efficacy of a busulfan. It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. Variation in prescribing patterns and therapeutic drug. Princeton, nj, tokyo, japan and redwood city, calif. Evaluation of the pharmacokinetics and efficacy of a.
Chantix is a prescription medicine to help people stop smoking. Bicitra citric acid sodium citrate fda package insert. Each vial of busulfex contains 60 mg 6 mgml of busulfan, the active ingredient, a white crystalline. Busulfex is contraindicated in patients with a history of hypersensitivity to any of its components. Iv busulfex busulfan package insert package insert tokyo, japan. In addition, the relationships among dose, plasma concentration, and pharmacodynamic effect may be. Busulfex busulfan injection is a potent cytotoxic drug that causes profound myelosuppression at the recommended dosage. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for bicitra citric acid sodium citrate. Engerixb can be given on either dosing schedule 0, 1, and 6 months or 0, 1, 2, and 12 months. If you have any further questions, ask your doctor. Precedex is supplied as a clear, colorless, isotonic solution with a ph of 4. Etopophos etoposide phosphate for injection is an antineoplastic agent which is available for intravenous infusion as a sterile lyophile in singledose vials containing etoposide phosphate equivalent to 100 mg etoposide, 32.
Busulfan is a bifunctional alkylating agent known chemically as 1,4 butanediol, dimethanesulfonate. Myeloablative doses of chemotherapy with or without radiation are commonly used for allogeneic hematopoietic cell transplantation allohct. Busulfex busulfan injection is intended for intravenous administration. Busulfex is an anticancer antineoplastic or cytotoxic chemotherapy drug. 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. Busulfex clearance is best predicted when the busulfex dose is administered based on adjusted ideal body weight. Cefazolin for injection, usp sagent pharmaceuticals. Chantix is indicated as an aid to smoking cessation treatment in adults. Each 1 ml of precedex contains 118 mcg of dexmedetomidine hcl equivalent to 100 mcg dexmedetomidine base and 9.
All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety. It is supplied as a clear, colorless, sterile, solution in 10 ml single use vials. Engerixb is indicated for immunization against infection. Darabinofuranosyladenine araa that is relatively resistant to deamination. Busulfex to 24 hours after the last dose of busulfex.
Mar 30, 2020 busulfex busulfan injection is supplied as a clear, colorless, sterile, solution in 10 ml singledose vials for intravenous administration upon dilution. Please see full prescribing and safety information, including boxed warning, for busulfan singledose vials. An ideal conditioning regimen allows for adequate disease control while minimizing toxicities. Patients with a history of a clinically significant low white blood cell count wbc or a druginduced leukopenianeutropenia should have their complete blood count cbc monitored frequently during the first few months of therapy and discontinuation of abilify should be considered at the first sign of a. Each 1 ml of precedex contains 118 mcg of dexmedetomidine hcl equivalent to 100 mcg dexmedetomidine base and 9 mg of sodium chloride in water. 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. Despite the widespread use of busulfan, pk studies in infants remain inadequate to ensure safe and efficacious drug therapy. Busulfan was teratogenic in mice, rats, and rabbits.
Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Please see full prescribing information and medication guide. Chantix should not be used in children 16 years of age and. Busulfan concentration and graft rejection in pediatric patients undergoing hematopoietic stem cell transplantation. Busulfex injection is supplied as a clear, colorless, sterile, solution in 10 ml singledose vial containing 60 mg of busulfan at a concentration of 6 mg per ml for intravenous use only. 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. Bleeding risk see full prescribing information for complete boxed warning. No centers use the package insert sampling schema, which states that pharmacokinetic sampling should occur at 2, 4, and 6 hours after the start of iv busulfan. Highlights of prescribing information these highlights do not include all the information needed to use vectibix safely and effectively. Busulfan busulfex is a bifunctional alkylating agent routinely used in conditioning regimens before hematopoietic cell transplantation hct to treat various childhood malignant and nonmalignant disorders.
Vials of vinblastine sulfate for injection usp contain 10 mg. Package insert fluorouracil injection, usp for intravenous use only description fluorouracil injection, an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. Methotrexate injection, usp is sterile and nonpyrogenic and may be given by the intramuscular, intravenous, intraarterial or intrathecal route. Each vial contains 60 mg of busulfan in n,ndimethylacetamide dma, 3. Chantix has not been shown to be effective in children 16 years of age and under. Advise pregnant women of the potential risk to a fetus. Captisol enabled busulfan potential benefits not seen with iv busulfan busulfan is a bifunctional alkylating agent known chemically as 1,4butanediol, dimethanesulfonate. Pfizer rxpathways connects eligible patients to assistance programs that offer insurance support, copay assistance, and medicines for free or at a savings. Bar codes included on the vial and carton for ease of scanning. R x only warning busulfex busulfan injection is a potent cytotoxic drug that causes profound myelosuppression at the recommended dosage. Fludarabine phosphate injection, usp is a sterile solution intended for intravenous administration. Highlights of prescribing information these highlights do not.
Busulfex is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation. Abilify has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mgday, when administered as the tablet. Busulfex can cause fetal harm when administered to a pregnant woman based on animal data. Busulfex fda prescribing information, side effects and uses. Easytoread drug name and dosage strength to aid in identifying the right product. Quitting smoking can lower your chances of having lung disease, heart disease or getting certain types of cancer that are related to smoking. Effect of weight and maturation on busulfan clearance in.
Contraindications warnings fluorouracil warnings see boxed. In those children weighing 12 kg, the initial dose ranged 5. Highlights of prescribing information these highlights do. Mar 10, 2017 myeloablative doses of chemotherapy with or without radiation are commonly used for allogeneic hematopoietic cell transplantation allohct.
On this page about busulfex you will find information relating to side effects, age restrictions, food interactions, whether the medicine is available at a government subsidised price on the pharmaceutical benefits scheme pbs as well as other useful information. Fludarabine phosphate injection contains fludarabine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9. This medicine or fluids is given through a needle or tube catheter inserted into a vein. Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. Busulfan is a widely used alkylating agent in conditioning regimens for allohct 1,2. Busulfan alone is minimally toxic to t lymphocytes, and thus it is used. The pharmacokinetics pk and pharmacodynamics of drugs in infants can differ widely between children and adults 1, 2, 3. Nov 16, 2017 busulfan is dissolved in n,ndimethylacetamide dma, 3.
Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. 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. Are your patients in need of prescription assistance. Sandimmune soft gelatin capsules cyclosporine capsules, usp and sandimmune oral solution. Population pharmacokinetics of busulfan in pediatric and.
Effect of weight and maturation on busulfan clearance in infants and small children undergoing hematopoietic cell transplantation. Busulfan alone is minimally toxic to t lymphocytes, and thus. The solvent, dma, may also cause fetal harm when administered to a pregnant woman based on findings in animals. The initial busulfan dose achieved the target exposure in only 24. It is supplied as a clear, colorless, sterile, solution in 10 ml single u. In some cases, health care professionals may use the trade names busulfex or myleran when referring to the generic drug name busulfan. The most common metric for busulfan exposure was auc 57%. Dec 18, 2007 princeton, nj, tokyo, japan and redwood city, calif. The clinical formulation is supplied in a sterile form for intravenous use only.
Baxdela delafloxacin tablets, for oral use baxdela delafloxacin for injection, for intravenous use initial u. Busulfan drug information, uses, side effects, chemistry. Pulmonary toxicity in a clinical investigation using fludarabine phosphate injection in combination with pentostatin deoxycoformycin for the treatment of refractory chronic lymphocytic leukemia cll in adults, there was an unacceptably high incidence of fatal pulmonary. Busulfex injection is supplied as a clear, colorless, sterile, solution in 10 ml single use vial containing 60 mg of busulfan at a concentration of 6 mg per ml for. Busulfex busulfan injection is supplied as a clear, colorless, sterile, solution in 10 ml singledose vials for intravenous administration upon dilution. Sandimmune cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Men with a partner who may get pregnant must use birth control while taking busulfex busulfan injection and for some time after the last.
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