Busulfex busulfan injection is intended for intravenous administration. Princeton, nj, tokyo, japan and redwood city, calif. Baxdela delafloxacin tablets, for oral use baxdela delafloxacin for injection, for intravenous use initial u. Only the preservative free formulation of methotrexate injection, usp may be administered by the intrathecal route. In some cases, health care professionals may use the trade names busulfex or myleran when referring to the generic drug name busulfan. Dec 18, 2007 princeton, nj, tokyo, japan and redwood city, calif. Highlights of prescribing information these highlights do. For current full prescribing information, please visit lab038212. Fludarabine phosphate injection contains fludarabine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9. Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. Men with a partner who may get pregnant must use birth control while taking busulfex busulfan injection and for some time after the last. Busulfex is an anticancer antineoplastic or cytotoxic chemotherapy drug. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for bicitra citric acid sodium citrate.
Evaluation of the pharmacokinetics and efficacy of a busulfan. Each vial of busulfex contains 60 mg 6 mgml of busulfan, the active ingredient, a white crystalline. Effect of weight and maturation on busulfan clearance in infants and small children undergoing hematopoietic cell transplantation. Lovaza omega3acid ethyl esters capsules are supplied as 1gram transparent, softgelatin capsules filled with lightyellow oil and bearing the designation gs fh2. Despite the widespread use of busulfan, pk studies in infants remain inadequate to ensure safe and efficacious drug therapy. Nov 16, 2017 busulfan is dissolved in n,ndimethylacetamide dma, 3. Each 1 ml of precedex contains 118 mcg of dexmedetomidine hcl equivalent to 100 mcg dexmedetomidine base and 9. Fludarabine phosphate injection, usp is a sterile solution intended for intravenous administration. 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. 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. Sandimmune cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. 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. Highlights of prescribing information these highlights do not. Highlights of prescribing information these highlights do not include all the information needed to use effientsafely and effectively.
Chantix should not be used in children 16 years of age and. Vials of vinblastine sulfate for injection usp contain 10 mg. Busulfex busulfan injection is supplied as a clear, colorless, sterile, solution in 10 ml singledose vials for intravenous administration upon dilution. Busulfex busulfan injection is a potent cytotoxic drug that causes profound myelosuppression at the recommended dosage. Precedex is supplied as a clear, colorless, isotonic solution with a ph of 4. Pfizer rxpathways connects eligible patients to assistance programs that offer insurance support, copay assistance, and medicines for free or at a savings.
Busulfex can cause fetal harm when administered to a pregnant woman based on animal data. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. 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. Women must use birth control while taking busulfex busulfan injection and for some time after the last dose. Busulfan is a widely used alkylating agent in conditioning regimens for allohct 1,2. The pharmacokinetics pk and pharmacodynamics of drugs in infants can differ widely between children and adults 1, 2, 3. This medicine or fluids is given through a needle or tube catheter inserted into a vein. The recommended starting and target dose for abilify is 10 or 15 mgday administered on a onceaday schedule without regard to meals. Busulfan alone is minimally toxic to t lymphocytes, and thus. Chantix is indicated as an aid to smoking cessation treatment in adults. The most common metric for busulfan exposure was auc 57%. Each vial contains 60 mg of busulfan in n,ndimethylacetamide dma, 3. Iv busulfex busulfan package insert package insert tokyo, japan. Chantix is a prescription medicine to help people stop smoking.
Bar codes included on the vial and carton for ease of scanning. Evaluation of the pharmacokinetics and efficacy of a. Contraindications warnings fluorouracil warnings see boxed. The solvent, dma, may also cause fetal harm when administered to a pregnant woman based on findings in animals. Busulfan alone is minimally toxic to t lymphocytes, and thus it is used.
Are your patients in need of prescription assistance. Mar 30, 2020 busulfex busulfan injection is supplied as a clear, colorless, sterile, solution in 10 ml singledose vials for intravenous administration upon dilution. It is supplied as a clear, colorless, sterile, solution in 10 ml single u. Methotrexate injection, usp is sterile and nonpyrogenic and may be given by the intramuscular, intravenous, intraarterial or intrathecal route. The nervous system has also been reported as affected by means of insomnia, anxiety and dizziness, and shortness of breath has also. R x only warning busulfex busulfan injection is a potent cytotoxic drug that causes profound myelosuppression at the recommended dosage. Please see full prescribing information and medication guide. Chantix has not been shown to be effective in children 16 years of age and under. Variation in prescribing patterns and therapeutic drug. Within the first year of life, agerelated developmental changes in physiological and metabolic processes can lead to significantly altered drug disposition 1, 4. Busulfan was teratogenic in mice, rats, and rabbits. Busulfex fda prescribing information, side effects and uses. An ideal conditioning regimen allows for adequate disease control while minimizing toxicities. Busulfex clearance is best predicted when the busulfex dose is administered based on adjusted ideal body weight.
Myeloablative doses of chemotherapy with or without radiation are commonly used for allogeneic hematopoietic cell transplantation allohct. Busulfan is a bifunctional alkylating agent known chemically as 1,4 butanediol, dimethanesulfonate. Busulfex is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation. Engerixb is indicated for immunization against infection. 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. 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. Please see full prescribing and safety information, including boxed warning, for busulfan singledose vials. 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. 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. Captisol enabled busulfan potential benefits not seen with iv busulfan busulfan is a bifunctional alkylating agent known chemically as 1,4butanediol, dimethanesulfonate. Effect of weight and maturation on busulfan clearance in.
It is supplied as a clear, colorless, sterile, solution in 10 ml single use vials. In addition, the relationships among dose, plasma concentration, and pharmacodynamic effect may be. Bleeding risk see full prescribing information for complete boxed warning. If you have any further questions, ask your doctor. 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. Population pharmacokinetics of busulfan in pediatric and. Package insert fluorouracil injection, usp for intravenous use only description fluorouracil injection, an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution 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. Busulfan drug information, uses, side effects, chemistry. It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety. Sandimmune soft gelatin capsules cyclosporine capsules, usp and sandimmune oral solution. Highlights of prescribing information these highlights do not include all the information needed to use vectibix safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively.
Busulfan all licensing, eu ctd dossiers, formulation. Quitting smoking can lower your chances of having lung disease, heart disease or getting certain types of cancer that are related to smoking. Busulfex is contraindicated in patients with a history of hypersensitivity to any of its components. The clinical formulation is supplied in a sterile form for intravenous use only. Advise pregnant women of the potential risk to a fetus. Cefazolin for injection, usp sagent pharmaceuticals. 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. Darabinofuranosyladenine araa that is relatively resistant to deamination. Toviaz is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge. Bicitra citric acid sodium citrate fda package insert. Easytoread drug name and dosage strength to aid in identifying the right product. 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.
2 387 1113 29 824 1572 701 566 1259 923 933 752 1163 675 806 588 351 1438 827 283 495 964 261 208 1052 243 640 869 123 383 376 637 1228 829 75 1278 363 266 206 582 1487 1290 1252 1368 550 568 1165