Highlights of prescribing information these highlights do not include all the information needed to use ferrlecit safely and effectively. Contraindications warnings fluorouracil warnings see boxed. Busulfan alone is minimally toxic to t lymphocytes, and thus it is used. 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. Myeloablative doses of chemotherapy with or without radiation are commonly used for allogeneic hematopoietic cell transplantation allohct. Dec 18, 2007 princeton, nj, tokyo, japan and redwood city, calif. Lovaza omega3acid ethyl esters capsules are supplied as 1gram transparent, softgelatin capsules filled with lightyellow oil and bearing the designation gs fh2. Highlights of prescribing information these highlights do not. Variation in prescribing patterns and therapeutic drug. Methotrexate injection, usp is sterile and nonpyrogenic and may be given by the intramuscular, intravenous, intraarterial or intrathecal route. Please see full prescribing information and medication guide. Busulfex is contraindicated in patients with a history of hypersensitivity to any of its components. R x only warning busulfex busulfan injection is a potent cytotoxic drug that causes profound myelosuppression at the recommended dosage.
Each vial contains 60 mg of busulfan in n,ndimethylacetamide dma, 3. Chantix is indicated as an aid to smoking cessation treatment in adults. Easytoread drug name and dosage strength to aid in identifying the right product. Busulfex clearance is best predicted when the busulfex dose is administered based on adjusted ideal body weight. It is supplied as a clear, colorless, sterile, solution in 10 ml single use vials. Baxdela delafloxacin tablets, for oral use baxdela delafloxacin for injection, for intravenous use initial u. Busulfex busulfan injection is a potent cytotoxic drug that causes profound myelosuppression at the recommended dosage. Women must use birth control while taking busulfex busulfan injection and for some time after the last dose. Busulfan drug information, uses, side effects, chemistry.
Busulfex fda prescribing information, side effects and uses. Princeton, nj, tokyo, japan and redwood city, calif. In addition, the relationships among dose, plasma concentration, and pharmacodynamic effect may be. 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. Please see full prescribing and safety information, including boxed warning, for busulfan singledose vials. Nov 16, 2017 busulfan is dissolved in n,ndimethylacetamide dma, 3. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for bicitra citric acid sodium citrate. Iv busulfex busulfan package insert package insert tokyo, japan. Toviaz is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge. Evaluation of the pharmacokinetics and efficacy of a busulfan.
Busulfan concentration and graft rejection in pediatric patients undergoing hematopoietic stem cell transplantation. Busulfex is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation. The recommended starting and target dose for abilify is 10 or 15 mgday administered on a onceaday schedule without regard to meals. Chantix is a prescription medicine to help people stop smoking. Package insert fluorouracil injection, usp for intravenous use only description fluorouracil injection, an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. Effect of weight and maturation on busulfan clearance in infants and small children undergoing hematopoietic cell transplantation. The solvent, dma, may also cause fetal harm when administered to a pregnant woman based on findings in animals.
Mar 10, 2017 myeloablative doses of chemotherapy with or without radiation are commonly used for allogeneic hematopoietic cell transplantation allohct. Within the first year of life, agerelated developmental changes in physiological and metabolic processes can lead to significantly altered drug disposition 1, 4. Busulfan is a widely used alkylating agent in conditioning regimens for allohct 1,2. 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. Engerixb can be given on either dosing schedule 0, 1, and 6 months or 0, 1, 2, and 12 months. Ferrlecit sodium ferric gluconate complex in sucrose injection, for intravenous use initial u. Engerixb is indicated for immunization against infection. 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 vial of busulfex contains 60 mg 6 mgml of busulfan, the active ingredient, a white crystalline. Cefazolin for injection, usp sagent pharmaceuticals. Highlights of prescribing information these highlights do not include all the information needed to use effientsafely and effectively. 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. Pfizer rxpathways connects eligible patients to assistance programs that offer insurance support, copay assistance, and medicines for free or at a savings. Busulfex busulfan injection is intended for intravenous administration. Chantix should not be used in children 16 years of age and. Sandimmune cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Each 1 ml of precedex contains 118 mcg of dexmedetomidine hcl equivalent to 100 mcg dexmedetomidine base and 9. In those children weighing 12 kg, the initial dose ranged 5. Busulfan is a bifunctional alkylating agent known chemically as 1,4 butanediol, dimethanesulfonate. Vials of vinblastine sulfate for injection usp contain 10 mg.
Sandimmune soft gelatin capsules cyclosporine capsules, usp and sandimmune oral solution. Effect of weight and maturation on busulfan clearance in. The nervous system has also been reported as affected by means of insomnia, anxiety and dizziness, and shortness of breath has also. Busulfex to 24 hours after the last dose of busulfex. Abilify has been systematically evaluated and shown to be effective in a dose range of 10 to 30 mgday, when administered as the tablet. 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.
Darabinofuranosyladenine araa that is relatively resistant to deamination. 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. It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. Quitting smoking can lower your chances of having lung disease, heart disease or getting certain types of cancer that are related to smoking. Busulfan all licensing, eu ctd dossiers, formulation. Busulfex busulfan injection is supplied as a clear, colorless, sterile, solution in 10 ml singledose vials for intravenous administration upon dilution. Only the preservative free formulation of methotrexate injection, usp may be administered by the intrathecal route. If you have any further questions, ask your doctor. The most common metric for busulfan exposure was auc 57%.
The initial busulfan dose achieved the target exposure in only 24. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Fludarabine phosphate injection, usp is a sterile solution intended for intravenous administration. 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. Fludarabine phosphate injection contains fludarabine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9.
Busulfex is an anticancer antineoplastic or cytotoxic chemotherapy drug. It is supplied as a clear, colorless, sterile, solution in 10 ml single u. Despite the widespread use of busulfan, pk studies in infants remain inadequate to ensure safe and efficacious drug therapy. Bicitra citric acid sodium citrate fda package insert. The clinical formulation is supplied in a sterile form for intravenous use only. Men with a partner who may get pregnant must use birth control while taking busulfex busulfan injection and for some time after the last. Highlights of prescribing information these highlights do. Busulfex can cause fetal harm when administered to a pregnant woman based on animal data.
Advise pregnant women of the potential risk to a fetus. Population pharmacokinetics of busulfan in pediatric and. For current full prescribing information, please visit lab038212. Chantix has not been shown to be effective in children 16 years of age and under. 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. The pharmacokinetics pk and pharmacodynamics of drugs in infants can differ widely between children and adults 1, 2, 3. Highlights of prescribing information these highlights do not include all the information needed to use vectibix safely and effectively.
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. Captisol enabled busulfan potential benefits not seen with iv busulfan busulfan is a bifunctional alkylating agent known chemically as 1,4butanediol, dimethanesulfonate. All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety. Precedex is supplied as a clear, colorless, isotonic solution with a ph of 4. Are your patients in need of prescription assistance.
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. 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. Evaluation of the pharmacokinetics and efficacy of a. In some cases, health care professionals may use the trade names busulfex or myleran when referring to the generic drug name busulfan. This medicine or fluids is given through a needle or tube catheter inserted into a vein. 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. Bar codes included on the vial and carton for ease of scanning.
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