AZACITIDINE PACKAGE INSERT PDF

MyAza (Azacitidine for Injection) contains Azacitidine IP, which is a pyrimidine The finished product is supplied in a sterile form for reconstitution as a. No formal clinical drug interaction studies with azacitidine have been conducted. The printed package leaflet of the medicinal product must state the name. Drug: Azacitidine – Vidaza® Oncology – Intravenous Dilution Data. (, ) – [ SEE PACKAGE INSERT FOR ADDITIONAL DETAILS]].

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Azacitidine (Vidaza)

Reconstitute each vial with 10 mL sterile water for injection. It is not known if azacitidine or its metabolites are secreted in human milk or if it has effects on the pcakage infant or on milk production.

Due to the risk of serious adverse reactions including tumorigenicity in nursing infants, women should discontinue breast-feeding during azacitidine therapy and for 1 week after the last dose.

If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.

Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Whether azacitidine metabolism may be affected by known microsomal enzyme inhibitors or inducers has not been studied. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The solution should be clear.

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Azacitidine – Drug Information – Chemocare

The primary route of elimination is urinary excretion. Hepatic disease, hepatotoxicity, hypoalbuminemia.

A dosage adjustment in subsequent cycles may be required based on nadir counts and hematologic response.

This suppressed reactivity can persist for up to 6 weeks after treatment discontinuation. For information about the 4th Angel Mentoring Program visit www. Azacitidine inhibition of DNA methyltransferase is dose- and time-dependent. We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. Azacitidine and its metabolites are primarily excreted by the kidney; therefore, use caution in geriatric patients azacitisine patients with renal impairment and closely monitor renal function.

It is recommended that patients be treated for a minimum of 4 to 6 treatment cycles. For the treatment of MDS subtypes of refractory anemia or refractory anemia with ringed sideroblasts if accompanied by neutropenia or thrombocytopenia or requiring transfusionsrefractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia. Your Name Your name inesrt required.

It is recommended that patients be treated for a minimum of 4 to 6 cycles. Shake azacitidie roll the vial vigorously until all powder azacitidie dissolved; the solution should be clear. Qzacitidine refrigeration 2 to 8 degrees C or 36 to 46 degrees Fthe solution in the vial or a syringe is stable for up to 8 hours when reconstituted with Sterile Water for injection that was not refrigerated or for up to 22 hours when reconstituted with Sterile Water for injection that was refrigerated.

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Azacitidine (Vidaza) | – A Hematology Oncology Wiki

Dilute immediately by injecting the calculated amount of azacitidine into a 50 to mL infusion bag of either 0. The mean elimination half-lives of total radioactivity azacitidine and its metabolites were similar after IV and SC administrations, about 4 hours. Monitor serum creatinine levels and electrolytes prior to starting azacitidine and prior to each cycle of therapy. Hypermethylation is thought to be an early step in malignant transformation of cells.

Several guidelines on this subject have been published. Dosage regimen not defined. Rotate sites for each injection thigh, abdomen, or upper arm. Affected cytochrome P isoenzymes or drug transporters: Hypomethylation may restore normal gene function to those genes critical for differentiation and proliferation. Counsel patients about the reproductive risk and contraception requirements during azacitidine treatment. Clinical trials have not demonstrated appreciable response in children with relapsed AML treated with azacitidine.

Administer the azacitidine suspension subcutaneously; inject in 2 different sites if 2 syringes are required. If reconstituted azacitidine contacts the skin, wash the skin immediately with soap and water.