AZACITIDINE PACKAGE INSERT PDF

Published by on August 26, 2021
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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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Observe and exercise usual precautions for handling, preparing, and administering solutions of cytotoxic drugs. Drug-Drug Interactions Drug interaction studies with azacitidine have not been conducted.

Storage following reconstitution mannitol-containing formulations: When suppressor gene activity is blocked, cell division becomes unregulated, leading to the formation of neoplastic cells. Do not save any unused portions for later administration.

Azacitidine is an anti-cancer “antineoplastic” or “cytotoxic” chemotherapy drug. Antimetabolites are very similar to normal substances within the cell. Progressive hepatic coma and death have been reported in azacitidine-treated patients with extensive tumor burden due to metastatic disease, particularly in patients with hypoalbuminemia i.

Vidaza (azacitidine) dose, indications, adverse effects, interactions from

In vitro studies ihsert human cultured hepatocytes indicate that azacitidine at concentrations of 1. Do not filter the suspension after reconstitution as this may remove the active substance. Once incorporated into tRNA, azacitidine inhibits tRNA methyltransferases and interferes with tRNA methylation and processing, which leads to inhibition of protein synthesis. New injections should be given at least one inch from an old site and never into areas where the site is tender, bruised, red, or hard.

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Another clinical trial included 26 patients with poor-risk AML subsequent to Philadelphia-negative myeloproliferative neoplasms.

Therapy interruption or a dose reduction may be necessary if a patient develops severe treatment-related toxicity. Rotate sites for each injection thigh, abdomen, or upper arm.

Azacitidine is contraindicated in patients with mannitol hypersensitivity or sensitivity to azacitidine. Shake or roll the vial vigorously until all powder is dissolved; the solution should be clear. Moderate Immunosuppressives may decrease the immunological response to tuberculin purified protein derivative, PPD.

A pyrimidine nucleoside analog that inhibits RNA and DNA synthesis Used for the treatment of patients with certain myelodysplastic syndrome subtypes Contraindicated in patients with advanced malignant hepatic tumors or hypersensitivity to mannitol.

Chemotherapy and biotherapy guidelines and recommendations for practice 2nd. An in vitro study indicated that it may be metabolized by the liver. Administer the azacitidine suspension subcutaneously; inject in 2 different sites if 2 syringes are required.

Azacitidine – Drug Information – Chemocare

Have questions about chemotherapy? Pregnancy testing should be performed prior to starting azacitidine in female patients of reproductive potential. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Warnings and Precautions 5.

This medication is classified as an “antimetabolite” and a “demethylation” agent. Patients should be premedicated for nausea and imsert.

Azacitidine

Among those patients, overall survival was Hepatotoxicity may occur in patients with severe hepatic impairment. Doses greater than 4 mL should be divided equally into 2 syringes and injected into 2 separate sites.

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Special Populations The effects of renal or hepatic impairment, gender, age, or race on the pharmacokinetics of azacitidine have not been studied [see Dosage and Administration 2.

Hypermethylation is thought to be an early step in malignant transformation of cells. The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis.

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. Monitor serum creatinine levels and electrolytes prior to starting azacitidine and prior to each cycle of therapy. Whether azacitidine metabolism may be affected by known microsomal enzyme inhibitors or inducers has not been studied.

Patients with MDS and renal impairment were excluded from clinical trials. 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. Monitor liver function tests prior to starting azacitidine and before each cycle of therapy. Moderate Palifermin should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of antineoplastic agents.

Not all side effects are listed above.