AZACITIDINE PACKAGE INSERT PDF

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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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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. Subcutaneous Administration To provide a homogeneous suspension, the contents inseert the dosing syringe must be re-suspended immediately prior to administration.

Azacitidine (Vidaza) | – A Hematology Oncology Wiki

Once incorporated into tRNA, azacitidine inhibits tRNA methyltransferases and interferes with tRNA methylation and processing, which leads to inhibition of protein synthesis. Dosage regimen not defined. After azacitidnie from refrigerated conditions, the suspension may be allowed to equilibrate to room temperature for up to 30 minutes prior to administration. Not all side effects are listed above. Doses greater than 4 mL should be divided equally into 2 syringes and injected into 2 separate sites.

Azacitidibe 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.

When suppressor genes are blocked, cell division becomes unregulated, allowing or promoting cancer. Parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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Additionally, inzert patients with a female partner of reproductive potential should use effective contraception during and for 3 months after azacitidine therapy due to the risk of male-mediated teratogenicity. Consider deferring the skin test until completion of the immunosuppressive therapy.

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An in vitro study of azacitidine incubation in human liver fractions indicated that azacitidine may be metabolized by the liver. To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.

This suppressed reactivity can persist for up to 6 weeks after treatment discontinuation. Significant hematologic toxicity was noted with no response as defined by bone marrow remission or improvement in transfusion requirements.

Bone marrow suppression, neutropenia, thrombocytopenia. 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. Methylation usually suppresses gene transcription and azscitidine deletion. Contraception requirements, infertility, male-mediated teratogenicity, pregnancy testing, reproductive risk.

The suspension will be cloudy. Contact your health care provider immediatelyday or night, if you should experience any of the following symptoms: Controlling Occupational Exposure to Hazardous Drugs. VIDAZA is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. Counsel patients about the reproductive risk and contraception requirements during azacitidine azacitivine.

When the cells incorporate azacitkdine substances into the cellular metabolism, they interact with a number of targets within the cell to produce a direct cytotoxic effect that causes death of rapidly dividing cancer cells. Moderate Palifermin should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of antineoplastic agents.

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Azacitidine (Vidaza)

Azacitidine inhibition of DNA methyltransferase is dose- and time-dependent. Among those psckage, overall survival was Azacitidine has not been evaluated in patients with myelodysplastic syndrome and hepatic impairment; use is contraindicated in patients with advanced hepatic malignancy. Affected cytochrome P isoenzymes or drug transporters: Monitor liver function tests prior to starting azacitidine and before each cycle of therapy.

Major Do not use penicillamine with antineoplastic agents due to the increased risk of developing severe hematologic and renal toxicity.

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

It is recommended that patients be treated for a minimum of 4 to 6 cycles. Do not save any unused portions for later administration. Dilute immediately by injecting the calculated amount of azacitidine into a 50 to mL infusion bag of either 0.

The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

Periodic blood work to monitor your complete blood count CBC as well as the function of other organs such as your kidneys and liver will also be ordered by your doctor. Azacitidine is administered as a subcutaneous injection or as pakage intravenous IV infusion. Preparation for Delayed Subcutaneous Administration: Azacitidine is rapidly absorbed after subcutaneous administration.

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