AZACITIDINE PACKAGE INSERT PDF

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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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. Bone marrow suppression, neutropenia, thrombocytopenia. When the cells incorporate these 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. We strongly encourage you to talk with your health care professional about your specific medical condition and treatments.

These patients should use effective contraception and avoid pregnancy during and for 6 months after azacitidine therapy. When suppressor genes are blocked, cell division becomes jnsert, allowing or promoting cancer. Shake or roll the vial vigorously until all powder is dissolved; the solution should be clear.

Treatment may be continued unsert long as the patient continues to benefit. Median time to leukemic transformation was 21 months in the azacitidine arm compared with 13 months in the supportive care arm.

This medication is classified as an “antimetabolite” and a “demethylation” agent. Females of reproductive potential should avoid pregnancy during treatment with azacitidine.

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Azacitidine may cause fetal harm when administered during pregnancy, based on its mechanism of action and data from animal studies; there are azacltidine data on the use of azacitidine in pregnant women. However, you should always inform your health care provider if you experience any unusual symptoms. The product may be inserg at room temperature for up to 1 hour, but must be administered within 1 hour after reconstitution. ASHP guidelines on handling hazardous drugs. Antimetabolites are very similar to normal substances within the cell.

Azacitidine (Vidaza) | – A Hematology Oncology Wiki

Azacitidine’s anticancer effects are believed to be twofold. Give new injections at least one inch from an old site; do not inject in a site that is tender, bruised, red, or hard. Allow refrigerated syringe s to warm to room temperature for up to 30 minutes prior to administration. Multiple dosing at the recommended dose-regimen does not result in drug accumulation. Azacitidine is contraindicated in patients with mannitol hypersensitivity or sensitivity to azacitidine. If the dose requires using more than one mg vial, divide the dose equally between 2 syringes; due to retention in the vial and needle, it may not be feasible to withdraw all of the azaciridine from the vial.

However, complete or partial response may require additional treatment cycles. Methylation of DNA is a major mechanism that regulates gene expression in cells.

Azacitidine – Drug Information – Chemocare

Non-proliferating cells are relatively insensitive to azacitidine. It is not known if azacitidine or its metabolites are secreted in human milk or azafitidine it has effects azacjtidine the breast-fed infant or on milk production.

Hypermethylation is thought to be an early step in malignant transformation of cells. Immediately prior to administration, invert the syringe 2 or 3 times and vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.

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If it comes into contact with mucous membranes, flush paxkage with water. Patients with MDS and renal impairment were excluded from clinical trials. Doses greater than 4 mL should be divided equally into 2 syringes.

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Administer the total dose over a period of 10 — 40 minutes. The cytotoxic effects of azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms.

Subcutaneous Administration To provide a homogeneous suspension, the contents of the dosing syringe must be re-suspended immediately prior to administration. Doses azacitudine than 4 mL should be divided equally into 2 syringes and injected into 2 separate sites.

Drug-Drug Interactions Drug interaction studies with azacitidine have not been conducted. Based on data in animals, infertility may occur in male or females treated with azacitidine.

innsert Azacitidine is rapidly absorbed after subcutaneous administration. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Azacitidine (Vidaza)

Monitor liver function tests prior to starting azacitidine and before each cycle of therapy. In vitro studies with human cultured hepatocytes indicate that azacitidine at concentrations of 1.

Patients should be premedicated for nausea and vomiting.