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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To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved. Do not store for later use. After removal from refrigerated conditions, the suspension may be allowed to equilibrate to room temperature for up to 30 minutes prior to administration.

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Under 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 azacitdine refrigerated. Contraception requirements, infertility, male-mediated teratogenicity, pregnancy testing, reproductive risk.

Azacitidine

The product may be held at room temperature for up to 1 hour, but must be administered within 1 hour after reconstitution. 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.

The suspension will be cloudy. Am J Health-Syst Pharm. The primary route of elimination is urinary excretion. Administer the azacitidine admixture IV over 10 to 40 minutes; complete the infusion within 1 hour of azacitidine vial reconstitution. Treatment may be continued as long as the patient continues to benefit. Several guidelines on this subject have been published. It is recommended that patients be treated for a minimum of 4 to 6 cycles. In vitro studies with human cultured hepatocytes indicate qzacitidine azacitidine at concentrations of 1.

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Preparation for Delayed Subcutaneous Administration: Do not save any unused portions for later administration.

Shake or roll the vial vigorously until all powder is dissolved; the solution should be clear. Controlling Occupational Exposure to Hazardous Drugs. Give new injections at least one inch from azaciticine old site; do not inject in a site that is tender, bruised, red, or hard. Administer the azacitidine suspension subcutaneously; inject in 2 different sites if 2 syringes are required.

The reconstituted product may be kept in the vial or drawn into a syringe. One way that it works is by demethylation or interfering with the methylation of DNA.

For more detail, see “How this drug works” section below. In some cancer cells, hypermethylation azaditidine the activity of tumor suppressor genes, which regulate cell division and differentiation to prevent malignant transformation. Azacitidine and its metabolites are primarily excreted by the kidney; therefore, use caution in geriatric patients or patients with renal impairment and closely monitor renal function.

Azacitidine – Vidaza® – GlobalRPH

A dosage adjustment in subsequent cycles may be required based on nadir counts and hematologic response. If the azaciidine 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 contents from the vial.

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The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice. Major Do not use penicillamine with antineoplastic agents due to the increased risk of developing severe hematologic and renal toxicity. Do not filter the suspension after reconstitution as this may remove the active substance. Under refrigeration 2 to 8 degrees C or 36 to 46 degrees F packkage, the solution in the vial or azaxitidine syringe is stable for up to 12 hours when reconstituted with Sterile Water for injection that was not refrigerated or for up to 30 hours when reconstituted with Sterile Water for injection that was refrigerated.

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

Patients should be monitored for hematologic response and renal toxicities [see Warnings and Precautions 5. Preparation for Immediate Subcutaneous Administration: 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.

Azacitidine is an anti-cancer “antineoplastic” or “cytotoxic” chemotherapy drug. Not all side effects are listed above. 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.

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.