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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Have questions about chemotherapy? Subcutaneous Administration To provide a homogeneous suspension, the contents of the dosing syringe must be re-suspended immediately prior to administration. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. The following symptoms require medical attention, but are not an emergency. To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.

After removal from refrigerated conditions, the suspension may be allowed to equilibrate to room temperature for up to 30 minutes prior to administration. Hepatic disease, hepatotoxicity, hypoalbuminemia.

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

Contact your health care provider immediatelyday or night, if you should experience any of the following symptoms: Progressive hepatic coma and death have been reported in azacitidine-treated patients azactidine extensive tumor burden due to metastatic disease, particularly in patients with hypoalbuminemia i. Pregnancy testing should be performed prior to starting azacitidine in female patients of reproductive potential.

You will be checked regularly by your health care professional while you are taking azacitidine, to monitor side effects and check your response to therapy. 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.

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It is recommended that patients be treated for a minimum of 4 to 6 treatment cycles.

All patients should receive antiemetics prior to each azacitidine dose. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever azacitidibe and container permit.

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Rotate sites for each packkage thigh, abdomen, azacktidine upper arm. Another clinical trial included 26 patients with poor-risk AML subsequent to Philadelphia-negative myeloproliferative neoplasms. 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. Shake or roll the vial vigorously until all powder is dissolved; the solution should be clear. Azacitidine is contraindicated in patients with advanced hepatic malignancies.

Azacitidine is a member of a new class of drugs known as DNA “demethylating” agents.

Azacitidine (Vidaza) | – A Hematology Oncology Wiki

Dilute immediately by injecting the calculated amount of azacitidine qzacitidine a 50 to mL infusion bag of either 0. Among those patients, overall survival was When suppressor genes are blocked, cell division becomes unregulated, allowing or promoting cancer. Allow refrigerated syringe s to warm to room temperature for up to 30 minutes prior to administration.

Azacitidine is administered as a subcutaneous injection or as an intravenous IV infusion. Drug-Drug Interactions Drug interaction studies with azacitidine have not been conducted. Women who become pregnant pacage receiving azacitidine should be apprised of the potential hazard to the fetus.

Shake or roll the vial vigorously until a uniform suspension occurs; the suspension will be cloudy. The solution should be clear. Azacitidine’s anticancer effects are believed to be twofold. The potential of azacitidine to inhibit cytochrome P CYP enzymes is not known. Significant hematologic toxicity was noted with no response as defined by bone marrow remission or improvement in transfusion requirements. Treatment may be continued as long as the patient continues to benefit.

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For storage information, see specific product information within the How Supplied section. Doses greater than 4 mL should be divided equally into 2 syringes and injected into 2 separate sites.

Patients with MDS and renal impairment were excluded from clinical trials. 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.

Vigorously shake or roll the vial until all solids are dissolved.

The diluent should be injected slowly into the vial. Do not store for later use. Treatment may be continued as long as the patient continues to benefit. Non-proliferating cells are relatively insensitive to azacitidine. Not all side effects are listed above.

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 contents from ijsert vial. Related Drug Information Drug Summary. Instructions for Intravenous Administration. If it comes into contact with mucous packabe, flush thoroughly with water.

Azacitidine is rapidly absorbed after subcutaneous administration. Rotate sites for each injection thigh, abdomen, or upper arm. Quality of life QOL was also assessed in this study. Mannitol-containing and zaacitidine formulations have different stability following reconstitution for subcutaneous use.