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]].
|Published (Last):||26 June 2014|
|PDF File Size:||5.93 Mb|
|ePub File Size:||7.59 Mb|
|Price:||Free* [*Free Regsitration Required]|
It is recommended that patients be treated for a minimum of 4 to 6 cycles. Dosage regimen not defined. 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.
Vidaza (azacitidine) dose, indications, adverse effects, interactions from
VIDAZA is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. Azacitidine also belongs to the category of chemotherapy called antimetabolites. The product may be held at room temperature for up to 1 hour, but must be administered within 1 hour after reconstitution. Clinical trials have not demonstrated appreciable response in children with relapsed AML treated with azacitidine.
Therapy interruption or a paxkage reduction may be necessary if a patient develops severe treatment-related toxicity.
Quality of life QOL was also assessed in this study. Recipient’s Email Separate multiple email address with a comma Please enter valid email address Recipient’s email is required. Vigorously shake or roll the vial until a uniform suspension is achieved. Azacitidine induces cytotoxicity in rapidly dividing cells that are no longer responsive to normal cell growth control mechanisms.
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.
We strongly encourage you to talk with your azaciticine care professional about your specific medical condition and treatments. Hepatic disease, hepatotoxicity, hypoalbuminemia.
Do not store for later use. Allow refrigerated syringe s to warm to room temperature for up to 30 minutes prior to administration. All patients should receive antiemetics prior to each azacitidine dose. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. 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.
Significant hematologic toxicity was noted with no response as defined by bone marrow remission or improvement in transfusion requirements. The cytotoxic effects of azacitidine cause azaditidine death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Preparation for Immediate Subcutaneous Administration: Pregnancy testing should be performed prior to starting azacitidine in female patients of reproductive potential.
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. Contact your health care provider within 24 hours of noticing any of the following: By this process of demethylation, normal function to the tumor suppressor genes is restored, thus restoring control over cell growth.
Tumor lysis syndrome TLS has pzckage reported in patients with myelodysplastic syndrome who received azacitidine.
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 was refrigerated. Have questions about chemotherapy?
Always inform your health care provider if you experience any unusual symptoms. Published studies indicate that urinary excretion is the primary route of elimination of azacitidine and its metabolites. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Instructions for Intravenous Administration. Rotate sites for each injection thigh, abdomen, or upper arm. Shake or roll the vial vigorously until a uniform suspension occurs; the suspension will be cloudy.
The mean elimination half-lives of total radioactivity azacitidine and its metabolites were similar after IV and SC administrations, about 4 hours. Azacitirine is administered as a subcutaneous injection or as an intravenous IV infusion. The reconstituted product may be kept in the vial or drawn into a syringe. Bone marrow suppression, neutropenia, thrombocytopenia.
Non-proliferating cells are relatively insensitive to azacitidine. Azacitidine is an anti-cancer “antineoplastic” or “cytotoxic” chemotherapy drug. For storage information, see specific product information within the How Supplied section.
The diluent should be injected slowly into the vial. Azacitidine is available as a single-use, mg lyophilized powder vial. Shake or roll the vial vigorously until all powder is dissolved; the solution should be clear. Major Do not use penicillamine with antineoplastic agents due to the increased risk of developing severe hematologic and renal toxicity.
The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis.
Am J Health-Syst Pharm.
Azacitidine – Drug Information – Chemocare
Azacitidine has been designated an orphan drug for this indication. Do not filter the suspension after reconstitution as this may remove the active substance. Administer the azacitidine admixture IV over 10 to 40 minutes; complete the infusion within 1 hour of azacitidine vial reconstitution.
Patients were reassessed after 4 cycles, and those paclage a complete response CR continued for 3 more cycles, those with a partial response PR or stable disease continued until CR or progressive disease. Azacitidine has not been evaluated in patients with myelodysplastic syndrome and hepatic impairment; use is contraindicated in patients with advanced hepatic malignancy. 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 12 hours when reconstituted with Sterile Water for ;ackage that was not refrigerated or for up to 30 hours when reconstituted with Sterile Water for injection that was refrigerated.
Packagr and biotherapy aaacitidine and recommendations for practice 2nd. Methylation of DNA is a major mechanism that regulates gene expression in cells.