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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Hypomethylation may restore normal gene function to those genes critical inseet differentiation and proliferation. Moderate Immunosuppressives may decrease the immunological response to tuberculin purified protein derivative, PPD. Azacitidine is a pyrimidine analog for cytosine. Median time to leukemic transformation was 21 months in the azacitidine arm compared with 13 months in the supportive care arm.
However, you should always inform your health care provider if you experience any unusual symptoms.
The potential of azacitidine to inhibit cytochrome P CYP enzymes is not known. Azacitidiine serum creatinine levels and electrolytes prior to starting azacitidine and prior to each cycle of therapy. 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. Hepatic disease, hepatotoxicity, hypoalbuminemia. Patients should be monitored for hematologic response and renal toxicities [see Warnings and Precautions 5.
This medication is classified as an “antimetabolite” and a “demethylation” agent. Bone marrow suppression including anemia, neutropenia, and thrombocytopenia has been commonly reported.
Treatment may be continued as long as the patient continues to benefit. The suspension will be cloudy. Major Do not use penicillamine with antineoplastic agents due to the increased risk of developing severe hematologic and renal toxicity. Additionally, male 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.
We strongly encourage you to talk with your health care professional about your specific medical condition and treatments.
To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved.
Multiple dosing at the recommended dose-regimen does not result in drug accumulation. Your email has been sent. Females of reproductive potential should avoid pregnancy during treatment with azacitidine. Dosage regimen not defined.
Azacitidine – Drug Information – Chemocare
The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis. Clinical trials have not demonstrated appreciable response in children with relapsed AML treated with azacitidine.
Knsert Name Your name is required. Treatment may be continued as long as the patient continues to benefit.
The product may be held at room temperature for up to 1 hour, but must be administered within 1 hour after reconstitution. After removal from refrigerated conditions, the suspension may be allowed to equilibrate to room temperature for up to indert minutes prior to administration.
Periodic blood work to monitor your complete blood count Azacitidne as well as the function of other organs such as your kidneys and liver will also be ordered by your doctor. Advise pregnant women of the potential risk to the fetus. Not all side effects are listed above. Administer the azacitidine admixture IV over 10 to 40 minutes; complete the infusion within 1 hour of azacitidine vial reconstitution.
The following symptoms require medical attention, but are not an emergency. 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. This suppressed reactivity can persist for up to 6 weeks after treatment discontinuation. Preparation for Delayed Subcutaneous Administration: If it comes in contact with mucous membranes, flush thoroughly with water.
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. It is recommended that patients be treated for a minimum azacitieine 4 to 6 cycles. Because azacitidune patients are more likely to have decreased inxert function, care should be taken in dose selection, and it may be useful to monitor renal function [see Warnings and Precautions 5.
Monitor liver function tests prior to starting azacitidine and before each cycle of therapy. When there is an increase in DNA methylation this can result in the blockage of the activity of “suppressor genes” that regulate cell division and growth.
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. The reconstituted product may be kept in the vial azacutidine drawn into a syringe. Storage following reconstitution mannitol-containing formulations: Hepatotoxicity may occur in patients with severe hepatic impairment. Preparation for Immediate Subcutaneous Administration: In some cancer cells, hypermethylation blocks the activity of tumor suppressor genes, which regulate cell division and differentiation to prevent malignant transformation.
Azacitidine inhibition of DNA methyltransferase is dose- and time-dependent.
In vitro studies with human cultured hepatocytes indicate that azacitidine at concentrations of 1. VIDAZA is believed to exert its antineoplastic effects by causing hypomethylation of DNA paciage direct cytotoxicity on abnormal hematopoietic cells in the bone marrow.
Another clinical trial included 26 patients with poor-risk AML subsequent to Philadelphia-negative myeloproliferative neoplasms. Reconstitute each vial with 10 mL sterile water for injection. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Azacitidine has been designated an orphan drug for this indication. However, complete or partial response may require additional treatment cycles.
No azacitidine dosage adjustment is necessary in cycle 1 in patients with pckage impairment.