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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Treatment may be continued as long as the patient continues azaitidine benefit. If it comes in contact with mucous membranes, flush thoroughly with water. We do not record any personal information entered above. Administer the total dose over a period of 10 — 40 minutes.
These patients should use effective contraception and avoid pregnancy during and for 6 months after azacitidine therapy. Give new injections at least one inch from an old azaditidine do not inject in a site that is tender, bruised, red, or hard.
VIDAZA is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow.
The product may be held at room temperature for up to 1 hour, but must be administered within 1 hour after reconstitution. The reconstituted product may be kept in the vial or drawn into a syringe.
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Controlling Occupational Exposure to Hazardous Drugs. Azacitidine’s anticancer effects are believed to be twofold. In vitro studies with human cultured azactidine indicate that azacitidine at concentrations of 1. If reconstituted azacitidine contacts the skin, wash the skin immediately with soap and water. Azacitidine induces cytotoxicity in rapidly dividing cells that are no longer responsive to normal cell growth control mechanisms.
Have questions about chemotherapy? If a imsert has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful. Non-proliferating cells are relatively insensitive to azacitidine. The solution is stable at room temperature 25 degrees C or 77 degrees F for up to 1 hour after reconstitution.
Do not store for later use. Rotate sites for each injection thigh, abdomen, or upper arm. Azacitidine is contraindicated in patients with advanced hepatic malignancies.
When the cells incorporate these substances into the cellular metabolism, oackage interact with a number of targets insrrt the cell to produce a direct cytotoxic effect that causes death of rapidly dividing cancer cells. The following symptoms require medical attention, but are not an emergency. Hypermethylation is thought to be an early step in malignant transformation of cells. 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.
Progressive hepatic coma and death have been reported in azacitkdine patients with extensive tumor burden due to metastatic disease, particularly in patients with hypoalbuminemia i. It is recommended that patients be treated for a minimum of 4 to 6 cycles.
Vidaza (azacitidine) dose, indications, adverse effects, interactions from
Vigorously shake or roll the vial until a uniform suspension is achieved. 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.
Moderate Palifermin should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of antineoplastic agents. Bone marrow suppression including anemia, neutropenia, and thrombocytopenia has been commonly reported.
Moderate Immunosuppressives azacitkdine decrease the immunological response to tuberculin purified protein derivative, PPD. Bone marrow suppression, neutropenia, thrombocytopenia. Rotate sites for each injection thigh, abdomen, or upper arm. Advise pregnant women of the potential risk to the fetus.
Animal studies have indicated increased response when smaller doses of azacitidine were given over a period of time versus larger doses given less frequently. Instructions for Intravenous Administration. Azacitidine is available as a single-use, mg iinsert powder vial. Allow refrigerated syringe s to warm to room temperature for up to 30 minutes prior to administration.
An in vitro study indicated that it may be metabolized by the liver. Hepatotoxicity may occur in patients with severe hepatic impairment. One way that it works is by demethylation or interfering with the methylation of DNA.