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Based on its mechanism of action and results in animals, VIDAZA can cause fetal harm when administered to a pregnant lady [see CLINICAL PHARMACOLOGY]. There isn't any details on using azacitidine in pregnant women.
Dependant on the system of motion and conclusions in animals, VIDAZA could cause fetal damage when administered to some Expecting female.
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Vidaza can lessen blood cells that support your body fight bacterial infections and help your blood to clot. Chances are you'll get an an infection or bleed much more quickly. Get in touch with your medical doctor if you have strange bruising or bleeding, or indications of an infection (fever, chills, entire body aches).
Immediately after administration of your encouraged dosage for the 1st cycle, alter dosage for subsequent cycles depending on nadir counts and hematologic response [see DOSAGE AND ADMINISTRATION].
Hypomethylation may perhaps restore normal function to genes which can be essential for differentiation and proliferation. The cytotoxic effects of azacitidine result in the Loss of life go now of speedily dividing cells, together with cancer cells which are not conscious of normal growth control mechanisms. Non-proliferating cells are comparatively insensitive to azacitidine.
Bear check my source in mind, hold this and all other medicines out from the attain of children, never share your medicines with others, and use Vidaza only for the indication prescribed.
Reconstitute the right amount of VIDAZA vials to obtain the specified dose. Reconstitute Each and every vial with 10 mL sterile h2o for injection. Vigorously shake or roll the vial until all solids are dissolved. The ensuing Resolution will have azacitidine 10 mg/mL. The solution need to be crystal clear.
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Caregivers should really have on rubber gloves even though cleaning up a individual's body fluids, dealing with contaminated trash or laundry or shifting diapers. Clean fingers before and soon after removing gloves. Clean soiled apparel and linens independently from other laundry.
1A affected person was regarded as RBC transfusion unbiased in the therapy interval If your affected person experienced no RBC transfusions in the course of any fifty six consecutive days or even more in the course of the treatment period of time. In any other case, the patient was viewed as transfusion dependent.
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VIDAZA was look at this now administered at a subcutaneous dose of 75 mg/m² day-to-day for seven times just about every four weeks. The dose was improved to one hundred mg/m² if no valuable outcome was noticed just after 2 remedy cycles. The dose was diminished and/or delayed determined by hematologic response or proof of renal toxicity. Individuals while in the observation arm were being authorized by protocol to cross more than to VIDAZA if they'd improves in bone marrow blasts, decreases in hemoglobin, boosts in pink mobile transfusion requirements, or decreases in platelets, or if they necessary a platelet transfusion or designed a medical infection requiring remedy with antibiotics. For needs of evaluating efficacy, the key endpoint was reaction level (as outlined in Table 4).