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VIDAZA
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VIDAZA
 
Package:
VIAL (lyophilized powder for injection): 1.
Dosage:
The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m2 subcutaneously, daily for seven days. Patients should be premedicated for nausea and vomiting. See prescribing information for full details for subsequent treatment cycles.
Prescribing Restrictions:  Kupah Pharmacy Only Medical Division Approval


Indications:
Treatment of patients with the following myelodysplastic syndrome subtypes: Refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
Contra-Indications:
Known hypersensitivity to azacitidine or mannitol. Patients with advanced malignant hepatic tumors.
Special Precautions:
Treatment is associated with neutropenia and thrombocytopenia. Complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle. After administration of the recommended dosage for the first cycle, dosage for subsequent cycles should be reduced or delayed based on nadir counts and hematologic response. Patients with severe pre-existing hepatic impairment, patients with liver disease. Renal abnormalities ranging from elevated serum creatinine to renal failure and death have been reported rarely in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents for non-MDS conditions. Patients with renal impairment should be closely monitored for toxicity. 
Pregnancy and lactation: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment. If used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women should not breastfeed during treatment. Men should be advised to not father a child while receiving treatment. 
Pediatric use: Safety and effectiveness have not been established.
Side Effects:
Nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, fatigue, injection site erythema, constipation, neutropenia, ecchymosis. Blood and lymphatic system disorders: agranulocytosis, bone marrow depression, splenomegaly. Cardiac disorders: atrial fibrillation, cardiac failure, cardiac failure congestive, cardio-respiratory arrest, congestive cardiomyopathy. Gastrointestinal disorders: diverticulitis, gastrointestinal hemorrhage, melena, perirectal abscess. Anaphylactic shock, hypersensitivity. Infections and infestations: abscess limb, bacterial infection, blastomycosis, injection site infection, Klebsiella sepsis, pharyngitis streptococcal, pneumonia Klebsiella, sepsis, Staphylococcal bacteremia, Staphylococcal infection, toxoplasmosis. Dehydration. Musculoskeletal and connective tissue disorders: bone pain aggravated, muscle weakness, neck pain. Nervous system disorders: convulsions, intracranial hemorrhage. Confusion. Hematuria, loin pain, renal failure. Respiratory, thoracic and mediastinal disorders: Hemoptysis, lung infiltration, pneumonitis, respiratory distress. Skin and subcutaneous tissue disorders: Pyoderma gangrenosum, rash, skin induration. See prescribing information for full details.
Drug Interactions:
Studies have not been conducted.