Vintor 2000 Injection

Epogen is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to: - Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). - Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). - The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ). Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery ( 1.4 ). Limitations of Use Epogen has not been shown to improve quality of life, fatigue, or patient well-being ( 1.5 ). …

• Evaluate iron status before and during treatment and maintain iron repletion
• Correct or exclude other causes of anemia before initiating treatment
• In pregnant women, lactating women, neonates, infants: Use only single-dose vials
• Patients with CKD: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (pediatric patients)
• Individualize maintenance dose
• Intravenous route recommended for patients on hemodialysis
• Patients on Zidovudine due to HIV infection: 100 Units/kg 3 times weekly
• Patients with Cancer on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (pediatric patients ≥ 5 years)
• Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly
• Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during treatment
• Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%
• The majority of patients with CKD will require supplemental iron during the course of ESA therapy
• Monitoring of Response to Therapy Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Epogen
• Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion. …

Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, and 10,000 Units/mL of Epogen as a clear and colorless liquid in single-dose vials. 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of Epogen as a clear and colorless liquid in multiple-dose vials (contains benzyl alcohol). …

• The multiple-dose vials are formulated with benzyl alcohol and are contraindicated for use in neonates and infants [see Contraindications , Warnings and Precautions ]
• When therapy with Epogen is needed in neonates and infants, use the single-dose vial, which is a benzyl alcohol-free formulation
• Do not mix the single-dose vials with bacteriostatic saline when administering Epogen to neonates or infants because it contains benzyl alcohol [se e Dosage and Administration ] . …

Of the 4553 patients who received Epogen in the 6 studies for treatment of anemia due to CKD not receiving dialysis, 2726 (60%) were age 65 years and over, while 1418 (31%) were 75 years and over. Of the 757 patients who received Epogen in the 3 studies of CKD patients on dialysis, 361 (47%) were age 65 years and over, while 100 (13%) were 75 years and over. …

• Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use )
• Inform patients: Of the increased risks of mortality, serious cardiovascular reactions, thromboembolic reactions, stroke, and tumor progression [ see Warnings and Precautions ]
• To undergo regular blood pressure monitoring, adhere to prescribed anti-hypertensive regimen and follow recommended dietary restrictions
• To contact their healthcare provider for new-onset neurologic symptoms or change in seizure frequency
• Of the need to have regular laboratory tests for hemoglobin. …

Epogen is contraindicated in patients with: Uncontrolled hypertension [see Warnings and Precautions ( 5.3 )] Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other erythropoietin protein drugs [see Warnings and Precautions ( 5.6 )] Serious allergic reactions to Epogen [see Warnings and Precautions ( 5.7 )] Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in: Neonates, infants, pregnant women, and lactating women [see Warnings and Precautions ( …

Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit ( 5.1 and 14.1 ). Use caution in patients with coexistent cardiovascular disease and stroke ( 5.1 ). Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer ( 5.2 ). Hypertension: Control hypertension prior to initiating and during treatment with Epogen ( 5.3 ). Seizures: Epogen increases the risk for seizures in patients with CKD ( 5.4 ). …

The following serious adverse reactions are discussed in greater detail in other sections of the label: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions ( 5.1 )] Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients with Cancer [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Seizures [see Warnings and Precautions ( 5.4 )] PRCA [see Warnings and Precautions ( 5.6 )] Serious Allergic Reactions [see Warnings and Precautions ( 5.7 )] Severe Cutaneous Reactions [see Warnings and Precautions ( 5.8 )] Patients with CKD: Adverse reactions in ≥ 5% of Epogen-treated patien …

8.1 Pregnancy Risk Summary Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications ( 4 )] . When therapy with Epogen is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial). …

Epogen overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Epogen dosage and/or with phlebotomy, as clinically indicated [see Clinical Pharmacology ( 12.2 )] . Cases of severe hypertension have been observed following overdose with ESAs [see Warnings and Precautions ( 5.3 )] .

9.1 Controlled Substance Epogen contains epoetin alfa, which is not a controlled substance. 9.2 Abuse Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Abuse of Epogen may be seen in athletes for the effects on erythropoiesis. …

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.