Glycinorm-80 Tablets

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. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.