Epogen

Epogen Manufacturers

• Amgen Inc
  

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  Epogen | Amgen Inc

  

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  2.1 Evaluation of Iron Stores and Nutritional Factors

  Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Epogen [see Warnings and Precautions (5.11)].

  2.2 Patients with Chronic Kidney Disease

  In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.  No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.  Individualize dosing and use the lowest dose of Epogen sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)].  Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events [see Boxed Warning and Clinical Studies (14)].

  For all patients with CKD:

  When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.

  Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments. If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Epogen by 25% or more as needed to reduce rapid responses. For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. For patients who do not respond adequately over a 12-week escalation period, increasing the Epogen dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Epogen if responsiveness does not improve.

  For patients with CKD on dialysis:

  Initiate Epogen treatment when the hemoglobin level is less than 10 g/dL. If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Epogen. The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 Units/kg 3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.

  For patients with CKD not on dialysis: 

  Consider initiating Epogen treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply: The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and, Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Epogen, and use the lowest dose of Epogen sufficient to reduce the need for RBC transfusions. The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously.

  When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (5.1 and 5.3).

  Refer patients who self-administer Epogen to the Instructions for Use [see Patient Counseling Information (17)].

  2.3 Zidovudine-treated HIV-infected Patients

  Starting Dose

  The recommended starting dose in adults is 100 Units/kg as an intravenous or subcutaneous injection 3 times per week.

  Dose Adjustment

  If hemoglobin does not increase after 8 weeks of therapy, increase Epogen dose by approximately
  50 to 100 Units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 Units/kg. Withhold Epogen if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.

  Discontinue Epogen if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.

  2.4 Patients on Cancer Chemotherapy

  Initiate Epogen in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.

  Use the lowest dose of Epogen necessary to avoid RBC transfusions.

  Recommended Starting Dose

  Adults:

  150 Units/kg subcutaneously 3 times per week until completion of a chemotherapy course or 40,000 Units subcutaneously weekly until completion of a chemotherapy course.

  Pediatric Patients (5 to 18 years):

  600 Units/kg intravenously weekly until completion of a chemotherapy course.

  Dose Reduction

  Reduce dose by 25% if:

  Hemoglobin increases greater than 1 g/dL in any 2-week period or Hemoglobin reaches a level needed to avoid RBC transfusion.

  Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required.

  Dose Increase

  After the initial 4 weeks of Epogen therapy, if hemoglobin increases by less than 1 g/dL and remains below 10 g/dL, increase dose to:

  300 Units/kg three times per week in adults or 60,000 Units weekly in adults 900 Units/kg (maximum 60,000 Units) weekly in children

  After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue Epogen.

  2.5 Surgery Patients

  The recommended Epogen regimens are:

  300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery.

  Deep venous thrombosis prophylaxis is recommended during Epogen therapy [see Warnings and Precautions (5.1)].

  2.6 Preparation and Administration Do not shake. Do not use Epogen that has been shaken or frozen. Protect vials from light.  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any vials exhibiting particulate matter or discoloration. Discard unused portions of Epogen in preservative-free vials. Do not re-enter preservative-free vials. Store unused portions of Epogen in multidose vials at 36°F to 46° F (2°C to 8°C). Discard 21 days after initial entry. Do not dilute. Do not mix with other drug solutions except for admixing as described below: Preservative-free Epogen from single-use vials may be admixed in a syringe with bacteriostatic 0.9% sodium chloride injection, USP, with benzyl alcohol 0.9% (bacteriostatic saline) in a 1:1 ratio using aseptic technique at the time of administration. Risks are associated with benzyl alcohol in neonates, infants, pregnant women, and nursing mothers [see Use in Specific Populations (8.1, 8.3, 8.4)].

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