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DOSING FOR ANEMIA DUE TO CHRONIC KIDNEY DISEASE

DOSING FOR ANEMIA DUE TO CHRONIC KIDNEY DISEASE

Anemia due to chronic kidney disease1

PROCRIT® is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis, to decrease the need for red blood cell (RBC) transfusion.

PROCRIT® has not been shown to improve quality of life, fatigue, or patient well-being.

PROCRIT® is not indicated for use:

Important dosing and administration information1

IMPORTANT DOSING CONSIDERATIONS

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 (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating PROCRIT®. Following initiation of therapy and after each dose adjustment, monitor hemoglobin (Hb) weekly until the Hb level is stable and sufficient to minimize the need for RBC transfusion.

Selection of formulation

In pregnant women, lactating women, neonates, and infants, use only single-dose vials (the benzyl alcohol–free formulation). Do not mix PROCRIT® with bacteriostatic saline (which also contains benzyl alcohol) when administering PROCRIT® to these patient populations.

In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target an Hb level of greater than 11 g/dL. No trial has identified an Hb target level, ESA dose, or dosing strategy that does not increase these risks.

Individualize dosing and use the lowest dose of PROCRIT® sufficient to reduce the need for RBC transfusions. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse reactions.

For all patients with CKD:

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

For adult patients with CKD on dialysis:

For adult patients with CKD not on dialysis:

For pediatric patients with CKD:

When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions (sections 5.1 and 5.2) of the FULL PRESCRIBING INFORMATION.

ESA=erythropoiesis-stimulating agent.

Individualized dosing options

PROCRIT® starting dose (range):

50 u/kg TIW - 100 u/kg TIW

TIW=3 times weekly.

Dosing algorithm for adults not on dialysis1

01 - Identify

PATIENT ASSESSMENT: OBTAIN AND MONITOR Hb

  • Correct or exclude other causes of anemia (eg, vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating PROCRIT®
  • Following initiation of therapy and after each dose adjustment, monitor Hb weekly until the Hb level is stable and sufficient to minimize the need for RBC transfusion
  • Evaluate the iron status in all patients before and during treatment
  • Administer supplemental iron therapy when serum ferritin is <100 mcg/L or when serum transferrin saturation is <20%
  • The majority of patients with CKD will require supplemental iron during the course of ESA therapy
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02 - Initiate

  • Consider initiating PROCRIT® treatment only when the Hb level is <10 g/dL and the following considerations apply:
    • The rate of Hb decline indicates the likelihood of requiring an RBC transfusion and
    • Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal
  • If the Hb level is <10 g/dL, reduce or interrupt the dose of PROCRIT®, and use the lowest dose of PROCRIT® sufficient to reduce the need for RBC transfusions
  • Evaluate iron status and consider supplemental iron therapy as needed to support erythropoiesis

50 to 100 Units/kg TIW, intravenously (IV) or subcutaneously (SC)

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03 - Assess and manage

Monitor Hb regularly during therapy

Monitor Hb at least weekly after initiation and following a dosage adjustment until stable, then monitor at least monthly

  • When adjusting therapy, consider Hb rate of rise, rate of decline, ESA responsiveness, and Hb variability
  • A single Hb excursion may not require a dosing change

Manage therapy

  • Evaluate lack of response per Prescribing Information, Warnings & Precautions section:
    • For lack or loss of Hb response to PROCRIT®, initiate a search for causative factors (eg, iron deficiency, infection, inflammation, or bleeding)
    • If typical causes of lack or loss of Hb response are excluded, evaluate for pure red cell aplasia (PRCA) [see Warnings and Precautions (5.6)]
    • In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient Hb response to PROCRIT® therapy [see Dosage and Administration (2.2)]
  • Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.
  • If Hb rises rapidly (eg, >1 g/dL in any 2-week period), reduce the dose of PROCRIT® by 25% or more as needed to reduce rapid responses.
  • For patients who do not respond adequately, if the Hb 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 PROCRIT® dose further is unlikely to improve response and may increase risks.
    • Use the lowest dose that will maintain an Hb level sufficient to reduce the need for RBC transfusions
    • Evaluate other causes of anemia
    • Discontinue PROCRIT® if responsiveness does not improve

PROCRIT® is contraindicated in patients with uncontrolled hypertension, pure red cell aplasia (PRCA) that begins after treatment with PROCRIT® or other erythropoietin protein drugs, or serious allergic reactions to PROCRIT®. PROCRIT® from multiple-dose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women.1 Please see the FULL PRESCRIBING INFORMATION to learn more.

Reference

  1. PROCRIT® (epoetin alfa) Prescribing Information. Janssen Products, LP.
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