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Anemia Due To Chronic Kidney Disease
Anemia Due To Zidovudine In HIV-infected Patients
Anemia Due To Chemotherapy In Patients With Cancer
PROCRIT is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
Reduction Of Allogeneic Red Blood Cell Transfusions In Patients Undergoing Elective, Noncardiac, Nonvascular Surgery
PROCRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. PROCRIT is not indicated for patients who are willing to donate autologous blood pre-operatively.
Limitations Of Use
PROCRIT has not been shown to improve quality of life, fatigue, or patient well-being.
PROCRIT is not indicated for use:
- In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
- In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
- In patients scheduled for surgery who are willing to donate autologous blood.
- In patients undergoing cardiac or vascular surgery.
- As a substitute for RBC transfusions in patients who require immediate correction of anemia [see CLINICAL PHARMACOLOGY].
DOSAGE AND ADMINISTRATION
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 PROCRIT [see WARNINGS AND PRECAUTIONS].
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 PROCRIT sufficient to reduce the need for RBC transfusions [see WARNINGS AND PRECAUTIONS]. 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].
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 PROCRIT 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 PROCRIT 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 PROCRIT if responsiveness does not improve.
For Patients with CKD on Dialysis
- Initiate PROCRIT 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 PROCRIT.
- 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 PROCRIT 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 PROCRIT, and use the lowest dose of PROCRIT 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.
Refer patients who self-administer PROCRIT to the Instructions for Use [see PATIENT INFORMATION].
Zidovudine-treated HIV-infected Patients
The recommended starting dose in adults is 100 Units/kg as an intravenous or subcutaneous injection 3 times per week.
- If hemoglobin does not increase after 8 weeks of therapy, increase PROCRIT 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 PROCRIT 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 PROCRIT if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.
Patients On Cancer Chemotherapy
Initiate PROCRIT 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 PROCRIT necessary to avoid RBC transfusions.
Recommended Starting Dose
- 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.
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.
After the initial 4 weeks of PROCRIT 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 PROCRIT.
The recommended PROCRIT 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.
Preparation And Administration
- Do not shake. Do not use PROCRIT 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 PROCRIT in preservative-free vials. Do not re-enter preservative-free vials.
- Store unused portions of PROCRIT 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 PROCRIT 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].
Dosage Forms And Strengths
Single-dose vials: 2000, 3000, 4000, 10,000, and 40,000 Units PROCRIT /1 mL
Multidose vials (contains benzyl alcohol): 20,000 Units PROCRIT /2 mL and 20,000 Units PROCRIT /1 mL
Storage And Handling
Store at 36°F to 46°F (2°C to 8°C). Do not freeze.
Do not shake. Protect from light; store PROCRIT in the carton until use.
Do not use PROCRIT that has been shaken or frozen.
Single-dose, Preservative-free Vial: Each 1 mL of solution contains 2000 (NDC 59676-302-01), 3000 (NDC 59676-303-01), 4000 (NDC 59676-304-01), or 10,000 Units (NDC 59676-310-01) of epoetin alfa. Each strength is supplied in cartons, each carton containing 6 single-dose vials.
Single-dose, Preservative-free Vial (Tray): Each 1 mL of solution contains 10,000 Units (NDC 59676-310-02) of epoetin alfa and is supplied in dispensing packs containing 25 single-dose vials.
Single-dose, Preservative-free Vial (in phosphate-buffered formulation): Each 1 mL of solution contains 40,000 Units (NDC 59676-340-01) of epoetin alfa and is supplied in dispensing packs containing 4 single-dose vials.
Multidose, Preserved Vial: 2 mL (20,000 Units total; 10,000 Units/mL). Each 1 mL of solution contains 10,000 Units (NDC 59676-312-04) of epoetin alfa and is supplied in dispensing packs containing 4 multidose vials.
Multidose, Preserved Vial: 1 mL (20,000 Units/mL). Each 1 mL of solution contains 20,000 Units (NDC 59676-320-04) of epoetin alfa and is supplied in dispensing packs containing 4 multidose vials.
Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799 U.S.A. Manufactured for: Janssen Products, LP, Horsham, Pennsylvania 19044. Revised: Dec 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/13/2016
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