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Reimbursement of PrEPREX® for Cancer Patients Receiving Chemotherapy
PrEPREX® (epoetin alfa)
DIN(s)
02231587 (10000IU/1.0mL)
02243239 (20000IU / 0.5mL)
02288680 (30000IU / 0.75mL)
02240722 (40000IU/mL)
PrEPREX® Product Monograph
PrEPREX® is an eligible benefit through most private insurance plans, provincial/ territorial drug benefit programs and federal drug plans. Please choose the appropriate drug plan/program from the sidebar menu for specific information on PrEPREX® reimbursement. PrEPREX® is indicated for use in a number of clinical settings. This information pertains to PrEPREX® prescribed for cancer patients receiving chemotherapy. For the full list of indications, please see the PrEPREX® Product Monograph
Treatment of Anemia Due to Chemotherapy in Patients With Non-Myeloid Malignancies:
PrEPREX® therapy is indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for RBC transfusions in patients with advanced or metastatic, non-myeloid malignancies receiving chemotherapy for a minimum of 2 months. Studies to determine whether PrEPREX® increases mortality or decreases progression-free/recurrence-free survival are ongoing.- In patients with a long life expectancy, the decision to administer ESAs should be based on a benefit-risk assessment with the participation of the individual patient. This should take into account the specific clinical context such as (but not limited to) the type of tumour and its stage, the degree of anemia, life expectancy, the environment in which the patient is being treated and known risks of transfusions and ESAs.
- If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long life expectancy and who are receiving myelosuppressive chemotherapy.
- PrEPREX® is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
PrEPREX® therapy is not intended for patients who require immediate correction of severe anemia. PrEPREX® epoetin alfa may obviate the need for maintenance transfusions but is not a substitute for emergency transfusion. Blood pressure should be adequately controlled prior to initiation of PrEPREX® therapy and must be closely monitored and controlled during treatment. PrEPREX® therapy is not indicated for other specific causes of anemia with established treatments such as iron or folate deficiencies, hemolysis, or gastrointestinal bleeding which should be managed appropriately.
PrEPREX® epoetin alfa is contraindicated in patients: who develop pure red cell aplasia (PRCA) following treatment with any erythropoiesis regulating hormone; with uncontrolled hypertension; with known hypersensitivity to mammalian cell-derived products, albumin (human) or any component of the product; who for any reason cannot receive adequate antithrombotic treatment.
In addition, the 20,000 IU/mL formulation, preserved with benzyl alcohol, is contraindicated in premature infants and newborns.
PrEPREX® should not be initiated at hemoglobin levels ≥100 g/L. PrEPREX® administration should be discontinued following completion of a chemotherapy course.
Serious Warnings and PrecautionsALL PATIENTS- To minimize the risks for death, serious cardiovascular events and stroke, follow the recommended dosage for each indication for PrEPREX® and other erythropoiesis stimulating agents (ESAs) (see WARNINGS AND PRECAUTIONS: Increased Mortality, Serious Cardiovascular, Thromboembolic Events and Stroke and DOSAGE AND ADMINISTRATION of the product monograph).
- In surgical patients treated with PrEPREX® for reduction of allogeneic red blood cell transfusions, adequate antithrombotic prophylaxis, as per current standard of care, is recommended in order to reduce the incidence of deep venous thrombosis.
- The multi-use preserved formulation contains benzyl alcohol. Benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications in premature infants which are sometimes fatal.
- Patients with uncontrolled hypertension should not be treated with PrEPREX®; blood pressure should be controlled adequately before initiation of therapy.
- PrEPREX® should be used with caution in patients with a history of seizures.
- Antibody-mediated pure red cell aplasia (PRCA) has been reported after months to years of treatment with ESAs.
CANCER PATIENTS- ESAs increased the risks for death and serious cardiovascular and thromboembolic events in some controlled clinical trials.
- ESAs shortened overall survival and/or increased the risk of tumour progression or recurrence in some clinical studies in patients with breast, head and neck, lymphoid, cervical and non-small cell lung cancers when dosed to target a hemoglobin of ≥120 g/L.
- To minimize the above risks, use the lowest dose needed to avoid red blood cell (RBC) transfusions.
- Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
- If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long life expectancy and who are receiving myelosuppressive chemotherapy.
- Discontinue PrEPREX® following completion of a chemotherapy course.
The recommended starting dose for adult cancer patients is 150 IU/kg subcutaneously three times per week or 40,000 IU subcutaneously once per week. The 20,000 IU/mL formulation, preserved with benzyl alcohol, is contraindicated in premature infants and newborns.
Please consult the prescribing information for complete dosing and administration instructions.
Hemoglobin levels during ESA treatment should not exceed 120 g/L in men and women.
The most common adverse events with PrEPREX® epoetin alfa administered thrice weekly in cancer patients include nausea (23%), pyrexia (22%), asthenia (17%), fatigue (15%), vomiting (15%), diarrhea (15%), edema (14%),dizziness (10%), skin reaction at administration site (10%) and constipation (10%).
The most common adverse events with PrEPREX® epoetin alfa administered once weekly in cancer patients include fatigue (51%), nausea (35%),alopecia (25%), neurosensory (23%), vomiting (20%), diarrhea—nocolostomy (20%), anorexia (18%), constipation (18%) and dyspnea (16%).
For more information, please contact JANSSEN Medical Information at 1-800-567-3331.
PrEPREX® Product Monograph. Janssen Inc. September 22, 2010.
Please consult the PrEPREX® Product Monograph for prescribing information, complete warnings and precautions, adverse events and patient selection criteria.
Resources for Healthcare Professionals and Your Patients
SPECTRUM* Patient Support Programme
For additional assistance with PrEPREX® reimbursement, call 1-877-793-7739.
SPECTRUM* Enrolment Form
 * All trademark rights used under license by Janssen Inc.
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