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 PRESCRIBING INFORMATION
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Introduction
PROCRIT® (Epoetin alfa) - Important Safety Information
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE
Chronic Renal Failure:
- In clinical studies, patients experienced greater risks for death, serious cardiovascular events, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target hemoglobin levels of 13 g/dL and above.
- Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
Cancer:
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (see WARNINGS: Table 1).
- To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
- Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense PROCRIT® to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
- Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
- ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
- Discontinue following the completion of a chemotherapy course.
Perisurgery: PROCRIT® (Epoetin alfa) increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.
(See WARNINGS: Increased Mortality, Serious Cardiovascular Events, Thromboembolic Events, and Stroke, WARNINGS: Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION.)
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For more information, see full Prescribing Information, including Boxed WARNINGS for PROCRIT® (Epoetin alfa)
Medication Guide for PROCRIT®
Please read the Medication Guide for PROCRIT® and discuss with your doctor.
Patient Instructions for Use
Instructions if you or your caregiver has been trained to give PROCRIT® injections at home.
LEUSTATIN® (cladribine injection) - Important Safety Information
Boxed WARNINGS: LEUSTATIN® (cladribine) Injection
- LEUSTATIN (cladribine) Injection should be administered
under the supervision of a qualified physician
experienced in the use of antineoplastic therapy.
Suppression of bone marrow function should be anticipated.
This is usually reversible and appears to be
dose dependent. Serious neurological toxicity (including
irreversible paraparesis and quadraparesis) has
been reported in patients who received LEUSTATIN
Injection by continuous infusion at high doses (4 to 9
times the recommended dose for Hairy Cell Leukemia).
Neurologic toxicity appears to demonstrate a dose
relationship; however, severe neurological toxicity has
been reported rarely following treatment with standard
cladribine dosing regimens.
- Acute nephrotoxicity has been observed with high
doses of LEUSTATIN (4 to 9 times the recommended
dose for Hairy Cell Leukemia), especially when given
concomitantly with other nephrotoxic agents/therapies.
For more information, see full Prescribing Information, including Boxed WARNINGS for LEUSTATIN® (cladribine)
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