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PEGASYS is a brand name for Peginterferon Alfa-2a, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions Alpha interferons, including PEGASYS (peginterferon alfa-2a), cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations.
Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many cases, but not all cases, these disorders resolve after stopping interferon therapy (see WARNINGS AND PRECAUTIONS).
General In order to improve traceability of biological medicinal products, the trade name of the administered product should be clearly recorded (or stated) in the patient file. The safety and efficacy of PEGASYS have not been established in patients who have failed other alpha interferon treatments.
Treatment with PEGASYS should be administered under the guidance of a qualified physician and may lead to moderate to severe adverse experiences requiring dose reduction, temporary dose cessation or discontinuation of therapy. Patients should be informed regarding the potential benefits and risks attendant to the use of PEGASYS.
If home use is determined to be desirable by the physician, instructions on appropriate use should be given, including review of the contents of the Consumer Information, which does not disclose all possible adverse effects of PEGASYS (see PART III: CONSUMER INFORMATION).
If home use is prescribed, patients should be thoroughly instructed in the importance of proper disposal of, and cautioned against, reuse of any needles and syringes. Patients should be cautioned not to change to other pegylated interferons or switch to other alpha interferons without a medical consultation; changing from one interferon to another may require dosage change or adjustment.
Patients who develop dizziness, confusion, somnolence, or fatigue should be cautioned to avoid driving or operating machinery. Cardiovascular Cardiovascular events such as hypertension, supraventricular arrhythmias, congestive heart failure, chest pain and myocardial infarction have been associated with interferon therapies, including PEGASYS.
Therefore, PEGASYS should be administered with caution to patients with pre existing cardiac disease. Patients should be assessed before initiation of therapy and should be appropriately monitored during therapy. It is recommended that patients who have pre existing cardiac abnormalities have an electrocardiogram prior to initiation of PEGASYS.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
As PEGASYS® Page 6 of 54 with other alpha interferons, treatment with PEGASYS is not recommended in patients with pre existing severe, unstable or uncontrolled cardiac disease; if there is any deterioration of cardiovascular status, PEGASYS therapy should be suspended or discontinued.
Cerebrovascular Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including PEGASYS. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age.
Because these are spontaneous reports, estimates of frequency cannot be made and a causal relationship between interferon alfa-based therapies and these events is difficult to establish. Endocrine and Metabolism Endocrine As with other interferons, PEGASYS may cause or aggravate hypothyroidism and hyperthyroidism.
Hypoglycemia, hyperglycemia, and diabetes mellitus have been observed in patients treated with PEGASYS. Patients with these conditions at baseline who cannot be effectively controlled by medication should not be started on PEGASYS therapy.
Patients who develop these conditions during treatment and cannot be controlled with medication should not continue PEGASYS therapy. Gastrointestinal Colitis Hemorrhagic/ischemic colitis, sometimes fatal, has been observed within 12 weeks of starting alpha interferon treatment.
Abdominal pain, bloody diarrhea, and fever are the typical manifestations of colitis. PEGASYS treatment should be discontinued immediately if these symptoms develop. The colitis usually resolves within 1 to 3 weeks following discontinuation of alpha interferon.
Ulcerative colitis has also been observed in patients treated with alpha interferon. Growth and Development (Pediatric Patients) During the course of PEGASYS plus ribavirin therapy lasting up to 48 weeks in patients aged 5 to 17 years, weight loss and growth inhibition were common (see ADVERSE REACTIONS).
At 2 years post-treatment, 16% of pediatric patients were more than 15 percentiles below their baseline weight curve and 11% were more than 15 percentiles below their baseline height curve. The available longer term data on subjects who were followed up to 6 years post-treatment is too limited to determine the risk of reduced adult height in some patients.
Safety and effectiveness have not been established in patients below the age of 18 (see INDICATIONS AND CLINICAL USE and Special Populations, Pediatrics). Hematologic Alpha interferons, including PEGASYS, may suppress bone marrow function which may result in severe cytopenias.
Very rarely alpha interferons may be associated with pancytopenia including aplastic anemia. Therefore, caution should be exercised when administering PEGASYS in combination with other potentially myelosuppressive agents. It is advised that PEGASYS® Page 7 of 54 complete blood counts (CBC) be obtained pre-treatment and monitored routinely during therapy (see WARNINGS AND PRECAUTIONS: Monitoring and Laboratory Tests).
5 x 109/L, with baseline platelets < 90 x 109/L or baseline hemoglobin < 100 g/L. 5 x 109/L) and/or platelet (< 25 x 109/L) counts (see DOSAGE AND ADMINISTRATION: Dose Adjustments). Hepatic/Biliary/Pancreas Hepatic In patients who […]