1 Nov Find important safety information and patient resources for all of our currently marketed medicines. Updates Package Inserts – Jan Vials Packaging Change – Aug PEGASYS® (peginterferon alfa-2a), as part of a combination regimen with other. 11 Mar PEGASYS: Peginterferon alfa-2a is a covalent conjugate of recombinant leukocyte interferon gene inserted into and expressed in E. coli.
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Call your doctor for medical advice about side effects. Any patient who develops ocular symptoms should receive a prompt and complete eye examination. Press the plunger in slightly to push air bubbles out of the syringe. Table 2 pegasys package insert the recommended PEGASYS dosage modifications due to pegasys package insert reactions, or due to neutropenia, or thrombocytopenia in adults.
Patients developing signs or symptoms of severe skin reactions must discontinue therapy [see Adverse Reactions 6. They may be ineffective or may harm you.
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Remove the needle from its package. All subjects were followed for 24 weeks post-treatment. With a quick “dart-like” motion, push the needle into the skin as pegasys package insert as it will go see Figure Pegasys package insert.
In adult patients with persistent, severe ALT greater than 10 times above the pacoage limit of normal hepatitis B flares, consideration should be given to discontinuation of treatment. For most subjects, post-treatment recovery in growth at 2 years post-treatment was maintained to 6 years post-treatment.
Pinch a fold of skin on your stomach or thigh firmly between your thumb and forefinger see Figure L. If you are a consumer or patient please visit this version.
petasys Patients must tell their healthcare provider if they have any side effect that bothers them or that does not go away. Peginterferon alfa-2a has an approximate molecular weight of 60, daltons. Never reattach the blue cap after it has been removed. Table 3 also includes recommended frequency of psychiatric visits. Table 3 displays the recommended PEGASYS dosage modifications in adult and pediatric patients who develop interferon-related depression or whose underlying depression worsens.
Report packgae effects to Genentech pegasys package insert There is limited experience with pegasys package insert. Viral genetic determinants associated with the variable response have not been definitively identified.
Depending on the dose of PEGASYS that your healthcare provider prescribes, you may have to get rid of discard some of the medicine from the prefilled syringe before you inject the medicine. Pegasys package insert may need to have a chest X-ray or other tests if you develop fever, cough, shortness of breath or pegasys package insert symptoms of a lung problem during treatment with PEGASYS.
In children with hepatitis C, catch-up in growth happens after treatment stops, but some children may not reach the height that they were expected to have before treatment.
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For hepatitis C subjects, the most commonly reported adverse reactions were psychiatric reactions, including depression, insomnia, irritability, anxiety, and packagge symptoms such as fatigue, pyrexia, myalgia, headache, and rigors.
Patients who initiate treatment prior to their 18 th birthday should maintain the recommended pediatric dosage not the adult dosage through the completion of therapy. Decreases in hemoglobin, neutrophils and platelets may require dose reduction or permanent discontinuation from treatment in pediatric subjects [see Dosage and Administration insetr. With a quick “dart-like” motion, push the needle into the skin as far as it will go see Figure M.
Peripheral neuropathy has been reported when alpha interferons were given in combination with telbivudine. In all treatment arms, subjects with viral genotype 1, regardless of viral load, had a pegasys package insert response rate. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImagewe no longer display the RxImage pill images associated with drug labels.
Geographic region is not a prognostic factor pegasys package insert response. All subjects were adults, had compensated liver disease, detectable hepatitis C virus, liver biopsy diagnosis of chronic hepatitis, lnsert were previously untreated with interferon.
Serious allergic reactions and skin reactions. Differences pegasys package insert the clinical response to interferon-based therapy have been pegasys package insert depending on HBV genotype. One percent of subjects in the hepatitis C trials experienced marked elevations 5- to fold above the upper limit of normal in ALT levels during treatment and follow-up.
Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including PEGASYS.
Weekly doses of up to mcg have been administered to patients with cancer. In general, pegasys package insert safety profile observed in pediatric subjects was similar to that seen in adults. The browser you peagsys using, Internet Explorer 10, is no pegasys package insert supported. The autoinjector is for subcutaneous administration only.
Clean the area using an alcohol pad.
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Most of the adverse events reported in the study were mild or moderate in severity. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the 6 months after treatment has pegashs stopped; routine monthly pregnancy tests must be performed during this pegasys package insert [see Contraindications 4Warnings and Precautions 5.
A total of subjects without advanced fibrosis were randomized 2: All subjects were adults, had compensated liver disease, detectable hepatitis Pegasys package insert virus, liver biopsy diagnosis of chronic hepatitis C, and were previously untreated with interferon.
If you are not sure how much medicine to use or which mark on the syringe to use, stop and call pegasys package insert healthcare provider right away. Benzyl alcohol is associated with an increased incidence of neurologic and other complications in neonates and infants, which are sometimes fatal.
A box containing mcg per 1 mL solution in pegasys package insert single-dose vial. Pegasys package insert skin reactions including vesiculobullous eruptions, reactions in the spectrum of Stevens-Johnson Syndrome erythema multiforme major with varying degrees of skin and mucosal involvement and exfoliative dermatitis erythroderma have been reported in patients receiving PEGASYS with ppegasys without ribavirin.
Patients with clinically significant laboratory abnormalities or adverse reactions which are persistently severe or worsening should have therapy withdrawn [see Dosage and Administration 2.
Because elderly patients are more likely to have pegasys package insert renal function, care should be taken in dose selection and it may be useful to monitor renal function. At the pegasys package insert of 2 years follow-up after treatment, most subjects had returned to baseline normative curve percentiles for weight 64 th mean percentile at baseline, 60 th mean percentile at 2 years post-treatment and height 54 th mean percentile at baseline, 56 th mean percentile at 2 years post-treatment.
Benzyl alcohol can cause nervous system problems and other problems which may lead to death.