What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug.
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Call a nurse at , Monday-Friday, 5am-5pm PT. Chat with a nurse using our live chat feature , Monday-Friday, 5am-5pm PT. Email a nurse by filling out this form. Learn about proper methods and find locations for sharps disposal. Important Safety Information PEGASYS, like other alpha interferons, may cause or make fatal or life-threatening problems worse like mental, immune system, heart, liver, lung, intestinal and infections.
If patients show signs or symptoms of these conditions, their doctor may stop their medication. Some of these side effects may cause death. Patients must not take PEGASYS if they: have certain other liver problems have certain types of hepatitis caused by their immune system attacking the liver autoimmune hepatitis have had a serious allergic reaction to another alpha interferon medicine or to any of the ingredients in PEGASYS Patients must not take PEGASYS in combination with ribavirin if they: are pregnant, or planning to get pregnant during treatment or during the 6 months after treatment are a male patient with a female sexual partner who is pregnant or plans to become pregnant at any time while they are being treated with ribavirin or during the 6 months after their treatment has ended PEGASYS cannot be given to a baby under 1 year of age.
Patients must tell their healthcare provider about all the prescription and non-prescription medicines, vitamins and herbal supplements they take.
PEGASYS can cause serious side effects including: blood problems, thyroid problems, blood sugar problems, serious eye problems, serious liver problems, worsening of liver problems including liver failure and death, lung problems, inflammation of the pancreas, inflammation of the intestines, serious allergic reactions and skin reactions, effect on growth in children, and nerve problems. The most common, but less serious, side effects of PEGASYS include: flu-like symptoms, tiredness and weakness, stomach problems, loss of appetite, skin reactions, hair thinning, trouble sleeping.
Patients must tell their healthcare provider if they have any side effect that bothers them or that does not go away. Patients and caregivers may also report side effects to Genentech at Tell us what you think about our company, products, or website.
Getting the most out of chemoexperts. Watch our video to find out. What is Polycythemia Vera? Polycythemia refers to an increased production of red blood cells. There can be many causes of this, including smoking, sleep apnea, or living at high altitudes. Polycythemia Vera, or "P. Vera", also causes increased red blood cell production, and is almost always the result of a gene mutation known as "JAK2VF.
WARNING: RISK OF SERIOUS DISORDERS
Benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications in neonates and infants which are sometimes fatal. Depression, suicidal ideation, and suicidal attempt may occur in patients with and without previous psychiatric illness. Neuropsychiatric adverse events observed with alpha interferon treatment include relapse of drug addiction, drug overdose, aggressive behavior, psychoses, hallucinations, bipolar disorders and mania. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. Patients should be advised to report any sign or symptom of depression or suicidal ideation to their prescribing physicians. Very rarely alpha interferons may be associated with aplastic anemia.
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If severe adverse reactions or laboratory abnormalities develop, ribavirin tablets should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. No data are available for pediatric subjects with renal impairment. Each tablet contains mg of ribavirin. Ribavirin tablets may cause fetal harm when administered to a pregnant woman.