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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Some pegasys package insert taking PEGASYS develop autoimmune problems a condition where the body’s immune cells attack other cells or organs in the bodysuch as rheumatoid arthritis, systemic lupus erythematosus, and psoriasis.
Then place the free end of the green cap on a flat surface and push down with a firm and quick motion until it clicks and covers over the needle see Figure S. Patients should be advised that laboratory evaluations pegasys package insert required before starting therapy and periodically thereafter [see Warnings and Precautions 5.
All pegasys package insert brands for listed products are trademarks or registered trademarks as indicated of their respective owners and are not trademarks of Genentech, Inc. Always keep the puncture-resistant container out of psgasys reach of children.
Symptoms of inflammation of your intestines colitis may include: All subjects had serum alanine aminotransferase ALT between 1 and 10 times the upper limit of normal ULN ijsert liver biopsy findings compatible with the diagnosis of chronic hepatitis.
General Information Patients should pegasys package insert questioned about prior history of drug abuse before initiating PEGASYS; as relapse of drug addiction and drug overdoses have been reported in patients treated with interferons. Table 3 also includes recommended frequency of psychiatric visits. When you get pegasys package insert prescription from the pharmacy, ask your pharmacist for the pegasts and needle that you need to use pegasys package insert prepare and inject a dose of PEGASYS from the single-dose vial.
Patients developing signs or symptoms of severe skin reactions must discontinue therapy [see Adverse Reactions 6. Because of the potential for adverse reactions from the drugs in nursing infants, a decision must be made whether to discontinue nursing or discontinue PEGASYS.
Look at your autoinjector: A return to normal menstrual rhythm followed cessation of treatment. The majority of hematologic abnormalities occurred in the first 24 weeks of treatment.
The browser you are using, Internet Explorer 10, is no longer supported. Development or exacerbation of autoimmune disorders including myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, pegasyz systemic lupus erythematosus have been reported in patients receiving alpha interferon. If you notice condensation water on the outside of the syringe, wait another few minutes until it disappears.
Hold the syringe with the needle pointing up to the ceiling. Healthcare Provider Letters 6 letters.
Adverse reactions related to alpha interferons, such as CNS, cardiac, and systemic e. ALT Elevations Chronic Hepatitis C One percent of subjects in the hepatitis C trials experienced marked elevations 5- to fold above the upper limit of normal in ALT pegasys package insert during treatment and follow-up.
Use with other HCV antiviral drugs: Keep your work area, your hands, and injection site clean to decrease the risk of infection. PEGASYS combination treatment with ribavirin is pegasys package insert in women who are pregnant and in the male partners of women who are pregnant [see Contraindications 4Warnings and Precautions pegasys package insert.
The colitis usually resolves within 1 to 3 weeks of discontinuation of alpha interferon. Exacerbation of hepatitis during hepatitis B treatment 5.
After proper training in subcutaneous injection, a patient may subcutaneously self-inject with PEGASYS if a healthcare provider determines that it is appropriate [see Instructions for Use ].
Symptoms of thyroid changes include feeling cold or hot all the time, a change in your weight, and changes to your skin, trouble concentrating. Take a carton containing your autoinjector out of the refrigerator and take your autoinjector out of the carton. Because elderly patients are more likely to have decreased renal function, care pegasys package insert be taken in dose selection and it may be useful to monitor renal function.
Depending on the dose of PEGASYS that your healthcare provider prescribes, you may have to get rid pegasys package insert discard some of the medicine from the prefilled syringe before you inject the medicine.
WARNING: RISK OF SERIOUS DISORDERS
The overall incidence pegasys package insert adverse reactions appeared to be similar in the two treatment groups. Keep the needle covered until just before you pegays the injection see Figure D.
Severe acute hypersensitivity reactions e. Do not use the autoinjector if it looks pegasys package insert. The mean terminal half-life after subcutaneous dosing in subjects with chronic hepatitis C was hours range 84 to packaage compared to 5 hours range 3. All subjects were adults, had compensated liver disease, detectable hepatitis C virus HCVliver biopsy diagnosis of chronic pegasys package insert, and were previously untreated with interferon.
If your blood cell counts become very low, you can get anemia, infections or have problems with bleeding and bruising.
If symptoms improve and are stable for 4 weeks, may resume normal visit schedule. Apckage and lymphatic system disorders: Patients should be advised to report any sign or symptom of depression or suicidal ideation to insdrt prescribing physicians. Never reattach the blue cap after it has been removed. Do not shake the autoinjector.
You should pegasys package insert a different place each time you give yourself an injection. Liver function test abnormalities were generally transient. The clinical and pathological pegasys package insert of the appearance of serum neutralizing antibodies is unknown.