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.
|Published (Last):||13 September 2006|
|PDF File Size:||11.58 Mb|
|ePub File Size:||18.98 Mb|
|Price:||Free* [*Free Regsitration Required]|
The green needle cover will pdgasys in the position you set. Differences in the clinical response to interferon-based therapy have been observed depending on HBV genotype. The PEG moiety is linked at a single site to the interferon alfa moiety via a stable amide bond to pegasys package insert.
Pegasys Authorized Distributor Directory Know your distributors. Pull the plunger of the syringe back slightly. People who take PEGASYS or other alfa interferon products with telbivudine Tyzeka pegasys package insert hepatitis B peegasys develop nerve problems such as continuing numbness, tingling, or burning sensation in the arms or legs peripheral neuropathy.
If patients show signs or symptoms of these conditions, their doctor may inssert their medication. Keep the needle covered until just before you give the injection see Figure D. For information about the recommended dosage and administration and the safe and effective use of these other HCV antiviral drugs, refer to their prescribing information.
Monthly pregnancy testing should be performed during combination therapy and for 6 months after discontinuing therapy. Interferon alfa-2a is produced using recombinant DNA technology in which a cloned pegasys package insert leukocyte interferon gene is inserted into and pegasys package insert in Escherichia coli.
Be sure that the plastic needle shield covers the needle. Stroke or symptoms pakage a stroke.
Genentech: Pegasys® (peginterferon alfa-2a) – Information for Healthcare Providers
Pegasys package insert testing should be performed periodically during therapy. The most common serious adverse event for PEGASYS with or without ribavirin was bacterial infection eg, sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia.
Warm the refrigerated medicine by gently rolling it in the palms of your hands for about one minute. Email us your question by using this form. This may make your liver disease worse. Most laboratory abnormalities noted during the CHC clinical trial Table insfrt returned to baseline levels shortly after completion of treatment.
We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Development or pegasys package insert of autoimmune disorders including myositis, hepatitis, pegasyx thrombocytopenic purpura, idiopathic thrombocytopenic purpura, psoriasis, rheumatoid arthritis, pegasys package insert nephritis, thyroiditis, and systemic lupus erythematosus have been reported in patients receiving alpha interferon.
Peripheral neuropathy has been reported when alpha interferons were given in combination with telbivudine. Therefore, only the first 24 weeks are presented pegasys package insert the comparison of combination therapy with pegasys package insert.
Patients who initiate treatment prior to their 18 th birthday should maintain the recommended lackage dosage not the adult dosage through the completion of therapy.
Medical Professional Resources
Ribavirin therapy should not be started unless a confirmed negative pregnancy test has been obtained immediately prior to initiation of therapy. Patients should be monitored closely with periodic clinical and laboratory evaluations. With a quick “dart-like” inserr, push the needle into the skin as far as it will go see Figure Q.
Patients nisert be advised to notify the healthcare provider pegasys package insert in the event of pegasys package insert pregnancy [see Contraindications 4 and Warnings and Precautions 5.
Refer to the prescribing information of the other HCV antiviral drugs, including ribavirin, for a list of their contraindications. Severe neutropenia and thrombocytopenia occur pegasys package insert a greater incidence in HIV coinfected patients than monoinfected patients and may result in serious infections or bleeding [see Adverse Reactions 6.
After the blue cap is removed, set it aside. Position the packabe of the pegasys package insert the bevel so it is facing insret see Figure O. Call your doctor for medical advice about side effects. Effect on growth in children. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Never let the needle touch any surface. See ” How should I dispose of used syringes, needles, and vials?
Do not use the autoinjector if the expiration date has passed see Figure “B”. Subjects with cirrhosis were not enrolled in this study. Continue reduced dosing If symptoms improve and are stable for 4 weeks, may resume normal visit pegasys package insert.
A return to normal menstrual rhythm followed cessation of treatment. All subjects had serum alanine aminotransferase ALT between 1 and 10 times the upper limit of normal ULN and liver biopsy findings compatible with the diagnosis of chronic hepatitis.
Lay the syringe on a flat clean surface and wait a few minutes until it reaches room temperature. Blood and lymphatic system disorders: Benzyl alcohol is associated with an increased incidence of neurologic and other complications which are sometimes fatal in neonates and infants. General disorders and administration site conditions. Check the expiration date on the carton and autoinjector to pegasys package insert sure that it has not passed expired.
Also inform patients which pegasys package insert medicines can be taken to pegasys package insert prevent or decrease some of the symptoms. The entrance criteria pacjage for the clinical studies of PEGASYS may be considered as a guideline to acceptable baseline values for initiation of treatment:. peasys
Exacerbation of hepatitis pegasys package insert hepatitis B treatment 5. If home use is prescribed, a puncture-resistant container for the disposal of used needles, syringes and autoinjectors should be supplied to the patients.
You may need to have a chest X-ray or other pegasys package insert if you develop fever, cough, shortness of breath or other symptoms of a lung problem during treatment with PEGASYS.
Treatment response rates are lower in subjects with poor pegasys package insert factors receiving pegylated interferon alpha therapy. Conclusions regarding comparative efficacy of PEGASYS and lamivudine treatment based upon the end of follow-up results are limited by the different mechanisms of action of the two compounds.
With your other hand, hold the needle close to the hub where the green needle cover connects to the syringe see Figure F. Symptoms of a serious allergic reaction to alpha-interferon may include itching, swelling of your face, tongue, throat, trouble breathing, feeling dizzy or faint, and chest pain.