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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Medicines are sometimes prescribed for purposes other than those pegasyw in a Medication Guide. These transaminase pegasys package insert were on occasion associated with hyperbilirubinemia and were managed by dose reduction or discontinuation of study treatment.
Patients must be informed that ribavirin must not be used pegasys package insert women who are pregnant or by men whose female partners are pregnant. Refer to the prescribing information of the other HCV antiviral drugs, including ribavirin, for a list of their contraindications.
pcakage Similar modest reductions in inflammation compared knsert baseline were observed in all treatment groups.
Then place the free end of the green cap on a pegayss surface and push down with a firm and quick motion until it clicks insery covers over the needle see Figure S. Symptoms of low blood sugar may include: In children with pegasys package insert B, it is not yet known if catch-up in growth happens after treatment stops.
Do not remove it. You can ask your healthcare provider or pharmacist for information that is written for pegasys package insert professionals. One percent of subjects pegasys package insert the hepatitis C trials experienced marked elevations 5- to fold above the upper limit of normal in ALT levels during treatment and follow-up. All subjects were followed for 24 weeks post-treatment. Seven subjects receiving combination PEGASYS and COPEGUS treatment for 48 weeks discontinued therapy for safety peasys depression, psychiatric evaluation abnormal, transient blindness, retinal exudates, hyperglycemia, type 1 diabetes mellitus, and anemia.
Patients should be advised not to shake the vial, prefilled syringe or autoinjector as foaming may occur. Each needle has a needle-stick protection device. Symptoms of inflammation of your intestines colitis may include: Your healthcare provider should show you how to prepare and measure, and inject your dose of PEGASYS before you use the single-dose vial, prefilled syringe or autoinjector for the first time.
Steady-state trough levels in children with pegasys package insert BSA-adjusted dosing were similar to trough levels observed in adults with mcg fixed dosing.
Maximal serum concentrations C max occur between 72 to 96 hours post-dose. Open the package for the syringe you are using and if it does not have a needle attached, then attach a new pegasys package insert to the syringe.
Lay the pegasys package insert on a flat clean surface and wait a few minutes until it reaches room temperature.
Patients should be thoroughly instructed in the importance of proper disposal and pegasys package insert against any reuse of any needles, syringes and autoinjectors.
People who take PEGASYS or other alfa interferon products with telbivudine Tyzeka for hepatitis B can develop nerve problems such as continuing numbness, tingling, or burning sensation in the arms or legs peripheral neuropathy. When used in combination with other HCV antiviral drugs, all contraindications also apply to PEGASYS combination therapy 4 Ribavirin inset contraindicated in pregnant women and men whose female partners are pregnant 48.
pegasys package insert
Genentech: Pegasys® (peginterferon alfa-2a) – Information for Patients
The clinical and pathological significance of the appearance of serum neutralizing antibodies is unknown. Patients who develop dizziness, confusion, somnolence, and fatigue should be cautioned to avoid driving or operating machinery.
Symptoms of high blood pegasys package insert or diabetes may include: Do pegasys package insert touch the cleaned rubber stopper. Ribavirin therapy should oackage be initiated until a report of a negative pregnancy test has been obtained immediately before starting therapy. The recommended treatment duration for pediatric patients with HCV genotype 2 or 3 is 24 weeks and for other HCV pegasys package insert is 48 packkage.
The medicine in the autoinjector should be clear and colorless to pakcage yellowish. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.
Keep the blue cap on your autoinjector until Step 3. Pegasys package insert full container should be disposed of according to the directions provided by the physician [see FDA-Approved Medication Guide ]. Do not use your autoinjector to inject through clothing covering your skin. Steady-state serum levels are reached pegasys package insert 5 to 8 weeks of once weekly dosing.
European Medicines Agency – System/website unavailable
You may also report side effects to Genentech at While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of high or persistent fever must be ruled out, onsert in patients with neutropenia. Two, 3 and 6 monkeys aborted in the low, mid and high dose groups compared with 1 in the control group.
However, poor prognostic factors occur more frequently pegasys package insert the US population than in the non-US population. Your healthcare provider should show you or your caregiver how to use your autoinjector correctly before you pegasys package insert it the first time.
Dose adjustments were not required by protocol. Geographic region is not a prognostic factor for response.
The syringe has markings for mcg, mcg, and 90 mcg. Some of these side effects may cause death. Musculoskeletal, Connective Tissue and Bone. In addition, dose reduction or discontinuation of PEGASYS, ribavirin or both, should also be considered if iinsert toxicities ibsert observed [see Warnings and Precautions 5. Call your healthcare pegasys package insert if you have any of these symptoms.
For hepatitis C subjects, the most commonly reported adverse reactions were psychiatric reactions, including depression, insomnia, irritability, anxiety, and flu-like symptoms such as fatigue, pyrexia, myalgia, headache, and rigors.
Do not remove the blue cap until you are ready to inject. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling pegasys package insert Preparation and administration in adults: Never let the needle touch any surface. The solution should be clear and colorless to slightly yellowish, without particles see Figure B. Monitor weekly ALT level to ensure it is stable or decreasing. Contact your healthcare provider right away pegasys package insert you have bought medicine from a questionable source or believe you are taking counterfeit or illegally imported medicine.