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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In neonates and infants, benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications which are pegasys package insert fatal in neonates and infants [see Contraindications 4 ].
Updated June 26, PEGASYS is a sterile, preservative-free, colorless to slightly yellowish solution available as an injection and is administered subcutaneously. Before and during treatment with PEGASYS you will need to see your healthcare provider regularly and have blood tests to pehasys sure that your treatment pegasys package insert working and to check for side effects. This is a safety device. Refer to the prescribing information of the other HCV antiviral drugs, including ribavirin, for their Warnings and Precautions.
WARNING: RISK OF SERIOUS DISORDERS
Severe acute hypersensitivity reactions e. Do not take more than your prescribed pegasys package insert. Patients should be advised pegasys package insert notify the healthcare provider immediately in the event of a pregnancy [see Contraindications 4 and Warnings and Precautions 5.
Hold the syringe and needle tightly at the hub. Never reuse the same autoinjector. Do not freeze or shake.
Genentech: Pegasys® (peginterferon alfa-2a) – Information for Patients
Pegasys package insert peginterferon alfa-2a injection is a sterile, preservative-free, colorless to slightly yellowish solution administered subcutaneously. Not all subjects provided packkage initial and end of follow-up biopsies missing biopsy rates: They may be ineffective or may harm you.
When you get your prescription from the pharmacy, ask your pharmacist for the syringe and needle that you need to use to prepare and inject a dose of PEGASYS from the single-dose vial. Turn the vial upside down. Median neutrophil counts return to pre-treatment levels 4 weeks pegasys package insert cessation of ;egasys [see Dosage and Administration 2.
The apparent clearance of peginterferon alfa-2a was similar between subjects with ESRD and subjects with normal renal function. Signs and symptoms of interferon toxicity should be pegasys package insert monitored in patients with severe renal impairment and the dose reduced to 90 mcg once weekly as appropriate [see Dosage and Administration 2.
Events occurred in patients with few or no reported risk factors for stroke, including pegasys package insert less than 45 years of age. Use a different place each time you give yourself an injection. Pinch a fold of skin on your stomach or thigh firmly between your thumb and forefinger see Figure L.
Never let the needle touch any surface. Determining the IL28B genotype should be considered. NDC National Drug Code pegasys package insert Each drug product is assigned this unique pegzsys which can be found on the drug’s outer packaging.
Patients should be instructed to allow the vial, prefilled syringe or autoinjector to come to room temperature and for condensation on the outside of the prefilled syringe or autoinjector to pegasys package insert before use.
Although efficacy was demonstrated in packqge HBV genotypes, genotypes A and B were associated with greater efficacy pegasys package insert than genotypes C and D the lowest response being observed with genotype D.
NDC A box containing one mcg per 0. Some people 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 pegasys package insert erythematosus, packate psoriasis. Symptoms of a serious allergic pegasys package insert to alpha-interferon may include itching, swelling of your face, tongue, throat, trouble breathing, feeling dizzy or faint, and chest pain.
You may need to have a chest X-ray or other tests if you develop fever, cough, shortness of breath or other symptoms of a lung problem during treatment with PEGASYS. Counterfeit and illegally imported medicines are unsafe.
Push the needle onto the syringe and tighten by using an easy twisting motion in the direction of the arrow see Figure G. 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, iinsert, and rigors. Choose and prepare an injection site Choose an pegasys package insert site on your stomach or thigh see Figure “C”. Take your next dose on the day you would usually take it.
The recommended treatment duration for oegasys patients with HCV genotype 2 or 3 is 24 weeks and for other HCV genotypes is 48 weeks. Then, pegasys package insert at the medicine inside of pegasys package insert autoinjector by looking through the inaert window.
How should I give an injection?
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Median lymphocyte CD4 and CD8 counts return to pre-treatment levels after 4 to 12 weeks of the cessation of therapy.
General disorders and administration site conditions. The detection of antibody formation is highly dependent on the sensitivity pegasys package insert specificity of the assay.