Alpha interferons, including PEGASYS peginterferon alfa-2a , may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. 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. The recommended treatment duration for pediatric patients with HCV genotype 2 or 3 is 24 weeks and for other HCV genotypes is 48 weeks.
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All medicines have risks and benefits. If you have any concerns about using this medicine, ask your doctor or pharmacist. Interferons are proteins that modify the response of the body's immune system to help fight infections and severe diseases. If these viral infections are not managed, in some people, the liver becomes badly damaged and scarred.
This is called cirrhosis. Cirrhosis can cause the liver to stop working. Most people who get hepatitis B or C carry the virus in their blood for the rest of their lives, unless successfully treated. Most of these people will have some liver damage, but not all feel sick from the disease.
While taking PEGASYS you will need to see your doctor regularly for medical examinations and blood tests to make sure your treatment is working and to check for side effects.
This product contains benzyl alcohol and should not be given to babies from birth up to the age of 3 years. Tell your doctor if you are taking any other medicines including any that you have bought without a prescription from a pharmacy, supermarket or health food shop.
You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor may discuss whether it would be more convenient for you to receive your injection at home, in which case, you or a family member would be instructed on how to give the injection. This is a simple procedure and many patients prefer it. You should read these directions from beginning to end before starting so that each step of the procedure becomes familiar.
These instructions must be carefully followed. Consult your doctor or nurse if you require further instructions. Remember: Most people can learn to give themselves a subcutaneous injection, but if you experience difficulty, please do not be afraid to ask for help and advice from your doctor, nurse or pharmacist.
Please note that the needle supplied with the PEGASYS pre-filled syringe is for subcutaneous injection only and is not suitable for any other type of injection e. Your doctor will tell you how often to use this medicine. If you realise you missed your injection within 2 days after the scheduled dose, you should inject your recommended dose as soon as you remember. Take your next injection on the following regularly scheduled day.
If you realise you missed your injection 3 to 5 days after your scheduled dose, you should inject your recommended dose as soon as you remember.
Take your next doses at 5 day intervals until you return to your regularly scheduled day of the week. If you realise you missed your injection 6 days after the scheduled dose, you should wait and inject your dose on the next day.
If you have trouble remembering when to use your medicine, ask your pharmacist for some hints. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Be sure to keep all of your appointments with your doctor so that your progress can be checked. Do not switch to any other brand of interferon without consulting your doctor because a change in dose may be required. Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.
If you drink alcohol, dizziness, drowsiness or light-headedness may be worse. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:.
These are serious side effects. You may need urgent medical attention. Serious side effects are rare. This is not a complete list of all possible side effects. Your doctor or pharmacist has a more complete list. Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list. The pre-filled syringe should be used once only and any remaining contents should be discarded with the needle. If your doctor tells you to stop using PEGASYS, or the pre-filled syringe has passed its expiry date, ask your pharmacist what to do with any pre-filled syringes that are left over.
This will help protect you and other people from accidental needle stick injuries. Being struck by a needle can pass diseases onto other people. Sharps containers are available from your pharmacist.
The solution is clear and colourless to light yellow. Chemical structure. CAS number. Pegasys peginterferon alfa-2a is made by conjugating a single branched polyethylene glycol chain PEG of approximate molecular weight of 40 kilodaltons kD to interferon alfa-2a 20 kD via a stable amide bond. The combination of PEG and interferon alfa-2a forms an intact active molecule known as peginterferon alfa-2a, having an approximate molecular weight of 60 kD.
Chemically, it is a bis- N-monomethoxypolyethylene-glycol-urethanyl lysyl interferon alfa-2a. Pegasys micrograms solution for injection in pre-filled syringe. Each syringe of 0. Excipient with known effect.
For the full list of excipients, see Section 6. Mechanism of action. The conjugation of a PEG reagent to interferon alfa-2a forms peginterferon alfa-2a Pegasys. Interferon alfa-2a is produced biosynthetically using recombinant DNA technology, and is the product of a cloned human leukocyte interferon gene inserted into and expressed in E.
The structure of the PEG moiety directly affects the clinical pharmacology of peginterferon alfa-2a. Specifically, the size and branching of the 40 kD PEG reagent define the absorption, distribution, and elimination characteristics of peginterferon alfa-2a.
Peginterferon alfa-2a possesses the in vitro anti-viral and anti-proliferative activities of interferon alfa-2a. Interferons bind to specific receptors on the cell surface initiating a complex intracellular signalling pathway and rapid activation of gene transcription. Interferon-stimulated genes modulate many biological effects including the inhibition of viral replication in infected cells, inhibition of cell proliferation, and immunomodulation.
HCV RNA levels decline in a biphasic manner in responding patients with hepatitis C who have received peginterferon alfa-2a. The first phase of decline occurs within h after the first dose of peginterferon alfa-2a and the second phase of decline occurs over the next weeks in patients who achieve a sustained response. Ribavirin had no significant effect on the initial viral kinetics over the first weeks in patients treated with peginterferon alfa-2a or interferon alfa in combination with ribavirin.
Peginterferon alfa-2a stimulates the production of effector proteins such as serum neopterin and 2',5'-oligoadenylate synthetase 2',5'-OAS in a dose dependent manner. The stimulation of 2',5'-OAS is maximal after single doses of peginterferon alfa-2a to microgram and stays maximal throughout the 1 week dosing interval. Clinical trials. Clinical trials have demonstrated that Pegasys alone or in combination with Copegus ribavirin is effective in the treatment of patients with CHC or CHB, including cirrhotic patients with compensated liver disease and in patients with HIV-HCV co-infection.
Chronic hepatitis C CHC. The safety and effectiveness of Pegasys for the treatment of hepatitis C were assessed in randomised, open-label, active-controlled clinical trials NV and NV Patients with cirrhosis. Patients with or without cirrhosis.
In all trials, most patients treated with Pegasys have normalisation or improvement of serum ALT during therapy. Whether or not ALT normalises, virological determination provides a more reliable means of determining the effectiveness of Pegasys treatment. Quality of life assessment. During treatment with Roferon-A, patients commonly experience shaking chills, body aches, headache, loss of concentration, fatigue, anxiety, and insomnia.
Such complaints reflect the significant quality of life reductions associated with standard interferon alfa-2a therapy. In NV, patients treated with Pegasys experienced superior quality of life during the first 12 weeks of therapy than those receiving standard interferon alfa-2a. Most of these differences were statistically and clinically significant in terms of physical health, mental health and fatigue severity.
Patients with elevated alanine transferase ALT levels. The safety and effectiveness of Pegasys in combination with ribavirin Copegus for the treatment of hepatitis C were assessed in two prospective, randomised controlled, multinational clinical trials NV and NV Assignment to the 4 treatment arms was stratified by viral genotype and baseline HCV viral titer.
Ribavirin or placebo treatment assignment was blinded. For patients infected with genotype 2 and 3 there was no statistically significant difference between 48 and 24 weeks of treatment and between the low and high dose of Copegus see Table 9.
The SVR in cirrhotic patients followed the same pattern as that of the overall population. Patients with normal ALT levels. The safety and effectiveness of Pegasys in combination with Copegus for the treatment of hepatitis C were assessed in a phase III, prospective, randomised, open-label, multinational clinical trial NR In NR, patients were randomised to receive Pegasys microgram SC once a week with Copegus mg daily for either 24 weeks followed by a 48 week treatment-free period; 48 weeks followed by a 24 week treatment-free period; or no treatment for 72 weeks.
The SVR rates reported in the treatment arms of this study were similar to the corresponding treatment arms from study NV No patients in the control arm achieved a SVR. Chronic hepatitis C. Prior treatment non-responder patients. Study MV In this open-label, randomised, Phase III study, a total of patients, who were previous non-responders to peginterferon alfa-2b in combination with ribavirin therapy at least 12 weeks of prior treatment , were randomised to 4 different treatments: Pegasys microgram once a week for 12 weeks, followed by microgram once a week for a further 60 weeks; Pegasys microgram once a week for 12 weeks, followed by microgram once a week for a further 36 weeks; Pegasys microgram once a week for 72 weeks; or Pegasys microgram once a week for 48 weeks.
Consumer medicine information
How does Peginterferon alfa-2a work? Peginterferon alfa-2a is a designed to slow the growth of red blood cells caused by polycythemia vera P. Peginterferon alfa-2a is not commonly given with the goal of cure , but has the potential of inducing long-term remissions. Peginterferon is usually given demonstrated in in the clinic before the first dose, then Peginterferon alfa-2a is usually taken at home. Peginterferon is repeated every week or 7 days.
Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Alpha interferons, including peginterferon alfa-2a, may cause or aggravate a psychiatric event or disorder. Patients should be monitored closely with periodic clinical and laboratory evaluations.
Medically reviewed by Drugs. Last updated on Nov 18, The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks. The dose should be individualized to the patient depending on baseline disease characteristics e. The recommended treatment duration for patients with genotype 2 or 3 is 24 weeks and for other genotypes is 48 weeks. COPEGUS is available only as a mg tablet and therefore the healthcare provider should determine if this sized tablet can be swallowed by the pediatric patient.
All medicines have risks and benefits. If you have any concerns about using this medicine, ask your doctor or pharmacist. Interferons are proteins that modify the response of the body's immune system to help fight infections and severe diseases. If these viral infections are not managed, in some people, the liver becomes badly damaged and scarred. This is called cirrhosis.