Loading…
Avonex is a brand name for Interferon Beta-1a. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AVONEX is indicated in adults for the treatment of • Patients diagnosed with relapsing multiple sclerosis (MS). In clinical trials, this was characterised by two or more acute exacerbations (relapses) in the previous three-years without evidence of continuous progression between relapses; AVONEX slows the progression…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease. 6). No additional benefit has been shown by administering a higher dose (60 micrograms) once a week. 8), titration can be performed at the initiation of treatment.
Titration using the pre-filled syringe can be 3 achieved by initiating therapy on ¼ dose increments per week reaching the full dose (30 micrograms/week) by the fourth week. An alternative titration schedule can be achieved by initiating therapy on approximately a ½ dose of AVONEX once a week before increasing to the full dose.
In order to obtain adequate efficacy, a dose of 30 micrograms once a week should be reached and maintained after the initial titration period. The AVOSTARTCLIP titration kit is designed for use with the pre-filled syringe only. It can be used to achieve the ¼ or ½ dose increments.
Each AVOSTARTCLIP should be used once and then discarded along with any remaining AVONEX in the syringe. Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with AVONEX administration.
These symptoms are usually present during the first few months of treatment.
Paediatric population:
The safety and efficacy of AVONEX in children and adolescents aged 10 to 18 years have not yet been fully established. 1 but no recommendation on a posology can be made. The safety and efficacy of AVONEX in children below 10 years of age have not yet been established.
No data are available.
Elderly:
Clinical studies did not include a sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients. However, based on the mode of clearance of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
3). Doctors may prescribe a 25 mm, 25 gauge needle to patients for whom such a needle is appropriate to administer an intramuscular injection. At the present time, it is not known for how long patients should be treated. Patients should be clinically evaluated after two years of treatment and longer-term treatment should be decided on an individual basis by the treating physician.
The highest incidence of adverse reactions associated with AVONEX therapy is related to flu-like symptoms. The most commonly reported flu-like symptoms are myalgia, fever, chills, sweating, asthenia, headache and nausea. Titrating AVONEX at the initiation of therapy has demonstrated a reduction in the severity and incidence of flu-like symptoms.
Flu-like symptoms tend to be most prominent at the initiation of therapy and decrease in frequency with continued treatment. Transient neurological symptoms that may mimic MS exacerbations may occur following injections. Transient episodes of hypertonia and/or severe muscular weakness that prevent voluntary movements may occur at any time during treatment.
These episodes are of limited duration, temporally related to the injections and may recur after subsequent injections. In some cases these symptoms are associated with flu-like symptoms. The frequencies of adverse reactions are expressed in patient-years, according to the following categories: Very common (≥1/10 patient-years); Common (≥1/100 to <1/10 patient-years); Uncommon (≥1/1, 000 to <1/100 patient-years); Rare (≥1/10, 000 to <1/1,000 patient-years); Very rare (<1/10,000 patient-years); Not known (cannot be estimated from the available data).
Patient-time is the sum of individual units of time that the patient in the study has been exposed to AVONEX before experiencing the adverse reaction. For example, 100 person-years could be observed in 100 patients who were on treatment for one year or in 200 patients who were on treatment for half a year.
Adverse reactions identified from studies (clinical trials and observational studies, with a period of follow-up ranging from two years to six years) and other adverse reactions identified through spontaneous reporting from the market, with unknown frequency, are provided in the table below.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 3). Depression and suicidal ideation are known to occur in increased frequency in the multiple sclerosis population and in 4 association with interferon use.
Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician. Patients exhibiting depression should be monitored closely during therapy and treated appropriately.
8). 8). Caution should be used and close monitoring considered when administering AVONEX to patients with severe renal and hepatic failure and to patients with severe myelosuppression.
Thrombotic microangiopathy (TMA):
Cases of thrombotic microangiopathy, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products. Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta.
g. confusion, paresis) and impaired renal function. Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film.
Therefore if clinical features of TMA are observed, further testing of blood platelet levels, serum LDH, blood films and renal function is recommended. If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of AVONEX is recommended.
Nephrotic Syndrome:
Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products.
1. 8).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Interferon Beta-1a in European Union.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Treatment should be discontinued if the patient develops chronic progressive MS.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4). ┼ Class label for interferon products, see below Pulmonary arterial hypertension. 1Injection site reactions including pain, inflammation and very rare cases of abscess or cellulitis that may require surgical intervention have been reported.
2The frequency of occurrence is higher at the beginning of treatment. 3A syncope episode may occur after AVONEX injection, it is normally a single episode that usually appears at the beginning of the treatment and does not recur with subsequent injections.
Pulmonary arterial hypertension Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products. Events were reported at various time points including up to several years after starting treatment with interferon beta.
Paediatric population 10 Limited data from literature, clinical trials and postmarketing experience suggest that the safety profile in children and adolescents from 10 to less than18 years of age receiving AVONEX 30 micrograms IM once per week is consistent with that seen in adults.
The safety information obtained from the use of AVONEX as an active comparator in a 96 week open label, randomised trial in paediatric patients with relapsing remitting multiple sclerosis aged 10 to less than 18 years (with only 10% of the overall study […]
Events were reported at various time points during treatment and may occur after several years of treatment with interferon beta. g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with AVONEX should be considered. 8). In some cases, these reactions have occurred in the presence of other medicinal products that have been associated with hepatic injury.
g. alcohol) has not been determined. Patients should be monitored for signs of hepatic injury and caution exercised when interferons are used concomitantly with other medicinal products associated with hepatic injury. Patients with cardiac disease, such as angina, congestive heart failure or arrhythmia, should be closely monitored for worsening of their clinical condition during treatment with AVONEX.
Flu-like symptoms associated with AVONEX therapy may prove stressful to patients with underlying cardiac conditions. Laboratory abnormalities are associated with the use of interferons. Therefore, in addition to those laboratory tests normally required for monitoring patients with MS, complete and differential white blood cell counts, platelet counts, and blood chemistry, including liver function tests, are recommended during AVONEX therapy.
Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts. Patients may develop antibodies to AVONEX. The antibodies of some of those patients reduce the activity of interferon beta-1a in vitro (neutralising antibodies).
Neutralising antibodies are associated with a reduction in the in vivo biological effects of AVONEX and may potentially be associated with a 5 reduction of clinical efficacy. It is estimated that the plateau for the incidence of neutralising antibody formation is reached after 12 months of treatment.
Recent clinical studies with patients treated up to three years with AVONEX suggest that approximately 5% to 8% develop neutralising antibodies. The use of various assays to detect serum antibodies to interferons limits the ability to compare antigenicity among different products.
8). To minimise the risk of injection site reactions, patients should be advised to use an aseptic injection technique and rotate the injection sites with each dose. The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
If the patient experiences any break in the skin, which may be accompanied by swelling or drainage of fluid from the injection site, the patient should be advised to speak with their doctor. Whether to discontinue therapy following a single site of necrosis is dependent on the extent of necrosis.
For patients who continue therapy with AVONEX after injection site necrosis has occurred, […]