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AVONEX is a brand name for Interferon Beta-1a, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AVONEXTM Prefilled Syringe (PS) / AVONEXTM Prefilled Autoinjector (PEN) (interferon beta-1a) is indicated for: Treatment of relapsing forms of multiple sclerosis (MS) o To slow the progression of disability o To decrease the frequency of clinical exacerbations o To reduce the number and volume of active brain…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Intended for use under the guidance and supervision of a physician. Patients may self-inject only: o If their physician determines that it is appropriate. o Appropriate medical follow-up is provided. o After proper training in IM injection technique for either AVONEXTM PS/AVONEXTM PEN.
Injection sites (thigh or upper arm for AVONEXTM PS, or upper, outer thigh for AVONEXTM PEN) should be rotated each week. Avoid injection into an area of skin that is sore, red, infected or otherwise damaged. Before initiating a patient on AVONEXTM PS/AVONEXTM PEN (interferon beta-1a) therapy, note the following Contraindications: o In patients with a known hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation.
Anaphylaxis has been observed with the use of AVONEXTM PS/AVONEXTM PEN. Review the 7 WARNINGS AND PRECAUTIONS section and ensure appropriate monitoring of patients with depression, hepatic dysfunction, a history of seizures, cardiac disease, thyroid dysfunction, myelosuppression, and female patients of child-bearing potential.
2 Recommended Dose and Dosage Adjustment 30 μg injected intramuscularly once per week. Patients with relapsing progressive MS or secondary progressive MS with recurrent attacks of neurological dysfunction could benefit from an increase of their dose of AVONEXTM up to 60 μg.
5 μg each week for the next three weeks until the recommended full dose of 30 μg/week is achieved (see Table 1 below). An AVOSTARTCLIPTM kit containing 3 titration devices can be used for titration. These devices are to be used only with AVONEXTM PS.
Each AVOSTARTCLIPTM should be used only once and disposed of, along with any remaining AVONEXTM PS in the syringe. 5 μg) Week 4+ Full dose (30 μg) 1 Dosed once a week, intramuscularly. A reduction in severity and incidence of flu-like symptoms with dose titration was observed in healthy volunteers (see Clinical Trials), but has not been well characterized in clinical trials in patients with MS.
An alternative titration schedule can be achieved by incremental ¼ dose increases every two weeks, reaching the full dose (30 μg/week) by the seventh week. Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is also advised to assist in decreasing flu-like symptoms associated with AVONEXTM administration.
). These symptoms tend to be most prominent at the initiation of therapy and decrease in frequency and severity with continued treatment. Gradual dose titration at the initiation of therapy has demonstrated a reduction in the severity and incidence of flu-like symptoms in healthy volunteers (see 4 DOSAGE AND ADMINISTRATION).
In addition, concurrent use of analgesics and/or antipyretics may help reduce flu-like symptoms on treatment days. To not stop or modify their treatment unless instructed by their physician. To report depression or suicidal ideation.
The risk of decreased blood counts including white blood cells and platelet counts and of the requirement for periodic laboratory testing. Patients should be advised to report immediately any clinical symptoms associated with blood cell count abnormalities and laboratory testing should be performed according to standard medical practice.
Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts. The potential risk of liver injury with AVONEXTM PS/AVONEXTM PEN therapy, and of the requirement for frequent laboratory testing.
Patients should be informed of the symptoms of suggestive liver dysfunction, such as loss of appetite accompanied by other symptoms such as nausea, vomiting, and jaundice, and advised to consult with their physician immediately should such symptoms arise.
AVONEXTM (interferon beta-1a) Page 8 of 46 To report any symptoms of thyroid dysfunction (hypo or hyperthyroidism) and thyroid function tests should be performed according to standard medical practice. Female patients should be advised about the abortifacient potential of AVONEXTM PS/AVONEXTM PEN and instructed to take adequate contraceptive measures.
Patients should be advised to discuss with their health care provider the potential risks and benefits of continued treatment while attempting to conceive. It is not known if interferons alter the efficacy of hormonal contraceptives.
section and ensure appropriate monitoring of patients with depression, hepatic dysfunction, a history of seizures, cardiac disease, thyroid dysfunction, myelosuppression, and female patients of child-bearing potential. 2 Recommended Dose and Dosage Adjustment 30 μg injected intramuscularly once per week.
Patients with relapsing progressive MS or secondary progressive MS with recurrent attacks of neurological dysfunction could benefit from an increase of their dose of AVONEXTM up to 60 μg. 5 μg each week for the next three weeks until the recommended full dose of 30 μg/week is achieved (see Table 1 below).
An AVOSTARTCLIPTM kit containing 3 titration devices can be used for titration. These devices are to be used only with AVONEXTM PS. Each AVOSTARTCLIPTM should be used only once and disposed of, along with any remaining AVONEXTM PS in the syringe.
5 μg) Week 4+ Full dose (30 μg) 1 Dosed once a week, intramuscularly. A reduction in severity and incidence of flu-like symptoms with dose titration was observed in healthy volunteers (see Clinical Trials), but has not been well characterized in clinical trials in patients with MS.
An alternative titration schedule can be achieved by incremental ¼ dose increases every two weeks, reaching the full dose (30 μg/week) by the seventh week. Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is also advised to assist in decreasing flu-like symptoms associated with AVONEXTM administration.
AVONEXTM (interferon beta-1a) Page 6 of 46 Health Canada has not authorized an indication for pediatric use. 4 Administration Patients should be advised of the side-effects of AVONEXTM PS/AVONEXTM PEN and instructed on the use of aseptic technique when administering AVONEXTM PS/AVONEXTM PEN.
PATIENT MEDICATION INFORMATION should be carefully reviewed with all patients, and patients should be educated on self-care and advised to continue to refer to Part III during treatment with AVONEXTM PS/AVONEXTM PEN. A shorter thinner needle for intramuscular injection of AVONEXTM PS may be substituted by the prescribing physician, if deemed appropriate.
AVONEXTM PS/AVONEXTM PEN (interferon beta-1a) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
AVONEXTM (interferon beta-1a) Page 5 of 46
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Interferon Beta-1a in Canada.
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AVONEXTM (interferon beta-1a) Page 6 of 46 Health Canada has not authorized an indication for pediatric use. 4 Administration Patients should be advised of the side-effects of AVONEXTM PS/AVONEXTM PEN and instructed on the use of aseptic technique when administering AVONEXTM PS/AVONEXTM PEN.
PATIENT MEDICATION INFORMATION should be carefully reviewed with all patients, and patients should be educated on self-care and advised to continue to refer to Part III during treatment with AVONEXTM PS/AVONEXTM PEN. A shorter thinner needle for intramuscular injection of AVONEXTM PS may be substituted by the prescribing physician, if deemed appropriate.
5 Missed Dose If a dose is missed, the next dose should be taken as soon as possible. The regular schedule should be continued the following week. Do not take AVONEXTM PS/AVONEXTM PEN on two consecutive days.
When a physician determines that AVONEXTM PS/AVONEXTM PEN can be used outside the physician’s office, persons who will be administering AVONEXTM PS/AVONEXTM PEN should receive instruction in reconstitution and/or injection, including the review of the injection procedures (see PATIENT MEDICATION INFORMATION).
If a patient is to self-administer, the physical ability of the patient to self-inject intramuscularly should be assessed. If home use is chosen, the first injection should be performed under the supervision of a qualified health care professional.
A puncture-resistant container for disposal of needles, syringes and autoinjectors should be used. Patients should be instructed in the technique and importance of proper syringe, needle and autoinjector disposal and be cautioned against reuse of these items.
Patients receiving AVONEXTM 60 μg IM once a week in the relapsing MS population showed similar adverse event and tolerability patterns to the 30 μg dose. g. flu syndrome, asthenia, depression, headache, myalgia, nausea, fever, diarrhea, dizziness and chills) generally occurred at similar frequencies between the two dose groups, with the exception of flu syndrome (AVONEXTM 30 μg vs AVONEXTM 60 μg: 85% vs.
92%, respectively). Carcinogenesis and Mutagenesis No carcinogenicity data for interferon beta-1a are available in animals or humans. Interferon beta-1a was not mutagenic when tested in the Ames bacterial test and in an in vitro cytogenetic assay in human lymphocytes in the presence and absence of metabolic activation.
These assays are designed to detect agents that interact directly with and cause damage to cellular DNA. Interferon beta-1a is a glycosylated protein that does not directly bind to DNA. Cardiovascular Patients with cardiac disease, such as angina, congestive heart failure, or arrhythmia, should be closely monitored for worsening of their clinical condition during initiation and continued treatment with AVONEXTM PS/AVONEXTM PEN.
While AVONEXTM PS/AVONEXTM PEN does not have any known direct- acting cardiac toxicity, during the post-marketing period infrequent cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition to these events or other known etiologies.
In rare cases, these events have been temporally related to the administration of AVONEXTM and have recurred upon re-challenge in patients with known predisposition. Endocrine and Metabolism Other interferons have been noted to reduce cytochrome P-450 oxidase-mediated drug metabolism.
Formal hepatic drug metabolism studies with AVONEXTM PS/AVONEXTM PEN in humans have not been conducted. Hepatic microsomes isolated from rhesus monkeys treated with AVONEXTM showed no influence of AVONEXTM on hepatic P-450 enzyme metabolism activity.
AVONEXTM (interferon beta-1a) Page 9 of 46 Hematologic Decreased Peripheral Blood Counts: Decreased peripheral blood counts in all cell lines, including very rare pancytopenia and thrombocytopenia have been reported from post-marketing experience (see 8 ADVERSE REACTIONS).
Some cases of thrombocytopenia have had nadirs below 10,000/mL. Some cases reoccur with re- challenge. Patients should be monitored for signs of these disorders (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
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 after several weeks to several years after starting treatment with interferon beta.
g. confusion, paresis) and […]
5 Missed Dose If a dose is missed, the next dose should be taken as soon as possible. The regular schedule should be continued the following week. Do not take AVONEXTM PS/AVONEXTM PEN on two consecutive days. 5 OVERDOSAGE In clinical studies, overdosage was not seen using interferon beta-1a at a dose of 75 μg given subcutaneously three times a week.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING AVONEXTM (interferon beta-1a) is available in the following presentations: Table 2 – Dosage Forms, Strengths, Composition and Packaging Packaging and Pack Size(s) AVONEXTM PS Available in a package containing 4 dose administration packs and a reclosable accessory pouch containing 4 alcohol wipes, 4 gauze pads and 4 adhesive bandages.
8. 8. AVONEXTM (interferon beta-1a) Page 7 of 46 contains 1 prefilled syringe of AVONEX PS liquid and 1 needle for injection. AVONEXTM PEN Available in a package containing 4 dose administration packs and a reclosable accessory pouch containing 4 alcohol wipes, 4 gauze pads and 4 adhesive bandages.
Each dose administration pack contains 1 prefilled autoinjector of AVONEXTM PEN, 1 needle for injection and 1 AVONEXTM PEN cover. Description AVONEXTM PS/AVONEXTM PEN (interferon beta-1a) are produced by recombinant DNA technology. Interferon beta-1a is a 166 amino acid glycoprotein with a predicted molecular weight of approximately 22,500 daltons.
It is produced by mammalian cells (Chinese Hamster Ovary cells) into which the human interferon beta gene has been introduced. The amino acid sequence of interferon beta-1a is identical to that of natural human interferon beta. Using the World Health Organization (WHO) natural interferon beta standard, Human Fibroblast (Gb- 23-902-531), AVONEXTM PS/AVONEXTM PEN have a specific activity of approximately 200 million international units (IU) of antiviral activity per mg; 30 μg of AVONEXTM PS/AVONEXTM PEN contains 6 million IU of antiviral activity.
7 WARNINGS AND PRECAUTIONS General AVONEXTM PS/AVONEXTM PEN (interferon beta-1a) should be used under the supervision of a physician. The first injection should be performed under the supervision of an appropriately qualified health care professional (see 4 DOSAGE AND ADMINISTRATION).
Patients should be informed of the following information: The most common adverse events associated with interferon beta administration, including symptoms of the flu-like syndrome (see