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BETASERON is a brand name for Interferon Beta-1b, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: BETASERON (interferon beta-1b) is indicated for: • the treatment of patients with a single demyelinating event accompanied by at least two clinically silent lesions typical of multiple sclerosis (MS) on magnetic resonance imaging, to delay progression to definite MS. Before initiating treatment with Betaseron,…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • FOR SUBCUTANEOUS USE ONLY • Betaseron (interferon beta-1b) should only be prescribed by (or following consultation with) clinicians who are experienced in the diagnosis and management of multiple sclerosis.
• Review 7 WARNINGS AND PRECAUTIONS, Information to be Provided to the Patient with the patient. 25 mg (8 MIU) injected subcutaneously every other day. Limited data regarding the activity of a lower dose in relapsing-remitting MS are presented in the 14 CLINICAL TRIALS section.
<BETASERON>< Interferon beta-1b (USAN)> Page 5 of 70 Dose titration was used at the start of treatment in the clinically isolated syndrome and secondary- progressive MS studies in order to increase the tolerability of Betaseron. In the study in patients with a single clinical event suggestive of MS (clinically isolated syndrome), dosage was increased as shown in Table 1.
0 mL a Titration scheme as used in the study in patients with a single clinical event suggestive of multiple sclerosis. The titration period may be adjusted if any significant adverse reaction occurs. In the secondary-progressive MS study, patients initiated treatment with half the dose (4 MIU SC every other day) for a period of 2 weeks prior to escalating to the recommended dose of 8 MIU (SC every other day).
Efficacy of treatment for longer than 2 years has not been substantially demonstrated in relapsing-remitting multiple sclerosis. Health Canada has not authorized an indication for pediatric use. 54% Solution into the Betaseron vial. Gently swirl the vial of Betaseron to dissolve the drug completely; do not shake.
Inspect the reconstituted product visually and discard the product before use if it contains particulate matter or is discolored. 25 mg/mL In the absence of compatibility studies, Betaseron should not be mixed with other medicinal products except for the supplied diluent.
4 Administration Subcutaneous injection: Withdraw 1 mL of reconstituted solution from the vial back into the syringe, fitted with a ½-inch needle, and inject the solution subcutaneously. Sites for self-injection include arms, abdomen, buttocks, and thighs.
). 5 Missed Dose If an injection is missed, it should be given as soon as feasible. The next injection should be given 2 days later. <BETASERON>< Interferon beta-1b (USAN)> Page 6 of 70
). These symptoms tend to be most prominent at the initiation of therapy and may decrease in frequency and severity with continued treatment. Flu-like symptoms are not uncommon following initiation of therapy with Betaseron. In the controlled MS clinical trials, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) were permitted for relief of fever or myalgia.
Cardiovascular Patients with pre-existing significant cardiac disease such as congestive heart failure, coronary artery disease, or arrhythmias should be monitored closely for worsening of their clinical conditions. While there is no evidence of a direct cardiotoxic potential of Betaseron, flu-like symptoms, which are commonly associated with beta interferons, exert cardiac stress through fever, chills, and tachycardia.
This may aggravate cardiac symptoms in patients with pre-existing significant cardiac disease. <BETASERON>< Interferon beta-1b (USAN)> Page 7 of 70 Cases of cardiomyopathy have been reported. If this occurs, and a relationship to Betaseron (interferon beta-1b) is suspected, treatment should be discontinued.
Dependence/Tolerance No evidence or experience suggests that abuse or dependence occurs with Betaseron therapy; however, the risk of dependence has not been systematically evaluated. Endocrine and Metabolism Cases of thyroid dysfunction (hyper- as well as hypothyroidism) associated with the use of Betaseron have been reported.
Exercise caution when administering Betaseron to patients with pre-existing thyroid disorders. Patients treated with Betaseron should be carefully monitored for evidence of thyroid dysfunction (most often presenting as hypothyroidism or hyperthyroidism), and development of thyroid auto-antibodies.
Thyroid testing is recommended at baseline and if abnormal, every 6 to 12 months following initiation of therapy. If normal, routine testing is not required but should be performed if clinical findings of thyroid dysfunction appear.
12/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .....................................................................................................
2 TABLE OF CONTENTS ....................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ..............................................................................
4 1 INDICATIONS................................................................................................................................ 1 Pediatrics ..............................................................................................................................
2 Geriatrics............................................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................................
4 4 DOSAGE AND ADMINISTRATION .................................................................................................. 1 Dosing Considerations ...........................................................................................................
2 Recommended Dose and Dosage Adjustment ....................................................................... 3 Reconstitution .......................................................................................................................
4 Administration ...................................................................................................................... 5 Missed Dose ..........................................................................................................................
Betaseron is contraindicated in patients: • who are hypersensitive to natural or recombinant interferon beta, albumin human or to any other ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
• with decompensated liver disease (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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General Disorders and Administration Site Conditions Overall, 80% of patients in the 2 controlled clinical trials reported injection site reactions at 1 or more times during therapy. Postmarketing experience has been consistent with this finding, with infrequent reports of injection site necrosis.
The onset of injection site necrosis usually appears early in therapy with most cases reported to have occurred in the first 2 to 3 months of therapy. The number of sites where necrosis has been observed is variable. Rarely has the area of injection site necrosis extended to subcutaneous fat or fascia.
Response to treatment of injection site necrosis with antibiotics and/or steroids has been variable. In some of these patients elective debridement and, less frequently, skin grafting took place to facilitate healing, which could take from 3 to 6 months.
If the patient has multiple lesions, Betaseron should be discontinued until healing has occurred. Patients with single lesions may continue on Betaseron provided the necrosis is not too extensive, as some patients have experienced healing of injection site necrosis while on Betaseron.
Injection site abscesses and cellulitis have been reported in the postmarketing setting with use of interferon beta products including Betaseron. Some cases required treatment with hospitalization for surgical drainage and intravenous antibiotics.
The nature and severity of all reported reactions should be carefully assessed. Hepatic/Biliary/Pancreatic Asymptomatic elevations of serum transaminases, in most cases mild and transient, occurred very commonly in patients treated with Betaseron during clinical trials.
It is recommended that liver function testing (eg, ASAT [SGOT], ALAT [SGPT], and Gamma-GT) occur at baseline and then every month for the first 6 months of treatment and at 6-month intervals thereafter. Dose reduction or discontinuation of therapy should be considered if alanine aminotransferase (ALAT) levels increase 5 times above the upper limit of normal.
Postmarket cases of serious hepatic injury, including autoimmune hepatitis, hepatitis, and hepatic failure, have been reported with interferon beta treatment for multiple sclerosis. The most severe events often occurred in patients exposed to other drugs or substances known to be associated with <BETASERON>< Interferon beta-1b (USAN)> Page 8 of 70 hepatotoxicity or in the presence of comorbid medical conditions (eg, metastasizing malignant disease, severe injection and sepsis, alcohol abuse).
Interferon beta therapy should be initiated with caution in patients with a history of significant liver disease or alcohol abuse and in patients with clinical evidence of acute liver disease. Caution must be exercised when prescribing drugs with documented hepatotoxicity to patients on interferon beta therapy for multiple sclerosis.
Treatment with Betaseron should be stopped if icterus or other clinical symptoms of hepatic dysfunction appear. Pancreatitis has been observed with Betaseron use, often associated with hypertriglyceridemia. Pancreatitis should be treated as per appropriate clinical management and in accordance with clinical practice guidelines.
Hypersensitivity Serious hypersensitivity reactions (severe acute reactions such as bronchospasm, anaphylaxis and urticaria) may occur. Severe reactions should be treated, and Betaseron should be discontinued. Immune The administration of cytokines to patients with pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Serum samples in controlled clinical trials were collected every 3 months for monitoring of development of antibodies to Betaseron. In the different controlled clinical trials of relapsing-remitting MS (RRMS) and secondary-progressive MS (SPMS) patients, between 23% and 41% of the patients developed serum interferon beta-1b […]
5 5 OVERDOSAGE .............................................................................................................................. 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..................................................
6 7 WARNINGS AND PRECAUTIONS ................................................................................................... 1 Special Populations .............................................................................................................
1 Pregnant Women .................................................................................................................... 2 Breast-feeding.........................................................................................................................
3 Pediatrics ................................................................................................................................ 4 Geriatrics .................................................................................................................................
12 8 ADVERSE REACTIONS ................................................................................................................. 1 Adverse Reaction Overview .................................................................................................
2 Clinical Trial Adverse Reactions ........................................................................................... 3 Less Common Clinical Trial Adverse Reactions .....................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings ...................................................................................................... 5 Post-Market Adverse Reactions ...........................................................................................
42 9 DRUG INTERACTIONS ................................................................................................................. 2 Drug Interactions Overview .................................................................................................
3 Drug-Behavioural Interactions ............................................................................................. 4 Drug-Drug Interactions ........................................................................................................
5 Drug-Food Interactions ........................................................................................................ 6 Drug-Herb Interactions ........................................................................................................
7 Drug-Laboratory Test Interactions ....................................................................................... 44 10 CLINICAL PHARMACOLOGY ......................................................................................................
1 Mechanism of Action ......................................................................................................... 3 Pharmacokinetics ..............................................................................................................
44 11 STORAGE, STABILITY AND DISPOSAL ........................................................................................ 44 12 SPECIAL HANDLING INSTRUCTIONS ..........................................................................................
45 <BETASERON>< Interferon beta-1b (USAN)> Page 3 of 70 PART II: SCIENTIFIC INFORMATION ............................................................................................... 45 13 PHARMACEUTICAL INFORMATION ...........................................................................................
45 14 CLINICAL TRIALS ....................................................................................................................... 1 Clinical Trials by Indication […]