Betaseron Prescription Drugs Side Effects
Betaseron, also known as interferon beta-1b, is used to treat relapsing forms of multiple sclerosis. The drug is produced by recombinant DNA techniques and is a sterile, purified, lyophilized protein product.
Interferon beta-1b is created by bacterial fermentation of a strain of Escherichia coilthat contains a genetically engineered plasmid containing the gene for human interferon betaser17 which was obtained from human fibroblast and then altered in an act that substitute serine for the cysteine residue. Interferon beta-1b has a molecular weight of 18,500 daltons and contains 165 amino acids.
Each vial of Betaseron contains 0.3mg of Interferin beta-1b and is a white to off-white, sterile powder to be used for subcontaneous injection after reform with the supplied diluents. The drug is used to treat relapsing forms of multiple sclerosis. This is to reduce the frequency if clinical exacerbations. Patients that have demonstated efficacy using Betaseron include patients who have MRI features that are consistant with multiple sclerosis and who have experienced a first clinical response.
The dose recommended to Betaseron Patients is 0.25mg injected every other day subcutaneously. Patients should initiate treatment at 0.0625mg every other day subcutaneously and should increase treatment to 0.25mg every other day over a six week period.
It has not been adequately evaluated to decide whether a dose higher than 0.25 is safe. It has not yet been determined what the maximum amount of Betaseron that can be safely administered is.
Betaseron should not be used in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), USP, or any other component of the formulation.
A family of naturally occurring proteins called Interferons (IFNs) are produced by eukaryotic cells in response to viral infection and other biologic agents. The three major groups of interferons that have been distinguished are alpha, beta, and gamma. The bioactivi-ties of IFNs are mediated by their interactions with certain receptors found on the surfaces of human cells.
Pharmacokinetic information in patients with MS receiving the recommended dose of Betaseron is not available because serum concentrations of Interferon beta-1b are low or not detectable following subcutaneous administration of 0.25 mg or less of Betaseron. Enhancement of suppressor T cell activity, reduction of pro-inflammatory cytokine production, down-regulation of antigen presentation, and inhibition of lymphocyte trafficking into the central nervous system are included in immunomodulatory effects of Interferon beta-1b. It is unknown what the mechanism of action of Interferon beta-1b in patients with multiple sclerosis is. Throughout the seven-day (168-hour) study, biologic response marker levels peaked between 40 and 124 hours and remained elevated above baseline. It is unknown what the relationship is between serum Interferon beta-1b levels or induced biologic response marker levels and the clinical effects of Interferon beta-1b in multiple sclerosis.
The leaflet provided with Betaseron should be read each time prescription is refilled as there may be new information. The medication guide does not substitute for talking with a healthcare professional. It is important to talk with your doctor before use of the drug.
The following adverse events and side effects are associated with Betaseron:
· Lymphocytes count decreased
· Absolute neutrophil count decreased
· White blood cell count decreased
· Lymphadenopathy
· Headache
· Insomnia
· Incoordination
· Hypertension
· Dyspnea
· Abdominal pain
· Increase in alanine aminotransferase
· Increase in aspartate aminotransferase
· Rash
· Hypertonia
· Myalgia
· Urinary urgency
· Metrorrhagia
· Impotence
· Various kinds of injection site reaction
· Asthenia
· Flu-like symptoms (complex)
· Pain
· Fever
· Chills
· Peripheral edema
· Chest pain
· Malaise
· Injection site necrosis
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