Betaferon is an immunomodulator used in multiple sclerosis.
Release form and composition
Betaferon is produced in the form of a lyophilisate for preparing a solution intended for subcutaneous administration. Externally, it is a mass of white. It is realized in glass bottles, in addition it is completed with solvent.
The composition of Betaferon includes recombinant interferon beta-1b. In 1 ml of its solution contains 8 million IU, in one bottle - 9.6 million IU.
Indications for use
According to the instructions to Betaferon, this drug is intended for the treatment of clinically isolated syndrome (ICD) - the only clinical epitode of demyelination, suggesting that a patient has multiple sclerosis (provided that alternative diagnoses are excluded), with such an intensity of the inflammatory process that the administration of GCS is considered appropriate. The goal of therapy is to slow the transition of this condition to clinically significant multiple sclerosis (CDRS) in patients with a high risk of its development. It should be noted that the concept of generally accepted high risk does not exist. According to studies, this group includes patients with mono-focal KIS (i.e., with clinical manifestations of only one lesion in the central nervous system) and T2 foci detected by MRI, or lesions accumulating a contrast agent. Patients with multifocal KIS (i.e., who have clinical manifestations of more than one lesion in the central nervous system) are at increased risk for developing CRDS, regardless of the number of lesions diagnosed on MRI.
Also, Betaferon, according to the instructions, is used to treat:
- Remitting multiple sclerosis - in order to reduce the severity and frequency of exacerbation of the disease in outpatient patients (i.e., able to move independently, without assistance) if they have at least two episodes of exacerbation of the disease in the past 2 years and subject to the following complete or incomplete recovery of neurological symptoms;
- Secondary progressive multiple sclerosis, characterized by an active course, exacerbations or marked deterioration of neurological functions over the past 2 years - in order to reduce the severity and frequency of exacerbations, as well as to slow the rate of disease progression.
According to the annotation to the drug, the use of Betaferon is contraindicated:
- During pregnancy;
- Breastfeeding women;
- With a history of hypersensitivity to interferon-beta (recombinant or natural) or human albumin.
Prescribe the drug, but with extreme caution to children and adolescents under 18 years of age (due to the lack of sufficient data on the safety of Betaferon in this age group), as well as patients with:
- Heart diseases, incl. with heart failure II-IV functional class according to the NYHA classification and cardiomyopathy;
- Depression and suicidal attempts / thoughts in the anamnesis;
- History of epileptic seizures;
- Impaired liver function.
Dosing and Administration
Betaferon therapy should be carried out under the supervision of a physician who has experience in treating multiple sclerosis.
The recommended dosage of the drug is 250 μg (8 million IU), which corresponds to 1 ml of the prepared solution. At this dose, Betaferon is injected subcutaneously every other day.
If for some reason the patient missed the next injection, he should do it as soon as he remembers, and the next after 48 hours, etc., starting from the new time of administration.
It is recommended to prepare the solution from Betaferon lyophilisate immediately before administration, since You can store it for no more than 3 hours and only in the refrigerator.
The duration of treatment in each case is determined by the attending physician, since the question of the duration of Betaferon therapy remains unresolved to this day. In clinical studies, the treatment of patients with secondary progressive and remittent multiple sclerosis in some cases reached 3 and 5 years, respectively.
At use of Betaferon, according to reviews of patients, development of side effects is possible.
Relatively often, flu-like symptoms occur - chills, headache, fever, myalgia, increased sweating, but the frequency of their manifestations decreases with time. In addition, these symptoms can be reduced by additional use of NSAIDs.
Local reactions, such as hyperemia, inflammation, local edema, pain, and necrosis at the injection site, are also often noted. Over time, their frequency usually decreases.
Rarely, including individual cases, the development of such side effects of Betaferon, such as:
- Chest pain, general malaise;
- Anemia, thrombocytopenia, leukopenia, lymphadenopathy;
- Arterial hypertension, tachycardia, cardiomyopathy, palpitations, vasodilation;
- Thyroid dysfunction, hypothyroidism, hyperthyroidism;
- Muscle hypertonia, convulsions, depression, agitation, confusion, emotional lability, dizziness, anorexia, suicidal attempts;
- Shortness of breath, bronchospasm;
- Nausea, vomiting, diarrhea, pancreatitis, hepatitis, increased bilirubin levels, AST, ALT and GGT activity;
- Arthralgia, myalgia;
- Menstrual disorders, menorrhagia;
- Anaphylactic reactions;
- Increased triglycerides;
- Urticaria, alopecia, itching and rash, discoloration of the skin.
Interferon beta-1b, Infibeta, Ronbetali Exceia are manufactured with the same active ingredient.
According to the similarity of the mechanisms of action, Betaferon analogues can be considered Avonex, Altevir, Alfaron, Alfaferon, Viferon, Genferon, Giaferon, Diaferon, Ingarol, Interferal, Human Recombinant Interferon, Human Leukocyte Interferon, Inferon, Lyfferon, Pegasys-ae Ron, and Pegasys-aephaman, Pegasys-aeacon, Iberferone, Infaron, Lypferon, Pegacen, Imero, Iparone
Terms and conditions of storage
Betaferon's shelf life is 2 years. It can be stored at temperatures up to 25 ºС.