Description of the active substance :.
This information is a reference and it is not enough that the drug was prescribed by a doctor. .
PHARMACHOLOGIC EFFECT
Recombinant human interferon, obtained by genetic engineering using the Chinese hamster ovary cell culture. The sequence of amino acids in the interferon beta-1a molecule is identical to that of endogenous human interferon beta.
It has immunomodulatory, antiviral and antiproliferative properties.
The mechanism of action in patients with multiple sclerosis is not fully understood; It is shown that this interferon helps to limit the damage to the CNS underlying the disease.
INDICATIONS
Outpatient treatment of patients with multiple sclerosis (to reduce the frequency and severity of exacerbations and slow the progression of disability).
DOSING MODE
Enter the SC. The recommended dose is 22-44 Ојg 3 times / week. at the same time (preferably in the evening), on certain days of the week, with an interval of at least 48 hours.
At the first application it is recommended to administer 8.8 mcg during the first 2 weeks, 22 mcg during the 3rd and 4th weeks, starting from the 5th week and then on - 44 mcg.
SIDE EFFECT
Grippopodobnye symptoms: headache, fever, chills, muscle and joint pain, nausea. These symptoms are usually mild, are observed more often at the beginning of treatment and decrease with continued therapy.
From the digestive system: rarely - diarrhea, loss of appetite, vomiting, liver damage.
From the side of the central nervous system: rarely - sleep disturbance, dizziness, nervousness; in isolated cases - depression, suicidal ideation, depersonalization, as well as convulsive seizures.
From the cardiovascular system: rarely - peripheral vasodilation, palpitations; in isolated cases - violations of the heart rhythm.
On the part of laboratory indicators: leukopenia, lymphocytopenia, thrombocytopenia, elevation of ALT, GGT and AFP levels are possible. These changes are usually negligible, reversible and asymptomatic.
Local reactions: redness, swelling, blanching of the skin, soreness (usually slightly pronounced and reversible); In isolated cases, necrosis can occur at the injection site, which usually passes by itself.
Other: rarely - skin rash, hives.
CONTRAINDICATIONS
Severe depression and / or suicidal ideation; epilepsy in the absence of effect from the application of appropriate therapy; pregnancy; lactation; children and adolescents under 16; hypersensitivity to endogenous or recombinant interferon beta, human serum albumin.
PREGNANCY AND LACTATION
Application during pregnancy and during lactation is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution and under the strict supervision of a physician, a drug should be prescribed to patients with severe renal insufficiency.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution and under the strict supervision of a physician, the drug should be administered to patients with severe hepatic impairment.
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 16 years.
SPECIAL INSTRUCTIONS
Use with caution in patients with depression. Patients should be warned that they should immediately inform the doctor about any symptoms of depression and / or the appearance of suicidal ideation. Treatment of patients with depression should be carried out under the strict supervision of a physician and, if necessary, prescribe appropriate therapy. In some cases, it may be necessary to stop the treatment with interferon beta-1a.
It should be used with caution in patients with a history of seizures. If seizures occur during treatment in patients who have not previously suffered such disorders, it is necessary to abolish interferon beta-1a, establish their etiology and prescribe anticonvulsant therapy before resuming treatment with interferon beta-1a.
At the first stages of treatment, strict observation of patients with angina pectoris, congestive heart failure, arrhythmia is necessary. With heart disease, the development of an influenza-like syndrome associated with interferon beta-1a therapy can contribute to worsening of patients.
With caution and under the strict supervision of a physician, the drug should be prescribed to patients with severe renal and hepatic impairment, as well as with severe myelosuppression.
The patient should be warned that with intensive or persistent manifestations of any of the flu-like symptoms, you should inform the doctor about it.
In the case of pronounced adverse reactions or persistence for a long time at the doctor's discretion, a temporary dose reduction or interruption of treatment is allowed.
The patient should not independently discontinue treatment or change the dose.
In addition to laboratory tests that are always performed for patients with multiple sclerosis, it is recommended that the complete and leukocyte blood count, platelet count, and blood biochemistry, including functional liver samples, be determined during interferon beta-1a treatment.
Impact on the ability to drive vehicles and manage mechanisms
Adverse reactions from the central nervous system to interferon therapy may influence the ability to drive vehicles and machinery.
DRUG INTERACTION
In humans and animals, interferons decrease the activity of cytochrome P450 isoenzymes in the liver. Therefore, it is necessary to use interferon beta-1a with simultaneous use with drugs, the metabolism of which occurs with the participation of these enzymes, including. with anticonvulsants and some antidepressants.
A systematic study of the interaction of interferon beta-1a with corticosteroids or ACTH was not carried out. Data from clinical trials indicate the possibility of prescribing corticosteroids and ACTH to patients with multiple sclerosis during relapse of the disease.
