Genfaxon
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Genfaxon is a drug of the cytokine group with antiviral, antiproliferative, immunomodulatory properties.
Release form and composition
Dosage form - solution for subcutaneous (s / c) administration: clear liquid from slightly yellow to colorless, without visible particles [6 million IU (international units) or 12 million IU: in a glass syringe without color with a needle - 0.5 each ml, in a plastic container 1 syringe, in a cardboard box 3, 12, 96 or 192 containers].
1 syringe contains:
- active substance: interferon beta-1a - 0.022 mg (equivalent to 6 million ME) or 0.044 mg (equivalent to 12 million ME);
- auxiliary components: human albumin, sodium acetate, acetic acid, mannitol, water for injection.
Indications for use
The use of Genfaxon is indicated for the treatment of remitting forms of multiple sclerosis.
Contraindications
- epilepsy (in the absence of effect from the use of special therapy);
- period of pregnancy;
- breast-feeding;
- severe depression, including those with suicidal thoughts;
- age up to 12 years;
- hypersensitivity to the components of the drug.
Caution should be exercised when prescribing Genfaxon to patients with a history of depression and / or seizures, cardiac arrhythmias, angina pectoris, heart failure, severe myelosuppression, severe renal or hepatic failure, thyroid disease.
Method of administration and dosage
The solution is intended for subcutaneous administration.
The syringe contains a ready-made solution, for the convenience of introducing the required dose, divisions are applied to its body. One syringe is intended for only one use, if the prescribed dose is less than the contents of the syringe, the remainder is disposed of.
Genfaxon should always be used at the same time of day (preferably in the evening) on the days of the week established by the doctor, the interval between injections should not be less than 48 hours.
The procedure should be carried out by constantly changing the place of administration of the drug.
Recommended to be injected into the upper thigh or lower abdomen.
The first injection of a patient or a person who will give injections at home should be done after a medical professional explains in detail the rules for carrying out the procedure for subcutaneous administration of the drug and under his supervision.
It is necessary to start treatment under the supervision of a physician with experience in the treatment of multiple sclerosis.
Recommended dosing regimen for initial therapy:
- 1st and 2nd weeks: 0.0088 mg, which corresponds to 0.2 ml in a 0.022 mg syringe or 0.1 ml in a 0.044 mg syringe;
- 3rd and 4th weeks: 0.022 mg, which corresponds to 0.5 ml in a syringe of 0.022 mg or 0.25 ml of 0.044 mg;
- 5th week: 0.044 mg, which corresponds to 0.5 ml in a 0.044 mg syringe (another dose may be prescribed).
The maintenance dose depends on the patient's age:
- patients over 16 years old: 0.044 mg 3 times a week, with poor tolerance to high doses of the drug - 0.022 mg 3 times a week;
- patients 12-16 years old: 0.022 mg 3 times a week.
The duration of maintenance therapy is prescribed by the doctor individually.
If you accidentally skip the introduction of the next dose, you should skip it and enter only the next therapy on the schedule. Do not allow a double dose.
Side effects
- general condition: often - flu symptoms in the form of headache, nausea, fever, chills, joint and muscle pain;
- local reactions: it is possible - the appearance at the injection site of redness, swelling, pale skin, pain; rarely - infection of the injection site with characteristic symptoms: pain, elastic skin, swelling; in isolated cases - necrosis;
- from the endocrine system: an increase or inhibition of the function of the thyroid gland;
- allergic reactions: very rarely - difficulty breathing (immediately after the injection), hives, feeling of discomfort or weakness;
- from the hepatobiliary system: nausea, vomiting, loss of appetite, jaundice;
- laboratory indicators: possibly - leukopenia, lymphopenia, thrombocytopenia, increased activity of alanine aminotransferase (ALT), gamma-glutamyl transferase, alkaline phosphatase (all disorders are mild and reversible);
- others: rarely - loss of appetite, diarrhea, vomiting, nervousness, dizziness, sleep disturbance, rash, palpitations, symptoms of vasodilation, disturbance or change in the menstrual cycle, depression.
special instructions
Before starting treatment and after 1, 3 and 6 months, and then regularly during the use of Genfaxon, it is necessary to conduct studies to determine the activity of ALT.
If ALT activity exceeds the upper limit of the norm by 5 times, the dose of the drug should be reduced and only after normalization of liver function can it be gradually increased.
If signs of liver dysfunction, including symptoms of jaundice, appear, therapy should be discontinued.
In addition to laboratory tests that are mandatory for patients with multiple sclerosis, during the period of application of interferon beta-1a, it is recommended to carry out liver tests every 1, 3 and 6 months, a blood test to determine the level of platelets and calculate the leukocyte formula.
The function of the thyroid gland must be examined before starting treatment and at intervals of 6-12 months during therapy.
The manifestations of influenza-like syndrome typical for interferons during the first six months of therapy are, as a rule, moderately pronounced. Symptoms are usually observed at the beginning of treatment and then diminish. The patient should know that in case of severe severity and long duration of symptoms, it is necessary to consult a doctor.
If side effects develop, the doctor should be informed about the degree of their manifestation. Based on a detailed description of undesirable phenomena, and, if necessary, laboratory tests, the doctor may temporarily reduce the dose of the drug or cancel therapy.
You can not independently reduce the dose or stop using the drug.
To reduce the risk of tissue necrosis at the injection site, strict adherence to the rules of asepsis is required. Do not inject the drug into areas of the body with damaged skin integrity, swelling or pain on palpation.
With the formation of neutralizing antibodies against the background of the use of Genfaxon, the doctor must decide on the advisability of continuing the treatment.
During the period of use of the drug, women of childbearing age should use reliable contraceptives.
When planning pregnancy or conception during the treatment period, it is necessary to inform the attending physician about this.
The effectiveness of using the drug for the treatment of secondary progressive multiple sclerosis has not been confirmed.
The drug has a negative effect on the patient's ability to drive vehicles and mechanisms.
Drug interactions
It is recommended to be careful while using Genfaxon with antiepileptic drugs and antidepressants, the clearance of which is significantly dependent on cytochrome P 450.
During an exacerbation of the disease, a combination with glucocorticosteroids or adrenocorticotropic hormones is possible.
Analogs
Genfaxon's analogues are: Gerpferon, Ingaron, Altevir, Alfarona, Interferal, Infibeta, Ronbetal, Layfferon, Diaferon.
Terms and conditions of storage
Keep out of the reach of children.
Store in a dark place at a temperature of 2-8 ° C, do not freeze.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
