Genfaxon® (Genfaxon®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceInterferon beta-1aInterferon beta-1a
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    • Dosage form: & nbsphypodermic solution
    Composition:In 1 syringe, 0.5 μl of the solution contains 22 μg (6 million ME) or 44 μg (12 million ME) of interferon beta-1a and auxiliaries: mannitol, human albumin, sodium acetate, acetic acid, water for injection.
    Description:Transparent, from a colorless to slightly yellowish color solution, free from foreign particles.
    Pharmacotherapeutic group:Cytokine
    ATX: & nbsp

    L.03.A.B.07   Interferon beta-1a

    Pharmacodynamics:
    Genfaxone® (recombinant human interferon beta-1a) is a naturally occurring amino acid sequence of human interferon beta obtained by genetic engineering techniques using the Chinese hamster ovary cell culture.
    Interferon beta-1a has immunomodulatory, antiviral and antiproliferative properties. The mechanism of action of interferon beta-1a in patients with multiple sclerosis is not fully understood.It is shown that the drug helps limit the damage to the central nervous system underlying the disease, reduces the incidence and severity of exacerbations in patients with a remitting form of multiple sclerosis.
    The action of Genfaxon® has not been studied in primary-progressive multiple sclerosis.
    Pharmacokinetics:When administered subcutaneously, the concentration of interferon beta-1a in serum is determined within 12-24 hours after the injection. After a single injection of a dose of 60 μg, the maximum concentration determined by immunological methods is 6-10 IU / ml 3 hours after the administration. At 4-fold subcutaneous injection of the same dose every 48 hours, a moderate accumulation of the drug occurs. After a single administration, the intracellular and serum 2-5A synthetase activity and serum concentrations of beta2-microglobulin and neopterin (bio-response markers) increase within 24 hours, and then decrease within 2 days. Interferon beta-1a is metabolized and excreted by the liver and kidneys.
    Indications:
    Remitting Multiple Sclerosis.
    Efficacy in patients with secondary-progressive multiple sclerosis in the absence of an active course of the disease has not been demonstrated.
    Contraindications:
    - Hypersensitivity to natural or recombinant interferon beta-1a, human serum albumin or to other components of the drug.
    - Pregnancy and lactation (see "Application during pregnancy and lactation")
    - Severe depressive disorders and / or suicidal thoughts.
    - Epilepsy in the absence of effect from the application of appropriate therapy.
    - Age to 12 years (the effect of the drug on this age group is not sufficiently studied).
    Carefully:A history of depression, previous history of cramps, angina pectoris, heart failure, heart rhythm disorder, severe renal or hepatic insufficiency, severe myelosuppression; Thyroid gland diseases.
    Pregnancy and lactation:
    Pregnancy
    Genfaxone® is not prescribed during pregnancy and lactation. Women of childbearing age should use effective methods of contraception. Given the potential danger to the fetus, patients planning pregnancy or becoming pregnant during treatment should inform their physician about this in order to decide on the continuation (cancellation) of therapy.
    Lactation
    Data on the excretion of Genfaxon® in breast milk are not available.Given the likelihood of developing serious adverse reactions in infants, a choice should be made between the cancellation of Genfaxon® and the cessation of breastfeeding.
    Dosing and Administration:
    Subcutaneously.
    The drug should be used at the same time (preferably in the evening), on certain days of the week, with an interval of at least 48 hours.
    Treatment is recommended to begin under the supervision of a doctor who has experience in the treatment of this disease.
    During the first 2 weeks of initiation of therapy, Genfaxon® should be administered at a dose of 8.8 μg (0.2 ml from a syringe containing 22 μg or 0.1 ml from a syringe containing 44 μg), during the 3rd and 4th week at a dose of 22 μg (0.5 ml from a syringe containing 22 μg or 0.25 ml from a syringe containing 44 μg). In appointing Genfaxon® at a dosage of 44 μg, starting at week 5, a dose of 0.5 ml of 44 μg is administered.
    Adults and adolescents over 16 years of age: a maintenance dose of the drug is usually 44 μg 3 times a week. In a dose of 22 mcg 3 times a week, Genfaxone® is prescribed to those patients who, according to the attending physician, do not tolerate the high dose well enough.
    To teenagers from 12 years to 16 years: 22 mcg 3 times a week.
    For convenience, the appropriate slicing is indicated on the syringe. The drug remaining in the syringe is not subject to further use.
    The decision on the duration of treatment should be taken individually by the attending physician. If you miss a dose, continue the injection, starting with the next on schedule. Do not administer a double dose.
    Side effects:

    Flu-like symptoms

    Approximately in 40% of patients during the first 6 months against the background of Genfaxon ® therapy, an influenza-like syndrome typical for interferons (headache, fever, chills, muscle and joint pains, nausea) can be observed. These manifestations are usually mild, are observed more often at the beginning of treatment and decrease with continued treatment. The patient should be informed that if any of the listed symptoms are severe or persistent, he should report this the doctor. The doctor may prescribe a painkiller or temporarily change the dose.

    Reactions at the injection site

    Also, reactions at the site of injection (redness, swelling, blanching of the skin, tenderness) are usually expressed slightly and are reversible. In isolated cases, necrosis occurs at the injection site, which usually passes by itself. Occasionally, infection of the injection site is possible.The skin in this area can become firm, swollen, and tenderness is noted.

    Reactions from the digestive, nervous, cardiovascular and other body systems

    The more rare side effects associated with the use of interferon beta-1a include diarrhea, loss of appetite, vomiting, sleep disturbance, dizziness, nervousness, rash, symptoms of vasodilation and palpitations, irregularities / changes in the menstrual cycle.

    Hypersensitivity and allergic reactions

    In exceptional cases, serious allergic reactions may occur. If immediately after the injection the patient has experienced difficulty breathing, which may be accompanied by hives, a feeling of weakness or discomfort, he should immediately seek medical help.

    Deviation of laboratory indicators

    There may be a deviation from the norm of laboratory indicators, manifested by leukopenia, lymphopenia, thrombocytopenia, increased activity of alanine aminotransferase (ALT), γ-glutamyltransferase and alkaline phosphatase. These changes are usually minor and reversible. Symptoms of liver disorders may occur, such as loss of appetite, nausea, vomiting, jaundice.

    Reactions from the endocrine system

    Interferons can influence the function of the thyroid gland, both upward and downward. These changes may not be noticeable to the patient, but the doctor may prescribe an additional examination.

    Depression

    Patients with multiple sclerosis may develop depression.

    It is necessary to inform the doctor about any of the above side effects of the drug, including those that are not specified in this manual. In the case of severe adverse reactions or persistence for a long time, at the discretion of the doctor, a temporary reduction in the dose of the drug or interruption of treatment is allowed.

    Do not discontinue treatment or change the dose without the indication of the attending physician.

    Overdose:
    No case of overdose has yet been described.
    In case of an overdose, the patient should be hospitalized to observe and carry out symptomatic therapy if necessary.
    Interaction:Specially planned clinical studies to study the interaction of the drug Genfaxon® with other drugs have not been conducted. However, it is known that in humans and animals, interferons decrease the activity of cytochrome P450-dependent liver enzymes.Therefore, care should be taken when administering Genfaxone® concomitantly with drugs that have a narrow therapeutic index, the clearance of which is largely dependent on cytochrome P450, for example, with antiepileptic drugs and some antidepressants. Systematic study of the interaction of the drug Genfaxon ® with glucocorticosteroids or adrenocorticotropic hormone (ACTH) has not been conducted. Data from clinical studies indicate the possibility of obtaining patients with multiple sclerosis of Genfaxon® and glucocorticosteroids or ACTH during exacerbations of the disease.
    Special instructions:
    There are isolated reports of tissue necrosis at the injection site. To minimize the risk of developing necrosis, strict adherence to the rules of asepsis during the injection and constant change of injection sites are necessary. If there is a violation of the integrity of the skin with the flow of fluid at the injection site, you should consult a doctor before continuing the drug. For multiple skin lesions, the drug should be discarded before healing.With a single lesion, continuation of Genfaxon® therapy is possible, provided that the lesion is moderately expressed. In clinical trials, increased activity of "liver" transaminases, especially ALT, has been demonstrated. In the absence of symptoms, the activity of ALT in the plasma should be determined before the initiation of Genfaxon® therapy and repeated at 1, 3 and 6 months and periodically with continued treatment. It is necessary to reduce the dose of the drug if ALT activity exceeds the upper limit by 5 times, and gradually increase the dose after its normalization. Caution should be exercised when assigning interferon beta-1a to patients with severe hepatic insufficiency in the anamnesis, with signs of liver disease, signs of alcohol abuse, ALT activity 2.5 times higher than the upper limit of the norm. Therapy should be discontinued if jaundice or other signs of liver dysfunction occur. Genfaxone®, like other interferons beta, can potentially cause serious damage from the liver, up to acute liver failure. The mechanism of these conditions is unknown, specific risk factors have not been identified.In addition to laboratory tests, which are always performed for patients with multiple sclerosis, it is recommended to perform an overall blood count with a count of the leukocyte count and platelet count during the treatment with interferon beta-1a every 1, 3 and 6 months, and also conduct a biochemical blood test, in particular functional hepatic tests.
    Patients receiving Genfaxone® sometimes develop or exacerbate disorders functions of the thyroid gland. It is recommended that the thyroid function be examined before treatment and, if violations are detected, every 6-12 months. In patients receiving interferons beta, the formation of neutralizing antibodies is possible. Their clinical value is not established. If the patient does not respond well enough to Genfaxon® therapy and has antibodies determined, the physician should evaluate the appropriateness of continuing therapy.
    Subcutaneous self-administration
    Since Genfaxone® is available as a pre-filled syringe for subcutaneous administration, you can safely use it at home, either alone or with the help of relatives or friends.If possible, the first injection should be done under the supervision of a qualified health professional.
    Before using Genfaxon ®, please read the following instructions carefully:
    - Wash your hands thoroughly with soap and water
    - Select the site for injection. Your doctor will advise you on possible places for injection (convenient areas are located at the top of the thigh or in the lower abdomen). It is recommended to alternate injection sites, avoiding frequent injections in the same place.
    - Do not administer the drug to places where you feel swelling, hard nodules or pain; Tell the doctor or nurse about the presence of such sites.
    - Remove the syringe with Genfaxon ® from the package.
    - Wipe the skin at the injection site with an alcoholic napkin. Allow the skin to dry. If alcohol partially remains on the skin, you may feel a burning sensation.
    - Gently squeeze the skin around the selected place so that it is slightly raised (to form a skin fold).
    - Pressing your wrist against the skin near the site, insert the needle at right angles into the skin with a quick and steady movement. Hold the syringe like a pencil or a dart.
    - Enter the drug with a slow and constant pressure in the dose (number of ml) prescribed by the doctor.
    - The drug remaining in the syringe is not subject to further use.
    - Press the injection site with a swab. Remove the needle from the skin.
    - Carefully massage the injection site with a dry cotton ball or gauze.
    - Dispose of the used syringe to the waste site.
    Effect on the ability to drive transp. cf. and fur:During the period of treatment, one should refrain from driving a car or engaging in activities that require the speed of psychomotor reactions.
    Form release / dosage:
    A solution for subcutaneous administration is 22 μg (6 million IU) or 44 μg (12 million ME).
    Packaging:
    A solution for subcutaneous administration is 22 μg (6 million IU) or 44 μg (12 million ME). 0.5 ml (22 μg) or 0.5 ml (44 μg) in a colorless transparent glass type I syringe with a stainless steel needle closed with a butyl cap placed in a plastic container with a paper coating.
    For 3 or 12 containers in a cardboard box with instructions for use.
    Storage conditions:At a temperature of 2 to 8 ° C in a dark place. Do not freeze. Keep out of the reach of children.
    Shelf life:2 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003037/10
    Date of registration:09.04.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Laboratory Tutor SAASIFAALaboratory Tutor SAASIFAA Argentina
    Manufacturer: & nbsp
    Representation: & nbspHEAD OF MEDICA SAHEAD OF MEDICA SASwitzerland
    Information update date: & nbsp24.03.2017
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