Avonex

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

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

Lyophilisate for the preparation of a solution for intramuscular administration Avonex

Avonex is an interferon, a drug for the treatment of multiple sclerosis.

Release form and composition

Lyophilisate for the preparation of a solution for intramuscular administration: a mass of almost white or white color (in glass vials, closed with bromobutyl stoppers and a Bio-Set device, 1 vial and a solvent (glass syringe) in a sealed plastic tray, in a cardboard box 4 trays);
Solution for intramuscular administration: transparent, colorless (0.5 ml each in glass syringes closed with bromobutyl caps, Luer Lock devices and a polypropylene plunger stopper, with a capacity of 1 ml, 1 syringe with a needle in a sealed plastic tray, 4 trays in a cardboard box) …

Active substance: interferon beta-1a, its content in 1 vial of lyophilisate and 1 syringe with a solution is 30 μg (6 million international units).

Auxiliary components of the lyophilisate: human serum albumin, sodium hydrogen phosphate, sodium dihydrogen phosphate and sodium chloride.

Solvent composition: water for injection.

Excipients of the solution: water for injection, arginine hydrochloride, sodium acetate trihydrate, polysorbate 20, glacial acetic acid.

Indications for use

Recurrent multiple sclerosis in case of at least two exacerbations during the previous 3 years in the absence of signs of disease progression between relapses (to slow the progression of functional disorders and reduce the frequency of relapses);
A clinically isolated case of demyelination in the presence of an active inflammatory process that required intravenous administration of glucocorticosteroids, if conditions other than multiple sclerosis are excluded and there is a high risk of its development.

Contraindications

Absolute:

Epilepsy resistant to therapy;
Severe depression;
The appearance of suicidal thoughts;
Pregnancy and lactation period;
Age up to 18 years - for solution, up to 16 years - for lyophilisate;
Hypersensitivity to natural or recombinant interferon beta, ancillary components of the drug, or human serum albumin.

Carefully:

Severe renal / hepatic impairment;
Expressed inhibition of bone marrow hematopoiesis;
A history of seizures;
Depressive disorders;
Heart disease (arrhythmia, angina pectoris, congestive heart failure, myocardial infarction).

Method of administration and dosage

Avonex is intended for intramuscular administration. Treatment is carried out under the supervision of a physician experienced in the treatment of multiple sclerosis (MS).

The recommended dose is 30 mcg once a week. If possible, injections should be made at the same time on the same day of the week. The injection site needs to be changed every week.

The lyophilisate is used to prepare a solution for intramuscular administration immediately before injection.

To reduce the incidence and severity of influenza-like symptoms, dose titration can be performed at the initial stage of therapy: treatment begins with ¼ of the dose and increases by ¼ every week until the full dose is reached (by the fourth week).

It is possible to introduce Avonex according to an alternative scheme: treatment begins with ½ dose 1 time per week, then it is increased to the full dose.

To reduce the severity of the flu-like reaction, it is recommended to take an antipyretic analgesic before injection and within 24 hours after each injection.

The duration of treatment is determined individually. 2 years after the start of therapy, the patient is referred for a clinical examination and assessment of the neurological status, based on the results of which the doctor will decide whether to continue the course. If chronic progressive MS develops, the drug should be discontinued.

Rules for using solution for injection:

Before administration, it is necessary to remove the drug from the refrigerator and leave it at room temperature (15-30 ºС) for about 30 minutes;
External sources, including hot water, cannot be used to warm the solution;
Do not use the drug if it contains solid impurities or is not transparent and colorless;
Each syringe is designed for one injection. The unused amount of solution should be disposed of.

Rules for preparing a solution for injection from a lyophilisate:

Check the integrity of the bottle and the Bio-Set device (if it is broken, the drug is prohibited to use);
Taking the Bio-Set by the base, turn the cap and remove it without touching the connecting hole;
Remove the cap (pull off) from the syringe with solvent, without touching the tip and without pressing the plunger;
Place the bottle vertically on a smooth surface, align with the syringe tip. Screw the syringe cannula clockwise into the Bio-Set. Holding the syringe by the base and following the direction of movement, sharply feed it down so that the tip is completely hidden and a click is heard;
Slowly pressing the plunger of the syringe, introduce the solvent into the bottle;
Without disconnecting the syringe from the Bio-Set, gently rotate the bottle until the powder is completely dissolved (about 1 minute). The ready-to-use solution should be colorless (or with a slight yellowish tinge) and transparent, free of mechanical impurities. Do not shake the bottle as foam formation is possible;
Press the syringe plunger all the way down to remove air;
Turn the vial and syringe vertically by 180 º and slowly pull the plunger to draw the solution into the syringe;
Without removing the cap from the needle, open its individual packaging;
Holding the syringe by the base and not touching its cannula, separate the syringe from the Bio-Set by turning it counterclockwise;
Turning the needle clockwise, insert it onto the filled syringe;
Place the syringe on a flat surface.

Rules for the introduction of a solution for injection prepared from a lyophilisate:

Treat the injection site with a cotton swab moistened with alcohol;
Remove the protective cap from the needle (not rotating, but pulling);
Turn the syringe with the needle up;
Remove air: knock on the base of the syringe so that the air bubbles rise up, then gently push the plunger until a small drop of liquid appears at the end of the needle;
Inject a needle into the muscle and slowly inject the drug;
Remove the syringe with the needle;
If blood appears at the injection site, seal it with a plaster.

Important information:

To prepare the solution, you can use only the solvent included in the kit with the lyophilisate;
When attaching the syringe to the device, no further action should be taken until a click is heard;
Do not inject the solvent too quickly, as the formation of foam is possible, which will complicate the collection of the drug into the syringe.

Each Avonex vial is designed for one injection. The remaining drug is not subject to further use.

Side effects

The most common side effect of the drug is flu-like syndrome, which is manifested by the following symptoms: fever, fatigue, chills, weakness, headache, muscle pain, nausea (usually manifested at the beginning of treatment and disappears with continued use). Less often, spastic phenomena and transient muscle weakness occur, up to reversible paralysis of the limbs (these manifestations can pass and appear again, usually of short duration).

During any period of treatment, neurological symptoms similar to an exacerbation of multiple sclerosis may occur: muscle weakness and / or episodes of muscle spasms that restrict voluntary movements (these episodes usually appear after injections of the drug, in some cases are accompanied by flu-like symptoms).

The following side effects are less common:

From the central and peripheral nervous system: headache, anxiety, decreased sensitivity, insomnia, dizziness, paresthesia; rarely - migraine, depression, confusion, epileptic seizures, emotional lability, psychosis, suicidal thoughts;
From the side of the cardiovascular system: arrhythmia, tachycardia, vasodilation, feeling of heat, heart failure, cardiomyopathy;
From the hematopoietic system: rarely - a decrease in hematocrit, neutropenia, lymphocytopenia, leukopenia, thrombocytopenia, pancytopenia;
From the respiratory system: rhinorrhea, shortness of breath, dyspnea;
On the part of the musculoskeletal system: pain in the limbs, myalgia, muscle spasms, arthralgia, muscle stiffness, pain in the neck and back, transient increase or decrease in muscle tone at the beginning of treatment;
From the endocrine system: hypo- or hyperthyroidism;
From the reproductive system: metrorrhagia, menorrhagia;
From the digestive system: liver dysfunctions, diarrhea, nausea, vomiting, loss of appetite;
Dermatological and allergic reactions: increased sweating, itching, rash, alopecia, urticaria, exacerbation of psoriasis, anaphylactic reactions, anaphylactic shock;
Others: change in body weight, increased sweating at night, chest pain, hyperkalemia, systemic lupus erythematosus, transient increase in serum urea;
Local reactions: burning sensation, pain, inflammation, hyperemia, abscess at the injection site.

special instructions

When prescribing Avonex, patients should be warned about the need for immediate medical attention in case of signs of depression or suicidal thoughts.

In addition to the usual laboratory tests, which are carried out for multiple sclerosis, during treatment, it is necessary to carry out a biochemical blood test (including checking the activity of liver enzymes), determine the leukocyte formula, monitor the picture of peripheral blood with the counting of corpuscles (including platelets). If symptoms of myelodepression appear, a more thorough blood test may be required.

During the period of treatment with Avonex, interferon-neutralizing antibodies may appear in the blood serum, which reduce the activity of interferon beta-la and, as a result, the effectiveness of the drug. According to available data, after 12 months of therapy, antibodies to interferon beta-1a appear in the serum in about 8% of patients.

Interferon beta-1a can have a negative impact on the speed of reactions and the ability to concentrate.

In the case of pregnancy in women with a high relapse rate of MS, the physician should compare the ratio of the risk of severe relapse due to discontinuation of Avonex and the increased likelihood of spontaneous termination of pregnancy while continuing to take it.

Drug interactions

Special studies on the interaction of Avonex with other drugs / drugs have not been conducted. According to clinical data, in patients with MS during an exacerbation, interferon beta-1a can be used concomitantly with glucocorticosteroids or adrenocorticotropic hormone.

It has been established that interferons can reduce the activity of enzymes of the cytochrome P _{450 system}, therefore, with caution, drugs should be used simultaneously with Avonex, the clearance of which largely depends on this system, for example, antidepressants and antiepileptic drugs.

Analogs

The analogues of Avonex are: SinoVex, Genfaxon, Rebif.

Terms and conditions of storage

Keep out of reach of children, protected from light at a temperature: lyophilisate - no more than 25 ºС, solution - 2-8 ºС (do not freeze). The solution may be stored at a temperature of 15-30 ºС, but not more than 1 week.

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!