Авонекс

Авонекс – interferon, drug for treatment of multiple sclerosis.

Form of release and structure

• Lyophilisate for preparation of solution for intramuscular introduction: the mass of almost white or white color (in the glass bottles closed by brombutilovy traffic jams and the Bio-Set device, 1 bottle and solvent (the glass syringe) in the soldered plastic tray, in a pack cardboard 4 trays);
• Solution for intramuscular introduction: transparent, colourless (on 0,5 ml in the glass syringes closed by brombutilovy caps, Luer Lock devices and a polypropylene stopper plunger with a capacity of 1 ml, 1 syringe with a needle in the soldered plastic tray, in a pack cardboard 4 trays).

Active agent: interferon beta 1а, its contents in 1 bottle of lyophilisate and 1 syringe with solution makes 30 mkg (6 million international units).

Auxiliary components of lyophilisate: albumine human serumal, sodium hydrophosphate, sodium dihydrophosphate and sodium chloride.

Composition of solvent: water for injections.

Solution excipients: water for injections, arginine a hydrochloride, sodium acetate trihydrate, polysorbate 20, glacial acetic acid.

Indications to use

• Recurrent multiple sclerosis in case of at least two aggravations within the previous 3 years in the absence of signs of progressing of a disease between a recurrence (for delay of progressing of functional disturbances and decrease in frequency of a recurrence);
• Clinically isolated demyelination case in the presence of the active inflammatory process which demanded intravenous administration of glucocorticosteroids if others are excluded, than multiple sclerosis, states and is available high risk of its development.

Contraindications

Absolute:

• Epilepsy steady against therapy;
• The expressed depression;
• Emergence of suicide thoughts;
• Period of pregnancy and lactation;
• Age up to 18 years – for solution, up to 16 years – for lyophilisate;
• Hypersensitivity to natural or recombinant interferon a beta, to auxiliary components of drug or seralbumin of the person.

With care:

• Heavy renal/liver failure;
• The expressed oppression of a marrowy hemopoiesis;
• Convulsive attacks in the anamnesis;
• Depressive frustration;
• Heart diseases (arrhythmia, stenocardia, congestive heart failure, the postponed myocardial infarction).

Route of administration and dosage

Авонекс it is intended for intramuscular introduction. Treatment is carried out under control of the doctor which has experience of treatment of the multiple sclerosis (MS).

The recommended dose makes 30 mkg once a week. The injection whenever possible should make at the same time on the same day weeks. The place of an injection needs to be changed every week.

From lyophilisate prepare solution for intramuscular introduction just before an injection.

For reduction of frequency of development and weight of grippopodobny symptoms at an initial stage of therapy titration of a dose can be carried out: treatment is begun about ¼ doses and every week it is increased on ¼ until the full dose is reached (by fourth week).

Avoneks's introduction according to the alternative scheme is possible: treatment is begun about ½ doses once a week, then it is raised to a full dose.

To reduce expressiveness of grippopodobny reaction, before an injection and within 24 hours after each introduction it is recommended to accept a febrifugal analgetic.

Duration of treatment is defined individually. 2 years later after the beginning of therapy of the patient direct to clinical inspection and assessment of the neurologic status on the basis of which results the doctor will make the decision on need of continuation of a course. In case of development of the chronic progressing RS drug should be cancelled.

Rules of use of solution for injections:

• Before introduction it is necessary to extract drug from the refrigerator and to leave it at the room temperature (15-30 ºС) approximately for 30 minutes;
• It is impossible to use external sources, including hot water for solution warming;
• Not to use drug if it contains solid impurity, or is not transparent and colourless;
• Each syringe is expected one injection. The unused amount of solution should be utilized.

Rules of preparation of solution for injections from lyophilisate:

• To check integrity of a bottle and the Bio-Set device (if it is broken, drug is forbidden to be used);
• Having taken for foundation of Bio-Set, to turn a cap and to remove it, without touching a connecting opening;
• From the syringe with solvent to remove a cap (to pull together), without touching a tip and without pressing the piston;
• To put a bottle vertically on a smooth surface, to combine with a syringe tip. To screw clockwise a syringe cannula in Bio-Set. Holding the syringe for the basis and following the direction of the movement, sharply its tax down that the tip completely disappeared and the click sounded;
• Slowly pressing on the syringe piston, to enter solvent into a bottle;
• Without separating the syringe with Bio-Set, to carefully rotate a bottle until powder completely is dissolved (about 1 minute). Solution, ready to use, has to be colourless (or with a subtle yellowish shade) and transparent, not to have mechanical impurity. It is not necessary to stir up a bottle since foaming is possible;
• To press on the syringe piston down to an emphasis to remove air;
• To turn a bottle and the syringe vertically on 180 º and to pull slowly for the piston to gather solution in the syringe;
• Without removing a cap from a needle, to open its individual packaging;
• Holding the syringe for the basis and not concerning its cannula, to separate the syringe from the Bio-Set device turn counterclockwise;
• Turning a needle clockwise, to get it on the filled syringe;
• To put the syringe on a plain surface.

Rules of administration of the solution for injections prepared from lyophilisate:

• To process the place of an injection the cotton plug moistened in alcohol;
• To remove a protective cap from a needle (without rotating, and pulling together);
• To turn the syringe a needle up;
• To remove air: to knock on the syringe basis that vials of air rose up, then to press slightly the piston until on the end of a needle the small droplet of liquid appears;
• To stick a needle in a muscle and to slowly administer the drug;
• To remove the syringe with a needle;
• In case of blood in the place of an injection to stick it with a plaster.

Important information:

• For preparation of solution it is possible to use only the solvent which is included in the package with lyophilisate;
• At connection of the syringe to the device it is impossible to take further actions, the click will not sound yet;
• It is not necessary to enter solvent too quickly since possibly foaming which will complicate a set of drug in the syringe.

Each bottle of Avoneks is intended for one injection. The remained drug is not subject to further use.

Side effects

The most frequent side effect of drug is the grippopodobny syndrome which is shown the following symptoms: fever, feeling of fatigue, a fever, weakness, a headache, muscular pains, nausea (are usually shown in an initiation of treatment and pass in process of use continuation). There are spastic phenomena and passing muscular weakness, up to reversible paralysis of extremities less often (these manifestations can pass and appear again, are usually short).

During any period of treatment there can be neurologic symptoms similar to an aggravation of a multiple sclerosis: the muscular weakness and/or episodes of muscular spasms limiting autokinesias (these episodes usually appear after drug injections, in certain cases are followed by grippopodobny symptoms).

The following side effects are less often observed:

• From the central and peripheral nervous system: headache, concern, decrease in sensitivity, sleeplessness, dizziness, paresthesias; seldom – migraine, a depression, confusion of consciousness, epileptopodobny attacks, emotional lability, psychosis, suicide thoughts;
• From cardiovascular system: arrhythmia, tachycardia, vazodilatation, feeling of heat, heart failure, cardiomyopathy;
• From system of a hemopoiesis: seldom – decrease in a hematocrit, a neutropenia, a lymphocytopenia, a leukopenia, thrombocytopenia, a pancytopenia;
• From respiratory system: rhinorrhea, asthma, диспноэ;
• From a musculoskeletal system: pain in extremities, a mialgiya, muscular spasms, an arthralgia, muscle tension, neck and spin pain, tranzitorny increase or decrease in a muscle tone in an initiation of treatment;
• From endocrine system: hypo - or a hyperthyroidism;
• From a reproductive system: metrorrhagias, menorrhagias;
• From the alimentary system: disturbances of functions of a liver, diarrhea, nausea, vomiting, appetite loss;
• Dermatological and allergic reactions: the strengthened sweating, an itch, rash, an alopecia, a small tortoiseshell, an exacerbation of psoriasis, anaphylactic reactions, an acute anaphylaxis;
• Others: change of body weight, sweating strengthening at night, a stethalgia, a hyperpotassemia, a system lupus erythematosus, tranzitorny increase in level of urea in blood serum;
• Local reactions: burning sensation, pain, an inflammation, a hyperemia, abscess in the place of an injection.

Special instructions

At Avoneks's appointment it is necessary to warn patients about need of the immediate address to the doctor in case of symptoms of a depression or suicide thoughts.

Except usual laboratory analyses which are carried out at multiple sclerosis during treatment it is necessary to carry out biochemical analysis of blood (including to check activity of enzymes of a liver), to define a leukocytic formula, to control a pattern of peripheral blood with calculation of uniform elements (including thrombocytes). In case of symptoms of a miyelodepressiya more careful blood analysis can be required.

During treatment by Avoneks in blood serum can appear interferon - the neutralized antibodies reducing activity of interferon of beta la and, as a result, efficiency of drug. According to the available data, 12 months of therapy of an antibody later to interferon beta 1а appear in serum approximately at 8% of patients.

Interferon beta 1а can exert a negative impact on the speed of reactions and ability to concentration of attention.

In case of pregnancy at women with high frequency of RS recurrence the doctor has to compare a ratio of risk of a heavy recurrence owing to Avoneks's cancellation and the increased probability of spontaneous abortion at continuation of its reception.

Medicinal interaction

Special researches on an occasion of interaction of Avoneks with other medicinal substances / drugs were not conducted. According to clinical data, patients with RS during an aggravation have beta interferon 1а it is possible to apply along with glucocorticosteroids or adrenocorticotropic hormone.

It is established that interferona can reduce activity of enzymes of system _{of P450 cytochrome} therefore with care along with Avoneks it is necessary to use drugs which clearance substantially depends on this system, for example, antidepressants and antiepileptic means.

Terms and storage conditions

To store in the unavailable to children, protected from light place at a temperature: lyophilisate – no more than 25 ºС, solution – 2-8 ºС (not to freeze). Solution is allowed to be stored at a temperature of 15-30 ºС, but no more than 1 week.

Period of validity – 2 years.