Axoglatiran FS - Instructions For Use, Indications, Doses, Analogues

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

Axoglatiran FS

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Axoglatiran FS is an immunomodulatory drug.

Release form and composition

Dosage form - solution for subcutaneous (s / c) administration: slightly opalescent or transparent, colorless or with a yellowish tinge liquid (1 ml each in glass sterile single-use syringes with a glued-in needle, inserted plunger and a protective cap in a blister strip, in a cardboard pack 1 pack, 28 or 30 packs in a cardboard box).

The active ingredient of Axoglatiran FS is glatiramer acetate, in 1 ml of solution - 20 mg.

Auxiliary components: D-mannitol, water for injection.

Indications for use

• Clinically isolated syndrome with a pronounced inflammatory process, requiring intravenous administration of glucocorticosteroids (to slow the development of clinically significant multiple sclerosis);
• Recurrent-remitting multiple sclerosis (to slow down the processes of disabling complications and reduce the frequency of exacerbations).

Contraindications

• Age under 18;
• Pregnancy period;
• Hypersensitivity to drug components.

Care should be taken to prescribe the drug to patients with a predisposition to allergic reactions, with cardiovascular diseases, impaired renal function, during breastfeeding (it is necessary to compare the expected effect of therapy for the mother and the potential threat to the child).

Method of administration and dosage

Axoglatiran FS solution is intended for s / c administration.

The syringe should be removed from the refrigerator 20 minutes before the injection to bring it back to room temperature.

The drug is administered in compliance with the rules of asepsis and antiseptics, changing the place for each next injection of the drug. Subcutaneous injections should be performed in places where there is minimal risk of damage to nerves and blood vessels, with light capture of the skin in a fold (these include the abdomen (about 5 cm around the navel), the outer surface of the shoulder, the front surface of the thigh, buttocks).

Recommended dosing regimen: 1 ml (20 mg of the drug) 1 time per day, preferably at the same time, every day. The doctor prescribes the course of application individually, the treatment is usually long.

Do not use the solution if it contains suspended particles or changes in color.

In case of an accidental delay in the introduction of the next dose, the injection should be given as soon as it is remembered, but this should not be the simultaneous introduction of a double dose.

Side effects

• Immune system: hypersensitivity reaction, anaphylactoid reaction, angioedema;
• Nervous system: nervousness, headache, depression, anxiety, euphoria, psychosis, pathological dreams, hallucinations, mania, fainting, hostility, personality disorder, taste perversion, suicidal behavior, cognitive disorders, migraine, tunnel syndrome, tremors, seizures, dyslexia, dysgraphia, myoclonus, impaired motor functions, neuromuscular blockade, neuritis, paralysis (including the peroneal nerve), stupor;
• Lymphatic system and circulatory system: leukocytosis, lymphadenopathy, leukopenia, thrombocytopenia, changes in the structure of lymphocytes, splenomegaly;
• Endocrine system: hyperthyroidism;
• Cardiovascular system: palpitations, increased blood pressure, tachycardia, sinus bradycardia, extrasystole, paroxysmal tachycardia, varicose veins;
• Metabolism: weight gain, anorexia, gout, alcohol intolerance, hypernatremia, hyperlipidemia, decreased serum ferritin levels;
• Respiratory system: cough, seasonal rhinitis, shortness of breath, apnea, laryngospasm, pulmonary hyperventilation;
• Organ of vision: dryness of the sclera and cornea, visual field defect, diplopia, impaired eye movement, corneal damage, eyelid ptosis, subconjunctival hemorrhage, mydriasis, optic nerve atrophy, nystagmus, visual impairment, cataract;
• Hearing and balance organ: hearing impairment, headache;
• Digestive tract: tongue edema, nausea, vomiting, enlarged salivary glands, belching, constipation, caries, dyspepsia, odontogenic periostitis, dysphagia, colitis, enterocolitis, esophageal ulcer, anorectal disorders, colon polyposis, rectal bleeding;
• Hepatobiliary system: hepatomegaly, cholelithiasis;
• Musculoskeletal system: pain in the cervical spine, arthralgia, back pain, bursitis, arthritis, flank pain, osteoarthritis, muscle atrophy;
• Breasts and genitals: enlargement of the mammary glands, amenorrhea, erectile dysfunction, violation of laboratory tests of smears from the cervical canal, prolapse of the pelvic organs, vulvovaginal disorders, menstrual cycle failure;
• Urinary system: pollakiuria, urge to urinate, urinary retention, nephrolithiasis, hematuria;
• Dermatological reactions: skin rash, itching, hyperhidrosis, ecchymosis, urticaria, erythema nodosum, contact dermatitis, skin nodules;
• Infections: bronchitis, otitis media, gastroenteritis, vaginal candidiasis, rhinitis, pyelonephritis, inflammation of the subcutaneous fat, herpes zoster, furunculosis, exacerbation of diseases caused by herpes simplex;
• Local reactions: after injections - pain, redness, hematoma, edema, lipoatrophy, abscess, skin necrosis;
• Others: fatigue, fever, chills, asthenia, nosebleeds, hangover, peripheral edema.

In addition, the patient may occasionally experience symptoms of systemic reactions in the form of chest pain, flushing, shortness of breath, palpitations, anxiety, hives, difficulty swallowing.

Usually, the use of Axoglatiran FS is well tolerated by patients, the listed side effects are found in some cases.

special instructions

It is necessary to start using Axoglatiran FS under the supervision of a neurologist and a specialist in the treatment of multiple sclerosis.

When prescribing the drug, the patient should be informed about the possible occurrence of systemic side reactions and undesirable effects from direct injection.

In the event of severe adverse reactions, therapy should be discontinued immediately and medical attention should be sought, since the use of symptomatic therapy should be prescribed by a doctor.

The onset of chest pain after injection is usually short-lived, transient and goes away on its own.

To prevent the development of local reactions (lipoatrophy, skin necrosis), the patient must strictly observe the sequence of injection sites, changing them daily.

Patients with functional kidney disorders or pathologies of the cardiovascular system should be monitored regularly by a physician.

Patients of childbearing age should use reliable methods of contraception while taking glatiramer acetate.

Treatment with the drug requires periodic monitoring of the state of the immune system.

The immunomodulatory agent does not affect the patient's ability to control complex mechanisms and vehicles.

Drug interactions

Clinically significant interaction of Axoglatiran FS with simultaneous use with other drugs has not been established.

Analogs

Analogs of Axoglatiran FS are: Glatirat, Copaxone 40, Copaxon-Teva, Timekson.

Terms and conditions of storage

Keep out of the reach of children.

Store in a dark place at temperatures up to 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!