Instruction for use: Remicade

Dosage form: Lyophilizate for the preparation of a solution for infusions

Active substance: Infliximabum

ATX

L04AB02 Infliximab

Pharmacological group:

Immunodepressants

The nosological classification (ICD-10)

K50.9 Crohn's disease, unspecified: Granuloma of intestine; Granulomatous colitis; Granulomatous enteritis; Protocollitis of Crohn; Regional ileitis; Regional enteritis; Terminal Ileitis

M06.9 Rheumatoid arthritis, unspecified: Rheumatoid arthritis; Pain syndrome in rheumatic diseases; Pain in rheumatoid arthritis; Inflammation in rheumatoid arthritis; Degenerative forms of rheumatoid arthritis; Children's rheumatoid arthritis; Exacerbation of rheumatoid arthritis; Acute articular rheumatism; Rheumatic arthritis; Rheumatic polyarthritis; Rheumatoid arthritis; Rheumatic polyarthritis; Rheumatoid arthritis; Rheumatoid arthritis; Rheumatoid arthritis of active course; Rheumatoid periarthritis; Rheumatoid polyarthritis; Acute rheumatoid arthritis; Acute rheumatism

Composition and release form

Powder lyophilized for the preparation of a solution for intravenous administration 1 fl.

Infliximab 100 mg

Auxiliary substances: sucrose; Polysorbate 80; Sodium phosphate monobasic; Sodium phosphate dibasic

In the box 1 glass bottle.

Description of dosage form

White dense mass without signs of reflow and foreign particles.

Pharmachologic effect

Mode of action - immunosuppressive.

Interacts with soluble and transmembrane forms of human tumor necrosis factor alpha (a cytokine of broad biological effect) and reduces its functional activity, due to the formation of a stable complex.

Indication of the drug Remicade

Rheumatoid arthritis (active form), Crohn's disease (active form).

Contraindications

Hypersensitivity (including other mouse proteins), sepsis, a clinically expressed infectious disease or abscess, pregnancy, breast-feeding.

Application in pregnancy and breastfeeding

Contraindicated. At the time of treatment should stop breastfeeding.

Side effects

From the nervous system and sensory organs: depression, psychosis, anxiety, amnesia, apathy, nervousness, drowsiness, headache, dizziness; Conjunctivitis, keratoconjunctivitis, and endophthalmitis.

From the cardiovascular system and blood (hematopoiesis, hemostasis): tides, petechiae, ecchymosis / hematoma, hyper / hypotension, fainting, thrombophlebitis, bradycardia, palpitation, vasospasm, cyanosis, peripheral circulation, arrhythmia; Anemia, leuko-, lympho-, neutro-, thrombocytopenia, lymphocytosis, lymphadenopathy.

On the part of the respiratory system: infections of the upper respiratory tract, bronchitis, pneumonia, dyspnea, sinusitis, epistaxis, bronchospasm and other allergic manifestations, pleurisy, pulmonary edema.

On the part of the intestine: cheilitis, dyspepsia, gastroesophageal reflux, nausea, diarrhea or constipation, abdominal pain, diverticulitis, cholecystitis, impaired liver function.

From the genitourinary system: edema, urinary tract infection, incl. Pyelonephritis; Vaginitis.

From the skin: rash, itching, urticaria, sweating, dry skin, fungal dermatitis (onychomycosis, eczema), seborrhea, erysipelas, warts, furunculosis, hyperkeratosis, skin pigmentation disorder, alopecia, bullous rash.

Other: myalgia, arthralgia; Periorbital edema, formation of autoantibodies, lupus syndrome; Development of infections (influenza, herpes, fever, abscess, cellulitis, sepsis, bacterial and fungal diseases); Infusion and pain syndrome (chest pain); Reaction at the site of administration and other allergic reactions.

Interaction

Methotrexate reduces the formation of antibodies to the drug and increases its concentration.

Dosing and Administration

IV, drop, for at least 2 hours, at a rate of no more than 2 ml / min, using an infusion system with an internal sterile pyrogen-free filter with low protein-binding activity.

Treatment of rheumatoid arthritis: the initial single dose is 3 mg / kg, then repeated in the same dose 2 and 6 weeks after the first injection and then every 8 weeks. In the absence of effect after 12 weeks of treatment should consider whether to continue therapy. Treatment with Remicade® should be carried out simultaneously with the use of methotrexate.

Treatment for severe active Crohn's disease: 5 mg / kg once. If there is no effect for 2 weeks after the first administration, the repeated administration of Remicade® is not advisable. For patients who responded to the first administration of Remicade®, treatment can be continued, and one of two possible options for treatment strategy should be selected:

- The drug is administered in the same dose after 2 weeks and 6 weeks after the first injection, and then every 8 weeks;

- The drug is administered at the same dose only if the disease recurs, provided that after the first administration no more than 16 weeks have elapsed (due to an increased risk of developing delayed-type allergic reactions).

Treatment of Crohn's disease with fistula: Remicade® is administered in a single dose of 5 mg / kg, again in the same dose - at 2 and 6 weeks after the first injection. In the absence of effect after the administration of these 3 doses, the continuation of Remicade® treatment is not advisable. If there is an effect, treatment can be continued, and one of two possible options for treatment strategy should be chosen:

- The drug is administered in the same dose after 2 weeks and 6 weeks after the first injection, and then every 8 weeks;

- The drug is administered repeatedly - at the same dose for a relapse of the disease, provided that after the first administration no more than 16 weeks have elapsed (due to an increased risk of developing delayed-type allergic reactions).

Comparative studies of these 2 treatment options for Crohn's disease have not been conducted. The available data on the use of the drug in the second variant of the treatment strategy - repeated administration in case of relapse - are limited.

Ankylosing spondylitis (treatment): the initial dose of Remicade® is 5 mg / kg. The drug is administered again in the same dose at 2 and 6 weeks after the first injection, and then every 6-8 weeks. In the absence of effect for 6 weeks (after the introduction of 2 doses) continue treatment is not recommended.

Psoriatic arthritis (treatment): the initial dose of Remicade® is 5 mg / kg. The drug is administered again in the same dose at 2 and 6 weeks after the first injection, and then every 6-8 weeks. Treatment is carried out in combination with methotrexate.

Re-administration of Remicade® in rheumatoid arthritis and Crohn's disease: in case of recurrence of the disease, Remicade® can be reassigned within 16 weeks after the last dose. Repeated use of the drug 2-4 years after the introduction of the last dose in a significant percentage of patients is accompanied by the development of allergic reactions of a delayed type. The risk of developing these reactions in the interval 16 weeks - 2 years is unknown, therefore, repeated treatment with an interval of more than 16 weeks is not recommended.

Re-appointment Remicade® with ankylosing spondylitis: the effectiveness and safety of the drug when it is repeated, with an interval of more than 6-8 weeks has not yet been studied.

Re-appointment Remicade® in psoriatic arthritis: the effectiveness and safety of the drug when it is repeated, with an interval of more than or less than 8 weeks to date, have not been established.

Precautionary measures

Before the start of treatment, it is necessary to cure manifest infections and abscesses. With the development of severe infection or sepsis, therapy should be discontinued. During treatment it is necessary to use reliable methods of contraception. It is recommended to use antihistamines and paracetamol for prophylaxis (premedication) or relief of allergic reactions. It should be refrained from using the drug in children and adolescents under the age of 17, since safety and effectiveness of its use in children are not defined.

Special instructions

First, the contents of each vial are dissolved in 10 ml of water for injection using a syringe with a needle of 0.8 mm or less, then the prepared solution is adjusted to 250 ml with a 0.9% solution of sodium chloride for injection (should be administered no later than 3 hours after preparation ). Infusion solution is not compatible (should not be mixed) with other drugs.

Manufacturer

Centokor BV, The Netherlands.

Storage conditions of the drug Remicade

At 2-8 ° C (do not freeze).

Keep out of the reach of children.

Shelf life of the drug Remicade

3 years.

Do not use after the expiry date printed on the package.