etanertsept | Enbrel lyophilisate for solution for p / leather. enter bottle of 25 mg 4 pcs.

release form

Lyophilisate for preparation of solution for SC injection in the form of a white powder or porous .

Packaging

In the package there are 4 bottles complete with solvent, syringes, d / and needles and napkins.

Indications

- Treatment of moderate or severe active rheumatoid arthritis (in combination with methotrexate or as monotherapy).

- Treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

- To reduce symptoms and slow the progression of structural damage in active arthritis and improve function in patients with psoriatic arthritis.

- To reduce symptoms in patients with active ankylosing spondylitis.

- For the treatment of adult patients (18 years of age and older) with chronic moderate or severe psoriasis (with plaques) who are indicated for systemic therapy or phototherapy.

Contraindications

Sepsis or conditions with an increased risk of developing severe active infections, including chronic or localized infections, simultaneous use with interleukin 1 inhibitors (including anakinra) pregnancy and lactation, children under 3 years of age, increased sensitivity to etanercept.

Caution is advised to prescribe a drug for demyelinating diseases, congestive heart failure, conditions of immunodeficiency, blood dysrasia, diseases predisposing to the development or activation of infections (diabetes mellitus, hepatitis).

Use during pregnancy and lactation

Pregnant women are not recommended therapy with Enbrel, because there is no experience in the use of this drug in this category of patients.

Women of childbearing age should not plan a pregnancy during treatment with Enbrel.

Unknown whether etanercept can be excreted in breast milk. Since immunoglobulins, like many other drugs, can be excreted in human milk, you should either stop breastfeeding, or stop taking Enbrel during breastfeeding.

Composition

1 vial contains: etanercept 25 mg.

Excipients: mannitol, sucrose, trometamol, trometamol hydrochloride (up to pH).

Solvent: benzyl alcohol, water d / i (up to 1 ml).

Dosage and administration of

Enbrel is administered sc. A single dose for adults is 50 mg, for children aged 8 to 17 years - 800 mcg / kg (but not more than 50 mg per week). For children 4 years of age and older, the dose is determined based on 400 mcg / kg body weight (maximum single dose 25 mg). The drug is administered 2 times a week at intervals of 3-4 days between doses.

The frequency of administration and the duration of use depend on the indications and tolerance of treatment.

Treatment should be prescribed and monitored by a physician experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic polyarthritis, psoriatic arthritis, ankylosing spondylitis, or psoriasis.

Side effects

Infections: possibly upper respiratory tract infections. In the treatment of rheumatoid arthritis - pyelonephritis, bronchitis, septic arthritis, abdominal abscess, cellulitis, osteomyelitis, wound infection, pneumonia, foot abscess, ulcer on the lower extremities, diarrhea, sinusitis, sepsis infections were caused by viruses, bacteria, fungi, protozoa. In the treatment of psoriasis - cellulitis, gastroenteritis, pneumonia, osteomyelitis. In some cases, pulmonary and extrapulmonary tuberculosis.

From the side of the central nervous system and peripheral nervous system: headache, dizziness, cerebral ischemia, depression, multiple sclerosis.

From the digestive system: abdominal pain, dyspepsia, vomiting, cholecystitis, pancreatitis, gastrointestinal bleeding, appendicitis.

From the respiratory system: pharyngitis, cough, sinusitis.

From the musculoskeletal system: bursitis, polymositis.

Dermatological reactions: rash, worsening of psoriasis.

From the cardiovascular system: heart failure, myocardial infarction, myocardial ischemia, arterial hypertension, arterial hypotension, deep vein thrombosis, thrombophlebitis.

From the urinary system: membranous glomerulonephropathy, kidney stones.

Local reactions: pain, swelling, redness.

Other: asthenia, peripheral edema, lymphadenopathy. The risk of malignancy cannot be ruled out: cases of development of lymphoma, colon cancer, breast, lung, prostate cancer, percutaneous solid cancer, skin cancer (non-melanomatous) are described. Sometimes the formation of autoimmune antibodies was observed that did not possess neutralizing properties.

Drug Interaction

In adult patients, a significant increase in the incidence of serious infections and neutropenia was observed in combination patients with Enbrel and anakinra compared to patients enrolled only with Enbrel. Co-administration of Enbrel and anakinra showed no clinical benefit and is therefore not recommended.

The simultaneous administration of abatacept and Enbrel was accompanied by an increase in the incidence of serious adverse events. This combination of drugs did not demonstrate clinical benefits and, therefore, not recommended.

Significant reductions in mean leukocyte counts have been reported in patients treated with sulfasalazine as compared to those treated with only Enbrel or only sulfasalazine.

No adverse interactions were observed when Enbrel was co-administered with GCS, salicylates (except sulfasalazine), NSAIDs, analgesics.

Methotrexate has no effect on the pharmacokinetics of etanercept. The effect of Enbrel on the pharmacokinetics of methotrexate in humans has not been studied.

No clinically relevant interactions were observed for pharmacokinetics with digoxin and Enbrel.

No clinically relevant interactions were observed for pharmacokinetics with warfarin and Enbrel.

Live vaccines should not be given against Enbrel treatment. There is no evidence of secondary transmission of live vaccine to patients receiving Enbrel. It is recommended that patients be given all vaccinations, in accordance with the current national vaccination calendar, prior to initiating Enbrel treatment.

Overdose

No excess toxic limit has been reported in patients with rheumatoid arthritis. The highest dose administered in / in was 32 mg / m2 followed by administration of 16 mg / m2 2 times a week. One patient with rheumatoid arthritis mistakenly self-administered 62 mg of Enbrel 2 times a week for 3 weeks without any adverse effects. The specific antidote for Enbrel is unknown.

Storage conditions

At 2–8 РC (do not freeze).

Expiration

3 years.

Deystvuyuschee substances

Эtanertsept

Dosage form

dosage form

solution for injection