Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Enbrel

Enbrel 25 mg solution for injection in dose-dispenser cartridge Enbrel 50 mg solution for injection in dose-dispenser cartridge · Abschnitt 4.5 · PDF-Seite 155

HOS-090502 · Präparat HOS-084041

In clinical trials, no interactions have been observed when Enbrel was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate. See section 4.4 for vaccination advice.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): sulfasalazine (HOS-089673) methotrexate (HOS-087522)

Wechselwirkungen · Enbrel

Enbrel 25 mg solution for injection in dose-dispenser cartridge Enbrel 50 mg solution for injection in dose-dispenser cartridge · Abschnitt 4.5 · PDF-Seite 155

HOS-090503 · Präparat HOS-084041

No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): digoxin (HOS-086172) warfarin (HOS-085950) methotrexate (HOS-087522)

Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 11

HOS-090252 · Präparat HOS-084041

Summary of the safety profile

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 11

HOS-090253 · Präparat HOS-084041

The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), headache, allergic reactions, development of autoantibodies, itching, and fever.

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 11

HOS-090254 · Präparat HOS-084041

Serious adverse reactions have also been reported for Enbrel. TNF-antagonists, such as Enbrel, affect the immune system and their use may affect the body’s defenses against infection and cancer. Serious infections affect fewer than 1 in 100 patients treated with Enbrel. Reports have included fatal and life-threatening infections and sepsis. Various malignancies have also been reported with use of Enbrel, including cancers of the breast, lung, skin and lymph glands (lymphoma).

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 11

HOS-090255 · Präparat HOS-084041

Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with Enbrel use. There have been rare reports of lupus, lupus-related conditions, and vasculitis.

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 11

HOS-090256 · Präparat HOS-084041

Tabulated list of adverse reactions

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 11

HOS-090257 · Präparat HOS-084041

The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience.

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 11

HOS-090258 · Präparat HOS-084041

Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 11

HOS-090259 · Präparat HOS-084041

System Organ Very Common Uncommon Rare Very Not Known Class Common ≥ 1/100 to ≥ 1/1,000 to ≥ 1/10,000 to Rare (Cannot be ≥ 1/10 < 1/10 < 1/100 < 1/1,000 < 1/10,000 Estimated from Available Data) Infections and Infection Serious infections Tuberculosis, Hepatitis B infestations (including (including opportunistic reactivation, listeria upper pneumonia, infection (including respiratory cellulitis, arthritis invasive fungal, tract bacterial, sepsis protozoal, bacterial, infection, and parasitic atypical bronchitis, infection)* mycobacterial, viral cystitis, infections, and skin Legionella)* infection)* Neoplasms Non-melanoma Malignant Merkel cell benign, skin cancers* (see melanoma (see carcinoma (see malignant and section 4.4) section 4.4),

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 11–12

HOS-090260 · Präparat HOS-084041

11 System Organ Very Common Uncommon Rare Very Not Known Class Common ≥ 1/100 to ≥ 1/1,000 to ≥ 1/10,000 to Rare (Cannot be ≥ 1/10 < 1/10 < 1/100 < 1/1,000 < 1/10,000 Estimated from Available Data) unspecified lymphoma, section 4.4), (including cysts leukaemia Kaposi’s sarcoma and polyps) Blood and Thrombocytopenia, Pancytopenia* Aplastic Histiocytosis lymphatic anaemia, anaemia* haematophagic system leukopenia, (macrophage disorders neutropenia activation syndrome)* Immune system Allergic Vasculitis Serious Worsening of disorders reactions (including anti- allergic/anaphylactic symptoms of (see Skin and neutrophilic reactions (including dermatomyositis subcutaneous cytoplasmic angioedema, tissue antibody positive bronchospasm), disorders), vasculitis) sarcoidosis autoantibody formation* Nervous system Headache CNS demyelinating disorders events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure Eye disorders Uveitis, scleritis Cardiac Worsening of New onset cardiac disorders cardiac failure failure congestive congestive (see (see section 4.4) section 4.4) Respiratory, Interstitial lung thoracic, and disease (including mediastinal pneumonitis and disorders pulmonary fibrosis)* Gastrointestinal Inflammatory disorders bowel disease Hepatobiliary Elevated liver Autoimmune disorders enzymes* hepatitis* Skin and Pruritus, rash Angioedema, Stevens-Johnson Toxic subcutaneous psoriasis (including syndrome, epidermal tissue disorders new onset or cutaneous vasculitis necrolysis worsening and (including pustular, primarily hypersensitivity palms and soles), vasculitis), erythema urticaria, multiforme, psoriasiform rash lichenoid reactions Musculoskeletal Cutaneous lupus and connective erythematosus, tissue disorders subacute cutaneous lupus

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 12–13

HOS-090261 · Präparat HOS-084041

12 System Organ Very Common Uncommon Rare Very Not Known Class Common ≥ 1/100 to ≥ 1/1,000 to ≥ 1/10,000 to Rare (Cannot be ≥ 1/10 < 1/10 < 1/100 < 1/1,000 < 1/10,000 Estimated from Available Data) erythematosus, lupus-like syndrome Renal and Glomerulonephritis urinary disorders General Injection Pyrexia disorders and site administration reactions site conditions (including bleeding, bruising, erythema, itching, pain, swelling)* *see Description of selected adverse reactions, below.

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 13

HOS-090262 · Präparat HOS-084041

Description of selected adverse reactions

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 13

HOS-090263 · Präparat HOS-084041

Malignancies and lymphoproliferative disorders One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with Enbrel for up to approximately 6 years, including 231 patients treated with Enbrel in combination with methotrexate in the 2-year active-controlled study. The observed rates and incidences in these clinical trials were similar to those expected for the population studied. A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 Enbrel-treated psoriatic arthritis patients. In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-treated patients. In a group of 2,711 plaque psoriasis patients treated with Enbrel in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported.

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 13

HOS-090264 · Präparat HOS-084041

In a group of 7,416 patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.

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Nebenwirkungen · Enbrel

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HOS-090265 · Präparat HOS-084041

Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the postmarketing period (see section 4.4).

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 13

HOS-090266 · Präparat HOS-084041

Injection site reactions Compared to placebo, patients with rheumatic diseases treated with Enbrel had a significantly higher incidence of injection site reactions (36% vs. 9%). Injection site reactions usually occurred in the first month. Mean duration was approximately 3 to 5 days. No treatment was given for the majority of injection site reactions in the Enbrel treatment groups, and the majority of patients who were given treatment received topical preparations, such as corticosteroids, or oral antihistamines. Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of injection, along with the simultaneous appearance of injection site reactions at previous injection sites. These reactions were generally transient and did not recur with treatment.

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 13

HOS-090267 · Präparat HOS-084041

In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with Enbrel developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment.

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 13

HOS-090268 · Präparat HOS-084041

Serious infections In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life-threatening, or requiring hospitalisation or intravenous antibiotics) was observed. Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with Enbrel for up to 48 months. These included abscess (at

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Nebenwirkungen · Enbrel

Enbrel 25 mg powder for solution for injection · Abschnitt 4.8 · PDF-Seite 13–14

HOS-090269 · Präparat HOS-084041

13 various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection. In the 2-year active-controlled study where patients were treated with either Enbrel alone, methotrexate alone or Enbrel in combination with methotrexate, the rates of serious infections were similar among the treatment groups. However, it cannot be excluded that the combination of Enbrel with methotrexate could be associated with an increase in the rate of infections.

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