Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.3 · PDF-Seite 6

HOS-089873 · Präparat HOS-083941

Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.3 · PDF-Seite 6

HOS-089874 · Präparat HOS-083941

Patients with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.3 · PDF-Seite 6

HOS-089875 · Präparat HOS-083941

Patients with moderate or severe heart failure (NYHA class III/IV) (see sections 4.4 and 4.8).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.5 · PDF-Seite 12

HOS-089876 · Präparat HOS-083941

No interaction studies have been performed.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.5 · PDF-Seite 12–13

HOS-089877 · Präparat HOS-083941

12 In rheumatoid arthritis, psoriatic arthritis and Crohn's disease patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab. However, the results are uncertain due to limitations in the methods used for serum analyses of infliximab and antibodies against infliximab.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

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

Wechselwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.5 · PDF-Seite 13

HOS-089878 · Präparat HOS-083941

Corticosteroids do not appear to affect the pharmacokinetics of infliximab to a clinically relevant extent.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.5 · PDF-Seite 13

HOS-089879 · Präparat HOS-083941

The combination of Remicade with other biological therapeutics used to treat the same conditions as Remicade, including anakinra and abatacept, is not recommended (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): abatacept (HOS-089881) anakinra (HOS-089880)

Wechselwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.5 · PDF-Seite 13

HOS-089882 · Präparat HOS-083941

It is recommended that live vaccines not be given concurrently with Remicade. It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab for 12 months following birth. If infant infliximab serum levels are undetectable or infliximab administration was limited to the first trimester of pregnancy, administration of a live vaccine might be considered at an earlier timepoint if there is a clear clinical benefit for the individual infant (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.5 · PDF-Seite 13

HOS-089883 · Präparat HOS-083941

Administration of a live vaccine to a breastfed infant while the mother is receiving infliximab is not recommended unless infant infliximab serum levels are undetectable (see sections 4.4 and 4.6).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.5 · PDF-Seite 13

HOS-089884 · Präparat HOS-083941

It is recommended that therapeutic infectious agents not be given concurrently with Remicade (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 14

HOS-089885 · Präparat HOS-083941

Summary of the safety profile Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials, occurring in 25.3% of infliximab-treated patients compared with 16.5% of control patients. The most serious ADRs associated with the use of TNF blockers that have been reported for Remicade include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn’s disease), and serious infusion reactions (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 14

HOS-089886 · Präparat HOS-083941

Tabulated list of adverse reactions Table 1 lists ADRs based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience. Within the organ system classes, adverse reactions are listed under headings of frequency 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 14

HOS-089887 · Präparat HOS-083941

Table 1 Undesirable effects in clinical studies and from post-marketing experience Infections and infestations Very Common: Viral infection (e.g. influenza, herpes virus infection). Common: Bacterial infections (e.g. sepsis, cellulitis, abscess). Uncommon: Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis). Rare: Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 14–15

HOS-089888 · Präparat HOS-083941

14  Not known: Vaccine breakthrough infection (after in utero exposure to infliximab)*. Neoplasms benign, malignant and unspecified (including cysts and polyps) Rare: Lymphoma, non-Hodgkin’s lymphoma, Hodgkin’s disease, leukaemia, melanoma, cervical cancer. Not known: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn’s disease or ulcerative colitis), Merkel cell carcinoma, Kaposi’s sarcoma. Blood and lymphatic system disorders Common: Neutropenia, leucopenia, anaemia, lymphadenopathy. Uncommon: Thrombocytopenia, lymphopenia, lymphocytosis. Rare: Agranulocytosis (including infants exposed in utero to infliximab), thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura. Immune system disorders Common: Allergic respiratory symptom. Uncommon: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction. Rare: Anaphylactic shock, vasculitis, sarcoid-like reaction. Metabolism and nutrition disorders Uncommon: Dyslipidaemia. Psychiatric disorders Common: Depression, insomnia. Uncommon: Amnesia, agitation, confusion, somnolence, nervousness. Rare: Apathy. Nervous system disorders Very common: Headache. Common: Vertigo, dizziness, hypoaesthesia, paraesthesia. Uncommon: Seizure, neuropathy. Rare: Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy). Not known: Cerebrovascular accidents in close temporal association with infusion. Eye disorders Common: Conjunctivitis. Uncommon: Keratitis, periorbital oedema, hordeolum. Rare: Endophthalmitis. Not known: Transient visual loss occurring during or within 2 hours of infusion. Cardiac disorders Common: Tachycardia, palpitation. Uncommon: Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia. Rare: Cyanosis, pericardial effusion. Not known: Myocardial ischaemia/myocardial infarction. Vascular disorders Common: Hypotension, hypertension, ecchymosis, hot flush, flushing. Uncommon: Peripheral ischaemia, thrombophlebitis, haematoma. Rare: Circulatory failure, petechia, vasospasm.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 15–16

HOS-089889 · Präparat HOS-083941

15 Respiratory, thoracic and mediastinal disorders Very common: Upper respiratory tract infection, sinusitis. Common: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis. Uncommon: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion. Rare: Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis). Gastrointestinal disorders Very common: Abdominal pain, nausea. Common: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation. Uncommon: Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis. Hepatobiliary disorders Common: Hepatic function abnormal, transaminases increased. Uncommon: Hepatitis, hepatocellular damage, cholecystitis. Rare: Autoimmune hepatitis, jaundice. Not known: Liver failure. Skin and subcutaneous tissue disorders Common: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia. Uncommon: Bullous eruption, seborrhoea, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation. Rare: Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions. Not known: Worsening of symptoms of dermatomyositis. Musculoskeletal and connective tissue disorders Common: Arthralgia, myalgia, back pain. Renal and urinary disorders Common: Urinary tract infection. Uncommon: Pyelonephritis. Reproductive system and breast disorders Uncommon: Vaginitis. General disorders and administration site conditions Very common: Infusion-related reaction, pain. Common: Chest pain, fatigue, fever, injection site reaction, chills, oedema. Uncommon: Impaired healing. Rare: Granulomatous lesion. Investigations Uncommon: Autoantibody positive, weight increased1. Rare: Complement factor abnormal. Injury, poisoning, and procedural complications Not known: Post-procedural complication (including infectious and non- infectious complications)

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 16–17

HOS-089890 · Präparat HOS-083941

16 * including bovine tuberculosis (disseminated BCG infection), see section 4.4 1 At month 12 of the controlled period for adult clinical trials across all indications, the median weight increase was 3.50 kg for infliximab-treated subjects vs. 3.00 kg for placebo-treated subjects. The median weight increase for inflammatory bowel disease indications was 4.14 kg for infliximab-treated subjects vs. 3.00 kg for placebo-treated subjects, and the median weight increase for rheumatology indications was 3.40 kg for infliximab-treated subjects vs. 3.00 kg for placebo-treated subjects.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 17

HOS-089891 · Präparat HOS-083941

Description of selected adverse drug reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 17

HOS-089892 · Präparat HOS-083941

Infusion-related reactions An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 hour after an infusion. In Phase III clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction. Overall, a higher proportion of patients receiving infliximab monotherapy experienced an infusion-related reaction compared to patients receiving infliximab with concomitant immunomodulators. Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy. Of infliximab-treated patients who had an infusion reaction during the induction period, through week 6, 27% experienced an infusion reaction during the maintenance period, week 7 through week 54. Of patients who did not have an infusion reaction during the induction period, 9% experienced an infusion reaction during the maintenance period.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 17

HOS-089893 · Präparat HOS-083941

In a clinical study of patients with rheumatoid arthritis (ASPIRE), infusions were to be administered over 2 hours for the first 3 infusions. The duration of subsequent infusions could be shortened to not less than 40 minutes in patients who did not experience serious infusion reactions. In this trial, sixty six percent of the patients (686 out of 1,040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1,040) received at least one shortened infusion of 60 minutes or less. Of the infliximab-treated patients who received at least one shortened infusion, infusion-related reactions occurred in 15% of patients and serious infusion reactions occurred in 0.4% of patients.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Remicade

Remicade 100 mg powder for concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 17

HOS-089894 · Präparat HOS-083941

In a clinical study of patients with Crohn’s disease (SONIC), infusion-related reactions occurred in 16.6% (27/163) of patients receiving infliximab monotherapy, 5% (9/179) of patients receiving infliximab in combination with AZA, and 5.6% (9/161) of patients receiving AZA monotherapy. One serious infusion reaction (< 1%) occurred in a patient on infliximab monotherapy.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.