Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.3 · PDF-Seite 5

HOS-119947 · Präparat HOS-095065

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to E. coli derived proteins.

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

Gegenanzeigen · Nplate

Nplate 250 micrograms powder and solvent for solution for injection Nplate 500 micrograms powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 27

HOS-119990 · Präparat HOS-095065

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to E. coli derived proteins.

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

Wechselwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-119948 · Präparat HOS-095065

No interaction studies have been performed. The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown.

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

Wechselwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-119949 · Präparat HOS-095065

Medicinal products used in the treatment of ITP in combination with romiplostim in clinical trials included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. Platelet counts should be monitored when combining romiplostim with other medicinal products for the treatment of ITP in order to avoid platelet counts outside of the recommended range (see section 4.2).

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): danazol (HOS-085473) azathioprine (HOS-089001)

Wechselwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-119950 · Präparat HOS-095065

Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1). Platelet counts should be monitored when reducing or discontinuing other ITP treatments in order to avoid platelet counts below the recommended range (see section 4.2).

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): danazol (HOS-085473) azathioprine (HOS-089001)

Wechselwirkungen · Nplate

Nplate 250 micrograms powder and solvent for solution for injection Nplate 500 micrograms powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 29

HOS-119991 · Präparat HOS-095065

No interaction studies have been performed. The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown.

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

Wechselwirkungen · Nplate

Nplate 250 micrograms powder and solvent for solution for injection Nplate 500 micrograms powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 29

HOS-119992 · Präparat HOS-095065

Medicinal products used in the treatment of ITP in combination with romiplostim in clinical trials included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. Platelet counts should be monitored when combining romiplostim with other

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): danazol (HOS-085473) azathioprine (HOS-089001)

Wechselwirkungen · Nplate

Nplate 250 micrograms powder and solvent for solution for injection Nplate 500 micrograms powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 29–30

HOS-119993 · Präparat HOS-095065

29 medicinal products for the treatment of ITP in order to avoid platelet counts outside of the recommended range (see section 4.2).

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

Wechselwirkungen · Nplate

Nplate 250 micrograms powder and solvent for solution for injection Nplate 500 micrograms powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 30

HOS-119994 · Präparat HOS-095065

Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim (see section 5.1). Platelet counts should be monitored when reducing or discontinuing other ITP treatments in order to avoid platelet counts below the recommended range (see section 4.2).

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): danazol (HOS-085473) azathioprine (HOS-089001)

Nebenwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-119951 · Präparat HOS-095065

Summary of the safety profile

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

Nebenwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-119952 · Präparat HOS-095065

Based on an analysis of all adult ITP patients receiving romiplostim in 4 controlled and 5 uncontrolled clinical trials, the overall subject incidence of all adverse reactions for romiplostim-treated subjects was 91.5% (248/271). The mean duration of exposure to romiplostim in this study population was 50 weeks.

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

Nebenwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-119953 · Präparat HOS-095065

The most serious adverse reactions that may occur during Nplate treatment include: reoccurrence of thrombocytopenia and bleeding after cessation of treatment, increased bone marrow reticulin, thrombotic/thromboembolic complications, medication errors and progression of existing MDS to AML. The most common adverse reactions observed include hypersensitivity reactions (including cases of rash, urticaria and angioedema) and headache.

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

Nebenwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-119954 · Präparat HOS-095065

Tabulated list of adverse reactions

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

Nebenwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-119955 · Präparat HOS-095065

Frequencies are defined as: 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) and not known (cannot be estimated from the available data). Within each MedDRA system organ class and frequency grouping, undesirable effects are presented in order of decreasing incidence.

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

Nebenwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-119956 · Präparat HOS-095065

MedDRA system Very common Common Uncommon organ class Infections and Upper respiratory tract Gastroenteritis Influenza infestations infection Pharyngitis*** Localised infection Rhinitis*** Conjunctivitis*** Nasopharyngitis Ear infection*** Sinusitis***/**** Bronchitis**** Neoplasms benign, Multiple myeloma malignant and Myelofibrosis unspecified (including cysts and polyps)

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

Nebenwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.8 · PDF-Seite 8–9

HOS-119957 · Präparat HOS-095065

8 MedDRA system Very common Common Uncommon organ class Blood and lymphatic Bone marrow Aplastic anaemia system disorders disorder* Bone marrow failure Thrombocytopenia* Leucocytosis Anaemia Splenomegaly Thrombocythaemia Platelet count increased Platelet count abnormal Immune system Hypersensitivity** Angioedema disorders Metabolism and Alcohol intolerance nutrition disorders Anorexia Decreased appetite Dehydration Gout Psychiatric disorders Insomnia Depression Abnormal dreams Nervous system Headache Dizziness Clonus disorders Migraine Dysgeusia Paraesthesia Hypoaesthesia Hypogeusia Neuropathy peripheral Transverse sinus thrombosis Eye disorders Conjunctival haemorrhage Accommodation disorder Blindness Eye disorder Eye pruritus Lacrimation increased Papilloedema Visual disturbances Ear and labyrinth Vertigo disorders Cardiac disorders Palpitations Myocardial infarction Heart rate increased Vascular disorders Flushing Hypotension Deep vein thrombosis Peripheral embolism Peripheral ischaemia Phlebitis Thrombophlebitis superficial Thrombosis Erythromelalgia Respiratory, thoracic Oropharyngeal Pulmonary embolism* Cough and mediastinal pain*** Rhinorrhoea disorders Dry throat Dyspnoea Nasal congestion Painful respiration

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

Nebenwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.8 · PDF-Seite 9–10

HOS-119958 · Präparat HOS-095065

9 MedDRA system Very common Common Uncommon organ class Gastrointestinal Upper abdominal Nausea Vomiting disorders pain*** Diarrhoea Rectal haemorrhage Abdominal pain Breath odour Constipation Dysphagia Dyspepsia Gastro-oesophageal reflux disease Haematochezia Mouth haemorrhage Stomach discomfort Stomatitis Tooth discolouration Hepatobiliary disorders Portal vein thrombosis Increase in transaminase Skin and subcutaneous Pruritus Alopecia tissue disorders Ecchymosis Photosensitivity Rash reaction Acne Dermatitis contact Dry skin Eczema Erythema Exfoliative rash Hair growth abnormal Prurigo Purpura Rash papular Rash pruritic Skin nodule Skin odour abnormal Urticaria Musculoskeletal and Arthralgia Muscle tightness connective tissue Myalgia Muscular weakness disorders Muscle spasms Shoulder pain Pain in extremity Muscle twitching Back pain Bone pain Renal and urinary Protein urine present disorders Reproductive system Vaginal haemorrhage and breast disorders General disorders and Fatigue Injection site administration site Oedema peripheral haemorrhage conditions Influenza like illness Chest pain Pain Irritability Asthenia Malaise Pyrexia Face oedema Chills Feeling hot Injection site reaction Feeling jittery Peripheral swelling***

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

Nebenwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.8 · PDF-Seite 10–11

HOS-119959 · Präparat HOS-095065

10 MedDRA system Very common Common Uncommon organ class Investigations Blood pressure increased Blood lactate dehydrogenase increased Body temperature increased Weight decreased Weight increased Injury, poisoning and Contusion procedural complications * see section 4.4 ** Hypersensitivity reactions including cases of rash, urticaria, and angioedema *** Additional adverse reactions observed in paediatric studies **** Additional adverse reactions observed in adult patients with ITP duration up to 12 months

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

Nebenwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.8 · PDF-Seite 11

HOS-119960 · Präparat HOS-095065

Adult population with ITP duration up to 12 months

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

Nebenwirkungen · Nplate

Nplate 125 micrograms powder for solution for injection Nplate 250 micrograms powder for solution for injection Nplate 500 micrograms powder for solution for injection · Abschnitt 4.8 · PDF-Seite 11

HOS-119961 · Präparat HOS-095065

The safety profile of romiplostim was similar across adult patients, regardless of ITP duration. Specifically in the integrated analysis of ITP ≤ 12 months duration (n = 311), 277 adult patients with ITP ≤ 12 months duration and who received at least one dose of romiplostim from among those patients in 9 ITP studies were included (see also section 5.1). In this integrated analysis, the following adverse reactions (at least 5% incidence and at least 5% more frequent with Nplate compared with placebo or standard of care) occurred in romiplostim patients with ITP duration up to 12 months, but were not observed in those adult patients with ITP duration > 12 months: bronchitis, sinusitis (reported commonly (≥ 1/100 to < 1/10)).

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