Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.3 · PDF-Seite 5

HOS-139501 · Präparat HOS-098360

• Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1 • Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.

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): oxygen (HOS-087778)

Wechselwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 9

HOS-139502 · Präparat HOS-098360

No formal drug interaction studies have been performed. Clinically significant interactions between trastuzumab and the concomitant medicinal products used in clinical trials have not been observed.

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

Wechselwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 9

HOS-139503 · Präparat HOS-098360

Effect of trastuzumab on the pharmacokinetics of other antineoplastic agents

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

Wechselwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 9

HOS-139504 · Präparat HOS-098360

Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxyl-paclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or 4 mg/kg intravenous loading dose followed by 6 mg/kg q3w or 2 mg/kg q1w intravenous dose, respectively). However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D). The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.

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): paclitaxel (HOS-087959) doxorubicin (HOS-084538)

Wechselwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 9

HOS-139505 · Präparat HOS-098360

Data from study JP16003, a single-arm study of trastuzumab (4 mg/kg intravenous loading dose and 2 mg/kg intravenous dose weekly) and docetaxel (60 mg/m2 intravenous dose) in Japanese women with HER2-positive MBC, suggested that concomitant administration of trastuzumab had no effect on the single-dose pharmacokinetics of docetaxel. Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without trastuzumab. The results of this substudy suggested that the exposure to the bioactive metabolites (e.g. 5-FU) of capecitabine was not affected by concurrent use of cisplatin or by concurrent use of cisplatin plus trastuzumab. However, capecitabine itself showed higher concentrations and a longer half-life when combined with trastuzumab. The data also suggested that the pharmacokinetics of cisplatin were not affected by concurrent use of capecitabine or by concurrent use of capecitabine plus trastuzumab.

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): cisplatin (HOS-086022) docetaxel (HOS-084505) capecitabine (HOS-090904)

Wechselwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 9

HOS-139506 · Präparat HOS-098360

Pharmacokinetic data from study H4613g/GO01305 in patients with metastatic or locally advanced inoperable HER2-positive cancer suggested that trastuzumab had no impact on the PK of carboplatin.

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): carboplatin (HOS-084540)

Wechselwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 9

HOS-139507 · Präparat HOS-098360

Effect of antineoplastic agents on trastuzumab pharmacokinetics

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

Wechselwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 9

HOS-139508 · Präparat HOS-098360

By comparison of simulated serum trastuzumab concentrations after trastuzumab monotherapy (4 mg/kg loading/2 mg/kg q1w intravenous) and observed serum concentrations in Japanese women with HER2-positive MBC (study JP16003) no evidence of a PK effect of concurrent administration of docetaxel on the pharmacokinetics of trastuzumab was found.

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): docetaxel (HOS-084505)

Wechselwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 9

HOS-139509 · Präparat HOS-098360

Comparison of PK results from two Phase II studies (BO15935 and M77004) and one Phase III study (H0648g) in which patients were treated concomitantly with trastuzumab and paclitaxel and two Phase II studies in which trastuzumab was administered as monotherapy (W016229 and MO16982), in women with HER2-positive MBC indicates that individual and mean trastuzumab trough serum concentrations varied within and across studies but there was no clear effect of the concomitant administration of paclitaxel on the pharmacokinetics of trastuzumab. Comparison of trastuzumab PK data from study M77004 in which women with HER2-positive MBC were treated concomitantly with trastuzumab, paclitaxel and doxorubicin to trastuzumab PK data in studies where trastuzumab was administered as monotherapy (H0649g) or in combination with anthracycline plus cyclophosphamide or paclitaxel (study H0648g), suggested no effect of doxorubicin and paclitaxel on the pharmacokinetics of trastuzumab.

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): cyclophosphamide (HOS-084539) paclitaxel (HOS-087959) doxorubicin (HOS-084538)

Wechselwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 9

HOS-139510 · Präparat HOS-098360

Pharmacokinetic data from study H4613g/GO01305 suggested that carboplatin had no impact on the PK of trastuzumab.

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): carboplatin (HOS-084540)

Wechselwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.5 · PDF-Seite 9–10

HOS-139511 · Präparat HOS-098360

9 The administration of concomitant anastrozole did not appear to influence the pharmacokinetics of trastuzumab.

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): anastrozole (HOS-090912)

Nebenwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-139512 · Präparat HOS-098360

Summary of the safety profile

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

Nebenwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-139513 · Präparat HOS-098360

Amongst the most serious and/or common adverse reactions reported in trastuzumab usage (intravenous and subcutaneous formulations) to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.

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

Nebenwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10–11

HOS-139514 · Präparat HOS-098360

10 Tabulated list of adverse reactions

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Nebenwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11

HOS-139515 · Präparat HOS-098360

In this section, the following categories of frequency have been used: 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, adverse reactions 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 · Trazimera

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HOS-139516 · Präparat HOS-098360

Presented in Table 1 are adverse reactions that have been reported in association with the use of intravenous trastuzumab alone or in combination with chemotherapy in pivotal clinical trials and in the post-marketing setting.

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

Nebenwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11

HOS-139517 · Präparat HOS-098360

All the terms included are based on the highest percentage seen in pivotal clinical trials. In addition, terms reported in the post-marketing setting are included in Table 1.

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

Nebenwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11

HOS-139518 · Präparat HOS-098360

Table 1 Undesirable effects reported with intravenous trastuzumab monotherapy or in combination with chemotherapy in pivotal clinical trials (N=8386) and in post-marketing System organ class Adverse reaction Frequency Infections and infestations Infection Very common Nasopharyngitis Very common Neutropenic sepsis Common Cystitis Common Influenza Common Sinusitis Common Skin infection Common Rhinitis Common Upper respiratory tract infection Common Urinary tract infection Common Pharyngitis Common Neoplasms benign, Malignant neoplasm progression Not known malignant and unspecified Neoplasm progression Not known (incl. cysts and polyps) Blood and lymphatic Febrile neutropenia Very common system disorders Anaemia Very common Neutropenia Very common White blood cell count Very common decreased/leukopenia Thrombocytopenia Very common Hypoprothrombinaemia Not known Immune thrombocytopenia Not known Immune system disorders Hypersensitivity Common + Anaphylactic reaction Rare + Anaphylactic shock Rare Metabolism and nutrition Weight decreased/Weight loss Very common disorders Anorexia Very common Tumour lysis syndrome Not known Hyperkalaemia Not known Psychiatric disorders Insomnia Very common Anxiety Common Depression Common 1 Nervous system disorders Tremor Very common Dizziness Very common Headache Very common Paraesthesia Very common Dysgeusia Very common Peripheral neuropathy Common

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

Nebenwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11–12

HOS-139519 · Präparat HOS-098360

11  System organ class Adverse reaction Frequency Hypertonia Common Somnolence Common Eye disorders Conjunctivitis Very common Lacrimation increased Very common Dry eye Common Papilloedema Not known Retinal haemorrhage Not known Ear and labyrinth disorders Deafness Uncommon 1 Cardiac disorders Blood pressure decreased Very common 1 Blood pressure increased Very common 1 Heart beat irregular Very common 1 Cardiac flutter Very common Ejection fraction decreased* Very common + Cardiac failure (congestive) Common +1 Supraventricular tachyarrhythmia Common Cardiomyopathy Common 1 Palpitation Common Pericardial effusion Uncommon Cardiogenic shock Not known Gallop rhythm present Not known Vascular disorders Hot flush Very common +1 Hypotension Common Vasodilatation Common + Respiratory, thoracic and Dyspnoea Very common mediastinal disorders Cough Very common Epistaxis Very common Rhinorrhoea Very common + Pneumonia Common Asthma Common Lung disorder Common + Pleural effusion Common +1 Wheezing Uncommon Pneumonitis Uncommon + Pulmonary fibrosis Not known + Respiratory distress Not known + Respiratory failure Not known + Lung infiltration Not known + Acute pulmonary oedema Not known + Acute respiratory distress syndrome Not known + Bronchospasm Not known + Hypoxia Not known + Oxygen saturation decreased Not known Laryngeal oedema Not known Orthopnoea Not known Pulmonary oedema Not known Interstitial lung disease Not known

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

Nebenwirkungen · Trazimera

Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 12–13

HOS-139520 · Präparat HOS-098360

12  System organ class Adverse reaction Frequency Gastrointestinal disorders Diarrhoea Very common Vomiting Very common Nausea Very common 1 Lip swelling Very common Abdominal pain Very common Dyspepsia Very common Constipation Very common Stomatitis Very common Haemorrhoids Common Dry mouth Common Hepatobiliary disorders Hepatocellular injury Common Hepatitis Common Liver tenderness Common Jaundice Rare Skin and subcutaneous Erythema Very common tissue disorders Rash Very common 1 Swelling face Very common Alopecia Very common Nail disorder Very common Palmar-plantar erythrodysaesthesia Very common syndrome Acne Common Dry skin Common Ecchymosis Common Hyperhydrosis Common Maculopapular rash Common Pruritus Common Onychoclasis Common Dermatitis Common Urticaria Uncommon Angioedema Not known Musculoskeletal and Arthralgia Very common connective tissue disorders 1Muscle tightness Very common Myalgia Very common Arthritis Common Back pain Common Bone pain Common Muscle spasms Common Neck Pain Common Pain in extremity Common Renal and urinary disorders Renal disorder Common Glomerulonephritis membranous Not known Glomerulonephropathy Not known Renal failure Not known Pregnancy, puerperium and Oligohydramnios Not known perinatal conditions Renal hypoplasia Not known Pulmonary hypoplasia Not known Reproductive system and Breast inflammation/mastitis Common breast disorders General disorders and Asthenia Very common administration site Chest pain Very common conditions Chills Very common Fatigue Very common Influenza-like symptoms Very common Infusion related reaction Very common

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