Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.3 · PDF-Seite 5

HOS-153616 · Präparat HOS-101026

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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Gegenanzeigen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.3 · PDF-Seite 5

HOS-153617 · Präparat HOS-101026

Poherdy is contraindicated in subjects with hereditary fructose intolerance (HFI). Prior to initiating treatment HFI should be excluded via medical history or on clinical grounds (see section 4.4).

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): fructose (HOS-117916)

Wechselwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.5 · PDF-Seite 8

HOS-153619 · Präparat HOS-101026

No pharmacokinetic (PK) interactions were observed between pertuzumab and trastuzumab, or between pertuzumab and docetaxel in a sub-study of 37 patients in the randomised, pivotal trial CLEOPATRA in metastatic breast cancer. In addition, in the population PK analysis, no evidence of a drug-drug interaction has been shown between pertuzumab and trastuzumab or between pertuzumab and docetaxel. This absence of drug-drug interaction was confirmed by pharmacokinetic data from the NEOSPHERE and APHINITY studies.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): docetaxel (HOS-084505) trastuzumab (HOS-090897)

Wechselwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.5 · PDF-Seite 8

HOS-153621 · Präparat HOS-101026

Five studies evaluated the effects of pertuzumab on the PK of co-administered cytotoxic agents, docetaxel, paclitaxel, gemcitabine, capecitabine, carboplatin and erlotinib. There was no evidence of any PK interaction between pertuzumab and any of these agents. The PK of pertuzumab in these studies was comparable to those observed in single-agent studies.

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RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): gemcitabine (HOS-113530) docetaxel (HOS-084505) carboplatin (HOS-084540) erlotinib (HOS-113527) capecitabine (HOS-090904) paclitaxel (HOS-087959)

Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 8

HOS-153627 · Präparat HOS-101026

Summary of the safety profile

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 8–9

HOS-153628 · Präparat HOS-101026

8 The safety of pertuzumab has been evaluated in more than 6,000 patients in Phase I, II, and III trials in patients with various malignancies and predominantly treated with pertuzumab in combination with other antineoplastic agents. Those studies included the pivotal trials CLEOPATRA (n=808), NEOSPHERE (n=417), TRYPHAENA (n=225), and APHINITY (n=4804) [pooled in Table 2]. The safety of pertuzumab was generally consistent across studies, although the incidence and most common adverse drug reactions (ADRs) varied depending on whether pertuzumab was administered as monotherapy or with concomitant anti-neoplastic agents.

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 9

HOS-153629 · Präparat HOS-101026

Tabulated list of adverse reactions

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 9

HOS-153630 · Präparat HOS-101026

Table 2 summarizes the ADRs from the pertuzumab-treated groups of the following pivotal clinical trials: • CLEOPATRA, in which pertuzumab was given in combination with docetaxel and trastuzumab to patients with metastatic breast cancer (n=453) • NEOSPHERE (n=309) and TRYPHAENA (n=218), in which neoadjuvant pertuzumab was given in combination with trastuzumab and chemotherapy to patients with locally advanced, inflammatory, or early breast cancer • APHINITY, in which adjuvant pertuzumab was given in combination with trastuzumab and anthracycline-based or non-anthracycline-based, taxane-containing chemotherapy to patients with early breast cancer (n=2364)

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 9

HOS-153631 · Präparat HOS-101026

In addition, ADRs reported in the post-marketing setting are included in Table 2. As pertuzumab was used with trastuzumab and chemotherapy in these trials, it is difficult to ascertain the causal relationship of an adverse event to a particular medicinal product.

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 9

HOS-153632 · Präparat HOS-101026

The ADRs are listed below by MedDRA system organ class (SOC) and categories of frequency: 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 · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 9

HOS-153633 · Präparat HOS-101026

Within each frequency grouping and SOC, ADRs are presented in the order of decreasing seriousness.

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 9

HOS-153634 · Präparat HOS-101026

The most common ADRs (≥30%) from this pooled data were diarrhoea, alopecia, nausea, fatigue, neutropenia, and vomiting. The most common NCI-CTCAE Grade 3-4 ADRs (≥10%) were neutropenia and febrile neutropenia.

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 9

HOS-153635 · Präparat HOS-101026

Table 2 Summary of ADRs in patients treated with Pertuzumab in clinical trials^, and in the Post-marketing setting†

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 9

HOS-153636 · Präparat HOS-101026

System organ Very Common Common Uncommon Rare class Infections and Nasopharyngitis Paronychia infestations Upper respiratory tract infection Blood and Febrile neutropenia* lymphatic system Neutropenia disorders Leucopenia Anaemia Immune system Infusion-related Hypersensitivity°, * Anaphylactic Cytokine disorders reaction°°, * Drug hypersensitivity°, reaction°, * release * syndrome°°

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 9–10

HOS-153637 · Präparat HOS-101026

9  System organ Very Common Common Uncommon Rare class Metabolism and Decreased appetite Tumour nutrition disorders lysis syndrome† Psychiatric Insomnia disorders Nervous system Neuropathy peripheral disorders Headache Dysgeusia Peripheral sensory neuropathy Dizziness Paraesthesia Eye disorders Lacrimation increased Cardiac disorders Left ventricular Cardiac failure dysfunction** congestive** Vascular disorders Hot flush Respiratory, Cough Interstitial lung thoracic and Epistaxis disease mediastinal Dyspnoea Pleural effusion disorders Gastrointestinal Diarrhoea disorders Vomiting Stomatitis Nausea Constipation Dyspepsia Abdominal pain Skin and Alopecia subcutaneous Rash tissue disorders Nail disorder Pruritus Dry skin Musculoskeletal Myalgia and connective Arthralgia tissue disorders Pain in extremity General disorders Mucosal inflammation Chills and administration Oedema peripheral Pain site conditions Pyrexia Oedema Fatigue Asthenia ^ Table 2 shows pooled data from the overall treatment period in CLEOPATRA (data cutoff 11 February 2014; median number of cycles of pertuzumab was 24); and from the neoadjuvant treatment period in NEOSPHERE (median number of cycles of pertuzumab was 4, across all treatment arms) and TRYPHAENA (median number of cycles of pertuzumab was 3 – 6 across treatment arms) and from the treatment period of APHINITY (median number of cycles of pertuzumab was 18). * ADRs with a fatal outcome have been reported. ** For the overall treatment period across the 4 studies. The incidence of left ventricular dysfunction and cardiac failure congestive reflect the MedDRA Preferred Terms reported in the individual studies. ° Hypersensitivity/anaphylactic reaction is based on a group of terms. °° Infusion-related reaction (IRRs) includes a range of different terms within a time window, see “Description of selected adverse reactions” below. † ADRs reported in the post marketing setting.

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 10

HOS-153638 · Präparat HOS-101026

Description of selected adverse reactions

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 10

HOS-153639 · Präparat HOS-101026

Left ventricular dysfunction (LVD)

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 10–11

HOS-153640 · Präparat HOS-101026

10 In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of LVD during study treatment was higher in the placebo-treated group than in the pertuzumab-treated group (8.6% and 6.6%, respectively). The incidence of symptomatic LVD was also lower in the pertuzumab-treated group (1.8% in the placebo-treated group vs. 1.5% in the pertuzumab-treated group) (see section 4.4).

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 11

HOS-153641 · Präparat HOS-101026

In the neoadjuvant trial NEOSPHERE, in which patients received 4 cycles of pertuzumab as neoadjuvant treatment, the incidence of LVD (during the overall treatment period) was higher in the pertuzumab, trastuzumab and docetaxel-treated group (7.5%) compared to the trastuzumab and docetaxel-treated group (1.9%). There was one case of symptomatic LVD in the pertuzumab and trastuzumab-treated group. In the neoadjuvant trial TRYPHAENA, the incidence of LVD (during the overall treatment period) was 8.3% in the group treated with pertuzumab plus trastuzumab and FEC (5-fluorouracil, epirubicin, cyclophosphamide) followed by pertuzumab plus trastuzumab and docetaxel; 9.3% in the group treated with pertuzumab plus trastuzumab and docetaxel following FEC; and 6.6% in the group treated with pertuzumab in combination with TCH (docetaxel, carboplatin and trastuzumab). The incidence of symptomatic LVD (congestive heart failure) was 1.3% in the group treated with pertuzumab plus trastuzumab and docetaxel following FEC (this excludes a patient who experienced symptomatic LVD during FEC treatment prior to receiving pertuzumab plus trastuzumab and docetaxel) and also 1.3% in the group treated with pertuzumab in combination with TCH. No patients in the group treated with pertuzumab plus trastuzumab and FEC followed by pertuzumab plus trastuzumab and docetaxel experienced symptomatic LVD.

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Nebenwirkungen · Poherdy

Poherdy 420 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 11

HOS-153642 · Präparat HOS-101026

In the neoadjuvant period of the BERENICE trial, the incidence of NYHA Class III/IV symptomatic LVD (congestive heart failure according to NCI-CTCAE v.4) was 1.5% in the group treated with dose dense doxorubicin and cyclophosphamide (AC) followed by pertuzumab plus trastuzumab and paclitaxel and none of the patients (0%) experienced symptomatic LVD in the group treated with FEC followed by pertuzumab in combination with trastuzumab and docetaxel. The incidence of asymptomatic LVD (ejection fraction decrease according to NCI-CTCAE v.4) was 7% in the group treated with dose dense AC followed by pertuzumab plus trastuzumab and paclitaxel and 3.5% in the group treated with FEC followed by pertuzumab plus trastuzumab and docetaxel.

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