Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.3 · PDF-Seite 7

HOS-298393 · Präparat HOS-288792

Hypersensitivity to the active substance 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.

Wechselwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 9

HOS-298394 · Präparat HOS-288792

No drug-drug interaction clinical trials have been conducted. A drug-drug interaction toxicity study with rFVIIa in concizumab treated cynomolgus monkeys was conducted. No sign of thrombosis or other adverse findings were observed in normo-coagulant monkeys when adding three consecutive doses of up to 1 mg/kg rFVIIa on top of concizumab at steady state, see section 5.3.

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

Wechselwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 9

HOS-298395 · Präparat HOS-288792

In vitro and ex vivo drug-drug interaction studies were performed with rFVIIa, aPCC, rFVIII or rFIX in blood from haemophilia patients who are on prophylactic treatment with concizumab. These studies did not suggest clinically relevant drug-drug interactions.

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

Wechselwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 9

HOS-298396 · Präparat HOS-288792

Additive and sometimes synergistic increase in thrombin peak as quantified in the thrombin generation assay has been observed in plasma from haemophilia patients who were on prophylactic treatment with concizumab with concomitant presence of rFVIII, rFIX or bypassing agents including rFVIIa and aPCC. Depending on concentrations of concizumab and haemostatic agents, the impact on thrombin peak ranged from being additive with all haemostatic agents to an extra 40% effect with rFVIIa, an extra 33% effect with aPCC, an extra 22% with rFVIII and less than 13% with rFIX.

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): thrombin (HOS-120053)

Wechselwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 9

HOS-298397 · Präparat HOS-288792

Adding concizumab to plasma containing a sequence-identical analogue (SIA) of emicizumab resulted in an 33% synergistic effect, without reinforcing the known positive interaction between emicizumab- SIA and aPCC, or the negative interaction between emicizumab-SIA and rFVIII. Drug interaction between concizumab and rFVIIa persisted when combined with emicizumab-SIA. For guidance on the use of bypassing agents for treatment of breakthrough bleeding episodes in patients receiving concizumab prophylaxis, 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): emicizumab (HOS-138540)

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298399 · Präparat HOS-288792

Summary of the safety profile

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298400 · Präparat HOS-288792

The overall safety profile of concizumab is based on data from clinical trials. The most serious adverse reactions in the clinical trials with concizumab were thromboembolic events (0.9%) and hypersensitivity (0.3%).

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298401 · Präparat HOS-288792

Tabulated list of adverse reactions

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298402 · Präparat HOS-288792

The following adverse reactions are based on data from post-marketing surveillance and pooled data from the clinical trials NN7415-4159 (phase 1b), NN7415-4310 (phase 2), NN7415-4255 (phase 2), NN7415-4311 (phase 3) and NN7415-4307 (phase 3), in which a total of 320 male patients with haemophilia A with and without inhibitors and haemophilia B with and without inhibitors received at least one dose of concizumab as routine prophylaxis. The patients were exposed for a total of 475 exposure years in clinical trials.

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298403 · Präparat HOS-288792

Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies have been evaluated according to the following convention: 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).

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298404 · Präparat HOS-288792

Table 2 Adverse reactions from pooled clinical trials with concizumab System Organ Class Adverse reaction Frequency Immune system disorders Hypersensitivity Common Vascular disorders Thromboembolic events Uncommon

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298405 · Präparat HOS-288792

General disorders and Injection site reactions Very common administration site disorders

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298406 · Präparat HOS-288792

Description of selected adverse reactions

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298407 · Präparat HOS-288792

Injection site reactions Injection site reactions were reported across the multiple dose clinical trials. The most frequently reported symptoms were injection site erythema (5.9%), injection site bruising (4.4%) and injection site haematoma (4.1%). The majority were reported as mild.

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298408 · Präparat HOS-288792

Paediatric population

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298409 · Präparat HOS-288792

78 of the clinical trial participants were adolescents (≥ 12 to < 18 years). The safety profile was similar between adolescent and adult patients and as expected for the age group.

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298410 · Präparat HOS-288792

The safety and efficacy of concizumab in children aged below 12 years have not yet been established. No data are available.

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298411 · Präparat HOS-288792

Reporting of suspected adverse reactions

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

Nebenwirkungen · Alhemo

Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen Alhemo 300 mg/3 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-298412 · Präparat HOS-288792

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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