Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 6

HOS-142756 · Präparat HOS-098870

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.

Gegenanzeigen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 6

HOS-142757 · Präparat HOS-098870

Known allergic reaction to hamster protein.

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

Wechselwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 7

HOS-142758 · Präparat HOS-098870

No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported.

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): factor VIII (HOS-089600)

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-142760 · Präparat HOS-098870

Summary of the safety profile

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-142761 · Präparat HOS-098870

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-142762 · Präparat HOS-098870

Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-142763 · Präparat HOS-098870

Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Esperoct. If such inhibitors occur, the condition will manifest itself as

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7–8

HOS-142764 · Präparat HOS-098870

7 an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre is contacted.

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-142765 · Präparat HOS-098870

Tabulated list of adverse reactions

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-142766 · Präparat HOS-098870

The frequencies of adverse reactions as observed across six clinical studies in a total of 270 PTPs and 81 PUPs with severe haemophilia A (< 1% endogenous factor VIII activity) and no history of inhibitors are listed in table 3. The categories of adverse reactions presented in table 3 is according to the MedDRA system organ classification (SOC and Preferred Term Level).

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-142767 · Präparat HOS-098870

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 · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-142768 · Präparat HOS-098870

Table 3 Frequency of adverse drug reactions in clinical studies System Organ Class Preferred term Frequency (PTPs) Frequency (PUPs) Blood and lymphatic Factor VIII inhibition* Uncommon Very common** system disorders Skin and subcutaneous Pruritus Common - tissue disorders Erythema Common Common Rash Common Common General disorders and Injection site reaction*** Common Common administration site conditions Immune system disorders Drug hypersensitivity - Common Hypersensitivity Uncommon - Investigations Coagulation factor VIII Not known**** - level decreased * The confirmed factor VIII inhibitor patient was identified by an initial inhibitor test result of ≥ 0.6 Bethesda units (BU) confirmed in a second sample taken no more than 2 weeks later. ** Covering confirmed factor VIII inhibitor patients in patients at risk (with at least 10 exposure days). *** Preferred terms included in injection site reactions: Injection site reaction, Vessel puncture site haematoma, Infusion site reaction, Injection site erythema, Injection site rash, Vessel puncture site pain, and Injection site swelling. **** Based on post marketing reports.

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-142769 · Präparat HOS-098870

Description of selected adverse reactions

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-142770 · Präparat HOS-098870

Factor VIII inhibitors One confirmed case of factor VIII inhibitor occurred in an 18 year-old previously treated patient on prophylactic treatment with Esperoct. The patient had a factor VIII gene intron 22 inversion and was at a high risk of developing factor VIII inhibitors. There is no indication of an increased risk of factor VIII inhibitor development with treatment of Esperoct as compared to other factor VIII products.

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-142771 · Präparat HOS-098870

Anti-drug antibodies There was one case of persistent anti-drug antibodies concomitant with the confirmed case of factor VIII inhibitors (see Factor VIII inhibitors above). Three patients had transiently positive test results for anti-drug antibodies after administration of Esperoct but no correlation with adverse events could be established.

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-142772 · Präparat HOS-098870

Anti-PEG antibodies During the clinical study programme, thirty-seven patients had pre-existing anti-PEG antibodies before administration of Esperoct. Twenty of the 37 patients were negative for anti-PEG antibodies post administration of Esperoct. Seventeen patients developed transient low titre anti-PEG antibodies. No correlation with adverse events could be established. From post-marketing reporting, occurrence of anti-PEG-antibodies has also been observed at time of switching to Esperoct. In some patients anti-PEG antibodies may have been associated with lower than expected level of FVIII activity.

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8–9

HOS-142773 · Präparat HOS-098870

8 Paediatric population

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-142774 · Präparat HOS-098870

No difference in the safety profile was observed between previously treated children and adult patients.

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-142775 · Präparat HOS-098870

In some PUPs, temporary decreased factor VIII IR has been observed in the absence of detectable factor VIII inhibitors (see section 4.4 for more details).

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

Nebenwirkungen · Esperoct

Esperoct 500 IU powder and solvent for solution for injection Esperoct 1 000 IU powder and solvent for solution for injection Esperoct 1 500 IU powder and solvent for solution for injection Esperoct 2 000 IU powder and solvent for solution for injection Esperoct 3 000 IU powder and solvent for solution for injection Esperoct 4 000 IU powder and solvent for solution for injection Esperoct 5 000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-142776 · Präparat HOS-098870

Reporting of suspected adverse reactions

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