Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 6

HOS-134313 · Präparat HOS-097550

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 · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 6

HOS-134314 · Präparat HOS-097550

Known allergic reactions to mouse or hamster proteins.

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

Wechselwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 8

HOS-134315 · Präparat HOS-097550

Interactions of human coagulation factor VIII (rDNA) products with other medicinal products have not 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 · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-134317 · Präparat HOS-097550

Summary of the safety profile

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-134318 · Präparat HOS-097550

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed 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 · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-134319 · Präparat HOS-097550

Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Jivi (see section 5.1). If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialized haemophilia centre be contacted.

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8

HOS-134320 · Präparat HOS-097550

The most frequently reported adverse reactions in clinical studies in PTPs were headache, cough and pyrexia.

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8–9

HOS-134321 · Präparat HOS-097550

8 Tabulated list of adverse reactions

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-134322 · Präparat HOS-097550

A total of 256 patients constituted the safety population from 4 pivotal Phase I and III studies (one phase I study and 3 phase III studies), 148 adolescents/adults and 108 paediatric patients < 12 years.

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-134323 · Präparat HOS-097550

The median number of exposure days to Jivi per patient was 195 (min-max: 1-698) for all patients in the clinical studies.

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-134324 · Präparat HOS-097550

Overall, in all studies 75 patients, 39 of them below 12 years of age, were observed for a treatment duration of more than 5 years. See section 5.1 for additional details on the clinical studies.

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-134325 · Präparat HOS-097550

The table 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). 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 · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-134326 · Präparat HOS-097550

Table 2: Frequency of adverse drug reactions in clinical studies

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-134327 · Präparat HOS-097550

MedDRA Standard Adverse reactions Frequency System Organ Class Blood and lymphatic system disorders FVIII inhibition uncommon (PTPs)a very common (PUPs)a Immune system disorders Hypersensitivity common Psychiatric disorders Insomnia common Nervous system disorders Headache very common Dizziness common Dysgeusia uncommon Vascular disorders Flushing uncommon Respiratory, thoracic and mediastinal Cough common disorders Gastrointestinal disorders Abdominal pain, Nausea, common Vomiting Skin and subcutaneous tissue disorders Erythemac, Rashd common Pruritus uncommon General disorders and administration Injection site reactions , b common site conditions Pyrexia PTPs: previously treated patients; PUPs: previously untreated patients a Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A; Jivi was not studied in PUPs b Includes injection site pruritus, injection site rash, infusion site pain and vessel puncture site pruritus c Includes erythema and erythema multiforme d Includes rash and rash papular

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-134328 · Präparat HOS-097550

There was no change in the safety profile during the PROTECT VIII and the PROTECT Kids extension studies.

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-134329 · Präparat HOS-097550

Description of selected adverse reactions

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-134330 · Präparat HOS-097550

Immunogenicity Immunogenicity was evaluated during clinical studies with Jivi in 159 (including surgery patients) previously treated adolescents (≥ 12 to < 18 years of age, n=14) and adults (n=145) diagnosed with

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9–10

HOS-134331 · Präparat HOS-097550

9 severe haemophilia A (FVIII:C < 1%), and ≥ 150 previous exposure days and 108 paediatric PTPs < 12 years of age (n=60 aged 7-<12 years) and ≥ 50 previous exposure days.

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 10

HOS-134332 · Präparat HOS-097550

FVIII inhibitors No de novo or confirmed cases of inhibitor against factor VIII occurred. A single unconfirmed positive result of a low titre of factor VIII inhibitor (1.7 BU/mL) was reported in one adult patient undergoing surgery. Jivi was not studied in previously untreated patients.

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

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 10

HOS-134333 · Präparat HOS-097550

Anti-PEG antibodies Immunogenicity against PEG with development of specific IgM anti-PEG antibodies was observed in 2 patients. In one patient > 12 years of age, the immune response was accompanied by a clinical hypersensitivity reaction after 4 injections of Jivi. Antibodies to PEG disappeared after discontinuation of Jivi. One child ˃ 7 years, developed high titre neutralising anti-PEG IgM antibodies within the first 4 exposure days associated with loss of drug effect. Antibodies disappeared after discontinuation and patient safely re-started treatment with Jivi 2 months later. Transient low titre anti-PEG antibodies of the IgM isotype were observed in some patients within the first 4 ED resulting in minor reduction of recovery.

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