Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.8 · PDF-Seite 26

HOS-114867 · Präparat HOS-094169

Bleeding This adverse reaction was identified through post-marketing surveillance but not observed in randomised controlled clinical trials (n = 6 300). RESIST participants receiving tipranavir with ritonavir tended to have an increased risk of bleeding; at 24 weeks the relative risk was 1.98 (95% CI = 1.03, 3.80). At 48-weeks the relative risk decreased to 1.27 (95% CI = 0.76, 2.12). There was no pattern for the bleeding events and no difference between treatment groups in coagulation parameters. The significance of this finding is being further monitored. Fatal and non-fatal intracranial haemorrhage (ICH) have been reported in patients receiving tipranavir, many of whom had other medical conditions or were receiving concomitant medicinal products that may have caused or contributed to these events. However, in some cases the role of tipranavir cannot be excluded. No pattern of abnormal haematological or coagulation parameters has been observed in patients in general, or preceding the development of ICH. Therefore, routine measurement of coagulation parameters is not currently indicated in the management of patients on Aptivus. An increased risk of ICH has previously been observed in patients with advanced HIV disease/AIDS such as those treated in the Aptivus clinical trials.

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