Incidence of infectious episodes: The overall incidence and profile of viral, bacterial and fungal infections among patients treated with basiliximab or placebo in combination with dual and triple immunosuppressive therapy was comparable between the groups. The overall incidence of infections was 75.9% in the basiliximab group and 75.6% in the placebo group and the incidence of serious infections was 26.1% and 24.8%, respectively. The incidence of CMV infections was similar in both groups (14.6% vs. 17.3%), following either dual or triple therapy regimen (see section 4.4).

 

The incidence and causes of deaths following dual or triple therapy were similar in basiliximab (2.9%) and placebo groups (2.6%), with the most common cause of deaths in both treatment groups being infections (basiliximab = 1.3%, placebo = 1.4%). In a pooled analysis of two five-year extension studies the incidence and cause of death remained similar in both treatment groups, (basiliximab 15%, placebo 11%), the primary cause of death being cardiac-related disorders such as cardiac failure and myocardial infarction (basiliximab 5%, placebo 4%).

 

Listing of adverse reactions from post-marketing spontaneous reports 

 

The following adverse reactions have been identified based on post-marketing spontaneous reports and are organised by system organ class. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

 

Immune system disorders  

 

Hypersensitivity/anaphylactoid reactions such as rash, urticaria, pruritus, sneezing, wheezing, bronchospasm, dyspnoea, pulmonary oedema, cardiac failure, hypotension, tachycardia, respiratory failure, capillary leak syndrome (see section 4.4). Cytokine release syndrome.

 

Reporting of suspected adverse reactions 

 

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

 

4.9 Overdose

 

In clinical studies basiliximab has been administered to humans in single doses of up to 60 mg and multiple doses of up to 150 mg over 24 days with no acute undesirable effects.

 

For information on preclinical toxicology see section 5.3.

5. Pharmacological properties

 

5.1 Pharmacodynamic properties

 

Pharmacotherapeutic group: Interleukin inhibitors, ATC code: L04AC02.

 

Mechanism of action