Pooled data from clinical studies and post-marketing experience.

• The most frequently reported adverse reactions are headache, pruritus, injection site reactions, and increase in bile salts; increase in bile salts were usually asymptomatic and reversible after discontinuation of treatment.¹

   

• The most frequently reported serious adverse reaction is an exacerbation of hepatitis after discontinuation of HEPCLUDEX®, possibly related to virologic rebound after treatment discontinuation.¹

   

Adverse reactions are listed by frequency. Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).

^aInjection site events include injection site erythema, injection site reaction, injection site pain, injection site induration, injection site rash, injection site haematoma, injection site pruritus and injection site dermatitis.¹

^bAdverse reaction identified through post-marketing surveillance.¹