Immediately seek medical attention if they experience symptoms of acute hepatitis such as nausea, vomiting, abdominal pain (especially RUQ abdominal pain), jaundice, dark urine, generalized pruritus, anorexia, etc. Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, palpitations, weight gain of more than 5 kgs in 24 hours, dizziness or loss of consciousness.

• Advise pregnant women and females of reproductive potential that SIGRIMA™ exposure can result in foetal harm, including embryo-foetal death or birth defects
• Advise females of reproductive potential to use effective contraception while receiving SIGRIMA™ and for 7 months following the last dose
• Advise women to discontinue breast feeding prior to initiating treatment with SIGRIMA™