There have been significant updates to several sections of the SPC, including the following:

Change to section 4.1 - Therapeutic indications

Soliris is indicated for the treatment of patients with atypical haemolytic uremic syndrome (aHUS).

Change to section 4.2 - Posology and method of administration

The aHUS dosing regimen for adult patients (≥18 years of age) consists of a 4 week initial phase followed by a maintenance phase.

aHUS patients should be monitored for signs and symptoms of thrombotic microangiopathy.

Change to section 4.3 - Contraindications

In aHUS patients with unresolved Neisseria meningitidis infection and who are not currently vaccinated against Neisseria meningitidis or do not receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.

Change to section 4.4 - Special warnings and precautions for Use

Treatment Discontinuation for aHUS:-Severe thrombotic microangiopathy complications were observed after Soliris discontinuation in the aHUS clinical studies. If aHUS patients discontinue treatment with Soliris they should be monitored closely for signs and symptoms of severe thrombotic microangiopathy complications.

Patients less than 2 years of age and those who are treated with Soliris less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.

Please refer to SPC link below for full information on all changes.