Safety profiles of eculizumab in REGAIN and its OLE were consistent with its known profile from over 10 years of clinical use in PNH and aHUS.2,3
Adapted from SOLIRIS® (eculizumab) EU Summary of Product Characteristics, EU/3/03/166, EU/3/09/653, EU/3/14/1304, EU/3/13/1185.1,4–7
Please refer to the Summary of Product Characteristics for more information.
* Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.1
† In 2023, there was an extension of the indication and SOLIRIS® was approved for the treatment of refractory generalised myasthenia gravis (gMG) in patients aged 6 years and above who are anti-acetylcholine receptor (AChR) antibody-positive.1
Please refer to the Summary of Product Characteristics for more information.
* Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.1
† In 2023, there was an extension of the indication and SOLIRIS® was approved for the treatment of refractory generalised myasthenia gravis (gMG) in patients aged 6 years and above who are anti-acetylcholine receptor (AChR) antibody-positive.1
Supportive safety data were obtained from 33 clinical studies that included 1,555 patients exposed to eculizumab in complement-mediated disease populations, including PNH, aHUS, refractory gMG and NMOSD. The most common adverse reaction was headache, (occurred mostly in the initial phase of dosing), and the most serious adverse reaction was meningococcal infection.1 For more information, please refer to the SmPC.
healthcare professional
Vaccination may further activate complement
- As a result, patients with complement-mediated disease may experience increased signs and symptoms of their underlying disease such as MG exacerbation (refractory gMG). Therefore, patients should be closely monitored for disease symptoms after recommended vaccination1
Vaccination may not be sufficient to prevent meningococcal infection
- Consideration should be given to official guidance on the appropriate use of antibacterial agents1
- Cases of serious or fatal meningococcal infections have been reported in SOLIRIS®-treated patients1
- Sepsis is a common presentation of meningococcal infections in patients treated with SOLIRIS®.1 All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with appropriate antibiotics if necessary. Patients should be informed of these signs and symptoms and steps taken to seek medical care immediately1
- Physicians must discuss the benefits and risks of SOLIRIS® therapy with patients and provide them with a patient information brochure and a patient safety card1
Vaccines against serogroups A, C, Y, W 135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups. Patients must receive vaccination according to current national vaccination guidelines for vaccination use.1
It is vital to follow the recommended guidance in the product SmPC with respect to SOLIRIS® and meningococcal infection.1
AChR, acetylcholine receptor; aHUS, acute haemolytic uraemic syndrome; AQP4, aquaporin–4; gMG, generalised myasthenia gravis; MG, myasthenia gravis; NMOSD, neuromyelitis optica spectrum disorder; OLE, open-label extension; PNH, paroxysmal nocturnal haemoglobinuria.
Healthcare professionals are asked to report any suspected adverse reactions. Please report any adverse reactions via your national reporting system. Adverse events should also be reported to Alexion pharmaceuticals by the following link: https://contactazmedical.astrazeneca.com/