Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Alexion Europe SAS, 103-105 rue Anatole France, 92300 Levallois-Perret, FRANCE
Soliris is indicated in adults and children for the treatment of:
Soliris is indicated in adults for the treatment of:
Soliris must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological, renal, neuromuscular or neuro-inflammatory disorders.
Home infusion may be considered for patients who have tolerated infusions well in the clinic. The decision of a patient to receive home infusions should be made after evaluation and recommendation from the treating physician. Home infusions should be performed by a qualified healthcare professional.
The PNH dosing regimen for adult patients (≥18 years of age) consists of a 4-week initial phase followed by a maintenance phase:
The aHUS, refractory gMG and NMOSD dosing regimen for adult patients (≥18 years of age) consists of a 4 week initial phase followed by a maintenance phase:
Available data suggest that clinical response is usually achieved by 12 weeks of Soliris treatment. Discontinuation of the therapy should be considered in a patient who shows no evidence of therapeutic benefit by 12 weeks.
Paediatric PNH, aHUS, or refractory gMG patients with body weight ≥40 kg are treated with the adult dosing recommendations.
In paediatric PNH, aHUS, and refractory gMG patients with body weight below 40 kg, the Soliris dosing regimen consists of:
| Patient Body Weight | Initial Phase | Maintenance Phase |
|---|---|---|
| 30 to <40 kg | 600 mg weekly for the first 2 weeks | 900 mg at week 3; then 900 mg every 2 weeks |
| 20 to <30 kg | 600 mg weekly for the first 2 weeks | 600 mg at week 3; then 600 mg every 2 weeks |
| 10 to <20 kg | 600 mg single dose at week 1 | 300 mg at week 2; then 300 mg every 2 weeks |
| 5 to <10 kg | 300 mg single dose at week 1 | 300 mg at week 2; then 300 mg every 3 weeks |
Soliris has not been studied in patients with PNH or refractory gMG who weigh less than 40kg. The posology of Soliris to be used in paediatric patients with PNH or refractory gMG patients weighing less than 40 kg is identical to the weight-based dose recommendation provided for paediatric patients with aHUS. Based on the pharmacokinetic (PK)/pharmacodynamic (PD) data available in patients with aHUS and PNH treated with Soliris, this body-weight based dose regimen for paediatric patients is expected to result in an efficacy and safety profile similar to that in adults. For patients with refractory gMG weighing less than 40 kg this body-weight based dose regimen is also expected to result in an efficacy and safety profile similar to that in adults.
Soliris has not been studied in paediatric patients with NMOSD.
Supplemental dosing of Soliris is required in the setting of concomitant plasmapheresis (PP), plasma exchange (PE), or fresh frozen plasma infusion (PI) as described below:
| Type of Plasma Intervention | Most Recent Soliris Dose | Supplemental Soliris Dose With Each PP/PE/PI Intervention | Timing of Supplemental Soliris Dose |
|---|---|---|---|
| Plasmapheresis or plasma exchange | 300 mg | 300 mg per each plasmapheresis or plasma exchange session | Within 60 minutes after each plasmapheresis or plasma exchange |
| ≥600 mg | 600 mg per each plasmapheresis or plasma exchange session | ||
| Fresh frozen plasma infusion | ≥300 mg | 300 mg per infusion of fresh frozen plasma | 60 minutes prior to each infusion of fresh frozen plasma |
Abbreviations: PP/PE/PI = plasmapheresis/plasma exchange/plasma infusion
Supplemental dose of Soliris is required in the setting of concomitant intravenous immunoglobulin (IVIg) treatment as described below (see also Section 4.5):
| Most Recent Soliris Dose | Supplemental Soliris Dose | Timing of Supplemental Soliris Dose |
|---|---|---|
| ≥900 mg | 600 mg per IVIg cycle | As soon as possible after IVIg cycle |
| ≤600 mg | 300 mg per IVIg cycle |
Abbreviation: IVIg = intravenous immunoglobulin
aHUS patients should be monitored for signs and symptoms of thrombotic microangiopathy (TMA) (see section 4.4 aHUS laboratory monitoring).
Soliris treatment is recommended to continue for the patient’s lifetime, unless the discontinuation of Soliris is clinically indicated (see section 4.4).
Soliris may be administered to patients aged 65 years and over. There is no evidence to suggest that any special precautions are needed when older people are treated–although experience with Soliris in this patient population is still limited.
No dose adjustment is required for patients with renal impairment (see section 5.1).
The safety and efficacy of Soliris have not been studied in patients with hepatic impairment.
The safety and efficacy of Soliris in children with refractory gMG aged less than 6 years old have not been established.
The safety and efficacy of Soliris in children with NMOSD aged less than 18 years old have not been established.
Do not administer as an intravenous push or bolus injection. Soliris should only be administered via intravenous infusion as described below.
For instructions on dilution of the medicinal product before administration, see section 6.6. The diluted solution of Soliris should be administered by intravenous infusion over 25–45 minutes (35 minutes ± 10 minutes) in adults and 1-4 hours in paediatric patients under 18 years of age via gravity feed, a syringe-type pump, or an infusion pump. It is not necessary to protect the diluted solution of Soliris from light during administration to the patient.
Patients should be monitored for one hour following infusion. If an adverse event occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician. If the infusion is slowed, the total infusion time may not exceed two hours in adults and four hours in paediatric patients under 18 years of age.
There is limited safety data supporting home-based infusions, additional precautions in the home setting such as availability of emergency treatment of infusion reactions or anaphylaxis are recommended. Infusion reactions are described in Sections 4.4 and 4.8 on the SmPC.
No case of overdose has been reported in any of the clinical studies.
30 months.
After dilution, the medicinal product should be used immediately. However, chemical and physical stability has been demonstrated for 24 hours at 2°C–8°C.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store in the original package in order to protect from light.
Soliris vials in the original package may be removed from refrigerated storage for only one single period of up to 3 days. At the end of this period the product can be put back in the refrigerator.
For storage conditions after dilution of the medicinal product, see section 6.3.
30 ml of concentrate in a vial (Type I glass) with a stopper (butyl, siliconised), and a seal (aluminium) with flip-off cap (polypropylene).
Pack size of one vial.
Prior to administration, the Soliris solution should be visually inspected for particulate matter and discolouration. Do not use if there is evidence of particulate matter or discolouration.
Instructions:
Reconstitution and dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.
Withdraw the total amount of Soliris from the vial(s) using a sterile syringe.
Transfer the recommended dose to an infusion bag.
Dilute Soliris to a final concentration of 5 mg/ml by addition to the infusion bag using sodium chloride 9 mg/ml (0.9%) solution for injection, sodium chloride 4.5 mg/ml (0.45%) solution for injection, or 5% dextrose in water, as the diluent.
The final volume of a 5 mg/ml diluted solution is 60 ml for 300 mg doses, 120 ml for 600 mg doses, 180 ml for 900 mg doses and 240 ml for 1,200 mg doses. The solution should be clear and colourless.
Gently agitate the infusion bag containing the diluted solution to ensure thorough mixing of the product and diluent.
The diluted solution should be allowed to warm to room temperature prior to administration by exposure to ambient air.
Discard any unused portion left in a vial.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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