Soliris Dosage/Direction for Use

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.
Posology: Paroxysmal Nocturnal Haemoglobinuria (PNH) in adults: The PNH dosing regimen for adult patients (≥18 years of age) consists of a 4-week initial phase followed by a maintenance phase: Initial phase: 600 mg of Soliris administered via a 25-45 minute (35 minutes±10 minutes) intravenous infusion every week for the first 4 weeks.
Maintenance phase: 900 mg of Soliris administered via a 25-45 minute (35 minutes±10 minutes) intravenous infusion for the fifth week, followed by 900 mg of Soliris administered via a 25-45 minute (35 minutes±10 minutes) intravenous infusion every 14±2 days (see Pharmacology: Pharmacodynamics under Actions).
atypical Haemolytic Uremic Syndrome (aHUS), refractory generalized Myasthenia Gravis (gMG) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in adults: 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: Initial phase: 900 mg of Soliris administered via a 25-45 minute (35 minutes±10 minutes) intravenous infusion every week for the first 4 weeks.
Maintenance phase: 1,200 mg of Soliris administered via a 25-45 minute (35 minutes±10 minutes) intravenous infusion for the fifth week, followed by 1,200 mg of Soliris administered via a 25-45 minute (35 minutes±10 minutes) intravenous infusion every 14±2 days (see Pharmacology: Pharmacodynamics under Actions).
Refractory gMG: 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 patients in PNH, aHUS, or refractory gMG: 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: See Table 20.

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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 as follows: See Table 21.

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Supplemental dose of Soliris is required in the setting of concomitant intravenous immunoglobulin (IVIg) treatment as described as follows (see also Interactions): See Table 22.

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Treatment monitoring: aHUS patients should be monitored for signs and symptoms of thrombotic microangiopathy (TMA) (see aHUS laboratory monitoring under Precautions).
Soliris treatment is recommended to continue for the patient's lifetime, unless the discontinuation of Soliris is clinically indicated (see Precautions).
Elderly: 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.
Renal impairment: No dose adjustment is required for patients with renal impairment (see Pharmacology: Pharmacodynamics under Actions).
Hepatic impairment: The safety and efficacy of Soliris have not been studied in patients with hepatic impairment.
Paediatric population: 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.
Method of administration: Do not administer as an intravenous push or bolus injection. Soliris should only be administered via intravenous infusion as described as follows.
For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions For Usage.
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 Precautions and Adverse Reactions.