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Soliris 300mg Injection
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Indications & Clinical Uses
- Soliris 300 mg/30 mL (eculizumab) is a complement C5 inhibitor given by intravenous infusion.
- It is indicated in adults, and in some indications children, for paroxysmal nocturnal haemoglobinuria (PNH) to reduce haemolysis, atypical haemolytic uraemic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy, generalised myasthenia gravis (gMG) in patients 6 years and older who are anti-AChR antibody positive, and neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-AQP4 antibody positive.
- Soliris is NOT approved for hereditary angioedema (HAE); this sheet's original therapeutic category has been corrected accordingly (see corrections).
- Soliris is given only as a hospital or specialist-infusion-centre intravenous infusion by trained healthcare staff, never self-injected, and treatment for the approved chronic conditions is usually long-term or indefinite.
- Ultomiris (ravulizumab), a related but distinct product, targets the same complement pathway with a longer dosing interval and is not interchangeable with Soliris.
Side Effects
- Soliris carries a BOXED WARNING: it increases the risk of serious, life-threatening or fatal meningococcal (Neisseria meningitidis) infections, so all patients must receive meningococcal vaccination against serogroups A, C, W, Y and B at least 2 weeks before the first dose, or receive antibiotic prophylaxis if urgent treatment cannot wait, and must be monitored for early signs of meningococcal infection.
- Soliris is available in the US only through the Soliris and Ultomiris REMS programme because of this risk.
- Depending on the condition treated, the most common side effects, affecting up to about 40% of patients in some groups, are headache, nasopharyngitis, back pain, nausea, diarrhoea, upper respiratory infection and hypertension.
- Seek emergency care for fever, severe headache with a stiff neck, confusion, rash or aching joints, which can signal meningococcal disease.
Precautions & Warnings
- Because of the boxed warning, meningococcal vaccination is required before starting Soliris, ideally at least 2 weeks beforehand, and vaccination status should be reviewed during long-term therapy per current booster recommendations.
- Soliris increases susceptibility to infections from other encapsulated bacteria, so vaccination against pneumococcus and Haemophilus influenzae type b is also recommended per local guidelines.
- Soliris is contraindicated in patients with an unresolved serious Neisseria meningitidis infection.
- Stopping Soliris in PNH or aHUS can cause serious complement-mediated events, such as haemolysis or thrombotic microangiopathy, for weeks afterward, so patients are monitored for at least 8 weeks (PNH) or 12 weeks (aHUS) after discontinuation.
- Soliris is given only by intravenous infusion in a monitored healthcare setting, never as a bolus injection or self-administered dose.
- Discuss pregnancy plans with your healthcare provider, as eculizumab crosses the placenta and data in human pregnancy are limited.
Avoid Interactions
- Tell your healthcare provider about all other treatments before starting Soliris.
- If you undergo plasmapheresis, plasma exchange, or receive fresh frozen plasma, an extra Soliris dose is usually needed within a set time of the procedure, because these remove circulating eculizumab; your infusion team will adjust the schedule.
- Intravenous immunoglobulin (IVIg) may also reduce Soliris levels through neonatal Fc receptor-mediated clearance.
- Live vaccines should be reviewed carefully with your healthcare provider because of your increased infection risk on complement-inhibitor therapy; inactivated vaccines, especially meningococcal, pneumococcal and Hib, are specifically recommended rather than avoided.
- Soliris should not be mixed or co-infused with other medicines in the same intravenous line; it is diluted and given exactly as directed by trained infusion staff.
References
Frequently Asked Questions
Soliris (eculizumab) is an infusion medicine that blocks part of the complement immune system. It treats paroxysmal nocturnal haemoglobinuria, atypical haemolytic uraemic syndrome, generalised myasthenia gravis, and neuromyelitis optica spectrum disorder. Soliris is not approved for hereditary angioedema, despite sometimes being listed under that category.
A healthcare provider gives Soliris (eculizumab) as an intravenous infusion, usually over about 25 to 45 minutes, in a hospital or infusion centre. After an initial weekly loading phase, most people move to maintenance infusions every 2 weeks. You never inject it yourself.
Soliris (eculizumab) carries a boxed warning for serious, sometimes fatal meningococcal infections. You must be vaccinated against meningococcal disease at least 2 weeks before starting, and it is only available through the Soliris and Ultomiris REMS programme. Seek emergency care for fever, headache, stiff neck or confusion.
Avoid Soliris if you have an unresolved serious meningococcal infection. Tell your care team about any plasma exchange, plasmapheresis, or IVIg treatment, since these can lower Soliris levels and change your dosing schedule. Discuss live vaccines and any pregnancy plans with your healthcare provider before and during treatment.
While on Soliris (eculizumab), you're monitored for early signs of meningococcal infection at every visit, and blood tests check how your PNH, aHUS or other condition is responding. If you stop Soliris, you're watched closely for 8 to 12 weeks, since your condition can return suddenly after stopping.
Soliris (eculizumab) and Ultomiris (ravulizumab) both block the same complement protein, C5, but Ultomiris lasts longer and is given every 8 weeks instead of every 2 weeks with Soliris. They are separate, non-interchangeable medicines, though both share the same meningococcal infection boxed warning and REMS programme.
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