Soliris, eculizumab
Named-patient access overview. Soliris is coordinated by Reserve Meds for international patients via physician-led cross-border sourcing.
This page is informational, not medical advice.
About Soliris
Soliris (eculizumab) is a humanized monoclonal antibody manufactured by Alexion Pharmaceuticals, a wholly owned subsidiary of AstraZeneca. It binds the complement protein C5 with high affinity and prevents its cleavage into C5a and C5b, blocking formation of the terminal complement complex C5b-9. By interrupting terminal complement activation, Soliris reduces intravascular hemolysis, thrombosis risk, and end-organ injury in a small family of complement-mediated diseases.
Soliris carries US FDA approval across four indications: paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor antibody-positive, and neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 antibody-positive. Each indication has a distinct dosing schedule that is built around a weight-based induction phase followed by every-two-week intravenous maintenance infusions.
Because Soliris blocks terminal complement, treated patients carry an increased risk of serious meningococcal infection. The US label includes a boxed warning, and every patient should be vaccinated against meningococcal serogroups A, C, W, Y, and B at least two weeks before the first dose, or receive antibiotic prophylaxis if treatment cannot be delayed. The drug is dispensed under a Risk Evaluation and Mitigation Strategy (REMS) program in the United States, and Reserve Meds confirms vaccination status and prescriber enrollment before any shipment is coordinated.
Soliris is supplied as a single-use 300 mg per 30 mL vial of concentrated solution for intravenous infusion. It must be stored refrigerated at 2 to 8 degrees Celsius, protected from light, and never frozen. Cold-chain integrity from the US specialty wholesaler to the destination physician or hospital is a non-negotiable element of every coordination Reserve Meds runs.
How Reserve Meds coordinates Soliris
- Patient or treating physician submits a named-patient request through the Patient Portal.
- Clinical team verifies appropriateness of Soliris for the patient's indication and destination country.
- Treating physician issues a prescription with clinical justification, vaccination record, and REMS attestation.
- Country-specific named-patient or personal-import documentation is prepared in the destination language.
- Soliris is sourced from a DSCSA-compliant US specialty wholesaler with full serialized traceability.
- Validated cold-chain shipment is coordinated to the patient's treating physician or hospital pharmacy.
- A named concierge stays with the case from intake through delivery confirmation.
Access by country
Reserve Meds publishes a detailed country deep-dive for Soliris in every market we coordinate. Each page below covers the destination-country regulatory pathway (named-patient framework), real costs in local currency and USD, indicative timelines, physician-credential requirements, vaccination prerequisites, and cold-chain handling for the route into that country. Tap any country to read the full deep-dive.
Indications, in brief
Paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare acquired clonal disorder of hematopoietic stem cells in which a somatic mutation in the PIGA gene leads to a deficiency of glycosylphosphatidylinositol-anchored complement regulators on red blood cells. The result is chronic intravascular hemolysis, fatigue, smooth muscle dystonia, and a markedly elevated risk of thrombosis, which is the leading cause of death in untreated PNH. Soliris was the first complement inhibitor approved for PNH and remains a foundational therapy where every-two-week IV infusion is feasible.
Atypical hemolytic uremic syndrome (aHUS). aHUS is a thrombotic microangiopathy driven by dysregulated alternative-pathway complement activation, with a clinical triad of microangiopathic hemolytic anemia, thrombocytopenia, and acute kidney injury. Untreated aHUS carries a high risk of progression to end-stage renal disease, especially in pediatric patients. Soliris interrupts the underlying complement-driven endothelial injury.
Generalized myasthenia gravis (gMG). In anti-acetylcholine receptor antibody-positive gMG, complement-mediated damage at the neuromuscular junction contributes to fatigable weakness. For patients who remain symptomatic despite conventional immunosuppression, terminal complement blockade with Soliris can produce meaningful and durable improvement in muscle strength and activities of daily living.
Neuromyelitis optica spectrum disorder (NMOSD). In anti-aquaporin-4 antibody-positive NMOSD, complement activation drives astrocyte injury, demyelination, and the severe attacks of optic neuritis and longitudinally extensive transverse myelitis that define the disease. Soliris reduces the annualized attack rate in this population.
What every destination country asks for
Patterns differ market by market, but the documentation set we prepare always covers the same core: a physician letter of medical necessity tied to the labeled indication, recent diagnostic confirmation (flow cytometry for PNH, ADAMTS13 and complement panel for aHUS, antibody serology for gMG and NMOSD), prior-therapy history, a current meningococcal vaccination record, the prescription itself with strength and quantity, and a country-specific named-patient or personal-import application. We translate the medical core into the destination language so reviewers see a clean, fully assembled file on first read.
Cold-chain and handling
Every Soliris vial in our supply chain travels under a validated 2 to 8 degree Celsius cold-chain with continuous temperature logging. The hand-off to the destination physician or hospital pharmacy is documented with the temperature record, the lot and serial number, and a chain-of-custody signature. If any segment falls out of the validated range, the lot is quarantined and replaced before infusion.
Start a request for Soliris
Submit a 60-second intake. Our clinical team will reach out as our first cohort opens with case-specific feasibility, an indicative timeline, and a formal quote in your local currency and USD.
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