Soliris, eculizumab

Named-patient access overview. Soliris is coordinated by Reserve Meds for international patients through cross-border sourcing coordinated with your treating doctor.

This page is informational, not medical advice.

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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.

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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

  1. Patient or treating physician submits a named-patient request through the Patient Portal.
  2. Clinical team verifies appropriateness of Soliris for the patient's indication and destination country.
  3. Treating physician issues a prescription with clinical justification, vaccination record, and REMS attestation.
  4. Country-specific named-patient or personal-import documentation is prepared in the destination language.
  5. Soliris is sourced from a US-licensed pharmaceutical wholesale partner with full serialized traceability.
  6. Validated cold-chain shipment is coordinated to the patient's treating physician or hospital pharmacy.
  7. A named coordinator stays with the case from intake through delivery confirmation.

Clinical trials and expanded access

On 17 October 2026 we searched ClinicalTrials.gov, the clinical study registry of the US National Library of Medicine, for studies that list eculizumab as an intervention. The search found studies that are recruiting or not yet recruiting. See the current list on ClinicalTrials.gov.

Expanded access records for eculizumab that were marked “Available” on 17 October 2026:

Whether a patient can join a trial or an expanded access program is decided by the study team or the manufacturer, together with the treating doctor. Reserve Meds does not run trials or supply investigational medicines. We can help you and your doctor read a listing and understand the route.

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), how quotes work, 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

Send us the medicine and your country. We reply within one business day with case-specific feasibility, an indicative timeline, and a formal written quote.

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Frequently asked questions

How can I get Soliris if it is not approved or available in my country?

Reserve Meds coordinates US-sourced Soliris for patients through a legal named-patient pathway, working with your treating doctor. Your treating physician provides the prescription and clinical justification; Reserve Meds prepares the named-patient documentation for your country and arranges DSCSA-compliant US sourcing and delivery to your physician or hospital pharmacy.

Can I access Soliris through a named-patient import?

Often, yes. Named-patient access (sometimes called personal import) is the legal route we use for FDA-approved medicines such as Soliris. It is different from compassionate use, which covers investigational medicines through the manufacturer's own program; we do not supply investigational medicines. Eligibility and paperwork depend on the regulator in your country, and Reserve Meds maps the specific pathway for each market it coordinates.

Do I need a prescription to access Soliris through Reserve Meds?

Yes. Reserve Meds is not a pharmacy and does not prescribe. A valid prescription and clinical justification from your treating physician are required, and all clinical decisions remain with your physician.

How does Reserve Meds deliver Soliris to a patient?

Medicines are supplied through a US-licensed pharmaceutical wholesale partner, and Reserve Meds coordinates delivery of Soliris to your treating physician or hospital pharmacy, with appropriate handling for the product.

How long does it take, and what does Soliris cost through Reserve Meds?

After a short intake, the clinical team responds within one business day with case-specific feasibility, an indicative timeline, and a formal written quote. Cost depends on the destination, the prescribed regimen, and the duration of therapy, and is confirmed in writing before anything proceeds.

How do I start a request for Soliris?

Submit a 60-second intake through the Reserve Meds patient portal, or message our team on WhatsApp. We reply within one business day. On WhatsApp we usually reply the same day.

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