Soliris® (Eculizumab) — Targeted Complement Inhibitor for Rare Diseases

A Sourcing Guide for Hospitals and Specialty Clinics

Soliris® (Eculizumab) is a humanised monoclonal antibody indicated, according to the manufacturer’s approved prescribing information, for the treatment of paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), and generalised myasthenia gravis in patients who are anti-acetylcholine receptor antibody positive, among other approved indications. As with all complement inhibitor therapies, the decision to prescribe Soliris, including risk assessment for meningococcal infection and vaccination requirements, rests entirely with the treating specialist, in accordance with the approved label. This page provides sourcing and procurement information for hospitals and specialty clinics, not clinical or treatment guidance.

As both a trusted medicine distributor in Delhi and a licensed pharmaceutical distributor in Delhi, A.K. Pharma supplies genuine Soliris (Eculizumab) 300mg to hospitals, haematology centres, neurology clinics, and pharmacies across India, with cold chain-compliant handling throughout procurement and delivery.

What is Soliris (Eculizumab)?

Soliris contains Eculizumab, a humanised monoclonal antibody that selectively binds to complement protein C5, a key component of the terminal complement pathway of the immune system.

The Complement System and Its Role in PNH, aHUS, and Myasthenia Gravis:

According to published immunology and haematology literature, the complement system is part of the innate immune response, and its terminal pathway culminates in the formation of the membrane attack complex, which can destroy target cells. In several rare diseases, this normally protective mechanism becomes dysregulated and drives disease pathology:

• In PNH, red blood cells lack certain protective surface proteins due to an acquired genetic mutation, leaving them vulnerable to complement-mediated destruction (haemolysis), causing anaemia, fatigue, and thrombosis risk
• In aHUS, uncontrolled complement activation drives widespread microvascular thrombosis, leading to haemolytic anaemia, thrombocytopenia, and acute kidney injury
• In generalised myasthenia gravis (in antibody-positive patients), complement activation at the neuromuscular junction, triggered by autoantibodies, contributes to the destruction of acetylcholine receptors, impairing nerve-to-muscle signal transmission

Eculizumab’s Mechanism: By binding to complement protein C5, Eculizumab prevents its cleavage into C5a and C5b, blocking the generation of the terminal membrane attack complex, according to the manufacturer’s prescribing information. This halts the complement-mediated destructive process common to these otherwise distinct diseases, addressing the shared underlying mechanism rather than the individual downstream conditions separately.

Full prescribing information is available at the FDA label for Eculizumab, with additional background on complement-mediated rare diseases available via the National Organization for Rare Disorders (NORD).

Clinical Studies and Evidence

Pivotal PNH Trials (Eculizumab in Paroxysmal Nocturnal Haemoglobinuria)
Published in the New England Journal of Medicine (2006), pivotal trials established Eculizumab’s efficacy in reducing intravascular haemolysis, stabilising haemoglobin levels, and reducing transfusion requirements in patients with PNH, forming the basis for its original regulatory approval — the first approved complement inhibitor therapy for this condition.

Pivotal aHUS Trials (Eculizumab in Atypical Haemolytic Uraemic Syndrome)
Published in the New England Journal of Medicine (2013), trials in aHUS demonstrated improvement in haematological parameters and renal function with Eculizumab treatment, establishing its role as the first targeted therapy for this life-threatening condition, which previously relied primarily on plasma exchange therapy.

REGAIN Trial (Eculizumab in Generalised Myasthenia Gravis)
Published in Lancet Neurology (2017), the REGAIN trial evaluated Eculizumab in patients with anti-acetylcholine receptor antibody-positive generalised myasthenia gravis refractory to standard therapies, demonstrating improvement in myasthenia gravis-specific outcome measures compared to placebo, supporting its approval in this additional indication.

For broader clinical context on complement-mediated disease management, the American Society of Hematology publishes ongoing clinical guidance.

Available Strength

Soliris is available as:

Dosing regimen, including loading and maintenance phase schedules, is determined by the prescribing specialist according to the specific indication being treated, in accordance with the approved label.

Indications — What Soliris is Used For

Paroxysmal Nocturnal Haemoglobinuria (PNH):

• Adults and paediatric patients (per approved age criteria) with PNH, to reduce haemolysis

Atypical Haemolytic Uraemic Syndrome (aHUS):

• Adults and paediatric patients with aHUS, to inhibit complement-mediated thrombotic microangiopathy

Generalised Myasthenia Gravis:

• Adults who are anti-acetylcholine receptor antibody positive

Additional approved indications exist per the current prescribing information, including neuromyelitis optica spectrum disorder in certain regulatory jurisdictions.

Given the complexity and rarity of these conditions, diagnosis and treatment initiation typically occur at specialist centres with experience managing complement-mediated diseases.

For detailed indication information refer to MedlinePlus Eculizumab.

Key Benefits of Soliris

First-in-Class Complement Inhibitor
Soliris was the first approved complement C5 inhibitor, establishing an entirely new therapeutic category for diseases driven by complement dysregulation, across what were previously difficult-to-treat rare conditions.

Addresses Shared Underlying Mechanism Across Distinct Diseases
By targeting the terminal complement pathway directly, Soliris addresses the common pathological mechanism across PNH, aHUS, and antibody-positive myasthenia gravis, despite these being clinically distinct conditions.

Established Evidence Base Across Multiple Rare Diseases
Pivotal trials across each approved indication have demonstrated meaningful clinical benefit, supporting Soliris’s role as a foundational option in complement-mediated disease management.

Dosage and Administration — General Reference

Dosing of Soliris is determined by the prescribing specialist according to the approved label for the specific indication being treated. General administration information from the manufacturer’s prescribing information includes:

• Administered as an intravenous infusion
• Typically involves an initial loading phase followed by a maintenance dosing schedule, with intervals varying by indication
• Requires appropriate infusion monitoring per standard clinical protocol

Monitoring (per manufacturer prescribing information):

• Meningococcal infection risk assessment — a Boxed Warning applies given the mechanism of complement inhibition; vaccination against meningococcal disease is required prior to initiating therapy, except in specific urgent circumstances defined in the approved label
• Signs and symptoms of infection throughout treatment, given increased susceptibility to encapsulated bacterial infections
• Haematological and renal parameters relevant to the specific indication being treated

Full dosing guidelines are available in the manufacturer’s official prescribing information and should always be followed exactly as directed by the treating specialist.

Who Should Use Soliris

Soliris is prescribed by haematologists, nephrologists, and neurologists for:

• Adults and paediatric patients with PNH
• Adults and paediatric patients with aHUS
• Adults with anti-acetylcholine receptor antibody-positive generalised myasthenia gravis

Soliris is prescribed by specialists managing complement-mediated rare diseases, typically at centres experienced with these conditions. A.K. Pharma supplies Soliris to hospitals and specialty clinics across Delhi and India.

Possible Side Effects

Common side effects reported in clinical trials include headache, nasopharyngitis, back pain, and nausea.

Serious side effects include:

Meningococcal Infection: A Boxed Warning addresses the serious risk of life-threatening meningococcal infection associated with complement C5 inhibition, given the role of the complement system in immune defence against encapsulated bacteria. Vaccination is required prior to treatment initiation per the approved label, except in defined urgent circumstances, and patients should be monitored for early signs of meningococcal infection throughout treatment.

Other Serious Infections: Increased susceptibility to infections caused by encapsulated bacteria, given the mechanism of terminal complement blockade.

Infusion Reactions: Reported with intravenous administration; monitoring during and after infusion is recommended per standard clinical protocol.

Full side effect information is available at FDA Eculizumab Safety Information.

Precautions

• Meningococcal infection — Boxed Warning; vaccination required prior to treatment except in defined urgent circumstances; ongoing monitoring for signs of infection throughout treatment
• Other serious infections — increased susceptibility given complement pathway inhibition
• Infusion reactions — monitoring during and after administration
• Treatment discontinuation — requires close monitoring given risk of disease recurrence for the underlying condition; should only be done under specialist guidance
• Pregnancy — use per physician assessment of benefit versus risk, in accordance with the approved label
• Refer to manufacturer prescribing information for complete management context

Storage and Handling

• Store in a refrigerator (2°C to 8°C)
• Do not freeze
• Protect from light
• Keep out of reach of children

As a responsible medicine distributor in Delhi, A.K. Pharma stores all complement inhibitor biologics including Soliris under manufacturer-recommended cold chain conditions ensuring product integrity for every supply.

Manufacturer Information

Soliris (Eculizumab) is manufactured by Alexion Pharmaceuticals (AstraZeneca). Eculizumab received regulatory approval as the first complement C5 inhibitor, with indications subsequently expanded to aHUS, generalised myasthenia gravis, and other complement-mediated conditions. A.K. Pharma supplies only genuine Soliris sourced from authorised distributors.

Related Rare Disease and Specialty Medicines Available at A.K. Pharma

• Emblaveo (Emapalumab) — another rare disease immunology biologic available from A.K. Pharma
• Sabril (Vigabatrin) — rare disease neurology medicine for infantile spasms
• Browse the full Products range available at A.K. Pharma
• Learn more About A.K. Pharma as a specialty medicine distributor

Frequently Asked Questions

Q. What is Soliris used for?
Soliris (Eculizumab) is used to treat paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), and generalised myasthenia gravis in antibody-positive patients, among other approved indications.

Q. What is the generic name of Soliris?
The generic name of Soliris is Eculizumab, the first approved complement C5 inhibitor.

Q. Why is meningococcal vaccination required before starting Soliris?
Because Soliris blocks part of the complement system that normally helps defend against certain bacterial infections, patients face an increased risk of meningococcal infection. Vaccination is required before starting treatment, except in defined urgent circumstances, per the approved prescribing information.

Q. Can Soliris treat more than one condition?
Yes. Soliris is approved for multiple complement-mediated conditions, including PNH, aHUS, and generalised myasthenia gravis, because these distinct diseases share a common underlying mechanism involving uncontrolled complement activation.

Q. Is Soliris available in India?
Soliris can be supplied to hospitals and specialty clinics across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi and pharmaceutical distributor in Delhi — for availability and pricing.

Q. What is the price of Soliris in India?
Soliris price in India varies by order quantity. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.

Q. How to order Soliris from A.K. Pharma?
You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.

Q. Does A.K. Pharma supply Soliris in bulk?
Yes. A.K. Pharma supplies Soliris in bulk to hospitals and specialty clinics across Delhi and India.

Why Order Soliris from A.K. Pharma?

• Licensed medicine distributor in Delhi and pharmaceutical distributor in Delhi with all required drug licenses
• 100% genuine Soliris sourced from authorised distributors
• Cold chain-compliant storage and delivery for biologic integrity
• Available alongside other rare disease and specialty biologics — Emblaveo, Sabril — simplifying procurement
• Bulk supply available for hospitals and specialty clinics
• Prompt response to all quote requests
• Serving haematologists, nephrologists, and neurologists across Delhi NCR and India

Contact A.K. Pharma for Soliris Supply

📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052
📞 011 4172 6999
📱 WhatsApp: +91 9810034827
🌐 akpharma.in

Disclaimer: This page is intended for informational and sourcing/procurement purposes only and does not constitute medical or clinical advice. All treatment decisions, including drug selection and dosing, should be made by a qualified healthcare professional in accordance with the approved prescribing information. A.K. Pharma is a licensed medicine distributor and does not provide clinical guidance.