Soliris 300mg Injection (Eculizumab) – Complete Product Description

Soliris 300mg Injection (Eculizumab) is a specialized prescription biological medicine manufactured by Alexion. It contains eculizumab, a monoclonal antibody and terminal complement inhibitor used to treat certain rare and serious disorders involving abnormal activation of the complement immune system.

Soliris works by binding to complement protein C5, preventing its cleavage into C5a and C5b. This inhibits the formation of the terminal complement complex and helps reduce complement-mediated damage to healthy cells and tissues.

Soliris is used in selected patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD), according to applicable approved indications.

The product listed here is Soliris 300mg Injection, supplied in a pack size of 1 injection/vial. Soliris is administered by intravenous infusion under the supervision of a qualified healthcare professional.

Soliris 300mg Injection – Product Information

Brand Name: Soliris
Active Ingredient: Eculizumab
Strength: 300mg
Presentation: 300mg/30mL
Dosage Form: Solution for intravenous infusion
Route of Administration: Intravenous (IV) infusion
Manufacturer: Alexion
Pack Size: 1 injection/vial
Drug Class: Complement inhibitor
Therapeutic Class: Immunological / Rare-disease medicine
Prescription Status: Prescription medicine

The 300mg presentation is supplied as a single-dose vial containing eculizumab for intravenous administration.

What Is Soliris 300mg Injection Used For?

Soliris (Eculizumab) is used for selected patients with disorders in which uncontrolled complement activation contributes to disease.

Approved indications include:

• Paroxysmal nocturnal hemoglobinuria (PNH)
• Atypical hemolytic uremic syndrome (aHUS)
• Generalized myasthenia gravis (gMG) in appropriate antibody-positive patients
• Neuromyelitis optica spectrum disorder (NMOSD) in appropriate AQP4-antibody-positive patients

The exact indication, treatment duration and dosage depend on the patient’s diagnosis, age, weight and clinical condition.

Soliris for Paroxysmal Nocturnal Hemoglobinuria

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired blood disorder characterized by complement-mediated destruction of red blood cells.

Eculizumab inhibits terminal complement activation and can reduce intravascular hemolysis in patients with PNH.

Treatment may help reduce complications associated with ongoing hemolysis and improve disease control in appropriately selected patients.

Soliris for Atypical Hemolytic Uremic Syndrome

Atypical hemolytic uremic syndrome (aHUS) is a rare disorder involving uncontrolled complement activation and thrombotic microangiopathy.

Soliris inhibits complement-mediated activity and is used to help control complement-mediated thrombotic microangiopathy in patients with aHUS.

Soliris is not indicated for Shiga toxin-producing E. coli-related hemolytic uremic syndrome (STEC-HUS).

Soliris for Generalized Myasthenia Gravis

Soliris may be used for selected patients with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor antibodies, according to the applicable indication.

By inhibiting terminal complement activation, eculizumab can reduce complement-mediated damage associated with the autoimmune process at the neuromuscular junction.

Soliris for Neuromyelitis Optica Spectrum Disorder

Soliris is also indicated for appropriate patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin-4 (AQP4) antibodies.

NMOSD is a rare autoimmune neurological disorder that can cause attacks affecting the optic nerves and spinal cord. Eculizumab helps suppress complement-mediated immune activity associated with the disease.

How Does Soliris (Eculizumab) Work?

Soliris contains eculizumab, a monoclonal antibody that specifically targets the complement system.

Eculizumab binds to complement protein C5 and prevents its activation into C5a and C5b.

This blocks the formation of the terminal complement complex, including the membrane attack complex (MAC).

By inhibiting terminal complement activation, Soliris can reduce complement-mediated destruction of cells and tissues.

This mechanism is particularly important in diseases such as PNH and aHUS, where excessive complement activity contributes directly to disease.

Soliris 300mg Dose and Administration

Soliris 300mg is administered by intravenous infusion only.

The appropriate dose depends on the disease being treated, the patient’s age and body weight, and the applicable treatment protocol.

For example, adult PNH treatment commonly begins with:

• 600mg weekly for the first 4 weeks
• 900mg during week 5
• 900mg every 2 weeks thereafter

For adult aHUS, the commonly used regimen is:

• 900mg weekly for the first 4 weeks
• 1200mg during week 5
• 1200mg every 2 weeks thereafter

Different dosing schedules apply to generalized myasthenia gravis and NMOSD, while pediatric dosing may be weight-based.

Therefore, the 300mg vial is a presentation strength and does not necessarily represent the complete dose for one treatment session.

The treating specialist determines the required number of vials and total dose.

Do not self-administer Soliris.

Meningococcal Vaccination Before Soliris

One of the most important safety considerations with eculizumab is the substantially increased risk of serious meningococcal infection.

Patients should generally receive appropriate meningococcal vaccination against relevant serogroups before starting treatment. Current prescribing information recommends vaccination at least 2 weeks before the first dose, unless urgent treatment is required and the risks of delaying therapy outweigh the infection risk.

Importantly, vaccination does not completely eliminate the risk of meningococcal infection.

Patients receiving Soliris should be educated about symptoms of meningococcal disease and seek immediate medical attention if symptoms occur.

Common Side Effects of Soliris 300mg

Like all medicines, Soliris can cause side effects.

Possible adverse effects may include:

• Headache
• Nasopharyngitis
• Upper respiratory tract infection
• Back pain
• Nausea
• Diarrhea
• Dizziness
• Fatigue
• Abdominal discomfort
• Infusion-related reactions
• Cough
• Sore throat

The type and frequency of adverse effects can vary depending on the condition being treated and the patient’s overall health.

Serious Side Effects of Soliris

Serious Meningococcal Infection

The most important serious risk associated with Soliris is meningococcal infection caused by Neisseria meningitidis.

Such infections can rapidly become life-threatening or fatal.

Symptoms may include:

• Severe headache
• Fever
• Neck stiffness
• Nausea or vomiting
• Confusion
• Muscle aches
• Rash
• Severe weakness

Patients should seek immediate emergency medical attention if meningococcal infection is suspected. Vaccination reduces but does not eliminate this risk.

Other Serious Infections

Because Soliris inhibits part of the complement immune system, patients may have increased susceptibility to certain infections.

Any unexplained fever, severe illness or signs of infection should be reported promptly.

Infusion-Related Reactions

Some patients may experience reactions during or after intravenous administration.

Symptoms can include:

• Headache
• Nausea
• Dizziness
• Rash
• Changes in blood pressure
• Breathing difficulties

Healthcare professionals monitor patients during infusion and can slow or stop the infusion if clinically necessary.

Precautions Before Using Soliris 300mg

Before receiving Soliris, inform your doctor if you:

• Have an active infection
• Have recently had an infection
• Have not received recommended meningococcal vaccinations
• Have a history of serious infections
• Are pregnant or planning pregnancy
• Are breastfeeding
• Are receiving other immune-modifying medicines

Your doctor should review your vaccination status and medical history before treatment.

Soliris and Discontinuation of Treatment

Patients should not stop Soliris abruptly without medical supervision.

Stopping eculizumab can allow the underlying complement-mediated disease process to return. In PNH, discontinuation may be associated with recurrence of hemolysis and an increased risk of serious complications, including thrombosis.

In aHUS, discontinuation can result in recurrence of complement-mediated thrombotic microangiopathy.

Patients who discontinue treatment require appropriate medical monitoring according to their condition.

Soliris During Pregnancy

Patients who are pregnant or planning pregnancy should discuss Soliris treatment with their healthcare provider.

The potential benefits and risks of eculizumab during pregnancy should be evaluated individually by the treating specialist.

Do not discontinue treatment without medical advice, particularly when Soliris is being used for a serious complement-mediated disorder.

Soliris and Breastfeeding

Patients should discuss breastfeeding with their healthcare provider before receiving Soliris.

Because eculizumab is a specialized biological medicine, the treating physician should assess the potential benefits of treatment against potential risks to the infant.

Soliris 300mg Storage

Soliris is a temperature-sensitive biological medicine and should be stored according to the manufacturer’s approved storage conditions.

The product should be protected from light and handled according to appropriate pharmaceutical procedures.

Do not freeze or shake Soliris.

The medicine should be prepared and administered only by qualified healthcare professionals.

Soliris 300mg Injection Price in Pakistan

The Soliris 300mg Injection price in Pakistan may vary depending on availability, supplier, import costs, exchange rates and prevailing market conditions.

For the latest Soliris 300mg price in Pakistan, customers can contact MedicineWalyDost.com to check current availability and pricing.

Because Soliris is a highly specialized rare-disease biological medicine, pricing and availability may vary significantly.

Why Choose Soliris 300mg Injection?

Soliris contains eculizumab, a targeted terminal complement inhibitor with an established role in the management of several rare complement-mediated disorders.

Its mechanism specifically targets complement protein C5, helping reduce excessive terminal complement activation.

The Alexion Soliris 300mg Injection presentation is supplied as a 300mg/30mL single-dose vial and is listed here with a pack size of 1 injection/vial.

Because Soliris carries a serious meningococcal infection risk, treatment requires careful specialist supervision, vaccination planning and ongoing monitoring.

Frequently Asked Questions About Soliris 300mg

What is Soliris 300mg Injection?

Soliris 300mg Injection is a prescription biological medicine containing eculizumab, a monoclonal antibody that inhibits the terminal complement pathway.

What is the generic name of Soliris?

The generic name is eculizumab.

Who manufactures Soliris 300mg Injection?

The product listed here is manufactured by Alexion.

What is the pack size of Soliris 300mg?

The pack size is 1 injection/vial.

What is Soliris used for?

Soliris is used for selected patients with PNH, aHUS, generalized myasthenia gravis and AQP4-antibody-positive NMOSD, according to applicable approved indications.

How is Soliris 300mg administered?

Soliris is administered by intravenous infusion under the supervision of a qualified healthcare professional.

Is 300mg the complete Soliris treatment dose?

Not necessarily. Soliris is supplied in a 300mg vial, while the total prescribed dose may require multiple vials depending on the disease and treatment schedule.

Is meningococcal vaccination required before Soliris?

Meningococcal vaccination is a critical safety requirement for patients starting Soliris. Current prescribing information recommends appropriate vaccination before treatment whenever possible. However, vaccination does not completely eliminate the risk of meningococcal infection.

Can Soliris be stopped suddenly?

No. Soliris should not be discontinued without specialist medical supervision because the underlying disease can return and serious complications may occur.

Is Soliris chemotherapy?

No. Soliris is a targeted biological complement inhibitor, not conventional chemotherapy.

Can Soliris 300mg be purchased without a prescription?

Soliris is a highly specialized prescription medicine and should only be used under the supervision of an appropriately qualified specialist.

Order Soliris 300mg Injection in Pakistan

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Important Medical Disclaimer

Soliris 300mg Injection is a highly specialized prescription biological medicine. This product description is provided for educational and e-commerce purposes only and does not replace professional medical advice. Eculizumab significantly increases the risk of serious meningococcal infection and requires appropriate vaccination, monitoring and specialist supervision. Do not start, stop or change Soliris treatment without consulting your treating healthcare professional.