Background: Soliris (Eculizumab Injection) is a medicine launched for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH), generalised myasthaenia gravis (GMG), atypical haemolytic uraemic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD).

The medication is developed and manufactured by the US based pharmaceutical company Alexion Pharmaceuticals, a subsidiary of AstraZeneca. It was given orphan drug designation by the FDA in the month of October, 2003. Alexion Pharma submitted a new drug application for Soliris (Eculizumab) to the Food and Drug Administration in the month of September, 2006.

The Food and Drug Administration first approved the drug in the year of 2007 for the treatment of patients with PNH. This medication is also approved by the FDA for the treatment of aHUS, gMG and NMOSD.

In the month of February, 2009, the Australian Therapeutic Goods Administration approved Soliris for the treatment of patients with PNH. The medication is also approved in Canada, EU, and Japan for the treatment of patients with PNH, aHUS and gMG. 

In the month of August, 2019, the European Commission (EC) granted the marketing authorisation approval (MAA) of Soliris. 

In the month of November, 2019, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Soliris for the prevention of relapse in patients with NMOSD.

Soliris (Eculizumab) is used as an experimental emergency treatment for Coronavirus (COVID-19) infection and severe pneumonia in a certain number of patients. The potential role of Soliris in Coronavirus Disease (COVID-19) treatment is still under investigation.

Dosage Forms, Strength and Administration: The drug Soliris is supplied as 300 mg single-use vials, containing 30 mL of 10 mg/mL sterile, preservative-free eculizumab solution. Do not administer this drug as an intravenous push or bolus injection. The eculizumab admixture should be given by IV over 35 minutes via gravity feed, a syringe type pump, or an infusion pump. Admixed solutions of eculizumab are stable for 24 hours at 2°C-8° C (36-46° F) and at room temperature. In case adverse reaction occurs while on therapy with eculizumab, the therapy may be slowed or interrupted at the discretion of your health specialist. In case the infusion is slowed, the total infusion time must not exceed a couple of hours. Patients should be monitored for at least 60 minutes after completion of the infusion for signs/symptoms of an infusion reaction.

How Soliris Works: Eculizumab, the API or active pharmaceutical ingredient of Soliris, is specifically  a recombinant monoclonal antibody that identifies and adheres to antigens that exist in the body. Eculizumab mainly adheres to the C5 complement protein as well as inhibits it. The protein (C5 complement) is a part of the immune (defense) system’s complement cascade whose activation causes the above conditions to develop.

More About Soliris (Eculizumab):

Possible Side Effects: In patients taking eculizumab injection, the possible reported side effects may include:

• Nausea and vomiting (throwing up)
• Pain in your abdomen
• Diarrhea (loose bowel movements)
• Fever
• Swelling of your legs, ankles and/or feet
• Urinary tract infection
• Headache
• Back pain
• Muscle and bone pain
• Cough and upper respiratory infection
• Inflammation of the nasal passages and throat
• High blood pressure
• Low level of red blood cells. This can make you feel extremely tired.

Note: Each of the adverse reactions above was reported in 10% or higher of patients treated with eculizumab for blood disorders. Not all possible adverse reactions are included above.

Reproduction Warnings:

Pregnancy warning: It is unspecified  if this medication may be responsible for causing harm to an unborn child. For this, besure to discuss with your health specialist in case you are pregnant or want to become pregnant while taking treatment with eculizumab. Let your healthcare professional know promptly in case you think you may be pregnant or may have impregnated your partner.

Breastfeeding warning: It is unspecified if this medication passes into the breast milk. For this, women must discuss to their health specialist about the possible risks as well as benefits of breastfeeding while on treatment with this medication because it may enter the breast milk and can be responsible for causing harm to a breastfeeding baby.

Fertility warning: Human fertility studies have not been performed with this medicine. Discuss with your health specialist in case you plan to have children. Ask for more information on sperm or egg banking.

Other Important Information:

• Eculizumab may exist in the tears, sweat, saliva, urine, stool, semen, vomit, and vaginal secretions. Discuss with your health specialist about the necessary precautions to consider during this time-span.
• The meningococcal vaccination is needed at least 2 weeks before starting eculizumab therapy or as soon as possible in case urgent therapy is required. In case you require urgent therapy, you should also receive 14 days of antibiotics with your vaccination. Discuss with your healthcare team about vaccination.
• You will be required to sign up for a special program known as Eculizumab REMS when you start taking this medicine. Your health specialist will help you get started.

Price of Soliris: The soliris price can vary depending on various factors, including nature of disease, severity of disease and patients overall condition. In order to procure soliris at the best discounted price, kindly reach out to us at TOLL-FREE: 1800-889-1064. We’re certified (WHO-GDP & ISO) supplier of soliris, based in India. 

How Supplied/Storage & Handling: Soliris (eculizumab) is supplied as 300 mg single-use vials containing 30 mL of 10 mg/mL sterile, preservative-free solution per vial. The vials need to be stored in the original carton until time of use under refrigerated conditions at 2°C to 8°C (36°F to 46°F) and protected from the light. Do not use the vials of eculizumab beyond the expiration date stamped on the carton. 

Note: Please read full soliris prescribing information (PI) before you start treatment with Soliris.