ECULIZUMAB
Background and Date of Approval
Eculizumab is a monoclonal antibody used to treat rare blood and kidney disorders. It received FDA approval in March 2007 for paroxysmal nocturnal hemoglobinuria (PNH), and was subsequently approved for additional conditions including atypical haemolytic uremic syndrome (aHUS) and generalised myasthenia gravis (gMG).
Uses
Eculizumab is approved for the following conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH): Prevents destruction of red blood cells and reduces anaemia and risk of blood clots. Atypical Hemolytic Uremic Syndrome (aHUS): Helps protect kidneys and prevents organ damage caused by uncontrolled complement activation. Generalised Myasthenia Gravis (gMG): Reduces muscle weakness and improves daily functioning in patients with antibodies against acetylcholine receptors. Prevention of Complement-Mediated Organ Damage: Used in conditions where overactivation of the complement system can harm organs. Other Rare Complement-Mediated Disorders : May be prescribed for other conditions as determined by a physician.
How is it administered?
Eculizumab is given intravenously (IV) by a healthcare professional in a hospital or clinic. Your doctor will determine the dose and frequency based on your condition. Infusions are typically administered every 2–4 weeks. You will be closely monitored for side effects during and after the infusion. Do not self-administer this medicine at home.
Side Effects
Like all medications, Eculizumab can cause side effects, although not everyone who takes it will experience them. Serious Severe infections (due to immune system suppression) Infusion-related reactions (fever, chills, low blood pressure, difficulty breathing) Blood clots (deep vein thrombosis or pulmonary embolism) Liver problems (jaundice, dark urine, abdominal pain, nausea, vomiting) Allergic reactions (rash, swelling, severe itching, anaphylaxis) Common Headache Fatigue Nausea Diarrhea Fever or mild chills Dizziness Cough or mild shortness of breath Skin rash or redness at the injection site
Warnings
Eculizumab increases susceptibility to certain infections, especially meningococcal disease. Patients must be vaccinated against Neisseria meningitidis at least 2 weeks before starting treatment. Inform your physician if you have a history of infections or immune disorders.
Precautions
Do not take Eculizumab if you are allergic to it or any of its ingredients. Inform your doctor about liver or kidney problems before starting therapy. Let your healthcare provider know all medications, including prescription drugs, supplements, and herbal products. Certain medicines may interact with Eculizumab. Eculizumab is intended for adult patients or children under specialist supervision
References
https://www.drugs.com/monograph/Eculizumab.html https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125166s358lbl.pdf https://pubchem.ncbi.nlm.nih.gov/compound/Eculizumab https://en.wikipedia.org/wiki/Eculizumab
Frequently Asked Questions
 Does Eculizumab interact with other medications?
Yes, Eculizumab can interact with other medications, including immunosuppressant drugs, vaccines, and certain antibiotics.
What is Eculizumab used for?
Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalised myasthenia gravis (gMG) by controlling harmful immune activity.
Can I take Eculizumab during pregnancy or breastfeeding?
Eculizumab is not recommended during pregnancy or breastfeeding. Women should discuss contraception and breastfeeding options with their doctor.
 What precautions should I take while on Eculizumab?
Follow your doctor’s instructions carefully, report side effects promptly, maintain a healthy diet, stay hydrated, and use sun protection. Women should use effective contraception if there’s a chance of pregnancy.
How is Eculizumab administered?
It is given as an intravenous (IV) infusion by a healthcare professional. Self-administration at home is generally not recommended.