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General Information on Eculizumab

Generic Name : Eculizumab

Pronunciation : E-kue-LIZ-oo-mab

Latest prescription information about Eculizumab. Learn how to pronounce the drug's name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
ICD Code : Y43.4 | Therapeutic Classification : Monoclonal antibodies

Trade Names/Brand Names of Eculizumab

International- Soliris.

Why is Eculizumab Prescribed? (Indications)

Eculizumab is a monoclonal antibody, which is prescribed for two conditions:
• Paroxysmal nocturnal hemoglobinuria (PNH) in which red blood cells (RBCs) are broken down resulting in anemia and decreased oxygen supply to the body.
• Atypical hemolytic uremic syndrome (aHUS), where small blood clots are formed which block blood supply and cause damage to kidney and other organs.
Eculizumab is an orphan drug since it is used only for the above rare conditions. It acts by blocking a part of the immune system called the complement system. In paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, the complement system acts abnormally and destroys the red blood cells and increases the risk of blood clots respectively.
 

When should Eculizumab not to be taken? (Contraindications)

Eculizumab is contraindicated in patients who are allergic to the drug, in patients with unresolved serious Neisseria meningitidis infection, or who have not been vaccinated against the infection, unless the benefit of the drug outweigh the risk of suffering from meningococcal infection.

What is the dosage of Eculizumab?

Paroxysomal nocturnal hemoglobinuria: Intravenous dose of 600 mg is administered weekly for the first 4 weeks, followed by 900 mg 7 days later for the fifth dose; thereafter 900 mg is administered once every two weeks.
Atypical hemolytic uremic syndrome: In adults, 900 mg is administered weekly for four weeks followed by fifth dose of 1200 mg after another week; thereafter 1200 mg is administered once every two weeks. Dosage in children depends on their body weight.
Additional doses are required if the patient undergoes plasma exchange or is administered fresh frozen plasma infusion.

How should Eculizumab be taken?

It comes as a solution for injection to be injected intravenously (into the vein) for over 35 minutes in adults and 1-4 hours in children. The drug should not be administered as intravenous push or bolus injection.

What are the warnings and precautions for Eculizumab?

• Caution should be exercised in patients with history of infection, fever, any allergy, who are taking other medications, children, during pregnancy and breastfeeding.

• Avoid contact with people who have infections.

• Immunize patients with meningococcal vaccine two weeks prior to the treatment, as eculizumab increases the risk of life-threatening and fatal meningococcal infections. Children should also be vaccinated against Streptococcus pneumoniae and Hemophilus influenza type b (Hib).

• Because of the risk of meningococcal infections, eculizumab is made available only to prescribers who enroll in Risk Evaluation and Mitigation Strategy (REMS) program. The physician should educate the patient about the risk of meningococcal infection following use of the drug. The patient should be followed up and carry a card indicating his/her risk for meningococcal infection till about three months following the completion of treatment.

• Inform your doctor about the use of other medications before the administration of eculizumab to avoid serious side effects.

What are the side effects of Eculizumab?

•  Infections: Meningococcal infections with symptoms of headache, fever, nausea, vomiting, stiff neck or stiff back, rash, muscle aches, flu-like syndrome and /or increased sensitivity of eyes to light; upper respiratory tract infections and urinary tract infections.
•  Gastrointestinal: Nausea, vomiting, stomach pain, diarrhea, constipation
•  Allergy: Allergy to the drug may include a severe anaphylactic reaction.
•  Central nervous system: Headache, difficulty in falling asleep
•  Muscular: Muscle, back, limb and/or joint pain.
•  Respiratory: Sore throat, cough, sinusitis, runny nose.
•  Cardiovascular: High blood pressure, fluid accumulation, increase in heart rate, low blood pressure.
•  Kidney: Reduced kidney function
•  Blood: Anemia, low white blood cell count, low blood potassium levels. Excessive clotting of blood may occur after stopping treatment in patients with atypical hemolytic uremic syndrome
•  Skin: Rash, itching.

What are the other precautions for Eculizumab?

Avoid excess dosage. Discontinue the drug if the patient suffers from severe meningococcal infections.

What are the Drug Interactions of Eculizumab?

Eculizumab may reduce the effects of vaccines.
Use with caution with other immunosuppressants due to possible additional effect or increased toxicity.
Consult a doctor before using other medications with eculizumab to avoid dangerous drug- drug interactions

What are the storage conditions for Eculizumab?

Store it in refrigerator (2-8ēC). Do not freeze and do not shake the vial. Protect it from light.

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