HUMAN C1-ESTERASE
Background and Date of Approval
The U.S. FDA approved Human C1-esterase inhibitor to prevent hereditary angioedema on 22 June 2017. Human C1-esterase inhibitor is a complement inhibitor medication. The active ingredient is Human C1-esterase inhibitor, a naturally occurring human protein found in blood that regulates inflammation and swelling.
Uses
Human C1-Esterase prevents hereditary angioedema in adults, adolescents, and children (six years or above) by increasing the amount of C1-esterase inhibitors in the bloodstream.
How is it administered?
The medicine will be administered to you by a healthcare professional in a hospital setting. It is usually administered as an intravenous injection into a vein. Your doctor will decide the dose, route of administration, and frequency based on your disease condition and other factors.
Side Effects
The most common side effects of Human C1-Esterase are headache, nausea, hypersensitivity, dizziness, vomiting, rashes or pain at the injection site, and fever. Serious side effects while taking Human C1-Esterase are sudden wheeziness, difficulty breathing, swelling in eyelids, face, or lips, and rash or itching.
Warnings
Do not take this medicine if you are allergic to Human C1-esterase or its other ingredients. Before starting the treatment, inform your doctor if you have a history of venous and arterial thromboembolic (blood clotting) conditions or plan to get a vaccination against hepatitis A or B. Notify your doctor if you have an indwelling venous catheter (a plastic tube facilitates urine drainage from the bladder), atherosclerosis, using oral contraception (androgen), morbid obesity and immobility (have been on bedrest or are unable to move around for a long time).
Precautions
Inform your physician if you are pregnant or planning to get pregnant, think you may be pregnant or breasting. Notify your doctor if you are on a sodium diet, as this medicine contains sodium. Consult your doctor for more information. This medicine is made from human blood, so there is a risk of viral transmission. The manufacturers take extensive measures to minimize this risk, including testing the plasma donors for various infectious agents and performing viral inactivation during manufacturing. However, it is crucial to discuss any concerns with your healthcare provider.
Word of Advice
Keep out of sight and reach of children and pets. Store below 25°C. Do not freeze. If you have missed any dosing appointments, inform your doctor and schedule the next appointment immediately. Inform your doctor of any other medicines you are taking alongside Human C1-esterase. Administer the injection as directed by your healthcare provider. Do not exceed or skip doses without consulting your doctor. Notify your doctor if you experience any serious side effects.
References
Takeda Manufacturing Austria AG, Electronic medicines compendium (emc), [Revised on Dec 2022], [ Accessed on 26th May 2023], Cinryze, INN-C1 inhibitor (human) (medicines.org.uk) Viro Pharma Biologics LLC, US Food and Drug Administration, [Revised on Mar 2022], [ Accessed on 24th May 2023], https://www.fda.gov/media/75907/download
Frequently Asked Questions
How is human C1-esterase administered?
Human C1-esterase products are administered intravenously (IV) under medical supervision, directly into the bloodstream. Kindly do not self-administer.
Can I take Human C1-Esterase if I'm pregnant?
There are only limited studies are available on pregnant women. Hence, notify your doctor if you are pregnant or planning to get pregnant.
Can Human C1-esterase injection cause skin problems?
One of the common side effects of Human C1-esterase injection is skin rash and itching. This usually gets normal when your treatment finishes. Contact your doctor if you experience it.
Can I use a Human C1-esterase injection for children?
Human C1-esterase injection is prescribed for children but not for under six years of age. Before injecting, consult your doctor and mention your children's age to find the right dosage.
When should I contact my doctor?
Notify your medical professional if you experience any side effects, especially allergic reactions with swelling of the face, tongue, genital, or lips, difficulty in breathing, rashes, itches or dizziness.