What is complement C1 esterase inhibitor?
Complement C1 esterase inhibitor is a man-made form of a protein that occurs naturally in the
bloodstream and helps control inflammation in the body. In people with hereditary angioedema,
complement C1 esterase inhibitor does not function properly or occurs in low levels.
Complement C1 esterase inhibitor is used to prevent atttacks of angioedema in people with
hereditary angioedema.
Complement C1 esterase inhibitor may also be used for other purposes not listed in this
medication guide.
What should I discuss with my healthcare provider before taking complement C1 esterase inhibitor?
You should not use this medication if you have ever had an allergic reaction to it, or if you
have ever had any other life-threatening allergic reaction.
If you have certain conditions, you may need a dose adjustment or special tests to safely use
this medication. Before using complement C1 esterase inhibitor, tell your doctor if you have a history of
stroke or blood clot.
FDA pregnancy category C. It is not known whether this medication is harmful to an
unborn baby. Before using complement C1 esterase inhibitor, tell your doctor if you are pregnant or
plan to become pregnant during treatment.
It is not known whether complement C1 esterase inhibitor passes into breast milk or if it
could harm a nursing baby. Do not use this medication without telling your doctor if you are
breast-feeding a baby.
Complement C1 esterase inhibitor is made from human plasma (part of the blood) and may
contain viruses and other infectious agents that can cause disease. Although donated human plasma is
screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there
is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of
using this medication.
Do not give this medication to a child, even if you think the child has the same condition you
have.
How should I take complement C1 esterase inhibitor?
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for
longer than recommended. Follow the directions on your prescription label.
Complement C1 esterase inhibitor is given as an injection through a needle placed into a vein.
Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how
to use your medicine at home.
Do not self-inject this medicine if you do not fully understand how to give the injection and
properly dispose of needles, IV tubing, and other items used in giving the medicine. This medication
comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your
doctor or pharmacist if you have any questions.
Complement C1 esterase inhibitor is usually given every 3 or 4 days for routine prevention of
angioedema attack. An IV infusion takes about 10 minutes to complete.
Complement C1 esterase inhibitor is a dry powder that must be mixed with a liquid (diluent)
before using it. If you do not receive the diluent with your medication at the pharmacy, talk to your
pharmacist.
If you are using the injections at home, be sure you understand how to properly mix and store
the medication. Do not mix the medicine until you are ready to give the injection.
Complement C1 esterase inhibitor contains no preservative. Once you have pierced the
rubber top of a vial with a needle, you must use that vial right away or throw it away.
Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one
use, even if there is still some medicine left in it after injecting your dose.
After mixing complement C1 esterase inhibitor with the diluent, use it right away or store the
mixture at room temperature and use it within 3 hours. The mixed medicine should be clear or slightly
blue in color. Do not use the mixed medication if it has changed colors, is cloudy, or has any particles
in it.
Use each disposable needle only one time. Throw away used needles in a puncture-proof
container (ask your pharmacist where you can get one and how to dispose of it). Keep this container
out of the reach of children and pets.
Store the unmixed dry powder in a refrigerator or in a dark cool place. Keep the medicine
protected from light and do not allow it to freeze. Throw away any unused vial after the expiration date
on the label has passed.
What happens if I miss a dose of complement C1 esterase inhibitor?
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until
then to use the medicine and skip the missed dose.
Do not
use extra medicine to
make up the missed dose.
Where can I get more information about complement C1 esterase inhibitor?
Your pharmacist has information about complement C1 esterase inhibitor written for health professionals that you may read.
What are the possible side effects of complement C1 esterase inhibitor?
Stop your IV infusion and get emergency medical help if you have any of these
signs of an allergic reaction:
hives; wheezing or difficult breathing; feeling like you might
pass out; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any other serious side effect, such as:
-
sudden numbness or weakness, especially on one side of the body;
-
sudden headache, confusion, problems with vision, speech,
or balance;
-
stomach pain or swelling;
-
chest pain, sudden cough, rapid breathing, fast heart rate;
or
-
pain or swelling in one or both legs.
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about complement C1 esterase inhibitor?
You should not use this medication if you have ever had an allergic reaction to it, or if you
have ever had any life-threatening allergic reaction.
If you have certain conditions, you may need a dose adjustment or special tests to safely use
this medication. Before using complement C1 esterase inhibitor, tell your doctor if you have a history of
stroke or blood clot.
Do not self-inject this medicine if you do not fully understand how to give the injection and
properly dispose of needles, IV tubing, and other items used in giving the medicine. This medication
comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your
doctor or pharmacist if you have any questions.
If you are using the injections at home, be sure you understand how to properly mix and store
the medication. Do not mix the medicine until you are ready to give the injection.
Stop your IV infusion and get emergency medical help if you have any of these
signs of an allergic reaction:
hives; wheezing or difficult breathing; feeling like you might
pass out; or swelling of your face, lips, tongue, or throat.
Other serious side effects may include sudden numbness or weakness, chest pain, confusion,
pain or swelling, and problems with vision, speech, or balance.
Complement C1 esterase inhibitor is made from human plasma (part of the blood) and may
contain viruses and other infectious agents that can cause disease. Although donated human plasma is
screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there
is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of
using this medication.
What should I avoid while taking complement C1 esterase inhibitor?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while
you are using complement C1 esterase inhibitor.
What other drugs will affect complement C1 esterase inhibitor?
There may be other drugs that can interact with complement C1 esterase inhibitor. Tell your
doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal
products, and drugs prescribed by other doctors. Do not start a new medication without telling your
doctor.
What happens if I have an overdose of complement C1 esterase inhibitor?
