What is alpha 1-proteinase inhibitor?
Alpha 1-proteinase inhibitor is a protein, also called alpha 1-antitrypsin. This protein
occurs naturally in the body and is important for preventing the breakdown of tissues in the
lungs.
In people who lack the alpha 1-antitrypsin protein, breakdown of lung tissues can lead to
emphysema (damage to the air sacs in the lungs).
Alpha 1-proteinase inhibitor is used to treat alpha 1-antitrypsin deficiency in people who
have symptoms of emphysema.
Alpha 1-antitrypsin deficiency is a genetic (inherited) disorder and alpha 1-proteinase
inhibitor will not cure this condition.
Alpha 1-proteinase inhibitor may also be used for other purposes not listed in this
medication guide.
What should I discuss with my healthcare provider before taking alpha 1-proteinase inhibitor?
You should not use this medication if you have ever had an allergic reaction to alpha
1-proteinase inhibitor, or if you have an IgA deficiency or antibody against IgA.
Before you receive alpha 1-proteinase inhibitor, tell your doctor about all of your
medication conditions.
FDA pregnancy category C. Alpha 1-proteinase inhibitor may be harmful to an
unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether alpha 1-proteinase 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.
Alpha 1-proteinase 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.
How should I take alpha 1-proteinase inhibitor?
Alpha 1-proteinase inhibitor is usually given once per week. 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.
Alpha 1-proteinase 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.
You will most likely receive your first few doses of this medication in a hospital or
clinic setting where your vital signs can be watched closely in case the medication causes serious
side effects.
You will need to mix alpha 1-proteinase inhibitor with a liquid (diluent) before using it.
If you are using the injections at home, be sure you understand how to properly mix and store the
medication. After mixing alpha 1-proteinase inhibitor with a diluent, you must use the medicine
within 3 hours. It is best not to mix your alpha 1-proteinase inhibitor dose until you are ready to
give the injection. The mixture should look clear or slightly yellow-green and may have a few
small particles in it.
Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine.
You may gently swirl the medication while mixing.
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
Aralast
brand of this medication in the refrigerator. Do
not freeze.
Store
Prolastin
or
Zemaira
at cool room
temperature (no warmer than 77 degrees F), away from moisture and heat.
Aralast
may also be stored at room temperature but you must use it within 30 days after
removing it from the refrigerator.
Do not use this medication after the expiration date on the medicine label has passed.
What happens if I miss a dose of alpha 1-proteinase inhibitor?
Call your doctor for instructions if you miss a dose of alpha 1-proteinase inhibitor.
Where can I get more information about alpha 1-proteinase inhibitor?
Your pharmacist has information about alpha 1-proteinase inhibitor written for health professionals that you may read.
What are the possible side effects of alpha 1-proteinase inhibitor?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; wheezing, difficulty breathing; feeling like you might pass out;
swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
-
chest pain, severe headache, buzzing in your ears, uneven
heartbeats;
-
fast heart rate;
-
problems with vision; or
-
fever, chills, runny nose, skin rash, and joint pain.
Less serious side effects may include:
-
drowsiness, dizziness, weakness;
-
cough, sore throat, stuffy nose;
-
pain or bleeding where the medication was injected;
-
warmth, redness, or tingly feeling under your skin;
-
nausea, diarrhea, stomach pain;
-
headache; or
-
mild itching.
This is not a complete list of side effects and others may occur. Tell
your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about alpha 1-proteinase inhibitor?
You should not use this medication if you have ever had an allergic reaction to alpha
1-proteinase inhibitor, or if you have an IgA deficiency or antibody against IgA.
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.
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; wheezing, difficulty breathing; feeling like you might pass out;
swelling of your face, lips, tongue, or throat.
You will most likely receive your first few doses of this medication in a hospital or clinic
setting where your vital signs can be watched closely in case the medication causes serious side
effects.
Alpha 1-proteinase 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 alpha 1-proteinase inhibitor?
Follow your doctor's instructions about any restrictions on food, beverages, or activity
while you are using alpha 1-proteinase inhibitor.
What other drugs will affect alpha 1-proteinase inhibitor?
There may be other drugs that can interact with alpha 1-proteinase 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 alpha 1-proteinase inhibitor?
