Uses of Prolastin-C:

• It is used to treat emphysema caused by alpha1-antitrypsin deficiency.

What do I need to tell my doctor BEFORE I take Prolastin-C?

• If you have an allergy to alpha1-proteinase inhibitor or any other part of Prolastin-C (alpha-proteinase inhibitor powder for injection).
• If you are allergic to Prolastin-C (alpha-proteinase inhibitor powder for injection); any part of Prolastin-C (alpha-proteinase inhibitor powder for injection); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have IgA deficiency.

This is not a list of all drugs or health problems that interact with Prolastin-C (alpha-proteinase inhibitor powder for injection).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Prolastin-C (alpha-proteinase inhibitor powder for injection) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Prolastin-C?

• Tell all of your health care providers that you take Prolastin-C (alpha-proteinase inhibitor powder for injection). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Check blood pressure and heart rate as the doctor has told you.
• Dizziness may happen after a dose of Prolastin-C (alpha-proteinase inhibitor powder for injection). Be sure to rest for a while after getting a dose.
• Allergic side effects may rarely happen.
• Your doctor will give you another drug (epinephrine) to use in case of an allergic reaction. Be sure you know how and when to use it. Certain drugs may make epinephrine not work as well or raise the chance of side effects. This includes some drugs used to treat depression, heart problems, or high blood pressure. There are many drugs that interact with epinephrine. Talk with your doctor or pharmacist to make sure it is safe to take epinephrine with all of your drugs.
• This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Prolastin-C) best taken?

Use Prolastin-C (alpha-proteinase inhibitor powder for injection) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Wash your hands before use.
• Wear gloves when preparing and giving a dose.
• This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
• Do not use if the solution is cloudy, leaking, or has particles.
• Different brands of Prolastin-C (alpha-proteinase inhibitor powder for injection) may be clear or have a slight color. Be sure you know what your brand needs to look like when ready to use. Do not use if the solution changes color. If you are not sure, talk with the pharmacist.
• Do not mix with any other liquid drugs.
• After mixing, you may store at room temperature for 3 hours.
• Do not shake.
• Each vial is for one use only. Throw away any part not used after the dose is given.
• Keep track of each infusion. Write down the product lot number and expiration date. Write down the date, the time the infusion started and ended, where the infusion was used, and any side effects you had.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Flushing.
• Chest pain or pressure or a fast heartbeat.
• Very bad dizziness or passing out.
• Feeling confused.
• Fever.
• Shortness of breath.
• Redness or white patches in mouth or throat.
• Trouble breathing that is new or worse.
• Coughing.

What are some other side effects of Prolastin-C?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Signs of a common cold.
• Sinus pain.
• Runny nose.
• Sore throat.
• Dizziness.
• Feeling tired or weak.
• Diarrhea.
• Muscle pain.
• Upset stomach.
• Back pain.
• Irritation where Prolastin-C (alpha-proteinase inhibitor powder for injection) is used.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Prolastin-C?

• Store at room temperature. Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• Store in the original container to protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Prolastin-C (alpha-proteinase inhibitor powder for injection), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.