Alpha-1-Proteinase Inhibitor Solution for injection

What is this medicine?

ALPHA-1-PROTEINASE INHIBITOR (AL fa - 1 - PROH tee neys in HIB i ter) is a drug that is used to replace an enzyme in patients with lung problems caused by low levels of alpha₁ antitrypsin. It is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart problems

• immune system problems

• an unusual or allergic reaction to alpha₁-proteinase inhibitor, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. Your healthcare professional will decide if infusion in your home is right for you. You should be trained on how to do infusions by your healthcare professional. Follow the directions on the prescription label. Do not use your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This medicine is used once a week. It is important not to miss your dose. Call your health care professional if you are unable to keep an appointment. If you use this medicine at home and you miss a dose, use it as soon as you can and get back to a weekly schedule. Call your healthcare professional if you are not sure what to do about a missed dose.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Your condition will be monitored carefully while you are receiving this medicine.

This medicine can cause serious allergic reactions. Ask your doctor or health care professional about an epinephrine pen and/or other supportive care for certain severe allergic reactions.

This medicine is made from human plasma, and there is a small risk that it may contain certain types of viruses or bacteria. All products are processed to kill most viruses and bacteria. If you have questions concerning the risk of infections, discuss them with your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain, tightness

• feeling faint or lightheaded, falls

• fever or other signs of infection, including symptoms of the common cold followed by a rash

• flushed or pale skin

• unusually high or low blood pressure

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache

• irritation at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Unopened vials may be stored in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. The vials may also be kept at room temperature, below 25 degrees C (77 degrees F) for up to 1 month. Do not re-refrigerate once the product has been stored at room temperature. Keep in the original carton until needed for use. Throw away any unused medicine after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.