ALPHA 1-PROTEINASE INHIBITOR

(AL fa 1-PRO tee nase in HIB i tor) Brand: Aralast, Aralast NP, Glassia, Prolastin, Prolastin-C, Zemaira

What is the most significant information I must know about alpha 1-proteinase inhibitor?

• You must not use this medicine if you have ever had an allergic reaction to alpha 1-proteinase inhibitor, or if you have an IgA (immunoglobulin A) deficiency or antibody against IgA.

• Some brands of alpha 1-proteinase inhibitor should be mixed with a liquid (diluent) till given as an injection. If you are using the injections at house, be certain you understand how to properly prepare and store your medication.

• Call your doctor at once if you have a serious side effect such as fever, chills, body aches, flu symptoms, mouth sores, pain or burning when you urinate, wheezing, chest pain or tightness, trouble breathing, or vision changes.

Alpha 1-proteinase inhibitor is made from human plasma (part of the blood) which may contain viruses and another infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a little possibility it could transmit malady. Conversation with your doctor about the risks and benefits of using this medication.

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 significant 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) mess and alpha 1-proteinase inhibitor will not cure this condition.

Alpha 1-proteinase inhibitor may also be used for purposes not listed in this medicine guide.

What must I discuss with my health care provider till using alpha 1-proteinase inhibitor?

• You must not use this medicine if you have ever had an allergic reaction to alpha 1-proteinase inhibitor, or if you have an IgA (immunoglobulin A) deficiency or antibody against IgA.

• To create certain you can safely use alpha 1-proteinase inhibitor, speak your doctor if you have any of these another conditions:

· liver malady; or

· asthma, chronic obstructive pulmonary malady (COPD), or another breathing disorder.

• FDA pregnancy category C. It is not known whether alpha 1-proteinase inhibitor will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medication.

• It is not known whether alpha 1-proteinase inhibitor passes into breast milk or if it could harm a nursing child. Do not use this medicine without telling your doctor if you are breast-feeding a baby.

Alpha 1-proteinase inhibitor is made from human plasma (part of the blood) which may contain viruses and another infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a little possibility it could transmit malady. Conversation with your doctor about the risks and benefits of using this medication.

How must I use alpha 1-proteinase inhibitor?

Alpha 1-proteinase inhibitor is injected into a vein through an IV. You may be shown how to use an IV at house. Do not self-inject this medication if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and another items used to inject the medicine.

Alpha 1-proteinase inhibitor is generally given once for week. Follow your doctor's dosing instructions very carefully.

• You will most likely receive your first little doses of this medicine in a hospital or clinic setting where your vital signs can be watched closely in case the medicine causes serious side effects.

• The Aralast, Prolastin, and Zemaira brands are powder forms of alpha 1-proteinase inhibitor. The powder form of this medicine should be mixed with a liquid (diluent) till preparing your doze.

• Do not shake the mixture or you may ruin the medication. Prepare your doze in a syringe only when you are ready to give yourself an injection. Do not use the medicine if it has changed colors or has particles in it. Call your doctor for a new prescription.

Glassia is a liquid form of alpha 1-proteinase inhibitor that does not need to be mixed with a diluent.

• If you are using the injections at house, be certain you understand how to properly mix and store the medication.

• This medicine comes with patient instructions for safety and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

• Every single use vial (bottle) of this medication is for one use only. Throw away after one use, even if there is still some medication left in it after injecting your dose.

• Store the powder medication (Aralast, Prolastin, Zemaira) at cold room temperature, away from moisture and heat. Do not freeze. The diluent bottle can interrupt if it becomes frozen.

After mixing alpha 1-proteinase inhibitor powder with a diluent, you should use the mixture within 3 hours.

• Store the liquid medication (Glassia) in its original container in the refrigerator. Do not freeze. Take the medicine out of the refrigerator and let it to reach room temperature till preparing your doze. Use the medicine within 3 hours after you have punctured the rubber stopper in the vial with a needle or IV spike.

• Do not use alpha 1-proteinase inhibitor after the expiration date on the medication label has passed.

What happens if I miss a dose?

• Call your doctor for instructions if you miss a doze of alpha 1-proteinase inhibitor.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking alpha 1-proteinase inhibitor?

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of alpha 1-proteinase inhibitor?

• Get abnormal 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 person, lips, tongue, or throat.

• Stop using alpha 1-proteinase inhibitor and call your doctor at once if you have a serious side effect such as:

· fever, chills, body aches, flu symptoms, sores in your mouth and throat;

· pain or burning when you urinate;

· wheezing, chest pain or tightness, trouble breathing; or

· vision changes.

• Smaller serious side effects may include:

· nausea, bloating;

· headache, dizziness, drowsiness;

· feeling tired;

· back pain, joint or muscle pain;

· swelling in your hands or feet;

· flushing (warmth, redness, or tingly feeling);

· cool symptoms such as stuffy nose, sneezing, sore throat, cough; or

· mild itching.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect alpha 1-proteinase inhibitor?

• There may be another drugs that can interact with alpha 1-proteinase inhibitor. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about alpha 1-proteinase inhibitor.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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