Frequently Asked Questions

alpha1-Proteinase Inhibitor (Human)

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Examples include Aralast NP and Zemaira

Miscellaneous respiratory agents


Alpha-1 proteinase inhibitor (human) is used for:

Treating emphysema caused by alpha-1 proteinase inhibitor deficiency (also known as alpha-1 antitrypsin deficiency).

Alpha-1 proteinase inhibitor (human) is an alpha-1 protease inhibitor. It works by blocking substances in the lungs that break down lung tissue and sometimes causes emphysema.

Do NOT use alpha-1 proteinase inhibitor (human) if:

  • you are allergic to any ingredient in alpha-1 proteinase inhibitor (human)
  • you have an immunoglobulin A (IgA) deficiency and have antibodies against IgA

Contact your doctor or health care provider right away if any of these apply to you.

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Before using alpha-1 proteinase inhibitor (human):

Some medical conditions may interact with alpha-1 proteinase inhibitor (human). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have heart or circulatory problems

Some MEDICINES MAY INTERACT with alpha-1 proteinase inhibitor (human). However, no specific interactions with alpha-1 proteinase inhibitor (human) are known at this time.

Ask your health care provider if alpha-1 proteinase inhibitor (human) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use alpha-1 proteinase inhibitor (human):

Use alpha-1 proteinase inhibitor (human) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Alpha-1 proteinase inhibitor (human) is administered as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • Do not miss any doses. If you miss a dose of alpha-1 proteinase inhibitor (human), contact your doctor.

Ask your health care provider any questions you may have about how to use alpha-1 proteinase inhibitor (human).

Important safety information:

  • Tell your doctor or dentist that you take alpha-1 proteinase inhibitor (human) before you receive any medical or dental care, emergency care, or surgery.
  • Alpha-1 proteinase inhibitor (human) contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used alpha-1 proteinase inhibitor (human).
  • PREGNANCY and BREAST-FEEDING: It is not known if alpha-1 proteinase inhibitor (human) can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using alpha-1 proteinase inhibitor (human) while you are pregnant. It is not known if alpha-1 proteinase inhibitor (human) is excreted in breast milk. If you are or will be breast-feeding while you use alpha-1 proteinase inhibitor (human), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of alpha-1 proteinase inhibitor (human):

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; muscle pain; nausea; pain, bruising, swelling, or redness at the injection site; runny nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; severe or persistent dizziness; shortness of breath or wheezing; swelling of the ankles or feet; symptoms of infection (eg, fever, chills, muscle aches, sore throat); tingling or numbness of the skin; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of alpha-1 proteinase inhibitor (human):

Alpha-1 proteinase inhibitor (human) is handled and stored by a health care provider. You will not store it at home. Keep all medicines, as well as needles and syringes, out of the reach of children and away from pets.

General information:

  • If you have any questions about alpha-1 proteinase inhibitor (human), please talk with your doctor, pharmacist, or other health care provider.
  • Alpha-1 proteinase inhibitor (human) is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take alpha-1 proteinase inhibitor (human) or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about alpha-1 proteinase inhibitor (human). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to alpha-1 proteinase inhibitor (human). This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using alpha-1 proteinase inhibitor (human).

Issue Date: February 4, 2015
Database Edition 15.1.1.002
Copyright © 2015 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Not all side effects for alpha 1-proteinase inhibitor may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to alpha 1-proteinase inhibitor: intravenous powder for solution, intravenous solution

In addition to its needed effects, some unwanted effects may be caused by alpha 1-proteinase inhibitor. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking alpha 1-proteinase inhibitor, check with your doctor or nurse immediately:

More common
  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Rare
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • cough producing mucus
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • feeling faint, dizzy, or lightheadedness
  • flushing or redness of the skin, especially on the face and neck
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • noisy breathing
  • pounding in the ears
  • rapid weight gain
  • shivering
  • shortness of breath
  • slow or fast heartbeat
  • stuffy nose
  • sweating
  • tightness in the chest
  • tingling of the hands or feet
  • trouble sleeping
  • unusual weight gain or loss
  • vomiting
  • wheezing
Incidence not known
  • Confusion
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • hives
  • itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash

Some of the side effects that can occur with alpha 1-proteinase inhibitor may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Feeling of warmth
  • itching skin
  • muscle or bone pain
  • pain or tenderness around the eyes and cheekbones
  • redness of the face, neck, arms, and occasionally, upper chest
  • sudden sweating
Rare
  • Back pain
  • bloating
  • change in taste
  • changes in vision
  • fever
  • hives or welts
  • loss of taste
  • pain
  • redness of the skin
  • sleepiness or unusual drowsiness
  • swelling of the joints
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

For Healthcare Professionals

Applies to alpha 1-proteinase inhibitor: intravenous powder for injection, intravenous solution

Respiratory

Respiratory side effects have included chest pain, pharyngitis, asthma, rhinitis, bronchitis, sinusitis, increased cough, upper and lower respiratory tract infections, dyspnea, chronic obstructive pulmonary disease (COPD) exacerbation, nasopharyngitis, pharyngolaryngeal pain, COPD, sore throat, bronchospasm, lung disorder, infective exacerbation of COPD, bilateral pulmonary infiltrates, and diffuse interstitial lung disease. Dyspnea has been reported during postmarketing experience.[Ref]

Nervous system

Nervous system side effects have included dizziness, headache, somnolence, dysgeusia, lethargy, lightheadedness, paresthesia, and migraine.[Ref]

Other

Other side effects have included pain, back pain, viral infection, peripheral edema, chills, fever, chest pain, chest discomfort, influenza-like illness, pyrexia, delayed fever, influenza-like symptoms, allergic-like reactions, malaise, hot flush, asthenia, infection, and accidental injury. Chest pain, chills, and influenza-like illness have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included vasodilation, hypertension, tachycardia, hypotension, and transient increase in blood pressure. Tachycardia, hypotension, and hypertension (including transient increases of blood pressure) have been reported during postmarketing experience.[Ref]

Hematologic

Hematologic side effects have included decreased platelet count, transient leukocytosis, dilutional anemia, ecchymosis, and hemorrhage.

Dermatologic

Dermatologic side effects have included pruritus, rash, erythema marginatum, and urticaria. Rash has been reported during postmarketing experience.[Ref]

Gastrointestinal

Gastrointestinal side effects have included bloating, nausea, abdominal pain, diarrhea, and dyspepsia.

Hepatic

Hepatic side effects have included elevations (greater than 2 times the upper limit of normal) in aminotransferases (ALT or AST), increased hepatic enzyme (unspecified), and cholangitis.[Ref]

Musculoskeletal

Musculoskeletal side effects have included musculoskeletal discomfort, joint swelling, arthralgia, and myalgia.

Ocular

Ocular side effects have included abnormal vision.[Ref]

Local

Local side effects have included injection site pain, injection site hemorrhage, and injection site reaction.

Genitourinary

Genitourinary side effects have included urinary tract infection.

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity during postmarketing experience.

References

1. "Product Information. Aralast (alpha 1-proteinase inhibitor)." Baxter I.V. Systems Division, Round Lake, IL.

More about alpha 1-proteinase inhibitor

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