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|Prolastin

ALPHA ₁ -PROTEINASE INHIBITOR, HUMAN (Systemic)

Some commonly used brand names are:

In the U.S.—

• Aralast
• Prolastin

In Canada—

• Prolastin

Another commonly used name is alpha ₁ -antitrypsin .

Category

• Alpha ₁ -antitrypsin replenisher

Description

Alpha ₁ -proteinase (AL-fa wun PRO-teen-ayce) inhibitor (alpha ₁ -PI) is used to treat emphysema caused by the lack of a certain protein, alpha ₁ -antitrypsin, in the body. This medicine replaces the protein when the body does not produce enough by itself.

Alpha ₁ -PI is prepared from human blood received from many donors. Each donor"s blood is tested for human immunodeficiency virus (HIV) and hepatitis B virus before it is used to prepare this medicine. Also, alpha ₁ -PI is treated with heat to reduce further the risk of transmission of virus infections. Other processes are also done to help make the alpha ₁ -PI more pure. However, no procedure has been found to be totally effective in removing viruses from blood products.

There have not been any reports of hepatitis developing in any patients receiving alpha ₁ -PI. Your doctor may want to vaccinate you with hepatitis B vaccine before you receive this medicine. In some cases, there may not be enough time for the vaccine to take effect before the alpha ₁ -PI is given. Therefore, you may be given hepatitis B immune globulin at the same time that you receive the hepatitis B vaccine.

Alpha ₁ -PI is given once a week. Your doctor may want you to receive this medicine regularly for a long time. However, it is not known what the effects of this medicine are when it is used regularly to treat emphysema caused by lack of alpha ₁ -antitrypsin. Be sure you have discussed this with your doctor.

Alpha ₁ -PI is administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

• Parenteral
• Injection (U.S. and Canada)

Before Receiving This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For alpha ₁ -proteinase inhibitor, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to alpha ₁ -proteinase inhibitor. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether alpha ₁ -proteinase inhibitor passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of alpha ₁ -proteinase inhibitor in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of alpha ₁ -proteinase inhibitor in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Proper Use of This Medicine

In order for alpha ₁ -proteinase inhibitor (alpha ₁ -PI) to work properly, it is important that you receive this medicine once a week on a regular schedule . If you have any questions about this, check with your doctor.

Dosing—The dose of alpha ₁ -proteinase inhibitor will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average dose of alpha ₁ -proteinase inhibitor. If your dose is different, do not change it unless your doctor tells you to do so.

• For emphysema caused by lack of the protein alpha ₁ -antitrypsin in the body :
  • For injection dosage form:
    • Adults—Dose is based on body weight and must be determined by your doctor. The usual dose is 60 milligrams (mg) per kilogram (kg) (27 mg per pound) of body weight, slowly injected into a vein over a period of several minutes. This dose is given once a week.
    • Children—Use and dose must be determined by your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Along with its needed effects, a medicine may cause some unwanted effects. The following side effects usually do not require medical attention. However, check with your doctor if any of these effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 06/19/2003

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