Pronunciation:

AL-fa 1 PRO-teen-aze in-HIB-i-tor HYOO-man

Brand Names:

• Aralast
• Aralast NP
• Prolastin
• Zemaira

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Blood Modifier Agent

Uses of This Medicine:

Alpha 1-proteinase 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.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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.

Frequency not determined

Cough

difficulty swallowing

dizziness

fast heartbeat

hives

itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

shortness of breath

skin rash

tightness in chest

unusual tiredness or weakness

wheezing

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.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Fever up to 38.9 °C (102 °F)

headache

lightheadedness

sleepiness or unusual drowsiness

Frequency not determined

Blurred vision

chills

confusion

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

diarrhea

difficult or labored breathing

eye pain

fast, pounding, or irregular heartbeat or pulse

general feeling of illness

joint pain

loss of appetite

muscle aches and pains

nausea

runny nose

shivering

sore throat

sweating

trouble sleeping

vomiting

Note: Chills and fever may occur several hours after you receive this medicine but are usually mild and only temporary. Also, fever up to 38.9 °C (102 °F) may occur up to 12 hours after you receive this medicine and will disappear within about 24 hours.

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