Pronunciation:

AL-fa 1 PRO-teen-aze in-HIB-i-ter HUE-man

Brand Names:

• Aralast
• Aralast NP
• Glassia
• Prolastin
• Prolastin-C
• Zemaira

Dosage Forms:

• Powder for Solution
• Solution

Classifications:

Therapeutic—

Blood Modifier Agent

Uses of This Medicine:

Alpha-1 proteinase inhibitor injection, also called alpha 1-PI, is used to treat a certain type of emphysema (a lung condition). The emphysema is caused by the lack of a protein called alpha 1-antitrypsin (AAT) in the body. This medicine replaces the protein when the body does not produce enough.

This medicine is to be given 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—

Appropriate studies have not been performed on the relationship of age to the effects of alpha-1 proteinase inhibitor in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of alpha-1 proteinase inhibitor in the geriatric population. Safety and efficacy have not been established.

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• IgA deficiency with antibodies against IgA—Should not be used in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or clinic setting. This medicine is given through a needle placed in one of your veins.

This medicine is usually given once a week on a regular schedule. If you have any questions about this, check with your doctor.

You may be taught how to give your medicine at home. Make sure you understand all instructions before you give yourself this medicine. Do not use more medicine or use it more often than your doctor tells you to.

This medicine should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Record and keep a treatment infusion log. This includes information, such as lot number, time, date, and any reactions.

Precautions While Using This Medicine:

It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, lightheadedness, dizziness, or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

Alpha 1-PI is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from alpha 1-PI is very low and has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns. Your doctor may give you a hepatitis B vaccine before receiving this medicine.

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.

Check with your doctor or nurse immediately if any of the following side effects occur:

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

runny or stuffy 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

slow or fast heartbeat

sweating

tightness in the chest

tingling of the hands or feet

trouble sleeping

unusual weight gain or loss

vomiting

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 or skin rash

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

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:

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

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

welts

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.