Aralast

Alpha 1-proteinase inhibitor is a protein, also called alpha 1-antitrypsin. This protein occurs naturally in the body and is important 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) disorder and alpha 1-proteinase inhibitor will not cure this condition.

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

You should not use this medication 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 must be mixed with a liquid (diluent) before given as an injection. If you are using the injections at home, be sure you understand how to properly prepare and store your medicine.

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 other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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

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

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

The Aralast, Prolastin, and Zemaira brands are powder forms of alpha 1-proteinase inhibitor. The powder form of this medication must be mixed with a liquid (diluent) before preparing your dose.

Do not shake the mixture or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication 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 home, be sure you understand how to properly mix and store the medicine.

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

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

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

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

Store the liquid medicine (Glassia) in its original container in the refrigerator. Do not freeze. Take the medication out of the refrigerator and allow it to reach room temperature before preparing your dose. Use the medication 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 medicine label has passed.

Get emergency 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 face, 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.

Less 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);

• cold 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 report side effects to FDA at 1-800-FDA-1088.

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.

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.

Pediatric

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.

Geriatric

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

This section provides information on the proper use of a number of products that contain alpha-1 proteinase inhibitor human. It may not be specific to Aralast. Please read with care.

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.

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

Along with its needed effects, alpha 1-proteinase inhibitor (the active ingredient contained in Aralast) 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 while taking alpha 1-proteinase inhibitor:

• 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

• 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

• 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 side effects of alpha 1-proteinase inhibitor 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:

• 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

• 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