Prolastin (Intravenous)

Alpha-1 proteinase inhibitor injection, also known as alpha 1-PI, is used to treat a specific type of emphysema (a lung condition). This emphysema happens because the body does not have enough of a protein called alpha 1-antitrypsin (AAT). This medicine provides the protein when the body is not making enough.

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor monitors you closely while you are using this medicine. This will help your doctor check if the medicine is working correctly and to determine if you should keep using it.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Call your doctor right away if you experience a rash, itching, hoarseness, lightheadedness, dizziness, 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 blood products have been known to transmit certain viruses to people who received them. The risk of getting a virus from alpha 1-PI is very low and has significantly decreased in recent years. This is due to required testing of human donors for specific viruses and testing during the production of these medicines. Even though the risk is low, discuss any concerns with your doctor. Your doctor may give you a hepatitis B vaccine before you receive this medicine.

In deciding to use a medicine, you and your doctor need to think about the risks of taking it compared to the benefits it may provide. Here are some important things to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been any appropriate studies on how alpha-1 proteinase inhibitor affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

There have not been any appropriate studies on how alpha-1 proteinase inhibitor affects older adults. Its safety and effectiveness have not been established for this age group.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if they might interact. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as eating food or certain types of food because interactions may happen. Drinking alcohol or using tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works for you. Make sure to tell your doctor if you have any other medical problems, especially:

• IgA deficiency with antibodies against IgA—This medicine should not be used in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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 healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare 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.

In the U.S.

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

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Blood Modifier Agent

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.