Prolastin-C

Generic Name: alpha-1 proteinase inhibitor human (Intravenous route)

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

Commonly used brand name(s)

In the U.S.

• Aralast


• Aralast NP


• Glassia


• Prolastin


• Prolastin-C


• Zemaira

Available Dosage Forms:

• Powder for Solution


• Solution

Therapeutic Class: Blood Modifier Agent

Uses For Prolastin-C

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 administered only by or under the immediate supervision of your doctor.

Before Using Prolastin-C

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.

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.

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.

Proper Use of alpha-1 proteinase inhibitor human

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 Prolastin-C. 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.

Precautions While Using Prolastin-C

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 with breathing; trouble with 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.

Prolastin-C Side Effects

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


• nasal congestion


• runny 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


• shortness of breath


• slow or fast heartbeat


• stuffy nose


• sweating


• tightness in the chest


• tingling of the hands or feet


• trouble sleeping


• unusual weight gain or loss


• vomiting


• wheezing

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


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


• skin rash

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


• 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

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.

See also: Prolastin-C side effects (in more detail)

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More Prolastin-C resources

• Prolastin-C Side Effects (in more detail)
• Prolastin-C Use in Pregnancy & Breastfeeding
• Prolastin-C Support Group
• 0 Reviews for Prolastin-C - Add your own review/rating

• Prolastin-C Prescribing Information (FDA)


• Aralast NP Prescribing Information (FDA)


• Aralast NP MedFacts Consumer Leaflet (Wolters Kluwer)


• Glassia Prescribing Information (FDA)


• Glassia Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Glassia Consumer Overview


• Zemaira Prescribing Information (FDA)


• Zemaira Consumer Overview

Compare Prolastin-C with other medications

• Alpha-1 Proteinase Inhibitor Deficiency