Prolastin

Name: Prolastin

Is alpha-1-proteinase inhibitor-injection safe to take if I'm pregnant or breastfeeding?

Alpha-1 proteinase inhibitor has not been adequately evaluated in pregnant women. Due to the lack of conclusive safety data, alpha-1 proteinase inhibitor should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Alpha-1 proteinase inhibitor is classified as FDA pregnancy risk category C.

It is not known if alpha-1 proteinase inhibitor is excreted in breast milk. Because many drugs enter human milk and can potentially cause harm to the nursing infant, alpha-1 proteinase inhibitor should be used cautiously in nursing mothers.

What else should I know about alpha-1-proteinase inhibitor-injection?

What preparations of alpha-1-proteinase inhibitor-injection are available?

Alpha-1 proteinase inhibitor is available in a kit containing a single-use vial of 1000 mg alpha-1 proteinase inhibitor as a lyophilized powder, one 20 ml vial of sterile water for dilution, a transfer needle, and a filter needle.

How should I keep alpha-1-proteinase inhibitor-injection stored?

Alpha-1 proteinase inhibitor should be stored below 25 C (77 F). This medicine does not require refrigeration and should not be stored in the freezer. After mixing, the solution can be kept at room temperature for administration within 3 hours.

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Reviewed on 3/20/2015 References REFERENCE: FDA Prescribing Information

What is Prolastin (alpha 1-proteinase inhibitor)?

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.

What is the most important information I should know about Prolastin (alpha 1-proteinase inhibitor)?

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.

How should I use Prolastin (alpha 1-proteinase inhibitor)?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Uses For Prolastin

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.

Prolastin 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
  • 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
  • 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.

For the Consumer

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 Prolastin) 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:

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
  • 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
  • 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:

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

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