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Glassia (alpha-1 proteinase inhibitor)

Basics, Side Effects, Reviews & More

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Alpha-1 proteinase inhibitor or alpha-1 PI is an injectable medication that gets infused into the vein. It treats lung problems (emphysema) in adults with extremely low levels of a protein called alpha-1 proteinase inhibitor. There are four brands available for this medication. It's given once a week at the clinic, hospital, or even in your own home in certain cases.

COMMON BRANDS

Glassia, Aralast NP, Prolastin-C, Zemaira

DRUG CLASS

Biologic

CONTROLLED SUBSTANCE CLASSIFICATION

Not a controlled medication

GENERIC STATUS

No lower-cost generic available

AVAILABILITY

Prescription only

Reviewed by:

Yen Nguyen, PharmD

Allison Barnes, PharmD

Last reviewed on:

August 9, 2022

What is alpha-1 PI?

How alpha-1 PI works

This medication is a biologic that's made from human blood consisting of alpha-1 proteinase inhibitor (alpha-1 PI). Alpha-1 PI, or also called alpha-1 antitrypsin (AAT), is a protein that your liver makes to help protect the lungs.

People with a genetic condition called alpha-1 PI deficiency, also known as AAT deficiency, have low levels of alpha-1 PI in the blood and lungs. This puts them at a higher risk of developing lung damage, including emphysema.

Alpha-1 PI replacement is given to raise the levels of alpha-1 PI in your blood and lungs. It blocks certain proteins that are responsible for damaging your lungs.

What is alpha-1 PI used for?

  • Lung disease (emphysema) due to severe alpha-1 proteinase inhibitor deficiency, also known as alpha-1 antitrypsin (AAT) deficiency

Alpha-1 PI dosage forms

Typical dosing for alpha-1 PI

The dose is based on body weight and is the same for the four brands available (Glassia, Aralast NP, Prolastin-C, and Zemaira). The typical dose is 60 mg/kg, given as an infusion into the vein (intravenous or IV) once a week.

Frequently asked questions about alpha-1 PI





Pros and cons of alpha-1 PI

Pros

Thumbs UpCan be given by a provider, caregiver, or yourself

Thumbs UpAvailable in different brands

Thumbs UpOnly needs to be given once a week

Cons

Thumbs DownGiven by injection into the vein

Thumbs DownSome brands have to be kept refrigerated.

Thumbs DownSome brands have to be mixed before it's given.

Pharmacist tips for alpha-1 PI

Capsule IconYou might feel dizzy after getting your infusion, so make sure you rest for a while before getting up.

Capsule IconIf your provider lets you give yourself infusions at home, make sure you or your caregiver has been properly trained how to do so correctly and safely. Ask your provider if you have any questions about how to use the medication.

Capsule IconCertain brands must be mixed before you can use it, such as Aralast NP powder, Prolastin-C powder, and Zemaira powder. Follow all of the instructions given by your provider to mix the powders properly. Ask your provider if you have any questions about how to prepare the medication.

Capsule IconLet the vial get to room temperature before using. Don't use any heat, place it in hot water, or microwave the vial. This can damage the medication.

Capsule IconUse the medication within 3 hours of preparing or mixing. There's a higher risk that bacteria can start to grow in the solution if you leave it out for longer than 3 hours.

Capsule IconEach vial of medication is for a one-time use only. Throw away any unused solution properly.

Capsule IconKeep a treatment infusion log, and write down the lot number of the vial you used, the time and date of your infusion, and any reactions that you experience. This is useful for you and your provider to keep track of your treatments.

Capsule IconMake sure you ask your provider to prescribe an epinephrine pen (EpiPen), and keep it near you during your infusions in case of an allergic reaction. Let your provider know right away if you experience signs of an allergic reaction, including hives, swelling in the mouth or throat, chest tightness, trouble breathing, or lightheadedness.

What are the side effects of alpha-1 PI?

With any medication, there are risks and benefits. Even if the medication is working, you may experience some unwanted side effects.

Warning Small Contact your doctor immediately if you experience any of the following:

  • Severe allergic reaction: anaphylaxis, hives, itching, swelling in the mouth or throat, chest tightness, trouble breathing, wheezing, feeling faint

Caution Small The following side effects may get better over time as your body gets used to the medication. Let your doctor know immediately if you continue to experience these symptoms or if they worsen over time.

Common side effects

Glassia

  • Headache (9%)
  • Cough (9%)
  • Upper respiratory infection (9%)
  • Sinus infection (6%)
  • Chest discomfort (6%)
  • Dizziness (6%)

Aralast NP

  • Headache (16%)
  • Muscle and joint discomfort (16%)
  • Bruise at the injection site (8%)
  • Nausea (8%)
  • Runny nose (4-6%)

Prolastin-C

  • Upper respiratory tract infection (13-16%)
  • Urinary tract infection (13%)
  • Nausea (4-11%)
  • Chest pain (8%)
  • Diarrhea (6%)
  • Tiredness (6%)

Zemaira

  • Headache
  • Sinus infection or other upper respiratory infection
  • Bronchitis
  • Weakness
  • Cough
  • Fever
  • Bleeding at injection site
  • Runny nose
  • Sore throat

Source: DailyMed

The following side effects have also been reported:

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.

What are the risks and warnings for alpha-1 PI?

Alpha-1 PI can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options

Allergic reaction

  • Risk factors: Immunoglobulin A (IgA) deficiency

Alpha-1 PI might contain a tiny amount of immunoglobulin A (IgA), which is one type of antibody that's naturally found in the body. People who have selective or severe IgA deficiency can have antibodies against IgA, which raises their risk of developing an allergic reaction, including anaphylaxis, to alpha-1 PI. Let your provider know right away or contact emergency medical help if you experience any signs and symptoms of a severe allergic reaction, such as hives, itching, swelling in the mouth or throat, chest tightness, trouble breathing, wheezing, or feeling faint or lightheaded. Your provider may prescribe an epinephrine pen (EpiPen) for you to use in case of a severe allergic reaction.

Infection

Alpha-1 PI is made from human blood, so it might have a risk of passing certain viruses and diseases to you. There are certain steps the manufacturer takes to lower this risk. Before alpha-1 PI is made, blood donors are screened, the blood is tested for infections, and the blood product is processed to remove or inactivate certain viruses. Despite these steps, be aware that there is still a small risk of getting an infection. Let your provider know right away if you experience any signs and symptoms of an infection, such as headache, fever, feeling sick, nausea, vomiting, diarrhea, weakness, or yellowing of the eyes and skin.

Interactions between alpha-1 PI and other medications

Alpha-1 PI may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with alpha-1 PI. Please note that only the generic name of each medication is listed below.

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.

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