Prolastin-C Liquid, commonly known as simply Prolastin, is an alpha-1 proteinase inhibitor. It's used as augmentation therapy to manage lung problems (emphysema) in adults with a genetic condition called alpha-1 antitrypsin (AAT) deficiency. This medication helps replace an enzyme that's missing in the body called AAT. Prolastin is given as an infusion into the veins (IV) once a week. Side effects aren't common, but can include headache and common cold symptoms.
Augmentation therapy for lung damage (emphysema) due to severe alpha-1 antitrypsin (AAT) deficiency
Alpha-1 antitrypsin (AAT), or alpha-1 proteinase inhibitor, is an enzyme (protein) that your body normally makes to help protect the lungs from damage. Without enough AAT, there's a higher risk for lung problems, like emphysema.
Prolastin is an enzyme replacement therapy. It restores the levels of AAT in adults with (AAT deficiency) to help protect the lungs.
Source:Â DailyMed
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
difficult, burning, or painful urination
difficulty with breathing
ear congestion
frequent urge to urinate
headache
loss of voice
lower back or side pain
runny or stuffy nose
unusual tiredness or weakness
Rare
Bloating or swelling of the face, arms, hands, lower legs, or feet
blurred vision
cough producing mucus
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
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:
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.
Helps replace missing AAT in your body
Can be given at home
Taken only once per week
Available as a ready-to-use liquid
Not clear if it can slow the worsening of emphysema due to AAT deficiency
Needs to be given as an infusion into the vein
Must be administered by a trained healthcare provider
Mark your calendar with your appointments to see your provider and when your Prolastin once-weekly infusions are due. This will help you and your provider keep track of your treatment and make sure you don't miss any doses.
Allergic reactions or infusion-related reactions can happen during or after your Prolastin infusion. Get medical help right away if you have any signs of an allergic reaction or anaphylaxis, including trouble breathing or rash, so you can get treated as soon as possible.
Getting Prolastin infusions at home (if instructed by your provider):
Depending on your insurance coverage and discussions with your provider, you might be able to get your Prolastin infusions at home. Your care team can arrange for a trained nurse to make a home visit to help administer the medication.
You'll get the Prolastin vials delivered directly to your home before your appointments with the nurse for your infusions.
Store Prolastin vials in the refrigerator and in the original container to protect them from light. You can also store them at room temperature for up to 1 month. But once the medication is at room temperature, don't put it back in the refrigerator and don't use it if it's been at room temperature for longer than 1 month.
When the nurse arrives for the appointment for your Prolastin infusion, they'll help prepare your dose. The nurse might need to transfer the liquid from multiple vials into an empty, sterile bag that's then used for the infusion.
Once your dose is prepared, it must be given within 3 hours. The medication doesn't contain any preservatives, so bacteria might start to grow in the solution if it hasn't been used for some time. Your nurse will need to prepare a new dose for your infusion.
After each Prolastin infusion, the home nurse will help you keep track of your infusions. The nurse will probably use a treatment log to write down the lot number of the vial(s) used, the time and date of your infusions, and any side effects or reactions that you have.
Prolastin 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.
Risk factors: Immunoglobulin A (IgA) deficiency
Prolastin might contain a tiny amount of immunoglobulin A (IgA), which is a type of protein that's naturally found in the body. People who have IgA deficiency can have antibodies against IgA. Having antibodies against IgA raises the risk of having an allergic reaction, including anaphylaxis, to Prolastin.
Let your provider know right away or contact emergency medical help if you have any signs 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 might prescribe an epinephrine pen (EpiPen) for you to use in case of a severe allergic reaction.
Because Prolastin is made from human blood products, there's a risk that it might contain viruses and other germs that can make you sick. But your risk of infection is low since the donors of these blood products are carefully screened. Also, there are high manufacturing standards put into place to make sure the germs are killed or removed.
To prevent serious infections in the rare case that your doses of Prolastin are affected, let your provider know right away if you start to feel sick or have symptoms, such as feeling confused and anxious or having trouble maintaining your balance.
The typical dose is 60 mg/kg of body weight, given as an infusion into the vein (intravenous or IV) once a week.
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.
People who are immunoglobulin A (IgA) deficient with antibodies against IgA
Severe allergy to other alpha 1-proteinase inhibitors
Augmentation therapy for lung damage (emphysema) due to severe alpha-1 antitrypsin (AAT) deficiency
Augmentation therapy for lung damage (emphysema) due to severe alpha-1 antitrypsin (AAT) deficiency
Augmentation therapy for lung damage (emphysema) due to severe alpha-1 antitrypsin (AAT) deficiency
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American Lung Association. (2023). Treating and managing alpha-1 antitrypsin deficiency.
Grifols USA, LLC. (2022). Prolastin-C liquid (alpha1-proteinase inhibitor- human injection, solution [package insert]. DailyMed.
Grifols USA, LLC. (2023). Frequently asked questions about PROLASTIN-C LIQUID.
Li, Z., et al. (2022). Comparative biochemical efficacy analysis of an alpha1-proteinase inhibitor (Glassia) in patients with alpha-1 antitrypsin deficiency. Pulmonary Pharmacology & Therapeutics.
MediMedia USA, Inc. (2010). Alpha1-proteinase inhibitor (human). Pharmacy & Therapeutics.
MedlinePlus. (2022). Selective deficiency of IgA.
National Heart, Lung, and Blood Institute. (2023). COPD: Alpha-1 antitrypsin deficiency. National Institutes of Health.
National Human Genome Research Institute. (2024). Antibody. National Institutes of Health.
Patel, A., et al. (2023). Biochemistry, immunoglobulin A. StatPearls.
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