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.
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.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Side effects reported by people within the first 2 months of starting Prolastin-C:
Contact your healthcare provider immediately if you experience any of the following.
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.
Getting Prolastin infusions at home (if instructed by your provider):
You'll probably get your first few Prolastin infusions at a clinic or infusion center so you can be closely monitored for side effects and allergic reactions to the medication. Plan for some time at the beginning of your appointment to check in and fill out some paperwork. Your care team might check your vitals and ask some questions to see how you're generally doing. The actual Prolastin infusion only takes about 15 minutes, as long as you're tolerating the infusion okay. It's also safe to drive yourself to and from the appointment because the medication doesn't typically cause sleepiness or dizziness. Call the place where you'll get Prolastin infusions if you have specific questions about what to expect.
It's possible to get your Prolastin infusions at home, depending on your insurance coverage and if your provider feels it's safe for you to do so. Your care team might arrange for a trained healthcare provider to make a home visit to administer Prolastin. In this case, you'll get the medication delivered directly to your home before your appointments with the home nurse. Discuss with your providers to see whether getting Prolastin infusions at home is right for you.
If you're feeling sick during the Prolastin infusion, let a healthcare provider know right away. The provider might slow down your infusion or stop the infusion until you feel better. They also might recommend other medications to help relieve your symptoms, for example acetaminophen (Tylenol) for fever. If you feel generally sick and aren't well enough to get your infusion, call your provider to see what to do and whether to reschedule your appointment.
Both Prolastin-C Liquid (or sometimes simply known as Prolastin) and Zemaira are brand-name medications that contain the same active ingredient, alpha 1-proteinase inhibitor. These two brands are very similar to each other. Studies show that brands of alpha 1-proteinase inhibitors are safe and work just as well as each other. Prolastin-C Liquid and Zemaira are given as once-weekly infusions through the vein with the help of a trained healthcare provider. The main difference between them is that Prolastin-C Liquid is available as a liquid that's ready for infusion, whereas Zemaira comes as a powder that needs to be mixed before administration. Discuss with your provider about which brand is right for you.
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.
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.
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Prolastin will not be safe for you to take.