Patient Medication Information: uses, side effects, how to take - Prolastin-C
What is Prolastin-C used for?
Alpha1 Antitrypsin Deficiency, also known as Alpha1, is an inherited disorder that causes significant reduction in the naturally occurring protein alpha1 antitrypsin (AAT).
Scientists also call this protein Alpha1-Proteinase Inhibitor (alpha1-PI) because it inhibits not only trypsin but also other enzymes called proteinases.
It is believed that Alpha1 affects as many as 100,000 people in the United States and similar numbers in Europe. Alpha1 is most common among Caucasians of Northern European and Iberian descent. It is the most common cause of genetic liver disease in children and genetic emphysema in adults.
Lung disease (emphysema) is the most common problem associated with a deficiency of AAT. AAT is produced by the liver and shields the body from damage caused by neutrophil elastase. Neutrophil elastase is an enzyme produced by white blood cells.
Under normal conditions, neutrophil elastase helps fight bacteria that cause infection. However, if not neutralized by AAT, neutrophil elastase can destroy healthy lung tissue.
Alveoli are tiny air sacs in the lungs, which are responsible for taking in oxygen and releasing carbon dioxide. When adequate levels of AAT are not present, the enzymatic activity of neutrophil elastase is not blocked and the fine elastic tissue supporting the alveoli is destroyed. Over time, enough alveoli are destroyed to cause the lungs to lose much of their elasticity, resulting in emphysema. Therefore, people with a deficiency of AAT are at high risk for developing emphysema.
There are many components to treating AAT. The goal is to maintain better lung function. This can be done through smoking cessation, asthma medications (if necessary), infection control, good nutrition, environment modifications, exercise, and stress management.
Prolastin-C is a treatment that helps restore the natural balance of enzymes in the lungs and protects them from the damage caused by neutrophil elastase.
How does Prolastin-C work?
Prolastin-C, made from human plasma, is a concentrated form of AAT. Given as prescribed, Prolastin-C raises the blood and lung levels of AAT. This may help lessen damage to the lungs caused by the enzymatic activity of neutrophil elastase. Because Prolastin-C therapy augments or replaces AAT, it is known as "augmentation" or "replacement" therapy.
What are the ingredients in Prolastin-C?
Medicinal ingredients: Human alpha1-proteinase inhibitor
Non-medicinal ingredients: sodium, chloride, and sodium phosphate
Prolastin-C comes in the following dosage forms:
single use vials with a functional activity of 1000 mg. An appropriate amount of Sterile Water for Injection, USP is also provided to dilute Prolastin-C.
Do not use Prolastin-C if:
- you are allergic to alpha1-proteinase inhibitor or to any ingredient in the formulation or component of the container.
- your body does not make enough immunoglobulin A (IgA), which could cause you to have an allergic reaction to blood products that contain IgA.
- you have previously had an allergic reaction to any alpha1-proteinase inhibitor product.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Prolastin-C. Talk about any health conditions or problems you may have, including if you:
are pregnant or breastfeeding
- have had an allergic reaction to alpha1-proteinase inhibitor or any of the other ingredients in the medicine
Other warnings you should know about:
Prolastin-C like other products made from human plasma, part of our blood, may contain viruses or other agents that can cause infection and illness. However, the processes used to make Prolastin-C are specifically designed with the ability to destroy or remove these agents if they are present. You should discuss the risks and benefits of this product with your healthcare professional.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take Prolastin-C:
A doctor, nurse or other caregiver trained to give injections will give your treatment. If you are receiving Prolastin-C infusions at home, rather than a hospital or clinic, be sure to closely follow all instructions from your doctor.
Usual dose:
Your doctor will determine the amount of Prolastin-C that is right for you and when your treatments should be given.
Overdose:
There have been no reported cases of overdose for Prolastin-C or other Alpha1 Proteinase Inhibitor (Human) products manufactured by Grifols. The effects of an overdose are not known.
| If you think you, or a person you are caring for, have taken too much Prolastin-C, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
It is important that you receive Prolastin-C as instructed by your healthcare professional. You should consult him/her if a treatment is missed.
What are possible side effects from using Prolastin-C?
These are not all the possible side effects you may have when taking Prolastin-C. If you experience any side effects not listed here, tell your healthcare professional.
Prolastin-C is well tolerated, but side effects are occasionally reported. The most common side effects were diarrhea and fatigue, each of which occurred in 6% of subjects enrolled in clinical studies. Talk with your healthcare provider if you have the following side effects following treatment: fever, light-headedness, dizziness, flu-like symptoms, allergic-like reactions, chills, trouble breathing, rash, abnormal heartbeat, changes in blood pressure, or chest pain.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
Severe allergic reaction (e.g. rash, hives, itching, difficulty breathing or swallowing, swelling of hands, face or mouth) | ||
| √ | √ | |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Prolastin-C should be stored at temperatures not to exceed 25°C. It should not be frozen. Administer within 3 hours after reconstitution.
Keep out of reach and sight of children.
If you want more information about Prolastin-C:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by calling 1-866-482-5226.
Grifols Therapeutics LLC (Manufacturer)
8368 US 70 Bus. Hwy West
Clayton, NC 27520
Grifols Canada Ltd. (Importer and Distributor)
5060 Spectrum Way, Suite 405
Mississauga, Ontario L4W 5N5