Prolastin-C

Pronunciation: PRO-last-in-C
Generic name: alpha 1-proteinase inhibitor
Brand name: Prolastin-C Liquid
Dosage form: solution for intravenous injection
Drug class: Miscellaneous respiratory agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 10, 2024.

What is Prolastin-C?

Prolastin-C Liquid may be used to replace missing alpha₁-proteinase inhibitor (alpha₁-PI) levels in people with a severe hereditary alpha₁-PI deficiency (also called alpha-1) who have symptoms of emphysema. Prolastin-C Liquid is a ready-to-use intravenous (into a vein) infusion given weekly for a person's life.

• Randomized controlled trials have not conclusively demonstrated a benefit for Prolastin-C on pulmonary exacerbations or the progression of emphysema.
• The long-term effects of augmentation (replacement) treatment with Prolastin-C are unknown.
• Prolastin-C should not be given to patients with lung disease who have not been diagnosed with severe Alpha-1 PI deficiency.

Prolastin-C Liquid is a concentrated, purified, form of the protein alpha₁ antitrypsin. Weekly administration raises plasma levels of alpha₁-PI although it is not known if this reduces pulmonary exacerbations or progression of emphysema. Alpha₁-PI deficiency is a rare genetic disease that is passed down through families. People with this condition do not make enough alpha₁-PI, a protein that protects your lungs from inflammation that can reduce lung function. 

Prolastin-C Liquid, a ready-to-use intravenous infusion, was FDA-approved on September 22, 2017. Prolastin-C, which required premixing, was first approved in February 1988 but is no longer available.

Prolastin-C side effects

Prolastin-C is well tolerated, and side effects are uncommon, but the most common side effects reported were diarrhea and fatigue.

Other side effects reported include:

• Upper respiratory tract infection
• Headaches
• Itchy skin
• Rash
• Nausea
• Edema
• Fever.

You may feel faint during the infusion and may need to rest for a short time afterward.

Serious side effects and warnings

Should not be given to people with a history of anaphylaxis or other severe systemic reactions to alpha₁-PI, Prolastin-C, or any of the inactive ingredients in the vial. Get emergency medical help if you have signs of an allergic reaction, such as hives, rash; confusion, feeling light-headed; fast heartbeats, chest tightness, difficulty breathing; or swelling of your face, lips, tongue, or throat.

Do not administer to immunoglobulin A (IgA deficient patients with antibodies against IgA).

Prolastin-C is not indicated for lung diseases that are not due to severe alpha₁-PI deficiency.

Prolastin-C is made from donated human plasma and may contain viruses or other infectious agents, although these are routinely screened for and treated to reduce the risk of contamination, there is still a small possibility it could transmit disease, such as the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD). Ask your doctor about any possible risks.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking

Before receiving Prolastin-C, tell your doctor about all your medical conditions, including if you:

• are allergic to alpha₁-PI, Prolastin-C, or any of the inactive ingredients in the vial
• have liver disease
• have chronic obstructive pulmonary disease (COPD), or other breathing disorders.

Tell your doctor if you are pregnant or breastfeeding.

Prolastin-C is not approved for use by anyone younger than 18 years old.

Pregnancy

There are no data about using Prolastin-C in pregnant women and it is not known if it can cause fetal harm. Only use in pregnant women if needed.

Lactation

There is no information regarding the presence of Prolastin-C in human milk, and its effects on the breastfed infant, or milk production.

How is Prolastin-C administered?

Prolastin-C Liquid is administered as an infusion into your vein (intravenous infusion) by a healthcare professional, either in your home or at a clinic.

• Most Prolastin C infusions take approximately 15 minutes.

When your doctor prescribes Prolastin-C Liquid you are automatically enrolled in the Prolastin Direct program.

• Your doctor will send your prescription to Eversana, the only specialty pharmacy that fills Prolastin-C Liquid prescriptions and manages the Prolastin Direct program (1-800-305-7881),
• The Prolastin Direct team will call you within 24 hours of receiving your prescription. If you are having your infusion at home then the Prolastin-C liquid will be delivered directly to your home before your appointment with your infusion nurse. If you go to an infusion center, it will be waiting for you when you get there.

Eversana Prolastin-C

Eversana is a specialty pharmacy and is the only pharmacy that fills and ships Prolastin-C liquid prescriptions. Eversana also manages the Prolastin Direct program which will provide, at no additional cost:

• Insurance verification and coordination
• Infusion coordination with a certified alpha–1–trained registered nurse
• Pharmacy services, supplies, and delivery
• 24/7 access to Alpha-1 Care, who will assist you with securing insurance coverage, coordinating infusions, and connecting you to AlphaNet.
• An alternative clinic for your infusion if you are traveling
• A phone call each month to check on your supplies and confirm shipment.

Prolastin-C Dosing

The recommended dose of Prolastin-C Liquid is 60 mg/kg of body weight infused intravenously (into a vein) once per week.

• The usual infusion rate is up to 0.08 mL/kg per minute.
• The average infusion takes about 15 minutes.
• Weekly infusions of Prolastin-C are usually given for the rest of a person's life.

Your first dose may be given in a medical setting so that any serious side effects can be treated quickly.

What happens if I miss a dose?

Call Prolastin Direct (1-800-305-7881) if you miss a dose and they will reschedule your next dose for you.

What happens if I overdose?

An overdose of Prolastin-C is unlikely but your infusion nurse or doctor will attend to any symptoms.

What other drugs will affect Prolastin-C?

Other drugs may affect Prolastin-C, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use. See the Prolastin-C Liquid Prescribing Information for a full list of interactions.

Storage

Vials of Prolastin-C should be stored in a refrigerator at 36-46°F (2-8°C). Do not freeze.

• The vials may be stored at room temperature not exceeding 77°F (25°C) for up to 1 month, after which the product must be used or immediately discarded. 

Ingredients

Active: alpha.1-proteinase Inhibitor Human 

Inactive: Sodium phosphate, alanine, water.

Prolastin-C Liquid is a solution for injection containing approximately 500 mg (10 mL), 1000 mg (20 mL), and 4000 mg (80 mL) in single-dose vials. 

• The actual amount of functionally active Alpha1-PI in milligrams is printed on the vial label and carton.

Who makes Prolastin-C?

Grifols Therapeutics Inc. makes Prolastin-C Liquid.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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