Prolastin-C is an injection for infusion that contains a protein (alpha₁-proteinase inhibitor [alpha₁-PI]) made from human plasma that can be used to provide a source of alpha₁-PI in people with symptoms of emphysema due to severe hereditary deficiency of alpha₁-PI (also called alpha₁-antitrypsin deficiency). Prolastin-C increases and maintains serum and lung epithelial lining fluid levels of alpha₁-PI. Prolastin-C requires mixing before use but Prolastin-C Liquid is a ready-to-use infusion.

Alpha₁-antitrypsin 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. Symptoms of Alpha₁ deficiency include shortness of breath, wheezing, chronic cough, phlegm production, and low exercise tolerance. Because these symptoms are similar to other conditions, more than 9 out of 10 people who have the deficiency, do not know that they have it. Alpha₁ is thought to be a contributing cause of up to 3% of all COPD cases in the United States. If one family member has been diagnosed with alpha₁-antitrypsin deficiency, then other family members should be tested for it.

Although there is no cure for alpha₁-antitrypsin deficiency, it can be treated. Prolastin-C is a concentrated form of alpha₁-PI that has been purified from human plasma. It is given as a lifelong, weekly infusion that takes approximately 15 minutes. 

Although Prolastin-C raises plasma levels of alpha₁-PI, randomized trials have failed to demonstrate that it slows the rate of progression of emphysema or prevents pulmonary exacerbations. 

Prolastin-C Liquid was FDA-approved on September 22, 2017. Prolastin-C was first approved in February 1988.

Should not be given to people with a history of anaphylaxis or other severe systemic reactions to alpha₁-PI.

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.

Tell your doctor if you have ever had:

• liver disease; or
• chronic obstructive pulmonary disease (COPD), or other breathing disorders.

Tell your doctor if you are pregnant or breastfeeding.

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.

Prolastin C is administered by a healthcare professional, either at your home or in a clinic.

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, 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 alpha₁–expert nurses and support
• An alternative clinic for your infusion if you are traveling
• A phone call each month to check on your supplies and confirm shipment.

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.

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

• The usual rate of infusion is up to 0.08 mL/kg per minute.
• The average infusion takes about 15 minutes.

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

Call Prolastin Direct if you miss a dose and they will reschedule your next dose for you.

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

Get emergency medical help if you have signs of an allergic reaction: hives, rash; confusion, feeling light-headed; fast heartbeats, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat.

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.

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 FDA at 1-800-FDA-1088.