Prolastin-C (alpha-1 proteinase inhibitor (human))
Also marketed as Aralast NP and Zemaira and Glassia. An approved treatment for Alpha-1 Antitrypsin Deficiency.
The same compound appears under different names depending on the context. Here is how to identify Alpha-1 proteinase inhibitor (human) wherever you encounter it, plus the key facts at a glance.
- Generic name
- Alpha-1 proteinase inhibitor (human)
- Brand names
- Prolastin-C, Aralast NP, Zemaira, Glassia
- Drug class
- Protein replacement therapy
- Manufacturer
- Grifols / Takeda / CSL Behring
- How it's taken
- The labeled dose for all 4 brands is 60 mg per kilogram of body weight, given as an IV infusion once a week.
Weekly IV infusions of purified AAT protein from human blood donors. The standard treatment for Alpha-1 lung disease, it raises AAT levels in the blood to help protect the lungs from damage.
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Where Alpha-1 proteinase inhibitor (human) fits
Approved for adults with emphysema due to severe alpha-1 antitrypsin deficiency. It raises blood levels of the protective protein; its labels state that an effect on emphysema progression has not been conclusively demonstrated in randomized, controlled trials.
How Alpha-1 proteinase inhibitor (human) works
Your lungs need a special protein called alpha-1 proteinase inhibitor to protect them from damage. People with alpha-1 antitrypsin deficiency don't have enough of this protective protein, which allows damaging enzymes to attack lung tissue. This medicine replaces the missing protein by giving you purified human alpha-1 proteinase inhibitor through an IV, like giving your lungs new armor.
Mechanism: IV replacement of the deficient AAT protein
Side effects and safety
The most common side effects differ by brand. Glassia's label lists headache and upper respiratory infection[4]; Zemaira's includes headache, sinusitis and upper respiratory infection[3]; Aralast NP's lists headache, muscle or joint discomfort, bruising where the needle went in, nausea and runny nose[2]; and Prolastin-C Liquid's lists diarrhea and fatigue[1].
People with IgA deficiency who have antibodies against IgA should not use these products because of the risk of a severe allergic reaction, and most labels also rule them out for anyone who has had anaphylaxis to an alpha-1 proteinase inhibitor. Get help right away for trouble breathing, chest tightness, hives or other signs of an allergic reaction.
Because these products are made from human plasma, their labels warn they may carry a risk of transmitting infectious agents such as viruses. Screening plasma donors and testing the plasma reduce that risk.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Alpha-1 proteinase inhibitor (human)
The labeled dose for all 4 brands is 60 mg per kilogram of body weight, given as an IV infusion once a week. At the labeled rate, a dose takes about 15 minutes to infuse for Prolastin-C Liquid, Zemaira and Glassia. Infusions can be given at an infusion center or at home, and Glassia's label allows trained patients or caregivers to self-infuse at home[4].
Availability and cost
Only available as the brand-name product.
Plasma-derived augmentation therapy requiring collection and purification from human blood plasma. The biologic source material and complex manufacturing process drive the cost of weekly IV infusions.
Help paying for Prolastin-C
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
PROLASTIN-C LIQUID: commercially insured patients may qualify for $0 copay via PROLASTIN DIRECT Assist, with help up to $10,000 per year.
For: private insurance · source - Insurance and case manager help
PROLASTIN DIRECT: automatic enrollment; insurance verification, delivery, home infusion nurses and connection to AlphaNet coordinators.
The official page does not say who qualifies. Ask the program. · source - Copay help
GLASSIA or ARALAST NP: Takeda Co-Pay Assistance Program can cover up to 100% of copay for eligible commercially insured patients; annual maximum applies.
For: private insurance · source - Insurance and case manager help
Takeda Patient Support: insurance help, pharmacy coordination and home infusion training for GLASSIA and ARALAST NP.
The official page does not say who qualifies. Ask the program. · source - Insurance and case manager help
ZEMAIRA Connect case managers do benefit checks; enrollment is required for CSL Behring financial help. Phone 1-866-936-2472.
The official page does not say who qualifies. Ask the program. · source
Good to know: Four brands, three companies, each with its own program. Takeda Patient Support: 1-866-888-0660. ZEMAIRA Connect: 1-866-936-2472. Takeda's copay excludes Medicare, Medicaid, TRICARE, VA and state programs. ZEMAIRA copay terms are not published on an official page; ask CSL Behring directly. PROLASTIN DIRECT enrollment is through your doctor's form.
- From a charity · NORD RareCareAlpha-1 Antitrypsin Deficiency Premium Copay Assistance fundOpen
Pays for: Insurance premiums and copays.
The foundation says: “Accepting new applications and re-enrollments for current year” - From a charity · The Assistance FundAlpha-1 Antitrypsin Deficiency fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
Prolastin was the first product approved by the FDA in 1987, on the basis of raising blood AAT levels. In the largest placebo-controlled trial, RAPID (180 patients, Lancet 2015), weekly Zemaira slowed the yearly loss of lung density measured at total lung capacity (p=0.03), but not significantly on the combined or functional residual capacity measures, and the FDA labels state that an effect on emphysema progression has not been demonstrated in randomized, controlled trials.
Development history
The first alpha-1 proteinase inhibitor, Prolastin, was approved by the FDA in 1987. The brands sold in the U.S. today are Prolastin-C (Grifols), Aralast NP (Takeda), Zemaira (CSL Behring) and Glassia (Takeda).
Explore Alpha-1 Antitrypsin Deficiency trials
Other Alpha-1 Antitrypsin Deficiency treatments
Alpha-1 proteinase inhibitor (human) in Trial Friend News and Guides
Common questions about Alpha-1 proteinase inhibitor (human)
▸What is Alpha-1 proteinase inhibitor (human) (Prolastin-C)?
Weekly IV infusions of purified AAT protein from human blood donors. The standard treatment for Alpha-1 lung disease, it raises AAT levels in the blood to help protect the lungs from damage.
▸How does Alpha-1 proteinase inhibitor (human) work?
Your lungs need a special protein called alpha-1 proteinase inhibitor to protect them from damage. People with alpha-1 antitrypsin deficiency don't have enough of this protective protein, which allows damaging enzymes to attack lung tissue. This medicine replaces the missing protein by giving you purified human alpha-1 proteinase inhibitor through an IV, like giving your lungs new armor.
▸What are the side effects of Alpha-1 proteinase inhibitor (human)?
The most common side effects differ by brand. Glassia's label lists headache and upper respiratory infection[4]; Zemaira's includes headache, sinusitis and upper respiratory infection[3]; Aralast NP's lists headache, muscle or joint discomfort, bruising where the needle went in, nausea and runny nose[2]; and Prolastin-C Liquid's lists diarrhea and fatigue[1].
People with IgA deficiency who have antibodies against IgA should not use these products because of the risk of a severe allergic reaction, and most labels also rule them out for anyone who has had anaphylaxis to an alpha-1 proteinase inhibitor. Get help right away for trouble breathing, chest tightness, hives or other signs of an allergic reaction.
Because these products are made from human plasma, their labels warn they may carry a risk of transmitting infectious agents such as viruses. Screening plasma donors and testing the plasma reduce that risk.
▸How is Alpha-1 proteinase inhibitor (human) taken?
The labeled dose for all 4 brands is 60 mg per kilogram of body weight, given as an IV infusion once a week. At the labeled rate, a dose takes about 15 minutes to infuse for Prolastin-C Liquid, Zemaira and Glassia. Infusions can be given at an infusion center or at home, and Glassia's label allows trained patients or caregivers to self-infuse at home[4].
▸Is Alpha-1 proteinase inhibitor (human) FDA approved?
Yes, Alpha-1 proteinase inhibitor (human) (Prolastin-C) is FDA approved (1987) for the treatment of Alpha-1 Antitrypsin Deficiency.
▸What is augmentation therapy for Alpha-1 AT deficiency?
Augmentation therapy provides purified alpha-1 proteinase inhibitor protein derived from human plasma to replace the AAT that patients cannot produce. This raises blood AAT levels to help protect the lungs from enzyme-mediated damage.
▸What brand names are available?
Multiple brands are available including Prolastin-C (Grifols), Aralast NP (Takeda), Zemaira (CSL Behring), and Glassia (Takeda). All provide the same purified human AAT protein but differ in formulation and infusion characteristics.
▸How long has augmentation therapy been available?
The first alpha-1 proteinase inhibitor product, Prolastin, was approved by the FDA in 1987, so augmentation therapy has been in use for nearly 40 years.
▸How is augmentation therapy administered?
Augmentation therapy is given as a weekly IV infusion of 60 mg per kilogram of body weight, which takes about 15 minutes at the labeled rate for most brands. It can be given at an infusion center or at home, and it is long-term treatment.
▸Does augmentation therapy reverse existing lung damage?
No trial has shown that augmentation therapy reverses lung damage that has already happened. It raises AAT levels in the blood, and in the RAPID trial weekly Zemaira slowed the yearly loss of lung density on one of its measures, but all 4 U.S. labels state that an effect on emphysema progression has not been conclusively demonstrated in randomized, controlled trials.
▸Is generic augmentation therapy available?
Multiple manufacturers produce alpha-1 proteinase inhibitor products, all derived from pooled human plasma. While not generics in the traditional sense, having multiple products helps with supply availability.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- DailyMed, U.S. National Library of Medicine. PROLASTIN-C LIQUID (alpha1-proteinase inhibitor (human)) prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2b620e6b-6a24-0957-1288-ae529c4cc3a2
- DailyMed, U.S. National Library of Medicine. ARALAST NP (alpha-1-proteinase inhibitor (human)) prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a9a5b46e-04da-41bd-bb5f-c4936b664fef
- DailyMed, U.S. National Library of Medicine. ZEMAIRA (alpha1-proteinase inhibitor (human)) prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0c3354b5-a1d8-4f98-ad55-2eafe4265c4e
- DailyMed, U.S. National Library of Medicine. GLASSIA (alpha1-proteinase inhibitor (human)) prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=83473cbb-48e4-42a2-81b6-4c851423da7b