What to Expect

Once you and your doctor have agreed on AAT augmentation, you’ll want to understand what will be involved in the process. Here is important information about what you can expect when your AAT augmentation begins.

You will receive your GLASSIA or ARALAST NP through an infusion, which means that an intravenous (IV) line will be used to get the GLASSIA or ARALAST NP into your bloodstream. The infusion will be administered by a healthcare professional, such as a doctor or nurse. GLASSIA or ARALAST NP is prescribed for infusion once a week.

Important Risk Information for GLASSIA

Administer GLASSIA within 3 hours of entering the vials.

Administer GLASSIA at room temperature at a rate not greater than 0.04 mL/kg body weight per minute. If anaphylactic or severe anaphylactoid reactions occur, discontinue the infusion immediately.

Important Risk Information for ARALAST NP

ARALAST NP should be administered at room temperature within three (3) hours after reconstitution and should be administered alone, without mixing with other agents or diluting solutions.

The recommended rate of administration (≤0.08 mL/kg/min) should be closely followed and vital signs monitored continuously. If anaphylactic or severe anaphylactoid reactions occur, the infusion should be discontinued immediately.

Selecting a Location

Depending upon your insurance coverage, your personal preference, and what you and your healthcare provider think might be best for you, you may receive your infusions in:

  • your home
  • your workplace
  • a hospital outpatient department
  • a freestanding infusion center or clinic

If you decide to receive your GLASSIA or ARALAST NP at home or in your workplace, a specialized homecare company will help you with all the arrangements.

You and your healthcare provider can select the homecare company that best fits your needs. To learn more about the homecare companies available to GLASSIA and ARALAST NP patients, visit the Home Care page of this website.

Home Care and Your Infusions

Once you have selected a homecare company, your healthcare provider will contact the company to begin the process.

First, you will receive a call from your specialized homecare agency – usually within a week of deciding that AAT augmentation is right for you. Together, you will set up the time and dates for your infusions.

When the homecare nurse arrives to administer your treatments, he or she will bring everything needed for your infusion. The complete infusion process, including set-up, usually takes about an hour.

Even though you will be getting infusions every week, you will continue to see your doctor regularly. Any questions you have about your therapy or care of your infusion site can be answered by your doctor, your homecare agency, and/or the nurse who administers your therapy.

GLASSIA [Alpha1-Proteinase Inhibitor (Human)]

GLASSIA is indicated for chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT) deficiency.

  • The effect of augmentation therapy with GLASSIA or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been demonstrated in randomized, controlled clinical trials.
  • Clinical data demonstrating the long term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available.
  • GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.

Detailed Important Risk Information for GLASSIA

  • GLASSIA is contraindicated in IgA deficient patients with antibodies against IgA. GLASSIA is contraindicated in individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to Alpha1-PI products.
  • GLASSIA is made from human plasma. It may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • Administer GLASSIA at room temperature at a rate not greater than 0.04 mL/kg body weight per minute. If anaphylactic or severe anaphylactoid reactions occur, discontinue the infusion immediately.
  • Administer GLASSIA within 3 hours of entering the vials.
  • Safety and effectiveness in patients over 65 years of age have not been established.
  • Two serious adverse reactions observed on two separate occasions during clinical studies with GLASSIA were cholangitis and exacerbation of chronic obstructive pulmonary disease (COPD).
  • The most common product-related adverse reactions in clinical studies were headache and dizziness.

Please see GLASSIA Full Prescribing Information for full prescribing details.

ARALAST NP [Alpha1-Proteinase Inhibitor (Human)]

ARALAST NP is indicated for chronic augmentation therapy in patients having congenital deficiency of A1-PI with clinically evident emphysema.

  • The effect of augmentation therapy with ARALAST NP on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.
  • Clinical data demonstrating the long-term effects of chronic augmentation or replacement therapy of individuals with ARALAST NP or ARALAST are not available.
  • ARALAST NP is not indicated as therapy for lung disease patients in whom congenital A1-PI deficiency has not been established.

Detailed Important Risk Information for ARALAST NP

  • ARALAST NP is contraindicated in IgA deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity.
  • ARALAST NP is derived from pooled human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • The recommended rate of administration (≤0.08 mL/kg/min) should be closely followed and vital signs monitored continuously. If anaphylactic or severe anaphylactoid reactions occur, the infusion should be discontinued immediately.
  • Safety and effectiveness in patients over age 65 years of age have not been established.
  • ARALAST NP should be administered at room temperature within three (3) hours after reconstitution and should be administered alone, without mixing with other agents or diluting solutions.
  • The safety of ARALAST NP was evaluated with ARALAST in a crossover clinical PK comparability study. The most common adverse events deemed related to ARALAST NP included headache and musculoskeletal discomfort. No serious adverse reactions or deaths were reported in the study. In the ARALAST pivotal study, the most common adverse events were headache and somnolence.

Please see ARALAST NP Full Prescribing Information for full prescribing details.