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. ARALAST NP is not indicated as therapy for lung disease patients in whom congenital A1-PI deficiency has not been established.

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.

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 (≤ 0.08mL/kg/min) should be closely followed and vital signs monitored continuously. If anaphylactic or severe anaphylactic 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 Prescribing Information for full prescribing details.

GLASSIA™ [Alpha1-Proteinase Inhibitor (Human)]

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.

Important Risk Information for GLASSIA™

GLASSIA™ is contraindicated in Immunoglobulin A (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 infections 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 product brought to room temperature within three hours of entering the vials to avoid microbial contamination.

Safety and effectiveness in patients over 65 years of age have not been established.

The most common product-related adverse reactions in clinical studies were headache and dizziness.

Please see GLASSIA™ Prescribing Information for full prescribing details.