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ARALAST NP Therapy Tolerability
ARALAST NP therapy is a similar product to ARALAST therapy, containing the same active components of plasma α1-PI with identical formulations.
In a PK (pharmacokinetic) study, no serious side effects, antibody formation, and viral seroconversions were observed.1
Important Risk Information for
ARALAST NP
ARALAST NP is contraindicated in individuals with selective IgA deficiencies (IgA level less than 15 mg/dL) who have known antibody against IgA since they may experience severe reactions, including anaphylaxis.
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 rate of administration should be closely followed and vital signs monitored continuously. If anaphylactic or severe anaphylactic reactions occur, the infusion should be discontinued immediately.
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.
As with all plasma-derived therapeutics, the potential to transmit infectious agents, e.g. viruses, and theoretically, the Creutzfeld-Jakob disease (CJD) agent can not be totally eliminated. Please refer to the ARALAST NP Important Risk Information on this page for more detailed information.
The most common adverse events deemed related to ARALAST NP therapy included: headache (4 of 61 [7%] events) and musculoskeletal discomfort (4 of 61 [7%] events).2
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.
Important Risk Information for ARALAST NP
ARALAST NP is contraindicated in individuals with selective IgA deficiencies (IgA level less than 15 mg/dL) who have known antibody against IgA, since they may experience severe reactions, including anaphylaxis.
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.
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.
References
- Data on file, Baxter Healthcare Corporation
- ARALAST NP [Alpha1–Proteinase Inhibitor (Human)] Prescribing Information, Baxter Healthcare Corporation; May 2007.
