Getting Your Patient Started on ARALAST NP

To start your patient on ARALAST NP, fill out and submit the Start Form below. Takeda Patient Support will review the Start Form and confirm patient eligibility.

INDICATION AND LIMITATIONS OF USE:

ARALAST NP is an Alpha₁-Proteinase Inhibitor (Alpha₁-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe congenital deficiency of Alpha₁-PI (alpha₁-antitrypsin deficiency). ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha₁-PI.

The effect of augmentation therapy with any Alpha₁-PI, including ARALAST NP, on pulmonary exacerbations and on the progression of emphysema in alpha₁-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.
Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with ARALAST NP or ARALAST are not available.
ARALAST NP is not indicated as therapy for lung disease in patients in whom severe Alpha₁ PI deficiency has not been established.

IMPORTANT SAFETY INFORMATION

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Contraindications: ARALAST NP is contraindicated in immunoglobulin A (IgA) deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity.

Warnings and Precautions

Hypersensitivity Reactions: ARALAST NP may contain trace amounts of IgA. Patients with known antibodies to IgA have a greater risk of developing severe hypersensitivity and anaphylactic reactions. Closely follow the recommended infusion rate, monitor vital signs continuously, and observe the patient carefully throughout the infusion. If hypersensitivity symptoms occur, discontinue the infusion and administer appropriate emergency treatment. Have appropriate supportive therapy available for any acute anaphylactic or anaphylactoid reaction.

Transmissible Infectious Agents: Because ARALAST NP is derived from pooled human plasma it may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No seroconversions for hepatitis B or C or human immunodeficiency virus or any other known infectious agent were reported with the use of ARALAST NP during the clinical trials.

ADVERSE REACTIONS

Hypersensitivity reactions have been reported in patients following administration of ARALAST NP.
The most common adverse reactions occurring in ≥5% of infusions in clinical trials were headache, musculoskeletal discomfort, vessel puncture site bruise, nausea, and rhinorrhea.

Please click for ARALAST NP Full Prescribing Information.