ARALAST® NP [Alpha1-Proteinase Inhibitor (Human)] 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. No randomized, controlled trials have demonstrated effects of augmentation therapy on pulmonary exacerbations or emphysema progression. Clinical data on long-term effects of ARALAST NP therapy are not available.
Please see full Indication and Limitations of Use below.
Administer ARALAST NP at a rate not to exceed 0.2 mL per kg body weight per minute, and as determined by the response and comfort of the patient.1
In a clinical trial, augmentation therapy with ARALAST NP was administered once weekly to patients with congenital Alpha1 deficiency at a dose of 60 mg/kg.*†1
During weeks 8 through 11 of the clinical trial, steady-stage trough levels of serum antigenic and functional Alpha1-PI remained above the 11 µM theoretical protective level.1
There were no deaths and no serious adverse reactions associated with ARALAST NP or ARALAST administration in clinical trials. The most common adverse reactions (>0.5% of infusions) in clinical trials were headache and upper respiratory infection.1
*Study Design: ARALAST NP was evaluated in a randomized, double-blind trial with partial crossover involving 26 Alpha1-PI deficient patients receiving ARALAST NP (n=13) or the comparator (n=13) at a dose of 60 mg/kg IV per week for 10 consecutive weeks. Following the first 10 weekly infusions, all patients received ARALAST NP at 60 mg/kg IV per week. The objectives of the study were to: demonstrate the pharmacokinetics of antigenic and/or functional Alpha1-PI in ARALAST NP were not inferior to the control; and determine whether ARALAST NP maintained antigenic and/or functional Alpha1-PI of at least 11 µM (57 mg/dL). A second clinical trial in 13 patients with severe congenital Alpha1-PI deficiency evaluated safety and effects of weekly augmentation therapy on levels of Alpha1-PI in the epithelial lining fluid.1
†The effect of augmentation therapy on pulmonary exacerbations and on the progression of emphysema in Alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials.1
Use the brochure for additional information on ARALAST NP as well as product support for your patients.
Learn how ARALAST NP is lyophilized for reconstitution and administered as a once-weekly infusion.
From the moment your patients enroll in OnePath, a dedicated Patient Support Manager will work with them one-on-one to help them access their prescribed Takeda medication.
The following are covered up to the program maximum and may be paid directly to the provider:
At a minimum, to be eligible for the program, a patient must:
Other eligibility requirements apply.
*IMPORTANT NOTICE: The OnePath Copay Assistance Program (the Program) is not valid for prescriptions eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Tricare, Medigap, VA, DoD, or other federal or state programs (including any medical or state prescription drug assistance programs). No claim for reimbursement of the out-of-pocket expense amount covered by the Program shall be submitted to any third party payer, whether public or private. The Program cannot be combined with any other rebate/coupon, free trial, or similar offer. Copayment assistance under the Program is not transferable. The Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes, you must notify the Program immediately at 1-866-888-0660. Coverage of certain administration charges will not apply for patients residing in states where it is prohibited by law. Takeda reserves the right to rescind, revoke, or amend the Program at any time without notice.