How is ARALAST NP administered?
ARALAST NP is infused through an intravenous (IV) line.1 Administered by a healthcare professional, the entire process, including setup and infusion, takes approximately 1 hour.
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.
If you have any questions about ARALAST NP or your infusion site, ask your doctor, your home care agency, and/or the infusion nurse.
Where is ARALAST NP administered?
Depending on your insurance coverage and personal preferences, ARALAST NP can be infused in your home, workplace, hospital outpatient department, or at a freestanding infusion center or clinic. If you receive your infusion at home or at work, a specialized home care agency will contact you to set up a convenient time for the procedure and provide everything needed to administer your ARALAST NP.
How often is ARALAST NP administered?
ARALAST NP is prescribed for infusion once a week.1 Of course, you should also continue to see your physician regularly so that he or she can watch and treat any symptoms related to emphysema.
Who makes ARALAST NP?
ARALAST NP is provided by Baxter Healthcare Corporation, which has a long history of offering innovative products and supportive patient programs. Healthcare professionals can prescribe ARALAST NP for congenital AATD for patients with clinically evident emphysema.
What can you expect from ARALAST NP?
ARALAST NP augments the level of AAT protein in your blood and lungs, but it is not a cure for AATD.
Sometimes, people who have been diagnosed with hereditary conditions can benefit from counseling or even medication. Don’t hesitate to seek the help you need. 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 [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.
References
- ARALAST NP [Alpha1–Proteinase Inhibitor (Human)] Prescribing Information. Baxter Healthcare Corporation, April 2010.
