WARNINGS
Because Alpha1-Proteinase Inhibitor (Human), Aralast™, 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. Stringent procedures designed to reduce the risk of adventitious agent transmission have been employed in the manufacture of this product, from the screening of plasma donors and the collection and testing of plasma through the application of viral elimination/reduction steps such as alcohol fractionation, PEG precipitation, solvent detergent treatment, and nanofiltration. Despite these measures, such products can still potentially transmit disease; therefore, the risk of infectious agents can not be totally eliminated. ALL infections thought by a physician possibly to have been transmitted by this product should be reported to the manufacturer at 1-888-675-2762 (US) or 1-323-225-9735 (International). The physician should weigh the risks and benefits of the use of this product and should discuss these with the patient.
The rate of administration specified in DOSAGE AND ADMINISTRATION should be closely followed, at least until the physician has had sufficient experience with a given patient. Vital signs should be monitored continuously and the patient should be carefully observed throughout the infusion. IF ANAPHYLACTIC OR SEVERE ANAPHYLACTOID REACTIONS OCCUR, THE INFUSION SHOULD BE DISCONTINUED IMMEDIATELY. Epinephrine and other appropriate supportive therapy should be available for the treatment of any acute anaphylactic or anaphylactoid reaction.
PRECAUTIONS
GENERAL
Alpha1-Proteinase Inhibitor (Human), Aralast™, should be administered within three (3) hours after the reconstituted product is warmed to room temperature. Partially used vials should be discarded and not saved for future use. The solution contains no preservative.
Aralast™ should be administered alone, without mixing with other agents or diluting solutions.
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with Aralast™. It is also not known whether Aralast™ can cause fetal harm when administered to pregnant women or can affect reproductive capacity.
NURSING MOTHERS
It is not known whether alpha1-proteinase inhibitor is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Aralast™ is administered to a nursing woman.
PEDIATRIC USE
Safety and effectiveness in pediatric patients have not been established.
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