Because 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. 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 ethanol fractionation, PEG
precipitation, solvent detergent treatment, and nanofiltration. Despite
these measures, such products can still potentially transmit disease;
therefore, the risk of infectious agents cannot be totally eliminated.
ALL infections thought by a physician possibly to have been transmitted
by this product should be reported to the manufacturer at 1-800-423-2090
(US). The physician should weigh the risks and benefits of the use of
this product and should discuss these with the patient.
ARALAST NP may contain trace amounts of IgA. Patients with known
antibodies to IgA, which can be present in patients with selective or
severe IgA deficiency, have a greater risk of developing potentially
severe hypersensitivity and anaphylactic reactions. ARALAST NP is
contraindicated in patients with antibodies against IgA due to risk of
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.
ARALAST NP should be administered at room temperature
within three (3) hours after reconstitution. Partially used
vials should be discarded and not saved for future use. The
solution contains no preservative.
ARALAST NP should be administered alone, without mixing
with other agents or diluting solutions.
Pregnancy Category C
Animal reproduction studies have not been conducted with
ARALAST NP. It is also not known whether ARALAST NP can cause
fetal harm when administered to pregnant women or can affect
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
NP is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not
Clinical studies of ARALAST NP did not include sufficient
numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects. As for all patients,
dosing for geriatric patients should be appropriate to their
overall situation. Safety and effectiveness in patients over age
65 years of age have not been established.
Information for Patients
Inform patients that administration of ARALAST NP has
been demonstrated to raise the plasma level of α1-PI,
but that the effect of this augmentation on the frequency of
pulmonary exacerbations and on the rate of progression of
emphysema has not been established by clinical