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AJN  June 2020  Vol. 120, No. 6
ajnonline.com
DRUG Watch

Information on drugs, including new approvals and indications, warnings, and other regulatory updates.
FIRST ORAL IMMUNOTHERAPY FOR
PEANUT ALLERGY
-  Peanut (Arachis hypogaea) aller
gen powder-dnfp (Palforzia) is
the first oral immunotherapy for
children ages four to 17 years
who have been diagnosed with
a peanut allergy.
-  Like subcutaneous forms of
immunotherapy, Palforzia intro
duces the allergen in increasing
doses and risks inducing allergic
responses, including anaphy
laxis.
P
eanut allergy affects ap
proximately 1 million U.S.
children, of whom only 20%
will outgrow the allergy. Allergic
responses can be triggered with
out directly eating peanuts (for
example, when a child touches a
surface or ingests food that has
come into contact with peanuts);
these responses can be severe
and potentially life-threatening
and can include anaphylaxis.
The Food and Drug Administra
tion (FDA) has approved peanut
(Arachis hypogaea) allergen
powder-dnfp (Palforzia), the first
oral immunotherapy to minimize
allergic reactions to peanuts.
Palforzia is a powder made
from defatted peanut flour and
is taken daily mixed in food such
as applesauce, yogurt, or pud
ding. It is approved for use in
children ages four to 17 years
with a confirmed peanut al
lergy. Patients receiving Palfor
zia still need to avoid eating
peanuts. The drug does not
cure the allergy, but instead de
creases the severity of the aller
gic response. It works similarly
to "allergy shots," gradually in
troducing increasing doses of
the allergen to decrease sensi
tivity to it. Although the im
mune system is stimulated, it's
not typically enough to cause
allergic reactions (yet allergy
shots and Palforzia can some
times induce allergic reactions).
Palforzia carries a boxed
warning that it may produce ana
phylaxis and should be avoided
in patients with uncontrolled
asthma, which increases the risk
of death from anaphylaxis. Pal
forzia should not be used during
acute allergic responses, including
anaphylaxis. It should also not be
given to those with a history of
eosinophilic esophagitis (inflam
mation and injury to esophageal
tissue from eosinophils) or other
eosinophilic gastrointestinal dis
ease, as Palforzia increased the
risk of this disorder in clinical tri
als, although its occurrence was
not common.
As with the administration of
other allergens, Palforzia requires
a slow dose escalation prior to
maintenance dosing. Palforzia
has three phases of treatment:
initial dose escalation (one day),
updosing (11 dose levels over
several months), and mainte
nance (expected to be lifelong).
The effectiveness of Palforzia
was determined in a randomized,
double-blind, placebo-controlled
trial of about 500 patients with
peanut allergies. The drug was
considered effective if, after six
months of maintenance treatment,
an oral dose of peanut powder
twice the daily dose of Palforzia
caused no more than mild allergy
symptoms. Most of those who re
ceived Palforzia (67.2%) had a
mild allergic response. In separate
double-blind, placebo-controlled
studies assessing safety, the most
common adverse effects of Palfor
zia were abdominal pain, vomit
ing, nausea, tingling in the mouth,
itching (mouth and ears), cough,
runny nose, throat irritation and
tightness, hives, wheezing and
shortness of breath, and anaphy
laxis.
The FDA is requiring a Risk
Evaluation and Mitigation Strat
egy (REMS) with Palforzia's ap
proval, which means the drug
will only be available from certi
fied providers, health care set
tings, and pharmacies enrolled
in the REMS program. Health
care providers will need to be
educated on the risk of anaphy
laxis. Nurses and NPs should
tell patients and their families to
carry an EpiPen and teach them
how to use it.
During the initial dose escala
tion and first updosing day-
dosing periods during which
patients have the highest risk of an
allergic response-patients must
be monitored for at least one hour
during and after receiving Palfor
zia. For that reason, they should
receive these first doses in a treat
ment environment able to manage
potentially severe adverse effects,
including anaphylaxis. Nurses
and NPs should tell patients and
their families to report severe, per
sistent symptoms of esophagitis or
gastrointestinal intolerance to the
prescriber, as Palforzia may need
to be discontinued if eosinophilic
esophagitis occurs.
To read the complete prescrib
ing information for Palforzia, go
to www.fda.gov/media/134838/
download.
THREE PRESCRIPTION DRUGS ARE NOW
AVAILABLE OVER THE COUNTER
-  Three drugs previously avail
able only by prescription will
now be available only over the
counter: diclofenac sodium
topical gel, 1% (Voltaren Arthri
tis Pain); olopatadine HCl oph
thalmic solution/drops, 0.1%
(Pataday Twice Daily Relief);
and olopatadine HCl ophthal
mic solution/drops, 0.2% (Pata
day Once Daily Relief).
T
he Food and Drug Admin
istration (FDA) is allowing
three previously prescription-
only drugs to be sold over the
counter: diclofenac sodium
topical gel, 1% (Voltaren Ar
thritis Pain); olopatadine HCl
ophthalmic solution/drops, 0.1%
(Pataday Twice Daily Relief);