and only† approved oral
immunotherapy that helps
mitigate the severity of
allergic reactions from
exposure to peanuts.1-4
patients aged 4 to 17 years with a confirmed
diagnosis of peanut allergy. PALFORZIA may be
continued in patients 18 years of age and older.
PALFORZIA should be used in conjunction with
a peanut-avoidant diet.1
†Date of first authorization: 17/12/2020 1
PALFORZIA is not intended for, and does not provide, immediate relief of allergic symptoms, and therefore is not to be
used for emergency treatment of allergic reactions, including anaphylaxis.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions. See section 4.8 of the summary of the product characteristics for
how to report adverse reactions
oral immunotherapy that:
via controlled increments
of allergens1,3,4
yields a product containing a
range of the major and minor
protein allergens found in
peanuts.2,5
trials, with over 3100 patients,
including PALISADE, the largest ever
peanut allergy clinical trial and
ARTEMIS, an efficacy and safety study
across 7 European countries.2-4,6-15
The highly reaction patient
The budding athlete
old who faces significant
challenges in his formative
years due to his severe
peanut allergy
faces significant challenges in his
formative years due to his severe
peanut allergy.
Oliver, unable to fully comprehend
the dangers, relies on the diligence
of teachers and caregivers to keep
him safe. Since Oliver started school, his mother struggles with entrusting his safety to others, dreading every phone call in fear of a reaction.
Oliver was first diagnosed with a peanut allergy aged 2 after having a severe allergic reaction from a small amount of peanut protein.
His allergy demands vigilant monitoring by his caregivers. Oliver also has a history of mild asthma which is controlled.
Oliver’s most recent exposure to peanuts occurred during a family dinner at a restaurant. Despite his mum thoroughly checking the restaurant’s menu beforehand and informing the staff of his allergy, Oliver consumed a meal with trace amounts of peanuts.
This incident led to an allergic reaction and a trip to the emergency room, reinforcing the need for constant vigilance and proactive management of his allergy.
escalation
in the clinic*, lasting about 4 hours
at that dose level at home.
Dose increases are made every 2 weeks at the clinic
for approximately 6 months.
complete; continued daily.
Maintenance dosing is required to
maintain the tolerability and clinical
effects of the product.
If treatment with PALFORZIA is stopped, patients must continue to carry self-injectable adrenaline
at all times.
first-year high school
student with a diagnosed
peanut allergy.
competing several times a week.
Anna experiences frustration with
the restrictions placed on her
attendance at sports competitions
because of her allergy.
Anna’s parents grapple with
constant fear regarding her risk of
having a reaction out of their care.
Anna was first diagnosed with a peanut
allergy aged 4 following a reaction to a
snack containing peanuts. Since then, she
adheres diligently to a strict avoidance
diet and communicates this requirement
to her teachers and coaches at school
and sporting events.
Anna also has a history of eczema and
mild asthma, which are both well
controlled.
Anna’s most recent exposure took place at a competitive rock
climbing meet away from home.
Another parent brought snacks which they believed to not
contain peanuts, but after consuming one Anna experienced
trouble breathing. This led to epinephrine being administered
and a visit to the emergency room.
This event knocked Anna’s confidence and instilled fear in
her parents, leading them to now accompany her to every
sporting event.
escalation
in the clinic*, lasting about 4 hours
the diagnosis and treatment of allergic diseases.
Initial dose escalation and the first dose of each new up-dosing level are to be administered in a health
care setting prepared to manage potential severe allergic reactions.
at that dose level at home.
Daily dose increases are made every 2 weeks at the
clinic for approximately 6 months.
the diagnosis and treatment of allergic diseases.
Initial dose escalation and the first dose of each new up-dosing level are to be administered in a health
care setting prepared to manage potential severe allergic reactions.
complete; continued daily.
Maintenance dosing is required to
maintain the tolerability and clinical
effects of the product.
If treatment with PALFORZIA is stopped, patients must continue to carry self-injectable adrenaline
at all times.
300mg of peanut protein with no
more than mild symptoms during the
exit DBPCFC 1,3†
single highest dose of 1000mg peanut
protein with no more than mild allergic
symptoms at an exit DBPCFC1,3†
accidental exposure is average 125 mg, less than half a kernel of peanut
to peanut protein with 96% tolerating
1000mg of peanut protein with no more
than mild symptoms at the exit DBPCFC 6†
2000mg of peanut protein with no more than
mild symptoms during exit DBPCFC 1,6†
**ARC003 was a phase 3, international, randomized, double-blind, placebo-controlled multicenter study at 66 sites in 10 countries in North America and Europe. … Read more Read less
¶Data are descriptive only and are not included in the FDA- or EMA-approved labelling for PALFORZIA.
PALFORZIA was consistent
across trials, manageable, and
improved over time 4,6,9,16
adverse events were
mild to moderate.2,4
frequently reported during Up-
Dosing with fewer reported during
Maintenance.2,4
systemic allergic
reactions
(anaphylaxis)* were
low and remained
low over time.1,16
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See section 4.8 of the Summary of Product Characteristics for how to report adverse reactions.
