first† and only‡ approved oral
immunotherapy that helps
mitigate the severity of allergic
reactions, including anaphylaxis,
that may occur with accidental
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: 17/12/20201
‡Only OIT at 28/10/2024.
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.1
▼ 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
with over 2300 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
‡Only OIT at 28/10/2024
‡Only OIT at 28/10/2024
‡Only OIT at 28/10/2024
*To date (28/10/2024) in North America and Europe
The highly reaction patient
The budding athlete
circumstances. The treatment and the success of the therapy depicted represent an idealized course.
This possible course of therapy has been confirmed by clinical studies. Nevertheless, each patient and
each course of disease is highly individual and a corresponding effect cannot be
expected and guaranteed for all patients.
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
the diagnosis and treatment of allergic diseases.1
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.1
at that dose level at home.
Dose increases are made every 2 weeks at the clinic
for approximately 6 months.1
the diagnosis and treatment of allergic diseases.1
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.1
complete; continued daily.1
Maintenance dosing is required to
maintain the tolerability and clinical
effects of the product.1
If treatment with PALFORZIA is stopped, patients must continue to carry self-injectable adrenaline
at all times.1
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.1
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.1
at that dose level at home.
Dose increases are made every 2 weeks at the clinic for approximately 6 months.1
the diagnosis and treatment of allergic diseases.1
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.1
complete; continued daily.1
Maintenance dosing is required to
maintain the tolerability and clinical
effects of the product.1
If treatment with PALFORZIA is stopped, patients must continue to carry self-injectable adrenaline
at all times.1
empowers, with Palforzia
exposure* in the short term4
of peanut protein with no more than mild
symptoms during the exit DBPCFC1,3†
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 peanut17
peanut protein with 96% tolerating 1000mg
of peanut protein with no more than mild
symptoms at the exit DBPCFC6†
of peanut protein with no more than mild
symptoms during exit DBPCFC 1,6†
**ARC010 was a phase 3, international, randomized, double-blind, placebo-controlled multicenter study at 18 sites in 10 countries in North America and Europe. … Read more Read less
§One peanut kernel is equivalent to 300 mg4
PALFORZIA was consistent
across trials, manageable, and
improved over time4,6,9,11,16
adverse events were
mild to moderate.2,4,11,16
frequently reported during Up-
Dosing with fewer reported during
Maintenance.1,2,4
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.