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Models for illustrative purposes only.
SAFETY: 1–3 YEARS
SAFETY: 4–17 YEARS
SAFETY: 4–17 YEARS
In the POSEIDON study, anaphylactic reaction was reported in 8 (8.2%) PALFORZIA-treated subjects (in no subjects during Initial Dose Escalation, 2 subjects during Up-Dosing, and 6 subjects during Maintenance) and 4 (8.3%) placebo-treated subjects (in no subjects during Initial Dose Escalation, 2 subjects during Up-Dosing, and 2 subjects during Maintenance). Of the 9 anaphylactic reactions reported, in 8 children receiving PALFORZIA, only 3 were attributed to PALFORZIA, all occurring during the Up-Dosing phase. The remaining 6 reactions were due to exposure to other food allergens.1
*Anaphylactic reactions were graded as Mild (skin and subcutaneous issues, gastrointestinal and/or mild respiratory), Moderate (mild symptoms + features suggesting moderate respiratory, cardiovascular, or gastrointestinal symptoms), or Severe (hypoxia, hypotension, or neurological compromise).3
†Most anaphylactic reactions were related to non-peanut food allergen exposure. Anaphylactic reactions by events: 13 anaphylactic reaction events (9 PALFORZIA, 4 placebo); 10 related to other food allergen exposure (6 PALFORZIA, 4 placebo); none related to accidental peanut exposure.1,2
‡Total percentage does not equal the sum of Mild and Moderate reactions because 1 subject experienced 2 related anaphylactic reactions (1 Mild and 1 Moderate).3
§PALFORZIA: 3 subjects with viral infections, 2 subjects with asthma, 1 subject with viral infection and asthma; placebo: 1 subject with asthma, 1 subject with carbon monoxide poisoning.3
¶No eosinophilic esophagitis.3
Treatment-emergent adverse reactions are included in the table if they occurred in ≥5% of PALFORZIA-treated subjects across all dosing phases combined. Data across all dosing phases combined are not shown.
At each level of summarization (any event, system organ class, and preferred term), subjects with more than one adverse reaction were counted only once within study period.
[1] Adverse reactions were coded to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA), version 21.1. [2] Includes preferred terms of rhinorrhea, rhinitis, and rhinitis allergic. [3] Includes preferred terms of wheezing and stridor. [4] Includes preferred term of abdominal pain, abdominal pain upper, and abdominal discomfort. [5] Includes preferred terms of vomiting and regurgitation. [6] Includes preferred terms of diarrhea and frequent bowel movements. [7] Includes preferred terms of oral pruritus, tongue pruritis, and lip pruritus. [8] Includes preferred terms of oropharyngeal pain, oral discomfort, odynophagia, and oral pain. [9] Includes preferred terms of urticaria and urticaria papular. [10] Includes preferred terms of rash, rash erythematous, rash generalized, rash macular, rash papular, rash pruritic, eczema, erythema, and papule. [11] Includes preferred terms of pruritus, pruritus generalized, ear pruritus, eye pruritus, and nasal pruritus.
A total of 15 (15.3%) PALFORZIA-treated subjects and 3 (6.3%) placebo-treated subjects discontinued for any reason in the POSEIDON study. Adverse reactions led to study discontinuation in 5.1% of PALFORZIA-treated subjects and no placebo-treated subjects during Up-Dosing in the POSEIDON study, and 2.3% PALFORZIA-treated subjects and no placebo-treated subjects during Maintenance dosing.1
Gastrointestinal reactions were the most common reason leading to discontinuation of study product during Up-Dosing (3.1% PALFORZIA, none in placebo), followed by respiratory disorders (3.1% PALFORZIA, none in placebo) in the POSEIDON study. No PALFORIZA-treated subjects discontinued during IDE.1
#At each level of summarization (any event, system organ class, or preferred term), participants with more than one AE related to trial product were counted only once within each trial period. Values in bold indicate AEs with 5 higher incidence in the PALFORZIA group than in the placebo group.
∆There were ≥20% of participants in either treatment group with a ≥5% higher incidence in the PALFORZIA group.
**Systemic allergic reactions were defined as anaphylactic reaction of any severity.
The maximum severity of symptoms at any exit challenge dose was predominately none to mild for PALFORZIA-treated participants and mild to moderate for placebo-treated participants.2
No participant had symptoms considered life threatening or fatal.2
Comparison of the maximum severity of symptoms at any challenge dose of peanut protein during the exit DBPCFC.1
5% of participants treated with PALFORZIA experienced severe symptoms compared with 10.5% of those given placebo, during the exit DBPCFC.1
5% of participants treated with PALFORZIA experienced severe symptoms compared with 10.5% of those given placebo, during the exit DBPCFC.1
*Participants without an exit DBPCFC were assigned the maximum severity during the screening DBPCFC, which equates to no change from screening. P-value <0.0001; symptom severity was assigned with equally spaced scores (e.g., 0, 1, 2, and 3 for none, mild, moderate, and severe, respectively), and the difference of mean scores between the two treatment arms was tested using the Cochran-Mantel-Haenszel statistic stratified by geographic region (North America, Europe).1
†Includes severe symptoms and life-threatening or fatal reactions. No participants had symptoms considered life threatening or fatal.1
In PALFORZIA safety data, anaphylactic reaction includes systemic allergic reactions of any severity:1
Severe anaphylaxis was reported in 0.6% of participants (4/709) during Up-Dosing and in 0.3% of participants (1/310) during Maintenance dosing across studies.1
‡Data was pooled across two phase 3 clinical trials of participants ages 4 through 17 years. (Study 1-PALISADE), (Study 2-RAMSES).
The majority of adverse reactions were mild to moderate and were more frequently reported during the Up-Dosing and decreased during Maintenance dosing.1,4
Symptoms during in-office PALFORZIA dosing had a median time to onset of 4 minutes for 71% of participants. Median time to resolution was 37 minutes.1
At each level of summarization (any event, system organ class, or preferred term), participants with more than one adverse reaction were counted only once within each study period.1
§TEAEs reported in ≥5% of participants treated with PALFORZIA and ≥5% percentage points were greater than reported in participants treated with placebo in any dosing phase (aged 4 through 17 years).
¶AEs were coded to system organ class and preferred term using the MedDRA, version 19.1. In RAMSES, no adverse events ≥5% were reported in participants following treatment with 300 mg PALFORZIA (n=265).1
#Study 1 (PALISADE) was a randomized, double-blind, placebo-controlled efficacy and safety study conducted in the United States, Canada, and Europe evaluating PALFORZIA vs placebo in 496 participants aged 4-17 years with peanut allergy. Participants were Up-Dosed for 20 to 40 weeks followed by Maintenance dosing for 24 to 28 weeks.1,3
ΔStudy 2 (RAMSES) was a randomized, double-blind, placebo-controlled safety study conducted in the United Staes and Canada evaluating PALFORZIA vs placebo in 506 participants aged 4 through 17 with peanut allergy. Participants were Up-Dosed for 20 to 40 weeks up to 300 mg daily dose with no extended Maintenance dosing.1
**Includes preferred terms of abdominal pain, abdominal pain upper, and abdominal discomfort.1
††Includes preferred terms of oral pruritus, tongue pruritus, and lip pruritus.1
‡‡The anaphylactic reaction preferred term includes systemic allergic reactions of any severity, or which severe anaphylaxis was reported in four PALFORZIA-treated participants (0.6%) during Up-Dosing and one PALFORZIA-treated participant (0.3%) during Maintenance dosing.1
PALFORZIA safety continued to improve over time (Pooled safety analysis of patients aged 4–17 years from 6 PALFORZIA clinical trials)4
Adapted from: Bird JA, et al. 2023.4
From a pooled safety analysis from six PALFORZIA clinical trials and three open-label extension studies to describe additional long-term pooled safety data from baseline through approximately 5 years of treatment.4
In children and adolescents, continued daily treatment with PALFORZIA beyond 1 year has demonstrated an acceptable safety profile with continued and improved efficacy.5
Overall summary of treatment-emergent adverse events (integrated safety population; N=351)6
§§Participants in cohorts 3B and 3C underwent initial daily dosing for 28 weeks.6
¶¶Participants with >1 AE were counted only once using the highest severity and closest relationship to study product.6
##Exposure-adjusted event rates were defined as the total number of events divided by the total number of participant-years at risk during the period.6
Study 1 (PALISADE) was a randomized, double-blind, placebo-controlled efficacy and safety study conducted in the United States, Canada, and Europe evaluating PALFORZIA vs placebo in 496 participants aged 4-17 years with peanut allergy. Participants were Up-Dosed for 20 to 40 weeks followed by Maintenance dosing for 24 to 28 weeks.
Study 2 (RAMSES) was a randomized, double-blind, placebo-controlled safety study conducted in the United Staes and Canada evaluating PALFORZIA vs placebo in 506 participants aged 4 through 17 with peanut allergy. Participants were Up-Dosed for 20 to 40 weeks up to 300 mg daily dose with no extended Maintenance dosing.
The majority of adverse reactions were mild to moderate and were more frequently reported during the Up-Dosing and decreased during Maintenance dosing.1,4
Symptoms during in-office PALFORZIA dosing had a median time to onset of 4 minutes for 71% of participants. Median time to resolution was 37 minutes.1
At each level of summarization (any event, system organ class, or preferred term), participants with more than one adverse reaction were counted only once within each study period.
*TEAEs reported in ≥5% of participants treated with PALFORZIA and ≥5% percentage points were greater than reported in participants treated with placebo in any dosing phase (aged 4 through 17 years).1
†AEs were coded to system organ class and preferred term using the MedDRA, version 19.1. In RAMSES, no adverse events ≥5% were reported in participants following treatment with 300 mg PALFORZIA (n=265).1
‡PALISADE was a randomized, double-blind, placebo-controlled safety and efficacy study conducted in the United States, Canada, and Europe evaluating PALFORZIA versus placebo in 496 participants aged 4 through 17 years with peanut allergy.1,6
§RAMSES was a randomized, double-blind, placebo-controlled safety study conducted in the United States and Canada evaluating PALFORZIA versus placebo in 506 participants aged 4 through 17 years with peanut allergy.1
¶Includes preferred terms of abdominal pain, abdominal pain upper, and abdominal discomfort.1
#Includes preferred terms of oral pruritus, tongue pruritus, and lip pruritus.1
∆The anaphylactic reaction preferred term includes systemic allergic reactions of any severity, or which severe anaphylaxis was reported in four PALFORZIA-treated participants (0.6%) during Up-Dosing and one PALFORZIA-treated participant (0.3%) during Maintenance dosing.1
In PALFORZIA safety data, anaphylactic reaction includes systemic allergic reactions of any severity:1
Severe anaphylaxis was reported in 0.6% of participants (4/709) during Up-Dosing and in 0.3% of participants (1/310) during Maintenance dosing across studies.1
PALFORZIA safety continued to improve over time (Pooled safety analysis of patients aged 4–17 years from 6 PALFORZIA clinical trials)4
Adapted from: Bird JA, et al. 2023.4
From a pooled safety analysis from six PALFORZIA clinical trials and three open-label extension studies to describe additional long-term pooled safety data from baseline through approximately 5 years of treatment.4
In children and adolescents, continued daily treatment with PALFORZIA beyond 1 year has demonstrated an acceptable safety profile with continued and improved efficacy.5
Models for illustrative purposes only.
Models for illustrative purposes only.
AE, adverse event; DBPCFC, double-blind, placebo-controlled food challenge; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.
References:
WARNING: ANAPHYLAXIS
INDICATION
PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.
PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 1 through 17 years. Up-Dosing and Maintenance may be continued in patients 1 years of age and older.
PALFORZIA is to be used in conjunction with a peanut-avoidant diet.
Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
CONTRAINDICATIONS
PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease.
WARNINGS AND PRECAUTIONS
ANAPHYLAXIS
PALFORZIA can cause anaphylaxis, which may be life-threatening. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA.
Anaphylaxis has been reported during all phases of PALFORZIA dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures.
Do not initiate PALFORZIA treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. PALFORZIA may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including but not limited to markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, PALFORZIA may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine.
All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered under observation in a certified health care setting.
Patients may be more likely to experience allergic reactions following PALFORZIA administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (e.g., viral infection), or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding PALFORZIA temporarily.
ASTHMA
Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of PALFORZIA.
PALFORZIA should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of PALFORZIA should be undertaken cautiously. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of PALFORZIA.
EOSINOPHILIC GASTROINTESTINAL DISEASE
Discontinue PALFORZIA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain.
GASTROINTESTINAL ADVERSE REACTIONS
Gastrointestinal adverse reactions were commonly reported in PALFORZIA-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms consider a diagnosis of eosinophilic esophagitis.
ADVERSE REACTIONS
The most common adverse reactions reported in subjects ages 1 through 3 years treated with PALFORZIA (incidence ≥5%) are cough, sneezing, rhinitis, nasal congestion, throat irritation, wheezing, abdominal pain, vomiting, diarrhea, oral pruritus, oropharyngeal pain, urticaria, rash, pruritus, and perioral dermatitis.
The most common adverse events reported in subjects ages 4 through 17 years treated with PALFORZIA (incidence ≥ 5% and at least 5% greater than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide.