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The information in this webpage is intended for US healthcare professionals only.
Models for illustrative purposes only.
Not actual size
Prepackaged in capsules and sachets that contain defined amounts of peanut protein
for standardized in-office and at-home dosing and administration.1,2
The controlled manufacturing process yields a product, containing a complete range of
the major and minor protein allergens found in peanuts, including Ara h 1, Ara h 2, Ara
h 3, Ara h 6, Ara h 7, Ara h 8, Ara h 9, Ara h 10, Ara h 11, Ara h 14, and Ara h 15.1,3
PALFORZIA has been tested using HPLC and ELISA to ensure that the relative potency
of immunodominant and clinically most relevant protein allergens (Ara h 1, Ara h 2 &
Ara h 6) is precise and consistent in each and across product lots.1,3
Each once-daily dose
contains defined,
prepackaged amounts
of peanut protein for
standardized dosing
and administration.1
PALFORZIA patients are gradually exposed to increasing amounts of peanut allergen to help
decrease their sensitivity over time to small amounts of peanuts that may be hidden in foods.
Treatment begins with a 0.5 mg dose taken during Initial Dose Escalation and culminates with a
300 mg dose, which is taking daily during Maintenance dosing.
1–3 year old
4–17 year old
One-time initiation dose appointment in-clinic/hospital
The first day of PALFORZIA treatment will run for approximately 4 hours, which includes observation time after each dose of the Initial Dose Escalation Pack.
A 6-month treatment plan that combines in-clinic dose increases with at-home dosing
Approximately every 2 weeks, dose escalation occurs with at least 60-minute in-clinic monitoring in a controlled environment, followed by continued daily dosing at home to build tolerability. All dose levels should be completed before starting maintenance.
An at-home dosing schedule
Continued daily Maintenance dosing, for a minimum of 6 months, is required to maintain treatment effect.*
Periodic follow-up visits give the physician the opportunity to reinforce adherence and determine appropriate length of time of Maintenance dosing.
*Minimum of 6 months Maintenance treatment based on clinical trial results.
One-time initiation dose appointment in-clinic/hospital
The first day of PALFORZIA treatment will run for approximately 4 hours, which includes observation time after each dose of the Initial Dose Escalation Pack.
A 6-month treatment plan that combines in-clinic dose increases with at-home dosing
Approximately every 2 weeks, dose escalation occurs with at least 60-minute in-clinic monitoring in a controlled environment, followed by continued daily dosing at home to build tolerability. All dose levels should be completed before starting maintenance.
An at-home dosing schedule
Continued daily Maintenance dosing, for a minimum of 6 months, is required to maintain treatment effect.*
Periodic follow-up visits give the physician the opportunity to reinforce adherence and determine appropriate length of time of Maintenance dosing.
*Minimum of 6 months Maintenance treatment based on clinical trial results.
Up-Dosing should be initiated within 4 days of successful Initial Dose Escalation—ideally the day after.1
During Initial Dose Escalation, each dose is separated by a 20–30 minute observation.1
The last dose of the Initial Dose Escalation is observed for at least 60 minutes.1
Temporary dose modification may be required for patients who experience allergic reactions during Up-Dosing or Maintenance, for patients who miss doses, or for practical reasons of patient management. Use clinical judgment to determine the best course of action, which can include maintaining the dose level for longer than 2 weeks or reducing, withholding, or discontinuing PALFORZIA doses.1
During treatment, patients and caregivers must be instructed to recognize the signs and symptoms of an allergic reaction and in the proper use of self-administrated epinephrine.1
Download the Dose Administration Overview Brochure for more information
ELISA, enzyme-linked immunoassay; HPLC, high-performance liquid chromatography.
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.