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Dosing & Administration

Treatment with PALFORZIA is administered in 3 sequential phases: Initial Dose Escalation, Up-Dosing, and Maintenance1

PALFORZIA patients are exposed to gradually increasing amounts of peanut allergen to help them decrease 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 taken daily during Maintenance dosing.

1. Initial Dose Escalation

  • Occurs on the first day of PALFORZIA dosing, which takes place at the clinic Lasts about 4 hours
  • Consists of 5 dose escalations
  • Each dose is separated by a 20- to 30-minute observation period
  • Patients must be observed for at least 60 minutes after the last dose

2. Up-Dosing

  • Starts within 4 days of Initial Dose Escalation—ideally the day after
  • Biweekly Up-Dosing at the clinic; patients take once-daily dosing at home between clinic visits
  • Takes around 6 months
  • Consists of 11 Up-Dosing levels
  • Requires in-clinic dosing for first dose of each dosing level
  • Patients must be observed for at least 60 minutes after in-clinic dosing

3. Maintenance Dosing

  • Starts after all Up-Dosing levels are complete
  • Follow-up clinic visit should be scheduled at the physician's discretion
  • Continued daily Maintenance dosing is required to maintain the treatment effect
Gradually increasing dosage by milligram illustrationGradually increasing dosage by milligram illustration

Maintenance dose

Temporary dose modifications may be required for some patients during Up-Dosing or Maintenance dosing. Dose modifications may include maintaining the dose level for longer than 2 weeks, or reducing, withholding, or discontinuing PALFORZIA doses.1

Download the Dose Administration Overview Brochure for more information.

Download Brochure

A standardized approach

Daily preparations of PALFORZIA for oral administration

  • PALFORZIA should be mixed well with a few spoonfuls of refrigerated or room-temperature semisolid food (eg, applesauce, yogurt, pudding), and consumed in its entirety. Patients do not swallow capsule(s) or inhale the powder

Controlled, in-office Up-Dosing enables collaboration with patients

  • In-office visits for the first dose of Up-Dosing provide opportunities for patients to discuss their progress
  • Daily oral dosing helps patients know their dosage, standardizes PALFORZIA protocol, and reinforces patient adherence
Daily dose preparation icon
Important Safety Information
Warning: Anaphylaxis
PALFORZIA can cause anaphylaxis, which may be life threatening and can occur at any time during PALFORZIA therapy.
Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.
Do not administer PALFORZIA to patients with uncontrolled asthma.
Dose modifications may be necessary following an anaphylactic reaction.
Observe patients during and after administration of the Initial Dose Escalation and the first dose of each Up-Dosing level, for at least 60 minutes.
PALFORZIA is available only through a restricted program called the PALFORZIA REMS.
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 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 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 events reported in subjects 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.

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 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 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.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide.

References

  1. PALFORZIA [package insert]. Brisbane, CA: Aimmune Therapeutics, Inc.