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 calendar icon

References

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