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.

Gradual dose escalation chart

With the PALFORZIA treatment pathway, patients receive gradually increasing doses of PALFORZIA over a 6-month period, then continue with daily Maintenance dosing.

Initial Dose Escalation chart

Patients who tolerate at least the 3-mg single dose of PALFORZIA during Initial Dose Escalation should return to the office, preferably the next day for initiation of Up-Dosing.

Up-Dosing chart

Each up-dose is conducted at the allergist’s office at approximately 2-week intervals. In between office visits, patients take remaining doses at home, once daily.

Maintenance dosing illustration

Periodic visits give the physician an opportunity to reinforce adherence and determine whether continuing with Maintenance dosing is appropriate.

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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 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, 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.