Usual Pediatric Dose for Allergic Reaction

4 to 17 years:
Initial dose escalation: Single doses of 0.5 mg, then 1 mg, 1.5 mg, 3 mg, and 6 mg orally

• Doses are administered on a single day under healthcare supervision.
• Separate doses with observation periods of 20 to 30 minutes.
• Do not omit any dose levels.
• Observe patient for at least 60 minutes after last dose until suitable for discharge.
• Discontinue if medical intervention is required after any dose.
• Patients who tolerate at least the 3 mg single dose must return to the healthcare setting for Up-dosing initiation.
• If possible, begin Up-dosing the day after initial dose escalation.
• Repeat initial dose escalation if patient does not begin Up-dosing within 4 days.

4 to 17 years: Up-dosing:
Dose level 1: 3 mg orally daily for 2 weeks
Dose level 2: 6 mg orally daily for 2 weeks
Dose level 3: 12 mg orally daily for 2 weeks
Dose level 4: 20 mg orally daily for 2 weeks
Dose level 5: 40 mg orally daily for 2 weeks
Dose level 6: 80 mg orally daily for 2 weeks
Dose level 7: 120 mg orally daily for 2 weeks
Dose level 8: 160 mg orally daily for 2 weeks
Dose level 9: 200 mg orally daily for 2 weeks
Dose level 10: 240 mg orally daily for 2 weeks
Dose level 11: 300 mg orally daily for 2 weeks

• Complete initial dose escalation prior to Up-dosing.
• The first dose of each new dosing level should be administered under healthcare supervision; observe patient for at least 60 minutes after dose until suitable for discharge.
• If first dose of each dose level is tolerated, patient may continue that dose level at home.
• Doses should be consumed with a meal at approximately the same time each day, preferably in the evening.
• Administer dose levels in sequential order; do not omit dose levels or progress more rapidly.
• Consider dose modification or discontinuation for patients who do not tolerate Up-dosing.

4 years and older: Maintenance dose: 300 mg orally daily

• Daily maintenance is required to maintain effect
• Assess patient at regular intervals for adverse effects.

Comments:

• Prior to initiation, verify that patient has injectable epinephrine and has been instructed on its appropriate use.
• Use in conjunction with a peanut-avoidant diet.
• Not indicated for emergency treatment of allergic reactions or anaphylaxis.

Use: Mitigation of allergic reactions, including anaphylaxis, to accidental peanut exposure in patients with confirmed peanut allergy.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dose adjustments:

• Dose adjustments are not appropriate during Initial dose escalation.
• Adjustments may be needed for allergic reactions, missed doses, or patient management needs during Up-dosing or Maintenance.
• Use dose adjustment to actively manage allergic reactions (including gastrointestinal) that are severe, recurrent, bothersome, or last longer than 90 minutes.
• Use clinical judgement when considering maintaining dose levels longer than 2 weeks, reducing or withholding doses, or discontinuation.

Consecutive Missed Doses:

• If one or two consecutive doses are missed, continue at same dose level.
• There is insufficient data on resumption of a dose level after 3 or more missed doses.

Discontinue for:

• Patients unable to tolerate up to 3 mg dose during Initial Dose Escalation
• Suspected eosinophilic esophagitis
• Inability to comply with daily dosing requirements
• Recurrent asthma exacerbations or persistent loss of asthma control

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for PALFORZIA. It includes certification, a medication guide, communication plan, elements to assure safe use, and implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNING(S): ANAPHYLAXIS

• This drug may cause anaphylaxis, which can be life threatening and may occur at any time during treatment.
• Prescribe injectable epinephrine, instruct/train patients on appropriate use and to seek immediate medical care upon use.
• Do not administer in patients with uncontrolled asthma.
• Dose adjustments may be necessary after anaphylactic reactions.
• Observe patients during and after administration (for at least 60 minutes) of initial dose escalation and first dose of each up-dosing level.
• Because of the anaphylaxis risk, this drug is only available through the PALFORZIA REMS.

CONTRAINDICATIONS:

• Uncontrolled asthma
• History of eosinophilic esophagitis and other eosinophilic gastrointestinal disease

Safety and efficacy have not been established in patients younger than 4 years; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For oral administration only; do not inhale powder.
• Do not swallow capsules.
• Empty entire contents of capsules or sachets onto a few spoonfuls of refrigerated or room temperature semisolid food (e.g. applesauce, yogurt, pudding).
• Mix well.
• Consume entire volume of prepared mixture promptly.
• Wash hands immediately after discarding capsules/sachets.

Storage requirements:

• Refrigerate; do not freeze.
• Store in original packaging to protect from moisture.