Peanut Allergen Powder Dosage
Medically reviewed by Drugs.com. Last updated on Mar 3, 2020.
Applies to the following strengths: 3 mg daily-dose; 6 mg daily-dose; 12 mg daily-dose; 20 mg daily-dose; 40 mg daily-dose; 80 mg daily-dose; 120 mg daily-dose; 160 mg daily-dose; 200 mg daily-dose; 240 mg daily-dose; 300 mg; 0.5 mg-1 mg-1.5 mg-3 mg-6 mg
Usual Pediatric Dose for:
Additional dosage information:
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.
-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 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.
-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
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.
-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.
Data not available
-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).
-Consume entire volume of prepared mixture promptly.
-Wash hands immediately after discarding capsules/sachets.
-Refrigerate; do not freeze.
-Store in original packaging to protect from moisture.