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Peanut allergen oral immunotherapy powder: Drug information

Peanut allergen oral immunotherapy powder: Drug information
(For additional information see "Peanut allergen oral immunotherapy powder: Pediatric drug information" and see "Peanut allergen oral immunotherapy powder: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Anaphylaxis

Peanut allergen powder can cause anaphylaxis, which may be life-threatening and can occur at any time during 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 peanut allergen powder 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. Because of the risk of anaphylaxis, peanut allergen powder is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Palforzia REMS.

Brand Names: US
  • Palforzia
Pharmacologic Category
  • Allergen-Specific Immunotherapy
Dosing: Adult

Note: Injectable epinephrine must be available during treatment. Do not initiate treatment in patients who experienced severe or life-threatening anaphylaxis in the last 60 days. Patients must continue to maintain a peanut-avoidant diet.

Peanut allergy immunotherapy

Peanut allergy immunotherapy: Oral: Treatment is administered in 3 phases:

Initial dose escalation phase: Refer to pediatric dosing.

Up-dosing phase:

Note: Up-dosing should begin the day after completion of the initial dose escalation phase or within 4 days; if not started within 4 days, the initial dose escalation phase must be repeated. The first dose of each up-dose must be administered under the direct supervision of a health care provider and the patient should be observed for ≥60 minutes. Administer subsequent doses at the same dose level once daily, preferably in the evening. Do not progress dose more frequently than 2-week intervals; do not omit any dose levels.

Daily Dosing for Up-Dosing Phase

Dose Level

Dose

Duration

1

3 mg

2 weeks

2

6 mg

2 weeks

3

12 mg

2 weeks

4

20 mg

2 weeks

5

40 mg

2 weeks

6

80 mg

2 weeks

7

120 mg

2 weeks

8

160 mg

2 weeks

9

200 mg

2 weeks

10

240 mg

2 weeks

11

300 mg

2 weeks

Dose modification: Allergic reactions, including GI reactions, that are severe, recurrent, bothersome, or last >90 minutes may require dose adjustments. Based on clinical judgement, may maintain dose level for >2 weeks, reduce dose, withhold dose, or discontinue therapy. Dose modifications may also be necessary for missed doses or patient convenience. Dose modification should not be attempted during initial dose escalation phase.

Maintenance dosing phase: Note: Initial dose escalation phase and up-dosing phase should be completed prior to maintenance dosing: 300 mg once daily.

Dose modification: Allergic reactions, including GI reactions, that are severe, recurrent, bothersome, or last >90 minutes may require dose adjustments. Based on clinical judgement, may reduce dose, withhold dose, or discontinue therapy. Dose modification should not be attempted during initial dose escalation phase.

Missed doses:

Missed 1 to 2 consecutive days: Resume dose at same dose level.

Missed ≥3 consecutive days: Has not been studied. Contact health care provider; resuming dose should only be done under direct supervision of health care provider.

Discontinuation of therapy: Discontinue therapy in patients who are unable to tolerate initial doses up to 3 mg during initial dose escalation phase, patients with suspected eosinophilic esophagitis, patients unable to comply with daily dosing, or patients with recurrent asthma exacerbations or persistent loss of asthma control.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

(For additional information see "Peanut allergen oral immunotherapy powder: Pediatric drug information")

Note: Injectable epinephrine must be available during treatment. Do not initiate treatment in patients who experienced severe or life-threatening anaphylaxis in the last 60 days. Patients must continue to maintain a peanut-avoidant diet.

Peanut allergy immunotherapy

Peanut allergy immunotherapy: Treatment is administered in 3 phases:

Initial dose escalation phase: Note: Initial dose escalation is to be completed on a single day under the direct supervision of a certified health care provider able to manage severe allergic reactions. Doses should not be modified during this phase.

Children ≥4 years and Adolescents ≤17 years: Oral:

Note: Observe patient for 20 to 30 minutes between each dose level and for 60 minutes after last dose of phase.

Initial Dose Escalation Phase

Dose Level

Dose

A

0.5 mg

B

1 mg

C

1.5 mg

D

3 mg

E

6 mg

Up-dosing phase: Children ≥4 years and Adolescents: Oral:

Note: Up-dosing should begin the day after initial dose escalation phase or within 4 days; if not started within 4 days, the initial dose escalation phase must be repeated. The first dose of each up-dose should be administered under the direct supervision of a health care provider and the patient should be observed for at least 60 minutes. Administer subsequent doses at the dose level once daily preferably in the evening. Do not progress dose more frequently than at 2-week intervals; do not omit any dose levels.

Daily Dosing for Up-Dosing Phase

Dose Level

Dose

Duration

1

3 mg

2 weeks

2

6 mg

2 weeks

3

12 mg

2 weeks

4

20 mg

2 weeks

5

40 mg

2 weeks

6

80 mg

2 weeks

7

120 mg

2 weeks

8

160 mg

2 weeks

9

200 mg

2 weeks

10

240 mg

2 weeks

11

300 mg

2 weeks

Dose modification: Allergic reactions, including GI reactions, that are severe, recurrent, bothersome, or last longer than 90 minutes may require dose adjustments. Based on clinical judgement, may maintain dose level for longer than 2 weeks, reduce dose, withhold dose, or discontinue therapy. Dose modifications may also be necessary for missed doses or patient convenience. Dose modification should not be attempted during initial dose escalation phase.

Maintenance dosing phase: Note: Initial dose escalation phase and up-dosing phase should be completed prior to maintenance dosing.

Children ≥4 years and Adolescents: Oral: 300 mg once daily.

Dose modification: Allergic reactions, including GI reactions, that are severe, recurrent, bothersome, or last longer than 90 minutes may require dose adjustments. Based on clinical judgement, may reduce dose, withhold dose, or discontinue therapy. Dose modification should not be attempted during initial dose escalation phase.

Missed doses:

Missed 1 to 2 consecutive days: Resume dose at same dose level.

Missed ≥3 consecutive days: Has not been studied, contact health care provider; resuming dose should only be done under direct supervision of health care provider.

Discontinuation of therapy: Discontinue therapy in patients who are unable to tolerate initial doses up to 3 mg during initial dose escalation phase, patients with suspected eosinophilic esophagitis, patients unable to comply with daily dosing, or in patients with recurrent asthma exacerbations or persistent loss of asthma control.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions (Significant): Considerations
Anaphylaxis

May cause anaphylaxis (including life-threatening cases).

Mechanism: Non-dose-related; immunologic; IgE-mediated (Ref)

Onset: Rapid; most commonly occurs within 2 hours after a dose; may be delayed for >10 hours in some patients. May occur at any time during therapy.

Risk factors:

• Patients who have had severe or life-threatening anaphylaxis in the previous 60 days

• Exercise (Ref)

• Hot water exposure

• Illness (ie, viral infection) (Ref)

• Fasting

• Menstruation (Ref)

• Sleep deprivation

• Concomitant use of nonsteroidal anti-inflammatory drugs

• Uncontrolled asthma

GI effects

GI adverse reactions have occurred, including abdominal pain, nausea, vomiting, local pruritus (oral), oral paresthesia, and eosinophilic esophagitis. In patients experiencing severe or persistent GI symptoms (eg, dysphagia, vomiting, nausea, gastroesophageal reflux disease, chest pain, abdominal pain), consider a diagnosis of eosinophilic esophagitis. Clinicians should note that, because not all GI adverse reactions prompt upper endoscopy testing, the incidence of eosinophilic esophagitis may be underreported (Ref).

Mechanism: Non-dose-related; immunologic

GI adverse reaction (excluding eosinophilic esophagitis): IgE-mediated (Ref)

Eosinophilic esophagitis: Eosinophilic infiltration of the esophagus (Ref); it is unknown whether oral immunotherapy is an initiating trigger to an esophageal inflammatory process independent of the initial food trigger (Ref).

Onset: Rapid; the highest incidence of GI adverse reactions occurred with increasing dose phase of treatment. Following discontinuation, GI adverse reactions generally resolve within 10 days (range: 1 to 42 days) (Ref). Eosinophilic esophagitis may also resolve following discontinuation (Ref).

Risk factors:

• Food allergies (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Dermatologic: Pruritus (8% to 33%), urticaria (4% to 28%)

Gastrointestinal: Abdominal pain (26% to 67%) (table 1), nausea (9% to 32%) (table 2), oral paresthesia (2% to 14%) (table 3), vomiting (3% to 37%) (table 4)

Peanut Allergen Powder: Adverse Reaction: Abdominal Pain

Drug (Peanut Allergen Powder)

Placebo

Dose

Number of Patients (Peanut Allergen Powder)

Number of Patients (Placebo)

67%

35%

Up-dosing

693

289

29%

17%

300 mg

310

118

26%

8%

Initial dose escalation

709

292

Peanut Allergen Powder: Adverse Reaction: Nausea

Drug (Peanut Allergen Powder)

Placebo

Dose

Number of Patients (Peanut Allergen Powder)

Number of Patients (Placebo)

32%

14%

Up-dosing

693

289

15%

7%

300 mg

310

118

9%

0.7%

Initial dose escalation

709

292

Peanut Allergen Powder: Adverse Reaction: Oral Paresthesia

Drug (Peanut Allergen Powder)

Placebo

Dose

Number of Patients (Peanut Allergen Powder)

Number of Patients (Placebo)

14%

4%

Up-dosing

693

289

7%

2%

300 mg

310

118

2%

2%

Initial dose escalation

709

292

Peanut Allergen Powder: Adverse Reaction: Vomiting

Drug (Peanut Allergen Powder)

Placebo

Dose

Number of Patients (Peanut Allergen Powder)

Number of Patients (Placebo)

37%

16%

Up-dosing

693

289

16%

12%

300 mg

310

118

3%

0.7%

Initial dose escalation

709

292

Local: Local pruritus (oral: 9% to 31%) (table 5)

Peanut Allergen Powder: Adverse Reaction: Local Pruritus

Drug (Peanut Allergen Powder)

Placebo

Dose

Number of Patients (Peanut Allergen Powder)

Number of Patients (Placebo)

31%

10%

Up-dosing

693

289

17%

6%

300 mg

310

118

9%

3%

Initial dose escalation

709

292

Respiratory: Cough (3% to 32%), pharyngeal edema (3% to 14%), rhinorrhea (1% to 21%), sneezing (3% to 20%), throat irritation (9% to 40%), wheezing (≤12%)

1% to 10%:

Dermatologic: Pruritus of ear (≤6%)

Gastrointestinal: Eosinophilic esophagitis (1%) (table 6)

Peanut Allergen Powder: Adverse Reaction: Eosinophilic Esophagitis

Drug (Peanut Allergen Powder)

Placebo

Number of Patients (Peanut Allergen Powder)

Number of Patients (Placebo)

1%

0%

1,050

292

Hypersensitivity: Anaphylaxis (≤9%) (table 7)

Peanut Allergen Powder: Adverse Reaction: Anaphylaxis

Drug (Peanut Allergen Powder)

Placebo

Dose

Number of Patients (Peanut Allergen Powder)

Number of Patients (Placebo)

9%

4%

Up-dosing

693

289

9%

2%

300 mg

310

118

0.7%

0.3%

Initial dose escalation

709

292

Respiratory: Dyspnea (≤8%)

Contraindications

Uncontrolled asthma; history of eosinophilic esophagitis and other eosinophilic GI disease.

Warnings/Precautions

Disease-related concerns:

• Respiratory disease: Uncontrolled asthma is a risk factor for serious outcome in anaphylaxis, including death. Withhold treatment if patient is experiencing an acute asthma exacerbation; resume therapy with caution after resolution of exacerbation. Reevaluate patients with recurrent asthma exacerbations and consider discontinuation. Use has not been studied in patients with severe asthma, persistently uncontrolled asthma, or in patients on long-term systemic corticosteroid therapy.

Other warnings/precautions:

• Appropriate patient selection: Use may not be suitable for patients with conditions that may reduce their ability to survive anaphylaxis, including but not limited to compromised lung function, severe mast cell disorder, or cardiovascular disease.

• Appropriate use: Discontinue use in patients who are unable to comply with the daily dosing requirements. Use may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine.

Dosage Forms Considerations

Palforzia is supplied in kits to allow for health care provider clinic/office and patient home administration in accordance with the manufacturer’s recommendations for initial dose escalation, up-dosing, and maintenance dosing phases.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Sprinkle Capsule, Oral:

Palforzia: 0.5 mg, 1 mg, 10 mg, 20 mg, 100 mg

Sprinkle Packet, Oral:

Palforzia: 300 mg

Pricing: US

Capsule Sprinkle Therapy Pack (Palforzia (12 MG Daily Dose) Oral)

2 x 1 MG &10 MG (per each): $15.58

Capsule Sprinkle Therapy Pack (Palforzia (120 MG Daily Dose) Oral)

20 MG &100 MG (per each): $23.37

Capsule Sprinkle Therapy Pack (Palforzia (160 MG Daily Dose) Oral)

3 x 20 MG &100 MG (per each): $11.69

Capsule Sprinkle Therapy Pack (Palforzia (20 MG Daily Dose) Oral)

20 mg (per each): $46.74

Capsule Sprinkle Therapy Pack (Palforzia (200 MG Daily Dose) Oral)

2 x 100 mg (per each): $23.37

Capsule Sprinkle Therapy Pack (Palforzia (240 MG Daily Dose) Oral)

2 x 20 MG &2 x 100 MG (per each): $11.69

Capsule Sprinkle Therapy Pack (Palforzia (3 MG Daily Dose) Oral)

3 x 1 mg (per each): $15.58

Capsule Sprinkle Therapy Pack (Palforzia (40 MG Daily Dose) Oral)

2 x 20 mg (per each): $23.37

Capsule Sprinkle Therapy Pack (Palforzia (6 MG Daily Dose) Oral)

6 x 1 mg (per each): $7.79

Capsule Sprinkle Therapy Pack (Palforzia (80 MG Daily Dose) Oral)

4 x 20 mg (per each): $11.69

Capsule Sprinkle Therapy Pack (Palforzia Initial Escalation Oral)

0.5 & 1 & 1.5 &3 & 6 MG (per each): $3.64

Pack (Palforzia (300 MG Maintenance) Oral)

300 mg (per each): $46.74

Pack (Palforzia (300 MG Titration) Oral)

300 mg (per each): $46.74

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral: For oral use only. Do not swallow capsule or inhale powder. Open capsule or sachet and empty the entire dose of peanut allergen powder onto a few spoonfuls of refrigerated or room temperature semisolid food (eg, applesauce, yogurt, pudding); mix well; do not use liquid to prepare. Consume the entire volume of prepared mixture promptly. Dispose of opened capsule or sachet and all unused peanut allergen powder. Wash hands immediately after handling capsule or sachet. Auto-injectable epinephrine must be available to patients at all times.

Administration: Pediatric

Oral: Do not swallow capsule whole; do not inhale powder. Open capsule or sachet and empty entire dose onto a small amount (a few spoonsful) of room temperature or refrigerated semisolid food (eg, applesauce, yogurt, pudding); mix well and administer immediately. Do not use liquid (eg, milk, water, juice) to prepare. Wash hands after handling. Auto-injectable epinephrine must be available to patients at all times.

Use: Labeled Indications

Peanut allergy: Oral immunotherapy for mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients with a confirmed diagnosis of peanut allergy. Initial dose escalation may be administered to patients 4 to 17 years of age. Up-dosing and maintenance may be continued in patients ≥4 years of age. Peanut allergen powder 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.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Accidental exposure to peanuts in a peanut allergic woman may cause anaphylaxis, which may then decrease maternal BP and placental perfusion. Anaphylaxis may also occur following exposure to peanut allergen powder. Pregnant women were excluded from initial studies of peanut allergen powder as oral immunotherapy (PALISADE Group [Vickery 2018]). In general, immunotherapy should not be initiated during pregnancy (Pitsios 2019). Data collection to monitor pregnancy and infant outcomes following exposure to peanut allergen powder is ongoing. Health care providers are encouraged to enroll females exposed to peanut allergen powder during pregnancy in the pregnancy registry (1-833-246-2566).

Breastfeeding Considerations

It is not known if peanut allergen powder is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Signs/symptoms of adverse reactions; monitor for ≥60 minutes after the last dose of the initial dose escalation and after the first dose of each new up-dosing level.

Mechanism of Action

Not established.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (PR) Puerto Rico: Palforzia
  1. Dunlop JH. Oral immunotherapy for treatment of peanut allergy. J Investig Med. 2020;68(6):1152-1155. doi:10.1136/jim-2020-001422 [PubMed 32665367]
  2. Lucendo AJ, Arias A, Tenias JM. Relation between eosinophilic esophagitis and oral immunotherapy for food allergy: a systematic review with meta-analysis. Ann Allergy Asthma Immunol. 2014;113(6):624-629. doi:10.1016/j.anai.2014.08.004 [PubMed 25216976]
  3. Palforzia (peanut [Arachis hypogaea] allergen powder) [prescribing information]. Brisbane, CA: Aimmune Therapeutics Inc; March 2023.
  4. Patrawala M, Shih J, Lee G, Vickery B. Peanut oral immunotherapy: A current perspective. Curr Allergy Asthma Rep. 2020;20(5):12. doi:10.1007/s11882-020-00908-6 [PubMed 32314071]
  5. Pepper AN, Assa'ad A, Blaiss M, et al. Consensus report from the Food Allergy Research & Education (FARE) 2019 Oral Immunotherapy for Food Allergy Summit. J Allergy Clin Immunol. 2020;146(2):244-249. doi:10.1016/j.jaci.2020.05.027 [PubMed 32505612]
  6. Pitsios C, Tsoumani M, Bilò MB, et al. Contraindications to immunotherapy: a global approach. Clin Transl Allergy. 2019;9:45. doi: 10.1186/s13601-019-0285-4. [PubMed 31528333]
  7. Vickery BP, Vereda A, Casale TB, et al; PALISADE Group of Clinical Investigators. AR101 oral immunotherapy for peanut allergy. N Engl J Med. 2018;379(21):1991-2001. doi:10.1056/NEJMoa1812856 [PubMed 30449234]
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