Version July 2025
Peanut allergen powder can cause anaphylaxis (also called anaphylactic reaction), 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.
Dosage guidance:
Safety: 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: Treatment is administered in 3 sequential phases:
Initial dose escalation phase: 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; do not omit any dose levels.
Note: Observe patient for 20 to 30 minutes before administration of the next dose level and for 60 minutes after final dose level of phase.
Children 1 to <4 years: Oral:
|
Dose level |
Dose |
|---|---|
|
A |
0.5 mg |
|
B |
1 mg |
|
C |
1.5 mg |
|
D |
3 mg |
Children ≥4 years and Adolescents ≤17 years: Oral:
|
Dose level |
Dose |
|---|---|
|
A |
0.5 mg |
|
B |
1 mg |
|
C |
1.5 mg |
|
D |
3 mg |
|
E |
6 mg |
Up-dosing phase:
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 doses at each dose level once daily preferably in the evening. Do not progress to next dose level more frequently than every 2 weeks; do not omit any dose levels.
Children 1 to <4 years: Oral:
|
Dose level |
Dose |
Duration |
|---|---|---|
|
0 |
1 mg |
2 weeks |
|
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 |
Children ≥4 years and Adolescents: Oral:
|
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 during up-dosing phase: Children and Adolescents: Oral: 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.
Maintenance dosing phase: Note: Initial dose escalation phase and up-dosing phase should be completed prior to maintenance dosing.
Children >1 year and Adolescents: Oral: 300 mg once daily.
Dose modification during maintenance phase: 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.
Discontinuation of therapy: Discontinue therapy in patients who are unable to tolerate any initial dose (patients 1 year to <4 years) or unable to tolerate initial doses up to 3 mg (patients ≥4 years) during initial dose escalation phase. For all ages, discontinue therapy in 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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Peanut allergen oral immunotherapy powder: 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: 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.
|
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.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Peanut allergy powder can 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 adverse reactions have occurred, including abdominal pain, diarrhea, 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)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children and adolescents.
>10%:
Dermatologic: Pruritus (2% to 33%), skin rash (8% to 27%), urticaria (4% to 28%)
Gastrointestinal: Abdominal pain (0% to 67%) (table 1), nausea (9% to 32%) (table 2), oral itching (0% to 31%) (table 3), oral paresthesia (2% to 14%) (table 4), vomiting (0% to 37%) (table 5)
|
Drug (Peanut Allergen Powder) |
Placebo |
Population |
Dose |
Number of Patients (Peanut Allergen Powder) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|
|
15% |
4% |
Age 1 through 3 years |
Up-dosing |
98 |
48 |
|
8% |
2% |
Age 1 through 3 years |
300 mg |
87 |
45 |
|
0% |
2% |
Age 1 through 3 years |
Initial dose escalation |
98 |
48 |
|
67% |
35% |
Age 4 through 17 years |
Up-dosing |
693 |
289 |
|
29% |
17% |
Age 4 through 17 years |
300 mg |
310 |
118 |
|
26% |
8% |
Age 4 through 17 years |
Initial dose escalation |
709 |
292 |
|
Drug (Peanut Allergen Powder) |
Placebo |
Population |
Dose |
Number of Patients (Peanut Allergen Powder) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|
|
32% |
14% |
Age 4 through 17 years |
Up-dosing |
693 |
289 |
|
15% |
7% |
Age 4 through 17 years |
300 mg |
310 |
118 |
|
9% |
0.7% |
Age 4 through 17 years |
Initial dose escalation |
709 |
292 |
|
Drug (Peanut Allergen Powder) |
Placebo |
Population |
Dose |
Number of Patients (Peanut Allergen Powder) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|
|
8% |
0% |
Age 1 through 3 years |
300 mg |
87 |
45 |
|
4% |
2% |
Age 1 through 3 years |
Up-dosing |
98 |
48 |
|
0% |
0% |
Age 1 through 3 years |
Initial dose escalation |
98 |
48 |
|
31% |
10% |
Age 4 through 17 years |
Up-dosing |
693 |
289 |
|
17% |
6% |
Age 4 through 17 years |
300 mg |
310 |
118 |
|
9% |
3% |
Age 4 through 17 years |
Initial dose escalation |
709 |
292 |
|
Drug (Peanut Allergen Powder) |
Placebo |
Population |
Dose |
Number of Patients (Peanut Allergen Powder) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|
|
14% |
4% |
Age 4 through 17 years |
Up-dosing |
693 |
289 |
|
7% |
2% |
Age 4 through 17 years |
300 mg |
310 |
118 |
|
2% |
2% |
Age 4 through 17 years |
Initial dose escalation |
709 |
292 |
|
Drug (Peanut Allergen Powder) |
Placebo |
Population |
Dose |
Number of Patients (Peanut Allergen Powder) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|
|
13% |
0% |
Age 1 through 3 years |
Up-dosing |
98 |
48 |
|
5% |
0% |
Age 1 through 3 years |
300 mg |
87 |
45 |
|
0% |
0% |
Age 1 through 3 years |
Initial dose escalation |
98 |
48 |
|
37% |
16% |
Age 4 through 17 years |
Up-dosing |
693 |
289 |
|
16% |
12% |
Age 4 through 17 years |
300 mg |
310 |
118 |
|
3% |
0.7% |
Age 4 through 17 years |
Initial dose escalation |
709 |
292 |
Respiratory: Cough (2% to 32%), pharyngeal edema (3% to 14%), rhinorrhea (1% to 21%), sneezing (3% to 20%), throat irritation (3% to 40%), wheezing (≤12%)
1% to 10%:
Dermatologic: Perioral dermatitis (1% to 6%), pruritus of ear (≤6%)
Gastrointestinal: Diarrhea (1% to 9%), eosinophilic esophagitis (1%) (table 6)
|
Drug (Peanut Allergen Powder) |
Placebo |
Population |
Dose |
Number of Patients (Peanut Allergen Powder) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|
|
9% |
10% |
Age 1 through 3 years |
Up-dosing |
98 |
48 |
|
3% |
0% |
Age 1 through 3 years |
300 mg |
87 |
45 |
|
1% |
2% |
Age 1 through 3 years |
Initial dose escalation |
98 |
48 |
|
Drug (Peanut Allergen Powder) |
Placebo |
Number of Patients (Peanut Allergen Powder) |
Number of Patients (Placebo) |
|---|---|---|---|
|
1% |
0% |
1,050 |
292 |
Hypersensitivity: Anaphylaxis (0% to 9%) (table 7)
|
Drug (Peanut Allergen Powder) |
Placebo |
Population |
Dose |
Number of Patients (Peanut Allergen Powder) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|
|
7% |
4% |
Age 1 through 3 years |
300 mg |
87 |
45 |
|
2% |
4% |
Age 1 through 3 years |
Up-dosing |
98 |
48 |
|
0% |
0% |
Age 1 through 3 years |
Initial dose escalation |
98 |
48 |
|
9% |
4% |
Age 4 through 17 years |
Up-dosing |
693 |
289 |
|
9% |
2% |
Age 4 through 17 years |
300 mg |
310 |
118 |
|
0.7% |
0.3% |
Age 4 through 17 years |
Initial dose escalation |
709 |
292 |
Respiratory: Dyspnea (≤8%), nasal congestion (3% to 4%), oropharyngeal pain (1% to 3%), rhinitis (3% to 9%)
Uncontrolled asthma; history of eosinophilic esophagitis and other eosinophilic GI disease.
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.
In two randomized, double-blind, placebo-controlled trials including children and adolescents 1 to 17 years of age, the protocols did not allow for H1 or H2 blockers, proton pump inhibitors, and inhaled beta-adrenergic medications as prophylaxis for allergic reactions. H1 or H2 blockers, proton pump inhibitors, and inhaled beta-adrenergic medications may mitigate adverse reactions to peanut allergen powder; therefore, patients should be closely monitored if these medications are discontinued during therapy with peanut allergen powder. Peanut allergen powder has not been studied in patients already taking these medications for another indication, and there is no manufacturer recommendation regarding management of these patients (Du Toit 2023; Vickery 2018).
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.
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
Capsule Sprinkle Therapy Pack (Palforzia (1 MG Daily Dose) Oral)
1 x 1 mg (per each): $76.77
Capsule Sprinkle Therapy Pack (Palforzia (12 MG Daily Dose) Oral)
2 x 1 MG &10 MG (per each): $17.06
Capsule Sprinkle Therapy Pack (Palforzia (120 MG Daily Dose) Oral)
20 MG &100 MG (per each): $25.59
Capsule Sprinkle Therapy Pack (Palforzia (160 MG Daily Dose) Oral)
3 x 20 MG &100 MG (per each): $12.80
Capsule Sprinkle Therapy Pack (Palforzia (20 MG Daily Dose) Oral)
20 mg (per each): $51.18
Capsule Sprinkle Therapy Pack (Palforzia (200 MG Daily Dose) Oral)
2 x 100 mg (per each): $25.59
Capsule Sprinkle Therapy Pack (Palforzia (240 MG Daily Dose) Oral)
2 x 20 MG &2 x 100 MG (per each): $12.80
Capsule Sprinkle Therapy Pack (Palforzia (3 MG Daily Dose) Oral)
3 x 1 mg (per each): $17.06
Capsule Sprinkle Therapy Pack (Palforzia (40 MG Daily Dose) Oral)
2 x 20 mg (per each): $25.59
Capsule Sprinkle Therapy Pack (Palforzia (6 MG Daily Dose) Oral)
6 x 1 mg (per each): $8.53
Capsule Sprinkle Therapy Pack (Palforzia (80 MG Daily Dose) Oral)
4 x 20 mg (per each): $12.80
Capsule Sprinkle Therapy Pack (Palforzia Initial Dose 1-3yrs Oral)
0.5 & 1 & 1.5 &3 MG (per each): $164.51
Capsule Sprinkle Therapy Pack (Palforzia Initial Dose 4-17yrs Oral)
0.5 & 1 & 1.5 &3 & 6 MG (per each): $88.58
Capsule Sprinkle Therapy Pack (Palforzia Initial Escalation Oral)
0.5 & 1 & 1.5 &3 & 6 MG (per each): $3.98
Pack (Palforzia (300 MG Maintenance) Oral)
300 mg (per each): $51.18
Pack (Palforzia (300 MG Titration) Oral)
300 mg (per each): $51.18
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.
Note: Auto-injectable epinephrine must be available to patients at all times.
Oral: Capsule, Sachet: 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. The manufacturer suggests immediate administration; for children <4 years of age, a 4-hour window was utilized in clinical trials; in situations of product shortage, food/dose mixture could be used up to 24 hours after preparation if food vehicle stored at appropriate temperature (Ref). Do not use liquid (eg, milk, water, juice) to prepare. Wash hands after handling.
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.
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.
Store at 2°C to 25°C (36°F to 77°F); avoid excessive heat. Do not freeze. Store in the original packaging until use to protect from moisture.
Oral immunotherapy for mitigation of allergic reactions, including anaphylaxis that may occur with accidental exposure to peanuts in patients with a confirmed diagnosis of peanut allergy and used in conjunction with peanut-avoidant diet (Initial dose escalation: FDA approved in ages 1 to 17 years; Up-dosing and maintenance: FDA approved in ages ≥1 year and adults).
Limitation of use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Ustekinumab: May decrease therapeutic effects of Allergen Immunotherapy. Risk C: Monitor
Accidental exposure to peanuts in a peanut allergic pregnant patient may cause anaphylaxis, which may then decrease maternal BP and placental perfusion. Anaphylaxis may also occur following exposure to peanut allergen powder. Pregnant patients 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 patients exposed to peanut allergen powder during pregnancy in the pregnancy registry ([email protected] or 844-725-3679).
Monitor for allergic reactions, including GI reactions; dose modification may be necessary. Monitor for signs and symptoms of asthma and eosinophilic esophagitis.
Not established.
