Dosing & Uses
See Pediatric Dosing
Dosage Forms & Strengths
Peanut (Arachis hypogaea) allergen powder-dnfp protein is a powder for oral administration (added to soft food) manufactured from defatted peanut flour
encapsulated oral powder
- 0.5mg
- 1mg
- 10mg
- 20mg
- 100mg
sachet oral powder
- 300mg
Peanut Allergy
Oral immunotherapy indicated for mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients with a confirmed diagnosis of peanut allergy
Administer initial dose escalation to patients aged 4-17 yr; up-dosing and maintenance may be continued in patients aged ≥4 yr
Use in conjunction with a peanut-avoidant diet
Treatment is administered in 3 sequential phases: Initial dose escalation, up-dosing, and maintenance
Mix capsule/sachet powder with a few spoonfuls of refrigerated or room temperature semisolid food (eg, applesauce, yogurt, pudding) and consume promptly
Initial dose escalation (single day dose escalation)
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Instructions
- Dose escalation supplied as a single card consisting of 5 blisters containing 13 capsules administered in sequential order on a single day
- Administer under supervision of a healthcare professional in a healthcare setting with ability to manage severe allergic reactions, including anaphylaxis
- Separate each dose by a 20- to 30-minute observation period
- Do not omit any dose level
- Observe for 60 minutes after last dose until patient is suitable for discharge
- Discontinue if symptoms requiring medical intervention (eg, use of epinephrine) occur with any dose
- Patients who tolerate at least the 3-mg single dose (Level D) must return to the healthcare setting for up-dosing initiation; if possible, begin up-dosing the next day
- Repeat initial dose escalation in a healthcare setting if patient is unable to begin up-dosing within 4 days
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Dosage for initial dose escalation
- Separate each dose by a 20- to 30-minute observation period
- Dose level A: 0.5 mg (one 0.5-mg capsule)
- Dose level B: 1 mg (one 1-mg capsule)
- Dose level C: 1.5 mg (one 0.5-mg capsule; one 1-mg capsule)
- Dose level D: 3 mg (three 1-mg capsules)
- Dose level E: 6 mg (six 1-mg capsules)
Up-dosing
-
Instructions
- Complete initial dose escalation before starting up-dosing
- Up-dosing consists of 11 dose levels and is initiated at a 3-mg dose (Level 1)
- The first dose of each new up-dosing level is administered under the supervision of a healthcare professional in a healthcare setting with the ability to manage potentially severe allergic reactions, including anaphylaxis
- Observe patients after administering first dose of a new up-dosing level for at least 60 minutes until suitable for discharge
- If the patient tolerates the first dose of the increased dose level, the patient may continue that dose level at home
- Each dose should be consumed daily with a meal at approximately the same time each day, preferably in the evening
- Administer all the dose levels in sequential order at 2-week intervals if tolerated; do not progress through up-dosing more rapidly or omit a dose level
- Do not consume more than 1 dose per day; instruct patients not to consume a dose at home on the same day as a dose consumed in the clinic
- Consider dose modification or discontinuation for patients who do not tolerate up-dosing
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Dose schedule for up-dosing
- Consume only 1 dose per day at approximately the same time each day
- Dose levels are at 2-week intervals (first dose of each level under observation in healthcare setting)
- Dose level 1: 3 mg (three 1-mg capsules)
- Dose level 2: 6 mg (six 1-mg capsules)
- Dose level 3: 12 mg (two 1-mg capsules; one 10-mg capsule)
- Dose level 4: 20 mg (one 20-mg capsule)
- Dose level 5: 40 mg (two 20-mg capsules)
- Dose level 6: 80 mg (four 20-mg capsules)
- Dose level 7: 120 mg (one 20-mg capsule; one 100-mg capsule)
- Dose level 8: 160 mg (three 20-mg capsules; one 100-mg capsule)
- Dose level 9: 200 mg (two 100-mg capsules)
- Dose level 10: 240 mg (two 20-mg capsules; two 100-mg capsules)
- Dose level 11: 300 mg (one 300-mg sachet)
Maintenance dosing
- 300 mg PO qDay
- Complete all dose levels of up-dosing before starting maintenance
- Daily maintenance is required to maintain effectiveness of immunotherapy
- Continue to monitor patient at regular intervals to assess for adverse effects
Dosage Modifications
Dose modifications are not appropriate during initial dose escalation
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
Modify dose for allergic reactions, including GI reactions, that are severe, recurrent, bothersome, or last >90 minutes during up-dosing or maintenance
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
Dosing Considerations
Limitation of use: Not indicated for emergency treatment of allergic reactions, including anaphylaxis
Verify the patient has injectable epinephrine and instruct patient on appropriate use
Adverse Effects
>10%
Initial dose escalation
- Abdominal pain (26.1%)
Up-dosing
- Abdominal pain (67.1%)
- Throat irritation (40.3%)
- Vomiting (36.5%)
- Skin pruritus (32.5%)
- Nausea (32.3%)
- Cough (31.9%)
- Oral pruritus (31.2%)
- Skin urticaria (28.4%)
- Rhinorrhea (20.9%)
- Sneezing (20.2%)
- Throat tightness (14.1%)
- Oral paresthesia (13.6%)
- Wheezing (12.3%)
300-mg maintenance
- Abdominal pain (29%)
- Skin urticaria (20.3%)
- Cough (19.7%)
- Oral pruritus (16.5%)
- Vomiting (16.1%)
- Rhinorrhea (14.8%)
- Nausea (14.5%)
- Skin pruritus (14.5%)
- Throat irritation (13.9%)
- Sneezing (10.6%)
1-10%
Initial dose escalation
- Throat irritation (9.3%)
- Oral pruritus (8.7%)
- Nausea (8.5%)
- Skin pruritus (7.9%)
- Skin urticaria (3.9%)
- Sneezing (3.4%)
- Vomiting (3.1%)
- Cough (2.5%)
- Throat tightness (2.5%)
- Oral paresthesia (1.8%)
- Rhinorrhea (1.3%)
Up-dosing
- Anaphylactic reaction (9.1%)
- Dyspnea (7.6%)
- Ear pruritus (5.9%)
300-mg maintenance
- Anaphylactic reaction (8.7%)
- Oral paresthesia (7.4%)
- Throat tightness (6.5%)
- Wheezing (6.1%)
- Dyspnea (5.5%)
- Ear pruritus (2.3%)
<1%
Initial dose escalation
- Anaphylactic reaction (0.7%)
- Ear pruritus (0.7%)
- Wheezing (0.6%)
- Dyspnea (0.3%)
Warnings
Black Box Warnings
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 to patients with uncontrolled asthma (contraindicated)
Dose modifications may be necessary following an anaphylactic reaction
Observe patients during and after administration of initial dose escalation and the first dose of each up-dosing level, for at least 60 minutes
Owing to anaphylaxis risk, available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Palforzia REMS
Contraindications
Uncontrolled asthma
History of eosinophilic esophagitis and other eosinophilic GI disease
Cautions
Anaphylaxis
- Can cause anaphylaxis, which may be life-threatening
- Anaphylaxis was reported during all phases of dosing, including maintenance and in patients who have undergone recommended up-dosing and dose modification procedures
- Do not initiate in patients who have had severe or life-threatening anaphylaxis within the previous 60 days
- All initial dose escalation doses and the first dose of each up-dosing level must be administered under observation in a healthcare setting that is able to manage severe allergic reactions, including anaphylaxis
- Patients may be more likely to experience allergic reactions following administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (eg, viral infection), or fasting; other potential cofactors may include menstruation, sleep deprivation, NSAID use, or uncontrolled asthma
- Consider dose reduction and dose reescalation based on clinical judgment
REMS program
- Owing to anaphylaxis risk, available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Palforzia REMS
- www.palforziarems.com or 1-844-PALFORZ (1-844-725-3679)
Asthma
- Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis
- Ensure patients with asthma have their asthma under control before initiating immunotherapy
- Temporarily withhold peanut oral allergen powder for an acute asthma exacerbation; following exacerbation resolution, resume cautiously according to dose interruption instructions
- Reevaluate patients who have recurrent asthma exacerbations and consider discontinuation
- Peanut oral allergen powder has not been studied with severe asthma, persistently uncontrolled asthma, or patients on long-term systemic corticosteroid therapy
Eosinophilic GI disease
- 12 of 17 patients who underwent esophagogastroduodenoscopy (EGD) examination were diagnosed with biopsy-confirmed eosinophilic esophagitis while receiving peanut oral allergen powder
- Symptomatic improvement reported in all 12 patients following discontinuance of peanut oral allergen powder
- Discontinue peanut oral allergen powder and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent GI symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain
GI adverse effects
- GI adverse reactions, including abdominal pain, vomiting, nausea, oral pruritus, and oral paresthesia, were commonly reported during clinical trials
- Consider dosage modification for patients who report these reactions
- For severe or persistent GI symptoms, consider a diagnosis of eosinophilic esophagitis
Pregnancy & Lactation
Pregnancy
Data are not available
Pregnancy registry
Encourage women exposed to peanut oral allergen powder during pregnancy to contact Aimmune by calling 1-833-246-2566
Disease-associated maternal and/or embryo/fetal risk
- Anaphylaxis may occur following accidental exposure to peanut in peanut-allergic pregnant women
- Anaphylaxis can cause a dangerous decrease in blood pressure, which could result in compromised placental perfusion and significant risk to a fetus
Lactation
There are no data available on the presence in human milk, effects on breastfed infants, or effects on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Oral immunotherapy for gradual desensitization and maintenance to protect peanut-allergic individuals in case of accidental exposure
Administration
Oral preparation
Open capsule(s) or sachet and empty the entire dose of powder onto a few spoonfuls of refrigerated or room temperature semisolid food (eg, applesauce, yogurt, pudding)
Do not use liquid (eg, milk, water, juice) to prepare
Mix well
Consume the entire volume of the prepared mixture promptly
Dispose of the opened capsule(s) or sachet
Wash hands immediately after handling capsule(s) or sachets
Dispose of all unused powder
Oral Administration
See Pediatric Dosing and Uses for complete instructions
For oral administration only
Do not swallow capsule(s); empty capsule powder content on few spoonfuls of refrigerated or room temperature semisolid food (eg, applesauce, yogurt, pudding) and mix; consume promptly
Do not inhale powder
Consecutive missed doses
- 1-2 consecutive days: Resume at same dose level
- ≥3 consecutive days: Instruct patient to consult clinician; resumption of dosing should be done under medical supervision
Discontinue treatment for
- Patients unable to tolerate doses up to and including 3-mg dose during initial dose escalation
- Patients with suspected eosinophilic esophagitis
- Patients unable to comply with the daily dosing requirements
- Patients with recurrent asthma exacerbations or persistent loss of asthma control
Storage
Refrigerate at 2-8ºC (36-46ºF)
Do not freeze
Store in original packaging until use to protect from moisture
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