peanut oral allergen powder (Rx)

Brand and Other Names:Palforzia, peanut Arachis hypogaea allergen powder-dnfp
  • Print

Dosing & Uses

AdultPediatric

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)

  • 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
  • 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
  • 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

Next:

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%)
Previous
Next:

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
Previous
Next:

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.

Previous
Next:

Pharmacology

Mechanism of Action

Oral immunotherapy for gradual desensitization and maintenance to protect peanut-allergic individuals in case of accidental exposure

Previous
Next:

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

Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.