Peanut Oral Allergen Powder

Peanut Oral Allergen Powder is an oral immunotherapy indicated for mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts in patients with a confirmed diagnosis of peanut allergy.

• Peanut Oral Allergen Powder is available under the following different brand names: Palforzia, peanut Arachis hypogaea allergen powder-dnfp

Common side effects of Peanut Oral Allergen Powder include:

• abdominal pain
• vomiting
• nausea
• oral itching
• oral numbness and tingling
• throat irritation
• cough
• runny nose
• sneezing
• throat tightness
• wheezing
• shortness of breath
• itching
• hives
• severe allergic reaction (anaphylaxis)
• ear itching

Serious side effects of Peanut Oral Allergen Powder include:

• wheezing or trouble breathing
• chest discomfort or tightness
• throat tightness
• trouble swallowing or speaking
• swelling of the face, lips, eyes, or tongue
• dizziness or fainting
• severe stomach cramps or pain, vomiting, or diarrhea
• hives (itchy, raised bumps on the skin)
• severe flushing of the skin

Rare side effects of Peanut Oral Allergen Powder include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

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

• 0.5 mg
• 1 mg
• 10 mg
• 20 mg

Peanut allergy

Pediatric dosage

• Administer initial dose escalation to patients aged 4 to 17 years; up-dosing and maintenance may continue in patients older than 4 years
• 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 spoonful of refrigerated or room temperature semisolid food (e.g., applesauce, yogurt, pudding) and consume promptly
• Initial dose escalation (single-day dose escalation)

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

• 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 a 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 orally once a day
• Complete all dose levels of up-dosing before starting maintenance
• Daily maintenance is required to maintain the effectiveness of immunotherapy
• Continue to monitor patients at regular intervals to assess for adverse effects

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Peanut Oral Allergen Powder has no noted severe interactions with any other drugs
• Peanut Oral Allergen Powder has no noted serious interactions with any other drugs
• Peanut Oral Allergen Powder has no noted moderate interactions with any other drugs
• Peanut Oral Allergen Powder has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Uncontrolled asthma
• History of eosinophilic esophagitis and other eosinophilic GI disease

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Peanut Oral Allergen Powder?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Peanut Oral Allergen Powder?”

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 can 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 (e.g., viral infection), or fasting; other potential cofactors may include menstruation, sleep deprivation, NSAID use, or uncontrolled asthma
• Consider dose reduction and dose re-escalation 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 was reported in all 12 patients following the 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 and Lactation

• Data is 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 peanuts 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 of human milk, its effects on breastfed infants, or milk production