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Palforzia (peanut (Arachis hypogaea) allergen powder-dnfp)
peanut (Arachis hypogaea) allergen powder
Black Box Warnings .
Appropriate Use
restricted distribution program (PALFORZIA REMS) due to anaphylaxis risk; prescribers, healthcare settings and pharmacies must be certified and patients must be enrolled in the program; only dispense to certified health care settings or patients who meet all Palforzia REMS requirements; 1-844-725-3679 or www.PALFORZIAREMS.com for more information
Anaphylaxis
life-threatening anaphylaxis (or anaphylactic reactions) may occur at any time during tx; do not give to patients with uncontrolled asthma; tx may not be suitable for patients with history of severe or life-threatening anaphylaxis to peanut, especially recent reactions; tx may not be suitable for patients with underlying medical conditions that may decr. ability to survive serious hypersensitivity reactions; observe patients for signs/symptoms of hypersensitivity reaction for at least 60min after initial dose escalation and 1st dose of each new up-dosing level; modify, hold, or D/C tx per pkg insert following an anaphylactic reaction; prescribe auto-injectable epinephrine and instruct patients on appropriate use and to seek immediate medical care upon use; allergen immunotherapy may not be suitable for patients potentially unresponsive to epinephrine or inhaled bronchodilators, such as patients taking beta-blockers
Adult Dosing .
Adult dosing is currently unavailable or not applicable for this drug.
Peds Dosing .
- Dosage forms: POWDER: 300 mg per packet; CAP (patients 1-3 yo initial dose escalation pack): 0.5 mg x2 and 1 mg x5; CAP (patients 4-17 yo initial dose escalation pack): 0.5 mg x2 and 1 mg x11; CAP (1 mg level 0 pack): 1 mg x15; CAP (3 mg level 1 pack): 1 mg x45; CAP (6 mg level 2 pack): 1 mg x90; CAP (12 mg level 3 pack): 1 mg x30 and 10 mg x15; CAP (20 mg level 4 pack): 20 mg x15; CAP (40 mg level 5 pack): 20 mg x30; CAP (80 mg level 6 pack): 20 mg x60; CAP (120 mg level 7 pack): 20 mg x15 and 100 mg x15; CAP (160 mg level 8 pack): 20 mg x45 and 100 mg x15; CAP (200 mg level 9 pack): 100 mg x30; CAP (240 mg level 10 pack): 20 mg x30 and 100 mg x30; POWDER (300 mg level 11 pack): 300 mg per packet x15
Restricted Distribution in US
- [1-844-725-3679 or www.PALFORZIAREMS.com for more info]
Special Note
- [drug name clarification]
- Info: nonproprietary name = peanut (Arachis hypogaea) allergen powder-dnfp
allergic reaction, peanut-induced
- [initial dose escalation phase, 1-3 yo]
- Dose: 0.5 mg PO x1, then 1 mg PO x1, then 1.5 mg PO x1, then 3 mg PO x1; Info: separate doses by 20-30min; open cap and sprinkle on soft food; repeat phase if unable to start up-dosing phase within 4 days after completion of initial dose escalation phase
- [initial dose escalation phase, 4-17 yo]
- Dose: 0.5 mg PO x1, then 1 mg PO x1, then 1.5 mg PO x1, then 3 mg PO x1, then 6 mg PO x1; Info: separate doses by 20-30min; open cap and sprinkle on soft food; repeat phase if unable to start up-dosing phase within 4 days after completion of initial dose escalation phase
- [up-dosing phase, 1-3 yo]
- Dose: 1 dose PO qd x2wk per dose level, incr. dose level 0 to 11 q2wk; Start: 1-4 days after completion of initial dose escalation phase; Info: open cap/packet and sprinkle on soft food; see pkg insert for dose adjustments based on allergic reaction and missed doses
- [up-dosing phase, 4-17 yo]
- Dose: 1 dose PO qd x2wk per dose level, incr. dose level 1 to 11 q2wk; Start: 1-4 days after completion of initial dose escalation phase; Info: open cap/packet and sprinkle on soft food; see pkg insert for dose adjustments based on allergic reaction and missed doses
- [maintenance phase, 1 yo and older]
- Dose: 300 mg PO qd; Start: after completion of up-dosing phase; Info: may continue maintenance phase in patients 18 yo and older; open packet and sprinkle on soft food; see pkg insert for dose adjustments based on allergic reaction and missed doses
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- asthma, uncontrolled
- eosinophilic esophagitis history
- caution: hypersensitivity to drug or ingredient
- caution: severe anaphylactic reaction, recent
- caution: asthma
- caution: pulmonary impairment
- caution: mast cell disorder, severe
- caution: cardiovascular disease
Drug Interactions .
Overview
peanut (Arachis hypogaea) allergen powder
allergen
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- eosinophilic esophagitis
Common Reactions
- abdominal pain
- throat irritation
- vomiting
- pruritus
- nausea
- cough
- urticaria
- rhinitis
- throat tightness
- oral paresthesia
- wheezing
- diarrhea (patients 1-3 yo)
- anaphylaxis
- dyspnea
- oropharyngeal pain (patients 1-3 yo)
Safety/Monitoring .
Monitoring Parameters
signs/symptoms of hypersensitivity reaction for at least 60min after initital dose escalation and 1st dose of each up-dosing level
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available, though risk of fetal harm not expected based on human data with other allergen immunotherapy agents
Pregnancy Registry
encourage patients to enroll in Palforzia pregnancy registry at 1-833-246-2566
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for peanut allergen powder: unknown; CYP450: unknown
Excretion: for peanut allergen powder: unknown; Half-life: unknown
Subclass: Allergen Immunotherapy
Mechanism of Action
for peanut allergen powder: exact mechanism of action unknown; alters immune response and promotes tolerance through repeated allergen-specific exposure
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Aimmune Therapeutic
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
oral powder in capsules:
- 0.5 mg and 1 mg (1 initial dose escalation pack): $38.00
oral powder:
- 300 mg (1 dose pack, Level 11 Maintenance): $1,004.00
oral capsule:
- 120 mg (1 dose pack, Level 7): $507.00
oral capsule:
- 200 mg (6 dose pack, Level 9): $2,927.00
oral capsule:
- 20 mg (1 dose pack, Level 4): $507.00
oral capsule:
- 160 mg (1 dose pack, Level 8): $507.00
oral capsule:
- 6 mg (1 dose pack, Level 2): $507.00
oral capsule:
- 12 mg (1 dose pack, Level 3): $507.00
oral capsule:
- 40 mg (1 dose pack, Level 5): $507.00
oral capsule:
- 3 mg (1 dose pack, Level 1): $507.00
oral capsule:
- 240 mg (1 dose pack, Level 10): $507.00
oral powder:
- 300 mg (1 dose pack, Level 11): $507.00
oral capsule:
- 80 mg (1 dose pack, Level 6): $507.00
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