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Palforzia Generic Name & Formulations
Legal Class
Rx
General Description
Peanut (Arachis hypogaea) Allergen Powder-dnfp 0.5mg, 1mg, 10mg, 20mg, 100mg; per cap; 300mg; per sachet; pwd for oral administration.
Pharmacological Class
Oral immunotherapy.
How Supplied
Kit (w. caps or sachets)—5, 15, 30
Manufacturer
Generic Availability
NO
Palforzia Indications
Indications
For use in patients with a confirmed diagnosis of peanut allergy: for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. To be used in conjunction with a peanut-avoidant diet.
Limitations of Use
Not for emergency treatment of allergic reactions, including anaphylaxis.
Palforzia Dosage and Administration
Adults and Children
<4yrs: not established. Do not swallow capsule or inhale powder. Open cap(s) or sachet and mix contents with only semisolid food (eg, applesauce, yogurt, pudding); then consume entire mixture. ≥4yrs: Administer in 3 sequential phases: Initial Dose Escalation, Up-Dosing, and Maintenance (see full labeling). For Initial Dose Escalation and the first dose of each new Up-Dosing level, must administer under the supervision of a health care professional and observe patients for ≥60mins until suitable for discharge.
Palforzia Contraindications
Contraindications
Uncontrolled asthma. History of eosinophilic esophagitis and other eosinophilic GI disease.
Palforzia Boxed Warnings
Boxed Warning
Anaphylaxis.
Palforzia Warnings/Precautions
Warnings/Precautions
Risk of anaphylaxis (may be fatal). Do not initiate if severe or life-threatening anaphylaxis occurred within the previous 60 days. Compromised lung function. Severe mast cell disorder. Cardiovascular disease. Prescribe and instruct patients on use of epinephrine inj. Avoid use in the presence of cofactors (eg, exercise, hot water exposure, intercurrent illness, fasting, menstruation, sleep deprivation); if unavoidable, consider withholding temporarily. Withhold if an acute asthma exacerbation occurs. Severe asthma, persistently uncontrolled asthma, on long-term systemic corticosteroid therapy: not studied. Monitor for eosinophilic esophagitis; discontinue if suspected. Pregnancy. Nursing mothers.
REMS
Palforzia Pharmacokinetics
See Literature
Palforzia Interactions
Interactions
Avoid concomitant NSAIDs; if unavoidable, consider withholding temporarily. May not be suitable with drugs that can inhibit or potentiate the effects of epinephrine.
Palforzia Adverse Reactions
Adverse Reactions
Abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, ear pruritus.
Palforzia Clinical Trials
See Literature
Palforzia Note
Not Applicable
Palforzia Patient Counseling
See Literature
