Indications for PALFORZIA:
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.
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.
Uncontrolled asthma. History of eosinophilic esophagitis and other eosinophilic GI disease.
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.
Avoid concomitant NSAIDs; if unavoidable, consider withholding temporarily. May not be suitable with drugs that can inhibit or potentiate the effects of epinephrine.
Abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, ear pruritus.
Kit (w. caps or sachets)—5, 15, 30