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Ragwitek Generic Name & Formulations
Legal Class
Rx
General Description
Short ragweed pollen allergen extract (Ambrosia artemisiifolia) 12 Amb a 1-Unit; sublingual tablets.
Pharmacological Class
Allergen extract.
How Supplied
Blisters—30
Manufacturer
Generic Availability
NO
Ragwitek Indications
Indications
Short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by (+) skin test or in vitro testing for pollen-specific IgE antibodies. Not for immediate relief of allergic symptoms.
Ragwitek Dosage and Administration
Adults and Children
<5yrs: not established. Initiate at least 12 weeks before onset of ragweed pollen season and continue throughout the season. Give 1st dose under physician supervision; observe ≥30 mins for any signs/symptoms of severe allergic reaction; if tolerated, subsequent doses may be taken at home. 5–65yrs: 1 tab daily. Allow complete dissolution under the tongue before swallowing. Avoid food or beverage for 5 mins after dosing.
Ragwitek Contraindications
Contraindications
Severe, unstable, or uncontrolled asthma. History of any severe systemic or local allergic reaction. History of eosinophilic esophagitis.
Ragwitek Boxed Warnings
Boxed Warning
Severe allergic reactions.
Ragwitek Warnings/Precautions
Warnings/Precautions
Risk of severe allergic reactions (eg, anaphylaxis, laryngopharyngeal restriction); discontinue if occurs. Prescribe auto-injectable epinephrine for emergency use. Underlying conditions that may reduce survival of a serious allergic reaction after epinephrine use (eg, markedly compromised lung function, severe mast cell disorder, unstable angina, recent MI, significant arrhythmia, uncontrolled HTN). Moderate or severe asthma. Withhold therapy in acute asthma exacerbation; consider discontinuing if recurrent. Consider discontinuation if persistent and escalating adverse reactions in the mouth or throat. Interrupt therapy for oral inflammation or wounds to allow complete healing. Elderly (>65yrs). Pregnancy. Nursing mothers.
Ragwitek Pharmacokinetics
See Literature
Ragwitek Interactions
Interactions
Concomitant other allergen immunotherapy: not studied; may increase risk of local or systemic adverse reactions. Avoid concomitant drugs that can potentiate or inhibit effects of epinephrine (eg, beta-adrenergic blockers, alpha-adrenergic blockers, ergot alkaloids, TCAs, levothyroxine, MAOIs, chlorpheniramine, diphenhydramine, [cardiac glycosides, diuretics; monitor for arrhythmias]).
Ragwitek Adverse Reactions
Adverse Reactions
Throat irritation, pruritus (oral, ear, tongue), oral paresthesia, mouth edema; children/adolescents: also lip swelling, glossodynia, nausea, oral pain, pharyngeal edema, swollen tongue, upper abdominal pain, stomatitis, enlarged uvula; severe systemic or local allergic reactions, eosinophilic esophagitis (discontinue if occurs).
Ragwitek Clinical Trials
See Literature
Ragwitek Note
Not Applicable
Ragwitek Patient Counseling
See Literature
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