short ragweed pollen allergen extract [Sublingual]

Adult Dosing

Allergic Rhinitis

Initiate treatment 12 weeks before the expected onset of ragweed pollen season and maintain it throughout the season
1 tablet Sublingually (SL) Daily; give 1st dose under the supervision of a physician and observe for 30 mins

Note:

Not approved for patient >65 yearsof age
Instruct patients to avoid swallowing for about 1 minute following SL administration
Wash hands after handling the tablet
Do not take with food or beverage; avoid food or beverages for 5 minutes after taking the SL tablet

Pediatric Dosing

[Outline]

Indications ⬆ ⬇

Treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis

Contraindications ⬆ ⬇

Black Box Warnings ⬆ ⬇

Life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction have been reported with therapy
Do not administer in patients with severe, unstable or uncontrolled asthma
Monitor patient under supervision of a physician at least 30 minutes following the initial dose
Patients should be prescribed autoinjectable epinephrine, trained on its appropriate use, and instructed to seek immediate medical care upon its use
Therapy may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction
Patients taking drugs that inhibit bronchodilator or epinephrine effects may be unresponsive to the usual doses of epinephrine

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Hepatic Dose Adjustment

Warnings/Precautions ⬆ ⬇

Therapy may cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Educate patients to recognize the signs and symptoms of these allergic reactions and advise them to seek immediate medical care and discontinue therapy should any of these occur
Patients should be prescribed autoinjectable epinephrine, trained on its appropriate use, and instructed to seek immediate medical care upon its use
Therapy may cause local reactions in the mouth or throat that could compromise the upper airway. Consider discontinuation of therapy in patients who experience persistent and escalating adverse reactions in the mouth or throat
Withhold dose if patient experiencing an acute asthma exacerbation; re-evaluate patients with recurrent asthma exacerbations and consider discontinuing the therapy
Eosinophilic esophagitis has been reported in association with SL tablet immunotherapy. Discontinue the therapy and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain
Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy
In case of oral inflammation or wounds, stop treatment to allow complete healing of the oral cavity

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Safety unknown. Manufacturer advises caution

Adverse Reactions ⬆ ⬇

CV: Chest discomfort
GI: Oral pruritus, oral paraesthesia, mouth edema, tongue pruritus, lip swelling, swollen tongue, lip pruritus, dry mouth, tongue edema, nausea, palatal edema, dysphagia
DERM: Pruritus
EENT: Ear pruritus
RESP: Throat irritation, oropharyngeal pain, throat tightness

Clinical Pharmacology ⬆ ⬇