General Information

Ragwitek contains pollen allergen extract from Short Ragweed (Ambrosia artemisiifolia). The precise mechanisms of action of allergen immunotherapy are not known.

Ragwitek allergen extract is specifically indicated as immunotherapy, for use in patients ages 5 to 65 years of age, for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen.

Ragwitek is supplied as a tablet for sublingual (under the tongue) administration. The recommended dose is one tablet daily. The first dose should be administered in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. The patient should be observed for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, subsequent doses may be taken at home. Treatment should be initiated at least 12 weeks before the expected onset of ragweed pollen season and continue treatment throughout the season.

Side Effects

Adverse effects associated with the use of Ragwitek may include, but are not limited to, the following:

throat irritation

oral pruritus

ear pruritus

oral paraesthesia

mouth edema

tongue pruritus

The Ragwitek drug label comes with the following Black Box Warning: Ragwitek can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer Ragwitek to patients with severe, unstable or uncontrolled asthma. Observe patients in the office for at least 30 minutes following the initial dose. Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. Ragwitek may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. Ragwitek may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

Clinical Trial Results

The FDA approval of Ragwitek was based on two double-blind, placebo-controlled clinical trials in 767 adults 18 through 50 years of age. The population included subjects with asthma. Subjects received Ragwitek or placebo for approximately 12 weeks prior to the start of the ragweed pollen season and throughout the ragweed pollen season. Symptom-relieving medications were allowed as needed. Efficacy was established by self-reporting of rhinoconjunctivitis daily symptom scores (DSS) and daily medication scores (DMS). Daily rhinoconjunctivitis symptoms included four nasal symptoms (runny nose, stuffy nose, sneezing, and itchy nose), and two ocular symptoms (gritty/itchy eyes and watery eyes). The rhinoconjunctivitis symptoms were measured on a scale of 0 (none) to 3 (severe). The sums of the DSS and DMS were combined into the Total Combined Score (TCS) which was averaged over the peak ragweed pollen season. Also, in each study, the average TCS over the entire ragweed season was assessed. A decrease in TCS during the peak ragweed season for subjects treated with Ragwitek compared to placebo treated subjects was demonstrated in both trials. Subjects treated with Ragwitek also showed a decrease in the average TCS from the start of and throughout the entire ragweed pollen season. TCS score Peak season: Ragwitek: 6.22 versus placebo: 8.46. TCS score Entire season: Ragwitek: 5.21 versus placebo: 7.01.

The FDA approval of Ragwitek in pediatrics was based, in part, on data from a phase 3 clinical trial in children with ragweed allergic rhinitis, with or without conjunctivitis. The randomized, double-blind, parallel group, multicenter clinical trial evaluated the efficacy and safety of Ragwitek in 1,022 children and adolescents ages five through 17 with a history of ragweed-induced rhinoconjunctivitis and sensitivity to short ragweed over an approximately 20-28 week treatment duration. Treatment with Ragwitek significantly improved symptoms and decreased symptom-relieving medication use compared to placebo.