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Adverse reactions reported in ≥5% of patients were: throat irritation, oral pruritus, ear pruritus, oral paraesthesia, mouth edema, and tongue pruritus.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In 4 placebo-controlled clinical trials, 1057 subjects 18 years of age and older with short ragweed pollen-induced rhinitis, with or without conjunctivitis, received at least one dose of RAGWITEK, of whom 642 (61%) completed at least 12 weeks of therapy. Of the subjects treated with RAGWITEK, 52% were male, 25% had mild asthma, and 82% were sensitized to other allergens in addition to ragweed pollen. The subject population was 83% White, 12% African American, and 2% Asian. Subject demographics in placebo treated subjects were similar to the active group. The pooled analysis includes safety data from two 28-day safety studies and safety data from the first 28 days of two 52-week safety and efficacy studies. Adverse reactions reported in ≥1% of subjects in the 28-day pooled analysis treated with RAGWITEK are shown in Table 1.

The most common adverse reactions reported in subjects treated with RAGWITEK were throat irritation (16.6% vs 3.3% placebo), oral pruritus (10.9% vs 2.0%), ear pruritus (10.4% vs 1.1%), and oral paraesthesia (10.0% vs 4.0%). The percentage of subjects who discontinued from the clinical trials because of an adverse reaction while exposed to RAGWITEK or placebo was 4.4% and 0.8%, respectively. The most common adverse reactions that led to study discontinuation in subjects who were exposed to RAGWITEK were mouth edema, swollen tongue, and dysphagia.

One subject (1/1057; 0.1%) who received RAGWITEK experienced a treatment-related severe systemic allergic reaction that led to discontinuation of RAGWITEK. The subject had local reactions starting on Day 1 of treatment with RAGWITEK. On Day 6 symptoms progressed and included swelling of the throat, dyspnea, nausea, and lightheadedness. The subject fully recovered after treatment with epinephrine (self-administered), antihistamines, and oral corticosteroids.

Table 1: Adverse Reactions Reported in ≥1% of Subjects Treated with RAGWITEK (28-day pooled analysis)

Adverse Reaction RAGWITEK
Ear and Labyrinth Disorders
Ear pruritus 10.4% 1.1%
Respiratory, Thoracic and Mediastinal Disorders
Throat irritation 16.6% 3.3%
Oropharyngeal pain 1.5% 0.7%
Throat tightness 1.3% 0.5%
Gastrointestinal Disorders
Oral pruritus 10.9% 2.0%
Paraesthesia oral 10.0% 4.0%
Mouth edema 6.1% 0.5%
Tongue pruritus 5.1% 0.5%
Lip swelling 3.0% 0.4%
Swollen tongue 2.9% 0.5%
Lip pruritus 1.5% 0.1%
Dry mouth 1.4% 0.7%
Tongue edema 1.3% 0.5%
Nausea 1.1% 0.3%
Palatal edema 1.1% 0%
Dysphagia 1.0% 0%
Skin and Subcutaneous Tissue Disorders
Pruritus 1.8% 1.3%
General Disorders and Administration Site Conditions
Chest discomfort 1.0% 0%

The overall safety profile beyond Day 28 in the two 52-week trials was similar to that observed in the pooled 28-day analysis.