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Oralair

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Oralair

SIDE EFFECTS

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

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 rate observed in practice.

Adults

Overall, in 6 placebo-controlled clinical trials, 1,038 adults 18 through 65 years of age received at least one dose of ORALAIR 300IR, of whom 611 (59%) completed at least four months of therapy. Of study participants, 56% were male, 17% had a history of mild intermittent asthma at study entry, and 64% were polysensitized. Data on race and ethnicity were not systematically captured in the five European studies (N=805). In the US study (N=233), a limited number of patients reported their race as other than White/Caucasian (Black/African American: 5.6%, Asian: 2.6%, Other: 2.1%) or their ethnicity as Hispanic or Latino (3.0%). Adverse events were captured on a daily diary card that did not solicit for specific adverse events.

Across the six clinical studies, adverse reactions reported at an incidence of ≥ 2% of ORALAIR recipients and at a greater incidence than that in participants treated with placebo are listed in Table 2.

Table 2: Adverse Reactions Reported by ≥ 2% of Adults Receiving ORALAIR 300 IR and at a Greater Incidence than that in Participants Treated with Placebo

Adverse Reactions ORALAIR 300 IR
(N=1,038)
PLACEBO
(N=840)
Ear and labyrinth disorders
  Ear pruritus 8.40% 0.60%
Respiratory, thoracic and mediastinal disorders
  Throat irritation 22.00% 3.70%
  Cough 7.30% 5.90%
  Oropharyngeal pain 5.10% 3.70%
  Pharyngeal edema 3.80% 0.10%
Gastrointestinal disorders
  Oral pruritus 25.10% 5.00%
  Edema mouth 8.20% 0.60%
  Tongue pruritus 7.90% 0.70%
  Lip edema 4.40% 0.40%
  Paraesthesia oral 4.30% 1.00%
  Abdominal pain 4.20% 1.30%
  Dyspepsia 3.90% 0.40%
  Tongue edema 2.70% 0.10%
  Hypoaesthesia oral 2.20% 0.10%
  Stomatitis 2.10% 0.70%
Skin and subcutaneous tissue disorders
  Urticaria 2.30% 1.50%

Additional adverse reactions of interest that occurred in < 2% of ORALAIR recipients include dysphagia, nausea, vomiting, esophageal pain, gastritis, and gastroesophageal reflux.

Children and Adolescents

Overall, in placebo-controlled clinical trials, 154 children and adolescents 5 through 17 years of age received ORALAIR 300 IR, of whom 147 were exposed for more than 3 months. Of study participants, 66% were male, and 21% had a history of mild intermittent asthma at study entry. Data on race and ethnicity were not systematically captured.

The safety profile in the pediatric population, was generally similar to that of adults. In pediatric patients receiving ORALAIR, additional adverse reactions reported at an incidence of ≥ 2% and at a greater incidence than that in participants treated with placebo are listed in Table 3.

Table 3: Additional Adverse Reactions Reported by ≥ 2% of Children and Adolescents Receiving ORALAIR 300 IR and at a Greater Incidence than that in Participants Treated with Placebo

Adverse Reactions ORALAIR 300 IR
(N=154)
PLACEBO
(N=158)
Infections and infestations
  Tonsillitis 5.80% 3.20%
  Upper respiratory tract infection 3.90% 1.90%
Respiratory, thoracic and mediastinal disorders
  Asthma 7.10% 3.80%
  Dysphonia 2.60% 1.30%
Gastrointestinal disorders
  Lip pruritus 3.20% 0.00%
Skin and subcutaneous tissue disorders
  Atopic dermatitis 3.20% 0.60%

Serious Adverse Reactions

At least 1 serious adverse event was reported in 22 of 1514 (1.5%) subjects who received ORALAIR at any dose, and 11 of 840 (1.1%) of placebo recipients. Of the 22 serious adverse events in the ORALAIR recipients, 2 were considered “definitely related” to ORALAIR.

The first subject was an adult who experienced a severe hypersensitivity reaction which began 5 minutes after administration of ORALAIR. The symptoms were violent coughing and marked dyspnea. The subject was treated with antihistamines, salbutamol and prednisolone and the reaction resolved without sequelae.

The second subject was an adult who experienced severe laryngeal edema. The subject was treated with prednisolone and event resolved without sequelae.

There was also one case of gastroenteritis with an onset on Day 93 of therapy that was possibly related to ORALAIR.

Postmarketing Experience

Post Marketing Safety Studies

A total of 1728 individuals (808 adults; 920 children 5 through 17 years of age) received ORALAIR in post marketing safety studies. Reported adverse reactions included: anaphylactic reaction, oral allergy syndrome, flushing, dyspnea, laryngeal edema, and diarrhea.

Spontaneous Postmarketing Reports

In addition to adverse reactions reported in clinical and post marketing safety studies, the following adverse reactions have been identified during post approval use of ORALAIR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: autoimmune thyroiditis, eosinophilic myocarditis, eosinophilic esophagitis, palpitations, tachycardia, hypotension, loss of consciousness, circulatory collapse, malaise, pallor, peripheral vascular disorder, stridor, angioedema, face edema, weight decreased, wheezing, exacerbation of asthma, chest discomfort, oropharyngeal blistering, headache, dizziness, tinnitus, asthenia, somnolence, anxiety, rash, pruritus, salivary gland enlargement and/or hypersecretion, dry mouth, dry eye, influenza-like syndrome, lymphadenopathy, eosinophil count increased.

Read the Oralair (sweet vernal, orchard, perennial rye, timothy, and kentucky blue grass mixed pollens allergen extract sublingual tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 4/15/2014
This monograph has been modified to include the generic and brand name in many instances.

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