Get your patient on Oralair (Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen)
Oralair prescribing information
WARNING: SEVERE ALLERGIC REACTIONS
- ORALAIR can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. (5.1)
- Do not administer ORALAIR to patients with severe, unstable or uncontrolled asthma. (4)
- Observe patients in the office for at least 30 minutes following the initial dose. (5.1)
- Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. (5.2)
- ORALAIR may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. (5.2)
- ORALAIR may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. (5.2)
1 INDICATIONS AND USAGE
ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age.
ORALAIR is not indicated for the immediate relief of allergy symptoms.
2 DOSAGE AND ADMINISTRATION
For sublingual use only.
2.1 Dose
For adults 18 through 65 years of age, the dose is 300 IR (index of reactivity) daily. For children and adolescents 5 through 17 years of age, the dose is increased over the first three days as shown in Table 1.
| Age (years) | Dose | ||
| Day 1 | Day 2 | Day 3 and following | |
| 5-17 | 100 IR | 2x100 IR | 300 IR |
| 18-65 | 300 IR | 300 IR | 300 IR |
2.2 Administration
Administer the first dose of ORALAIR in a healthcare setting in which acute allergic reactions can be treated under the supervision of a physician with experience in the diagnosis and treatment of severe allergic reactions. After receiving the first dose of ORALAIR, observe the patient 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, the patient may take subsequent doses at home.
Administer ORALAIR to children under adult supervision.
Remove the ORALAIR tablet from the blister just prior to dosing.
Place the ORALAIR tablet immediately under the tongue until complete dissolution for at least 1 minute before swallowing.
Wash hands after handling the ORALAIR tablet.
Do not take the ORALAIR tablet with food or beverage. To avoid swallowing allergen extract, food or beverage should not be taken for 5 minutes following dissolution of the tablet.
Initiate treatment 4 months before the expected onset of each grass pollen season and maintain it throughout the grass pollen season.
Data regarding the safety of starting treatment during the pollen season are not available. Data regarding the safety of restarting treatment after missing a dose of ORALAIR are not available.
It is recommended that auto-injectable epinephrine be made available to patients prescribed ORALAIR. Patients who are prescribed epinephrine while receiving immunotherapy should be instructed in the proper use of emergency self-injection of epinephrine [ See Warnings and Precautions (5.2) ].
3 DOSAGE FORMS AND STRENGTHS
ORALAIR tablets are available as follows:
- ORALAIR 100 IR tablets are round and biconvex, slightly speckled white to beige with "100" engraved on both sides
- ORALAIR 300 IR tablets are round and biconvex, slightly speckled white to beige with "300" engraved on both sides
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Available human data do not establish the presence or absence of ORALAIR-associated risks during pregnancy, labor and delivery. Two developmental toxicity studies were performed in female rats and female rabbits given doses up to 250 IR/day and 3500 IR/day of ORALAIR, respectively, during gestation.
Data In developmental toxicity studies, the effect of ORALAIR on embryo/fetal development was evaluated in female rats and female rabbits administered with doses up to 250 IR/day and 3500 IR/day of ORALAIR, respectively, by oral gavage on days 6-17 of gestation for rats, and days 6-18 of gestation for rabbits. The human dose is 300 IR/day. There were no ORALAIR-related fetal malformations or other evidence of teratogenesis noted in these studies.
8.2 Lactation
Risk Summary Data are not available to assess the effects of ORALAIR on the breastfed child or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ORALAIR and any potential adverse effects on the breastfed child from ORALAIR or from the underlying maternal condition.
8.4 Pediatric Use
The safety and effectiveness of ORALAIR have not been established in children below 5 years of age.
8.5 Geriatric Use
ORALAIR has not been studied in patients over 65 years of age.
4 CONTRAINDICATIONS
ORALAIR is contraindicated in patients with:
- Severe, unstable or uncontrolled asthma
- History of any severe systemic allergic reaction
- History of any severe local reaction to sublingual allergen immunotherapy
- A history of eosinophilic esophagitis
- Hypersensitivity to any of the inactive ingredients (mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and lactose monohydrate) contained in this product [ See Description (11) ]
5 WARNINGS AND PRECAUTIONS
5.1 Severe Allergic Reactions
ORALAIR can cause systemic allergic reactions including anaphylaxis which may be life-threatening. In addition, ORALAIR can cause severe local reactions, including laryngopharyngeal swelling, which can compromise breathing and be life-threatening.
Patients who have a systemic allergic reaction to ORALAIR should stop taking ORALAIR.
Patients who have either escalating or persistent local reactions to ORALAIR should be reevaluated and considered for discontinuation of ORALAIR.
Administer the initial dose of ORALAIR in a healthcare setting under the supervision of a physician prepared to manage a severe
systemic or a severe local allergic reaction. Observe patients in the office for at least 30 minutes following the initial dose of ORALAIR.
Severe and serious allergic reactions may require treatment with epinephrine [ See Warnings and Precautions (5.2) ].
5.2 Epinephrine
Prescribe auto-injectable epinephrine to patients receiving ORALAIR. Instruct patients to recognize the signs and symptoms of a severe allergic reaction and in the proper use of emergency self-injection of epinephrine, and instruct patients to seek immediate medical care upon its use [ See Patient Counseling Information (17) ].
ORALAIR may not be suitable for patients with certain medical conditions that may reduce the ability to survive a serious allergic reaction or increase the risk of adverse reactions after epinephrine administration. Examples of these medical conditions include but are not limited to: markedly compromised lung function (either chronic or acute), unstable angina, recent myocardial infarction, significant arrhythmia, and uncontrolled hypertension.
ORALAIR may not be suitable for patients who are taking medications that can potentiate or inhibit the effect of epinephrine. These medications include:
Î’eta-adrenergic blockers : Patients taking beta-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, beta-adrenergic blockers antagonize the cardiostimulating and bronchodilating effects of epinephrine.
Alpha-adrenergic blockers, ergot alkaloids : Patients taking alpha-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, alpha-adrenergic blockers antagonize the vasoconstricting and hypertensive effects of epinephrine. Similarly, ergot alkaloids may reverse the pressor effects of epinephrine.
Tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors and certain antihistamines : The adverse effects of epinephrine may be potentiated in patients taking tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and the antihistamines chlorpheniramine, and diphenhydramine.
Cardiac glycosides, diuretics : Patients who receive epinephrine while taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias.
5.3 Eosinophilic Esophagitis
Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy [ See Contraindications (4) and Adverse Reactions (6.2) ]. Discontinue ORALAIR and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain.
5.4 Asthma
ORALAIR has not been studied in subjects with moderate or severe asthma or any subjects who required daily medication.
Immunotherapy with ORALAIR should be withheld if the patient is experiencing an acute asthma exacerbation. Reevaluate patients who have recurrent asthma exacerbations and consider discontinuation of ORALAIR.
5.5 Concomitant Allergen Immunotherapy
ORALAIR has not been studied in subjects receiving concomitant allergen immunotherapy. Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy.
5.6 Oral Inflammation
Stop treatment with ORALAIR to allow complete healing of the oral cavity in patients with oral inflammation (e.g., oral lichen planus, mouth ulcers or thrush) or oral wounds, such as those following oral surgery or dental extraction.
5.7 Initiation of ORALAIR Therapy during Grass Pollen Season
The risk of ORALAIR may be increased when treatment is initiated during the grass pollen season.
6 ADVERSE REACTIONS
Adverse reactions reported in > 5% of patients were: oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, oropharyngeal pain.
6.1 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.
| Adverse Reactions | ORALAIR 300 IR (N=1,038) | PLACEBO (N=840) |
| Ear and labyrinth disorders | ||
| Ear pruritus | 8.4% | 0.6% |
| Respiratory, thoracic and mediastinal disorders | ||
| Throat irritation | 22.0% | 3.7% |
| Cough | 7.3% | 5.9% |
| Oropharyngeal pain | 5.1% | 3.7% |
| Pharyngeal edema | 3.8% | 0.1% |
| Gastrointestinal disorders | ||
| Oral pruritus | 25.1% | 5.0% |
| Edema mouth | 8.2% | 0.6% |
| Tongue pruritus | 7.9% | 0.7% |
| Lip edema | 4.4% | 0.4% |
| Paraesthesia oral | 4.3% | 1.0% |
| Abdominal pain | 4.2% | 1.3% |
| Dyspepsia | 3.9% | 0.4% |
| Tongue edema | 2.7% | 0.1% |
| Hypoaesthesia oral | 2.2% | 0.1% |
| Stomatitis | 2.1% | 0.7% |
| Skin and subcutaneous tissue disorders | ||
| Urticaria | 2.3% | 1.5% |
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.
| Adverse Rections | ORALAIR 300 IR (N=154) | PLACEBO (N=158) |
| Infections and infestations | ||
| Tonsillitis | 5.8% | 3.2% |
| Upper respiratory tract infection | 3.9% | 1.9% |
| Respiratory, thoracic and mediastinal disorders | ||
| Asthma | 7.1% | 3.8% |
| Dysphonia | 2.6% | 1.3% |
| Gastrointestinal disorders | ||
| Lip pruritus | 3.2% | 0.0% |
| Skin and subcutaneous tissue disorders | ||
| Atopic dermatitis | 3.2% | 0.6% |
An open-label study was conducted to evaluate the 30-day safety profile of ORLAIR in 307 children 5 through 9 years of age. Of study participants, 71% were male and 36% had a history of mild intermittent asthma at study entry. Data on race and ethnicity were not systematically captured. Adverse reactions reported at an incidence of > 2% were: throat irritation (22.1%), oral pruritus (11.7%), oral paresthesia (11.1%), tongue pruritus (8.1%), mouth edema (6.2%), cough (6.2%), oropharyngeal pain (4.2%), ear pruritus (5.2%), eye pruritus (4.6%), lip edema (3.3%), vomiting (2.6%), tongue edema (2.3%), abdominal pain (2.3%), oral discomfort (2.3%), and ocular hyperemia (2.0%).
Serious Adverse Reactions
At least 1 serious adverse event was reported in 22 of 1514 (1.5%) pediatric and adult subjects from randomized clinical trials 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.
In the open-label study conducted in 307 children 5 through 9 years of age, 2 serious adverse events were considered "likely" related to ORALAIR.
The first subject was an 8-year-old subject with a history of allergic bronchial asthma who developed oral pruritus, conjunctivitis, urticaria and asthma exacerbation 15 minutes after administration of ORALAIR on Day 5. The subject was treated with antihistamines and inhaled salbutamol and the reactions fully resolved in 30 minutes. The subject continued ORALAIR.
The second subject was a 6-year-old subject who developed severe lip, eye and eyelid swelling after administration of ORALAIR on Day 26 of therapy. The subject was treated with intravenous antihistamines and prednisolone. Reaction fully resolved within 6 hours. Treatment with ORALAIR was discontinued.
6.2 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 paresthesia, 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.
11 DESCRIPTION
ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal ( Anthoxanthum odoratum L ), Orchard ( Dactylis glomerata L ), Perennial Rye ( Lolium perenne L ), Timothy ( Phleum pratense L ), and Kentucky Blue Grass ( Poa pratensis L ).
ORALAIR is available as a sublingual tablet in the following strengths:
- 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units)
- 300 IR (equivalent to approximately 9000 BAU
Inactive ingredients: mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and lactose monohydrate.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The precise mechanisms of action of allergen immunotherapy are not known.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity studies were conducted in animals. There was no evidence of mutagenic or clastogenic activity in response to ORALAIR in the in vitro bacterial mutagenesis assay and mouse lymphoma thymidine kinase cell assay or the in vivo bone marrow micronucleus and unscheduled DNA synthesis tests in rats.
No fertility study was conducted with ORALAIR.
14 CLINICAL STUDIES
The efficacy of ORALAIR for the treatment of grass pollen-induced allergic rhinoconjunctivitis was investigated in five double-blind, placebo-controlled clinical trials: four natural field studies and an environmental exposure chamber study.
The natural field studies included these trials, each conducted over a single season (two in adults and one in adolescents and children) and one five-year study (adults). Participants received ORALAIR or placebo daily for four months prior to grass pollen season and throughout grass pollen season.
Study participants reported at least a two grass pollen season history of rhinoconjunctivitis symptoms. For the European studies, subjects had a positive skin prick test to 5-grass pollen extract and positive in vitro testing for timothy grass-specific serum IgE. For the US study, subjects had a positive skin prick test to Timothy grass pollen extract.
With the exception of those with mild intermittent asthma, patients with asthma were excluded. Approximately 16% had asthma at baseline and 65% were polysensitized (i.e., sensitized to the 5-grass pollen allergen extract and at least one other unrelated allergen). Overall, the mean age of study participants was 28 years and 56% were male.
Natural Field Studies
In the natural field studies, efficacy of ORALAIR as immunotherapy to treat symptoms of allergic rhinoconjunctivitis due to the grass pollens included in ORALAIR was assessed via daily recording of symptoms and rescue medication use. The daily Combined Score (CS, range: 0-3) equally weights symptoms and rescue medication use. The daily Rhinoconjunctivitis Total Symptom Score (RTSS, range 0-18) is the total of the six individual symptom scores (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each graded by participants on a 0 (no symptoms) to 3 (severe symptoms) scale. The daily Rescue Medication Score (RMS, range 0-3) grades the intake of rescue medication as 0 = absent, 1 = antihistamine, 2 = nasal corticosteroid, 3 = oral corticosteroid. In case of multiple medications, the higher score is retained. Least Squares (LS) means are within-group means adjusted for the covariates in the statistical models (i.e., analyses of covariance for average scores and linear mixed models with repeated measures for daily scores). The Relative Difference is the LS mean difference between ORALAIR and Placebo divided by the LS mean of Placebo, expressed as a percentage.
US Study
In this study, 473 adults aged 18 through 65 years received ORALAIR or placebo, starting approximately four months prior to the expected onset of the grass-pollen season and continuing for the duration of the pollen season. The results of the analysis of the daily Combined Score (CS), daily Rhinoconjunctivitis Total Symptom Score (RTSS), and daily Rescue Medication Score (RMS) are summarized in Table 4.
| Efficacy endpoint | ORALAIR (N=208) LS• Mean | Placebo (N=228) LS Mean | LS Mean Difference ORALAIR - Placebo | Relative Difference | |
| Estimate | 95% CI | ||||
| Daily CS †| 0.32 | 0.45 | -0.13 | -28.2% | [-43.4%;-13.0%] |
| Daily RTSS ‡ | 3.21 | 4.16 | -0.95 | -22.9% | [-38.2%;-7.5%] |
| Daily RMS ‡ | 0.11 | 0.20 | -0.09 | -46.5% | [-73.9%;-19.2%] |
• LS: Least Squares †Primary efficacy analysis ‡ Secondary efficacy analysis
European Study
In this study, adults aged 18 to 45 years received one of 3 different doses of 5-grass pollen extract sublingual tablet or placebo. A total of 311 subjects received ORALAIR or placebo starting approximately 4 months prior to the expected onset of the grass pollen season and continuing for the duration of the grass pollen season. The results of the analysis of the daily CS, daily RTSS and daily RMS for ORALAIR (300 IR) are shown in Table 5.
| Efficacy endpoint | ORALAIR (N=136) LS• Mean | Placebo (N=148) LS Mean | LS Mean Difference ORALAIR - Placebo | Relative Difference | |
| Estimate | 95% CI | ||||
| Daily CS | 0.50 | 0.70 | -0.21 | -29.6% | [-43.1%;-16.1%] |
| Daily RTSS | 3.48 | 4.91 | -1.44 | -29.2% | [-43.4%;-15.1%] |
| Daily RMS | 0.41 | 0.59 | -0.18 | -30.1% | [-49.5%;-10.6%] |
• LS: Least Squares
Long Term Study
In this study, adults received ORALAIR or placebo according to two different treatment regimens. A total of 426 subjects received ORALAIR or placebo starting approximately 4 months prior to the grass pollen season and continuing for the entire season. Subjects were treated for three consecutive grass pollen seasons (Year 1 to Year 3). The primary evaluation was the Year 3 pollen period. Participants then entered two years of immunotherapy-free follow-up (Year 4 and Year 5). The results of the analysis of the daily Combined Score for ORALAIR (4M) for treatment Years 1-3 are summarized in Table 6. Data are insufficient to demonstrate efficacy for one or two years after discontinuation of ORALAIR.
| Year | ORALAIR (4M) | Placebo | LS Mean Difference ORALAIR - Placebo | Relative Difference | |||
| N | LS• Mean | N | LS Mean | Estimate | 95% CI | ||
| Year 1 | 188 | 0.56 | 205 | 0.67 | -0.11 | -16.4% | [-27.0%;-5.8%] |
| Year 2 | 160 | 0.35 | 172 | 0.56 | -0.21 | -38.0% | [-53.4%;-22.6%] |
| Year 3 | 149 | 0.31 | 165 | 0.50 | -0.19 | -38.3% | [-54.7%;-22.0%] |
• LS: Least Squares
Pediatric Study
In this study, 278 children and adolescents 5 through 17 years of age received ORALAIR or placebo starting approximately 4 months prior to the grass-pollen season and continuing for the duration of the pollen season. The results of the daily CS, daily RTSS, and daily RMS are summarized in Table 7.
| Efficacy endpoint | ORALAIR (N=131) LS• Mean | Placebo (N=135) LS Mean | LS Mean Difference ORALAIR - Placebo | Relative Difference | |
| Estimate | 95% CI | ||||
| Daily CS | 0.44 | 0.63 | -0.19 | -30.1% | [-46.9%;-13.2%] |
| Daily RTSS | 2.52 | 3.63 | -1.11 | -30.6% | [-47.0%;-14.1%] |
| Daily RMS | 0.46 | 0.65 | -0.19 | -29.5% | [-50.9%;-8.0%] |
• LS: Least Squares
Allergen Environmental Chamber Study
In an allergen environmental chamber study, 89 adults with grass pollen-associated allergic rhinoconjunctivitis were challenged with four of the five grass pollens contained in ORALAIR at baseline and after 4 months of treatment with ORALAIR (n=45) or placebo (n=44). The average Rhinoconjunctivitis Total Symptom Score (RTSS) of each group during the 4 hours of the allergen challenge was assessed; use of rescue medication was not permitted. The results of this study are shown in Table 8.
| Efficacy endpoint | ORALAIR (N=45) LS• Mean | Placebo (N=44) LS Mean | LS Mean Difference ORALAIR - Placebo | Relative Difference | |
| Estimate | 95% CI | ||||
| Average RTSS †| 4.88 | 6.84 | -1.97 | -28.7% | [-43.7%;-13.7%] |
• LS: Least Squares †Primary efficacy analysis
16 HOW SUPPLIED/STORAGE AND HANDLING
ORALAIR is available as a sublingual tablet equivalent to 100 IR and 300 IR of five grass mixed pollens allergen extract.
| Description | NDC Number | |
Children and Adolescents Sample Kit (5 to 17 years of age) | One box of the 100 IR Starter Pack Two boxes of the 300 IR Sample Packs | NDC 59617-0020-1 |
| Adult Sample Kit (18 to 65 years of age) | One box of 300 IR Starter Pack Two boxes of 300 IR Sample Packs | NDC 59617-0025-1 |
Children and Adolescents Starter Pack (5 to 17 years of age) | 1 blister pack of three 100 IR tablets | NDC 59617-0010-1 |
| Adult Starter Pack (18 to 65 years of age) | 1 blister pack of three 300 IR tablets | NDC 59617-0016-1 |
| Sample Pack | 1 blister pack of three 300 IR tablets | NDC 59617-0015-3 |
| Commercial Pack | 1 blister pack of thirty 300 IR tablets | NDC 59617-0015-2 |
Storage: Store at controlled room temperature (20°C-25°C/68°F-77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.
