Oralair: Package Insert and Label Information

ORALAIR- anthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen
ORALAIR 100 IR- poa pratensis pollen, dactylis glomerata pollen, anthoxanthum odoratum pollen, lolium perenne pollen and phleum pratense pollen tablet, orally disintegrating
ORALAIR 300 IR- dactylis glomerata pollen, anthoxanthum odoratum pollen, lolium perenne pollen, phleum pratense pollen and poa pratensis pollen tablet, orally disintegrating
ORALAIR 300 IR- poa pratensis pollen, dactylis glomerata pollen, anthoxanthum odoratum pollen, lolium perenne pollen and phleum pratense pollen tablet, orally disintegrating
Stallergenes

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ORALAIR safely and effectively. See full prescribing information for ORALAIR.

ORALAIR ® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract)

Tablet for Sublingual Use

Initial U.S. Approval: 2014

WARNING: SEVERE ALLERGIC REACTIONS See full prescribing information for complete boxed warning

  • ORALAIR can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal edema. (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)

RECENT MAJOR CHANGES

Indications and Usage (1) 11/2018
Dosage and Administration (2.1) 11/2018

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.

DOSAGE AND ADMINISTRATION

For sublingual use only.

Age (years) Dose
Day 1 Day 2 Day 3 and following
5-17 100 IR 2× 100 IR 300 IR
18-65 300 IR 300 IR 300 IR
  • Initiate treatment 4 months before the expected onset of each grass pollen season and continue treatment throughout the season. (2.2)
  • Place the tablet under the tongue for at least 1 minute, until complete dissolution and then swallow. (2.2)
  • Administer the first dose of ORALAIR under the supervision of a physician with experience in the diagnosis and treatment of severe allergic reactions. Observe the patient for at least 30 minutes. (2.1)

DOSAGE FORMS AND STRENGTHS

  • Tablets, 100 IR and 300 IR (3)

CONTRAINDICATIONS

  • Severe, unstable or uncontrolled asthma (4)
  • History of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy (4)
  • A history of eosinophilic esophagitis (4)
  • Hypersensitivity to any of the inactive ingredients contained in this product (4)

WARNINGS AND PRECAUTIONS

  • Inform patients of the signs and symptoms of severe allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur. (5.1)
  • In case of oral inflammation or wounds, stop treatment with ORALAIR to allow complete healing of the oral cavity. (5.5)

ADVERSE REACTIONS

Adverse reactions reported in > 5% of patients were: oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, asthma, oropharyngeal pain, tonsillitis, and oral paresthesia (6)

To report SUSPECTED ADVERSE REACTIONS, contact Stallergenes at 1-855-274-1322 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

See 17 for Patient Counseling Information and FDA approved Medication Guide

TABLE OF CONTENTS

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SEVERE ALLERGIC REACTIONS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION
2.1 Dose
2.2 Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS
5.1 Severe Allergic Reactions
5.2 Epinephrine
5.3 Eosinophilic Esophagitis
5.4 Asthma
5.5 Concomitant Allergen Immunotherapy
5.6 Oral Inflammation
5.7 Initiation of ORALAIR Therapy during Grass Pollen Season

6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience

8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

* Sections or subsections omitted from the full prescribing information are not listed.

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.

Table 1. Dosage for Adults and Children for the Days 1-3 (and following)
Age (years) Dose
Day 1 Day 2 Day 3 and following
5-17 100 IR 2×100 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

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:

Βeta-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.

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 8.4% 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.

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 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.

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