Oralair

HIGHLIGHTS OF PRESCRIBING INFORMATION

SPL UNCLASSIFIED SECTION

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

SPL INDEXING DATA ELEMENTS SECTION

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.

BOXED WARNING SECTION

BOXED WARNING SECTION

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

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

For sublingual use only.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

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

CONTRAINDICATIONS SECTION

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

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

11 DESCRIPTION

DESCRIPTION SECTION

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

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

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. Table 4. Daily Combined Score (CS), Daily Rhinoconjunctivitis Total Symptom Score (RTSS), and Daily Rescue Medication Score (RMS) during the Grass Pollen Period (US study) 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. Table 5. Daily Combined Score (CS), Daily Rhinoconjunctivitis Total Symptom Score (RTSS), and Daily Rescue Medication Score (RMS) during the Grass Pollen Period (European study) 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. Table 6. Analysis of Daily Combined Score for Each Grass Pollen Period (Long Term study) 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. Table 7. Daily Combined Score (CS), Daily Rhinoconjunctivitis Total Symptom Score (RTSS), Daily Rescue Medication Score (RMS) during the Grass Pollen Period (Pediatric study) 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. Table 8. Average Rhinoconjunctivitis Total Symptom Score (RTSS) during Grass Pollen Allergen Challenge in an Environmental Exposure Chamber after 4 months of ORALAIR or placebo 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

HOW SUPPLIED SECTION

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.

17 PATIENT COUNSELING INFORMATION

PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Keep ORALAIR out of the reach of children. Inform patients that ORALAIR is used for sublingual immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis and is not indicated for the immediate relief of allergy symptoms. Severe Allergic Reactions Advise patients that ORALAIR may cause systemic allergic reactions, including anaphylactic reactions, and severe local allergic reactions [ See Warnings and Precautions (5.1) ]. Educate patients about the signs and symptoms of a severe systemic allergic reaction and a severe local allergic reaction. The signs and symptoms of a severe allergic reaction may include: syncope, dizziness, hypotension, tachycardia, dyspnea, wheezing, bronchospasm, chest discomfort, cough, abdominal pain, vomiting, diarrhea, rash, pruritus, flushing, and urticaria [ See Warnings and Precautions (5.2) ]. Ensure that patients have injectable epinephrine available and are appropriately trained in its use. Instruct patients who experience a severe allergic reaction to seek immediate medical care, discontinue therapy, and resume treatment only at the instruction of a physician [ See Warnings and Precautions (5.2) ]. Inform the patient that the first dose of ORALAIR is administered in a healthcare setting under the supervision of a physician and s/he will be monitored for at least 30 minutes to watch for signs and symptoms of a severe systemic or a severe local allergic reaction [ See Dosage and Administration (2.2) ]. Inform parents/guardians that ORALAIR should be administered to children only under adult supervision [ See Dosage and Administration (2.2) ]. Because of the risk of eosinophilic esophagitis, instruct patients with severe or persistent symptoms of esophagitis to discontinue ORALAIR and to contact their healthcare professional. [ See Warnings and Precautions (5.3) ] Asthma Instruct patients with asthma that if they have difficulty breathing or if asthma becomes difficult to control, they are to stop taking ORALAIR and contact their healthcare professional immediately [ See Warnings AND Precautions (5.3) ]. Administration Instructions Instruct patients to carefully remove the ORALAIR tablet from the blister just prior to dosing and to take the sublingual tablet immediately by placing it under the tongue where it will dissolve. Also instruct patients to avoid swallowing for about 1 minute, to wash their hands after handling the tablet, and to avoid food or beverages for 5 minutes after taking the tablet [ See Dosage and Administration (2.2) ].

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

ORALAIR ® is a registered trademark of Stallergenes SAS Manufactured by: Stallergenes SAS Antony, 92183, France U.S. License # 1893 Distributed by: GREER Laboratories, Inc. Lenoir, N.C. 28645

MEDICATION GUIDE

SPL MEDGUIDE SECTION

ORALAIR ® (OR-AL-AIR): (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Carefully read this Medication Guide before you or your child start taking ORALAIR and each time you get a refill. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about ORALAIR. What is the Most Important Information I Should Know about ORALAIR? ORALAIR can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to ORALAIR include: Trouble breathing Throat tightness or swelling Trouble swallowing or speaking Dizziness or fainting Rapid or weak heartbeat Severe stomach cramps or pain, vomiting, or diarrhea Severe flushing or itching of the skin If any of these symptoms occur, stop taking ORALAIR and immediately seek medical care. For home administration of ORALAIR, your doctor should prescribe auto-injectable epinephrine for you to keep at home for treating a severe reaction, should one occur. Your doctor will train and instruct you on the proper use of auto-injectable epinephrine. What is ORALAIR ORALAIR is a prescription medicine used for sublingual (under the tongue) immunotherapy prescribed to treat sneezing, runny or itchy nose, nasal congestion or itchy and watery eyes due to allergy to these grass pollens. ORALAIR may be prescribed for persons 5 to 65 years of age whose doctor has confirmed are allergic to any of the grass pollens contained in ORALAIR. ORALAIR is taken for about four months before the expected start of the grass pollen season and is continued throughout the grass pollen season. ORALAIR is NOT a medication that gives immediate relief of allergy symptoms. Who Should Not Take ORALAIR You or your child should not take ORALAIR if: You or your child has severe, unstable, or uncontrolled asthma You or your child had a severe allergic reaction in the past that included any of these symptoms: Trouble breathing Dizziness or fainting Rapid or weak heartbeat You or your child has ever had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before. You or your child has ever been diagnosed with eosinophilic esophagitis. You or your child is allergic to any of the inactive ingredients contained in ORALAIR The inactive ingredients contained in ORALAIR are: mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and lactose monohydrate What Should I Tell My Doctor Before Taking ORALAIR Your doctor may decide that ORALAIR is not the best course of therapy if: You or your child has asthma, depending on how severe it is You or your child suffers from lung disease such as chronic obstructive pulmonary disease (COPD) You or your child suffers from heart disease such as coronary artery disease, an irregular heart rhythm, or you have hypertension that is not well controlled. You or your daughter is pregnant, plans to become pregnant during the time you will be taking ORALAIR, or is breast-feeding. You or your child is unable or unwilling to administer auto-injectable epinephrine to treat a severe allergic reaction to ORALAIR You or your child is taking certain medicines that enhance the likelihood of a severe reaction, or interfere with the treatment of a severe reaction. These medicines include: beta blockers and alpha-blockers (prescribed for high blood pressure) cardiac glycosides (prescribed for heart failure or problems with heart rhythm) diuretics (prescribed for heart conditions and high blood pressure) ergot alkaloids (prescribed for migraine headache) monoamine oxidase inhibitors or tricyclic antidepressants (prescribed for depression) thyroid hormone (prescribed for low thyroid activity); You should tell your doctor if you or your child is taking or has recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of ORALAIR. Ask your doctor or pharmacist for advice before taking ORALAIR. Are there any reasons to stop taking ORALAIR? Stop ORALAIR and contact your doctor if you or your child: has any type of a serious allergic reaction develops throat tightness or swelling of the tongue or throat that causes trouble speaking, breathing or swallowing after taking ORALAIR has trouble breathing or asthma or another breathing condition that gets worse experiences dizziness or fainting develops rapid or weak heartbeat experiences severe stomach cramps or pain, vomiting, or diarrhea develops severe flushing or itching of the skin has heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens has any mouth surgery procedures (such as tooth removal), develops any mouth infections, ulcers or cuts in the mouth or throat How should I take ORALAIR? Take ORALAIR exactly as your doctor tells you. ORALAIR is a prescription medicine that is placed under the tongue. 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. Do not take ORALAIR with food or beverage. Food and beverage should not be taken for the following 5 minutes. Wash hands after handling the tablet. Take the first tablet of ORALAIR in your doctor's office. After taking the first tablet, you or your child will be observed for at least 30 minutes for symptoms of a serious allergic reaction. The first dose for children will be one 100 IR tablet. The first dose for adults will be one 300 IR tablet. If you or your child tolerates the first dose of ORALAIR, you or your child will continue daily ORALAIR therapy at home. The first dose at home for children is two 100 IR tablets. The first dose at home for adults is one 300 IR tablet. After the first dose at home, the dose for children and adults is one 300 IR tablet each day. Children should be given each dose of ORALAIR by an adult who will watch for any symptoms of a serious allergic reaction. Take ORALAIR as prescribed by your doctor until the end of the treatment course. If you forget to take ORALAIR, do not take a double dose. Take the next dose at your normal scheduled time the next day. If you don't take ORALAIR for more than one day, contact your health provider before restarting. What are the possible side effects of ORALAIR? In children and adults, the most commonly reported side effects were itching of the mouth, lips, tongue or throat. These side effects, by themselves, are not dangerous or life-threatening. ORALAIR can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to ORALAIR include: Trouble breathing Throat tightness or swelling Trouble swallowing or speaking Dizziness or fainting Rapid or weak heartbeat Severe stomach cramps or pain, vomiting, or diarrhea Severe flushing or itching of the skin For additional information on the possible side effects of ORALAIR, talk with your doctor or pharmacist. You may report side effects to the US Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch. How should I store ORALAIR? Keep ORALAIR out of the reach of children. Throw away any unused ORALAIR after the expiration date which is stated on the carton and blister pack after "EXP." Store ORALAIR in a dry place at room temperature, 20°C to 25°C (68°F to 77°F), in the original package. General information about ORALAIR Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ORALAIR for a condition for which it was not prescribed. Do not give ORALAIR to other people, even if they have the same symptoms. It may harm them. This Medication Guide summarizes the most important ...

PRINCIPAL DISPLAY PANEL - CHILDREN KIT CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

O ralair ® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet For Sublingual Use For persons 5 to 17 years of age Manufactured by: Stallergenes SAS 92183 Antony France US License # 1893 STALLERGENES Distributed by: GREER Laboratories, Inc. Lenoir, NC 28645 GREER ® 1 box of 3 tablets of 100 IR 2 boxes of 3 tablets of 300 IR NDC 59617-0020-1 Children and Adolescents Sample Kit Dispense the enclosed Medication Guide to the patient. Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Store in original package. USUAL DOSE: See accompanying circular. INACTIVE INGREDIENTS: Mannitol, Microcrystalline cellulose, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate, Lactose monohydrate. No preservatives. Keep out of the reach of children Rx only Sample – Not for Sale 41000

PRINCIPAL DISPLAY PANEL - ADULT KIT CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oralair ® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet For Sublingual Use For persons 18 to 65 years of age Manufactured by: Stallergenes SAS 92183 Antony France US License # 1893 STALLERGENES Distributed by: GREER Laboratories, Inc. Lenoir, NC 28645 GREER ® 3 boxes of 3 tablets of 300 IR NDC 59617-0025-1 Adult Sample Kit Dispense the enclosed Medication Guide to the patient. Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Store in original package. USUAL DOSE: See accompanying circular. INACTIVE INGREDIENTS: Mannitol, Microcrystalline cellulose, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate, Lactose monohydrate. No preservatives. Keep out of the reach of children Rx only Sample – Not for Sale 41004

PRINCIPAL DISPLAY PANEL - 300 IR 30 TABLET BLISTER PACK BOX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oralair ® 300 IR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet For Sublingual Use For Persons 5 to 65 years of age Manufactured by: Stallergenes SAS 92183 Antony France US License # 1893 STALLERGENES Distributed by: GREER Laboratories, Inc. Lenoir, NC 28645 GREER ® 1 blister of 30 tablets of 300 IR NDC 59617-0015-2 Dispense the enclosed Medication Guide to the patient Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Store in original package. USUAL DOSE: See accompanying circular. INACTIVE INGREDIENTS: Mannitol, Microcrystalline cellulose, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate, Lactose monohydrate. No preservatives. Keep out of the reach of children Rx only

PRINCIPAL DISPLAY PANEL - 300 IR 3 TABLET BLISTER PACK BOX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oralair ® 300 IR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet For Sublingual Use For Persons 18 to 65 years of age Manufactured by: Stallergenes SAS 92183 Antony France US License # 1893 STALLERGENES Distributed by: GREER Laboratories, Inc. Lenoir, NC 28645 GREER ® 1 blister of 3 tablets of 300 IR NDC 59617-0016-1 Adult Starter Pack Dispense the enclosed Medication Guide to the patient Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Store in original package. USUAL DOSE: See accompanying circular. INACTIVE INGREDIENTS: Mannitol, Microcrystalline cellulose, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate, Lactose monohydrate. No preservatives. Keep out of the reach of children Rx only Sample – Not for Sale

PRINCIPAL DISPLAY PANEL - 100 IR 3 TABLET BLISTER PACK BOX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oralair ® 100 IR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet For Sublingual Use For Persons 5 to 17 years of age Manufactured by: Stallergenes SAS 92183 Antony France US License # 1893 STALLERGENES Distributed by: GREER Laboratories, Inc. Lenoir, NC 28645 GREER ® 1 blister of 3 tablets of 100 IR NDC 59617-0010-1 Children and Adolescents Starter Pack Dispense the enclosed Medication Guide to the patient Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Store in original package. USUAL DOSE: See accompanying circular. INACTIVE INGREDIENTS: Mannitol, Microcrystalline cellulose, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate, Lactose monohydrate. No preservatives. Keep out of the reach of children Rx only Sample – Not for Sale