Grass Pollen Allergen Extract (5 Grass Extract)

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Itching in the ear, mouth, or tongue.
• Cough.
• Throat pain.
• Throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store in the original container at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Sublingual [preservative free]:

Oralair: 300 IR (30s)

Oralair Adult Sample Kit: 300 IR (9s)

Oralair Childrens and Adolescents Sample Kit: 100 IR (3s) & 300 IR (6s)

Store between 20°C and 25°C (68°F and 77°F); excursions are permitted between15°C and 30°C (59°F and 86°F). Protect from moisture.

Grass pollen allergen extract can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer to patients with severe, unstable, or uncontrolled asthma. Observe patients in the office for at least 30 minutes following the initial dose. Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. Grass pollen allergen extract may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. Grass pollen allergen extract may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

Concerns related to adverse effects:

• Eosinophilic esophagitis: Eosinophilic esophagitis has been reported with use. Discontinue therapy in patients who experience severe or persistent gastroesophageal symptoms (including dysphagia or chest pain) and consider a diagnosis of eosinophilic esophagitis.

• Hypersensitivity reactions: [US Boxed Warning]: Severe, life-threatening allergic reactions, including anaphylaxis and severe laryngopharyngeal restrictions, may occur. Discontinue use if systemic allergic reactions occur. Re-evaluate patients with escalating or persistent local reactions; consider discontinuation. Increased risk of local or systemic adverse reactions may occur when given with concomitant allergen immunotherapy; the initiation of therapy during grass pollen season may increase the risk of adverse reactions.

Disease-related concerns:

• Respiratory disease: [US Boxed Warning]: Do not administer to patients with severe, unstable, or uncontrolled asthma; use has not been studied in patients with moderate or severe asthma or in patients requiring daily medication. Withhold treatment if patient is experiencing an acute asthma exacerbation. Re-evaluate patients with recurrent asthma exacerbations and consider discontinuation.

Concurrent drug therapy issues:

• Vaccines: Effect of vaccination during therapy has not been evaluated.

Dosage form specific issues:

• Lactose: May contain lactose.

Other warnings/precautions:

• Administration: [US Boxed Warning]: Auto-injectable epinephrine should be prescribed to patients; instruct patients on appropriate use and to obtain immediate medical care upon its use.

• Appropriate patient selection: [US Boxed Warning]: Use may not be suitable for patients with conditions that may reduce their ability to survive a serious allergic reaction, including but not limited to compromised lung function (either chronic or acute) and cardiovascular conditions (eg, unstable angina, recent MI, arrhythmia, and uncontrolled hypertension).

• Appropriate use: [US Boxed Warning]: Use may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators due to concomitant drug therapy. The effect of epinephrine may be potentiated or inhibited by the following medications: beta blockers, alpha blockers, ergot alkaloids, tricyclic antidepressants, levothyroxine, monoamine oxidase inhibitors, antihistamines, cardiac glycosides, and diuretics.

• Monitoring: [US Boxed Warning]: Monitor all patients for at least 30 minutes after initial dose in a health care setting. Each subsequent dose in pediatric patients should be done under direct adult supervision.

• Oral inflammation/wounds: Discontinue therapy to allow for complete healing of the oral cavity due to oral inflammation (eg, oral lichen planus, mouth ulcers, or thrush) or oral wounds following oral surgery or dental extraction.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience ear, mouth, or throat irritation. Have patient report immediately to prescriber dysphagia, difficulty speaking, heartburn, angina, tachycardia, passing out, dizziness, flushing, shortness of breath, cough that will not go away, severe diarrhea, severe nausea, vomiting, abdominal cramps, or severe abdominal pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Applies to mixed grass pollens allergen extract: sublingual tablet

General

The most common side effects reported were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, oropharyngeal pain.[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reaction, oral allergy syndrome, angioedema[Ref]

Respiratory

Very common (10% or more): Throat irritation (22%)
Common (1% to 10%): Cough, oropharyngeal pain, pharyngeal edema, tonsillitis, upper respiratory tract infection, asthma, dysphonia
Postmarketing reports: Dyspnea, laryngeal edema, stridor, wheezing, exacerbation of asthma, oropharyngeal blistering[Ref]

Cardiovascular

Postmarketing reports: Flushing, eosinophilic myocarditis, palpitations, tachycardia, hypotension, circulatory collapse, pallor, peripheral vascular disorder, chest discomfort[Ref]

Dermatologic

Common (1% to 10%): Urticaria, atopic dermatitis
Postmarketing reports: Rash, pruritus[Ref]

Endocrine

Postmarketing reports: Autoimmune thyroiditis[Ref]

Gastrointestinal

Very common (10% or more): Oral pruritus (25.1%)
Common (1% to 10%): Mouth edema, tongue pruritus, lip edema, oral paresthesia, abdominal pain, dyspepsia, tongue edema, oral hypoesthesia, stomatitis, dysphagia, nausea, vomiting, esophageal pain, gastritis, gastroesophageal reflux, lip pruritus
Postmarketing reports: Diarrhea, eosinophilic esophagitis, salivary gland enlargement and/or hypersecretion, dry mouth, dry eye[Ref]

Hematologic

Postmarketing reports: Lymphoadenopathy, increased eosinophilic count[Ref]

Metabolic

Postmarketing reports: Decreased weight[Ref]

Nervous system

Postmarketing reports: Loss of consciousness, headache, somnolence, dizziness[Ref]

Other

Common (1% to 10%): Ear pruritus
Postmarketing reports: Malaise, face edema, tinnitus, asthenia, influenza-like illness[Ref]

Psychiatric

Postmarketing reports: Anxiety[Ref]

Some side effects of mixed grass pollens allergen extract may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Initial Dose: 100 IR (index of reactivity) sublingually on Day 1 followed by 200 IR sublingually on Day 2.
Maintenance Dose: 300 IR sublingually once a day starting on Day 3

Comments:
-For sublingual use only
-For children and adolescents 10 to 17 years of age
-Administer mixed grass allergen to children under adult supervision.
-Initiate treatment 4 months before the expected onset of each grass pollen season and continue treatment throughout the season.
-The risk of mixed grass allergen may be increased when treatment is initiated during the grass pollen season.

Use: 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 following five grass species: 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).