Oralair

Mixed grass pollens allergen extract is made from certain pollens that can cause seasonal allergies (hay fever).

Mixed grass pollens allergen extract is used to help your body develop an immunity to certain pollens that can cause allergy symptoms such as sneezing, itching, and watery eyes. This medicine is for use in adults up to age 65, and children who are at least 10 years old.

This medicine will not provide immediate relief from allergy symptoms.

Mixed grass pollens allergen extract may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have uncontrolled asthma, or if you have a history of allergic reaction to a pollen-extract medicine, or allergic reaction that affected your esophagus.

You may not be able to use mixed grass pollens allergen extract if you have certain medical conditions, such as breathing problems, heart disease, or high blood pressure. This medicine also may not be safe for you if you take certain medicines.

Mixed grass pollens allergen extract may cause a severe allergic reaction. Your doctor will give you the first dose and watch you closely to make sure you do not have a reaction.

Your doctor may also prescribe epinephrine (Epi-Pen) to keep with you in case you ever have an allergic reaction to mixed grass pollens allergen extract.

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction: severe dizziness, feeling like you might pass out; fast heart rate, cough, chest tightness, wheezing, trouble breathing; stomach pain, vomiting, diarrhea; hives, itching, flushing (warmth, redness, or tingly feeling); swelling of your face, lips, tongue, or throat.

You should not use mixed grass pollens allergen extract if you have ever had an allergic reaction to similar pollen-extract medicines, or if you have:

• severe or uncontrolled asthma; or
• a history of allergic reaction that affected your esophagus (the tube that connects your mouth and stomach) and caused heartburn or trouble swallowing.

To make sure mixed grass pollens allergen extract is safe for you, tell your doctor if you have:

• breathing problems;
• heart disease;
• uncontrolled high blood pressure;
• mouth sores, swollen gums, or other wounds or irritations inside your mouth;
• if you take an antidepressant or migraine headache medicine; or
• if you take medicine to treat heart problems, high blood pressure, or a prostate disorder.

FDA pregnancy category B. Mixed grass pollens allergen extract is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether mixed grass pollens allergen extract passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Mixed grass pollens allergen extract should not be given to a child younger than 10 years old.

This medicine is not for use in people older than 65.

Ask your doctor before starting any new medicine or treatments, including allergy shots.

Other drugs may interact with mixed grass pollens allergen extract, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Included as part of the PRECAUTIONS section.

Serious side effects have been reported with Oralair. See the “Oralair Precautions” section.

Common side effects of Oralair include the following:

• Oral pruritus
• Throat irritation
• Ear pruritus
• Mild to moderate local allergic reactions (i.e. oral swelling or discomfort)

This is not a complete list of Oralair side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

If you take too much Oralair, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Mixed grass pollens allergen extract is made from certain pollens that can cause seasonal allergies (hay fever).

Mixed grass pollens allergen extract is used to help your body develop an immunity to certain pollens that can cause allergy symptoms such as sneezing, itching, and watery eyes. This medicine is for use in adults up to age 65, and children who are at least 10 years old.

This medicine will not provide immediate relief from allergy symptoms.

Mixed grass pollens allergen extract may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have uncontrolled asthma, or if you have a history of allergic reaction to a pollen-extract medicine, or allergic reaction that affected your esophagus.

You may not be able to use mixed grass pollens allergen extract if you have certain medical conditions, such as breathing problems, heart disease, or high blood pressure. This medicine also may not be safe for you if you take certain medicines.

Mixed grass pollens allergen extract may cause a severe allergic reaction. Your doctor will give you the first dose and watch you closely to make sure you do not have a reaction.

Your doctor may also prescribe epinephrine (Epi-Pen) to keep with you in case you ever have an allergic reaction to mixed grass pollens allergen extract.

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction: severe dizziness, feeling like you might pass out; fast heart rate, cough, chest tightness, wheezing, trouble breathing; stomach pain, vomiting, diarrhea; hives, itching, flushing (warmth, redness, or tingly feeling); swelling of your face, lips, tongue, or throat.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Oralair® in children 10 to 17 years of age. However, safety and efficacy have not been established in children younger than 10 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Oralair® in the elderly. However, safety and efficacy have not been established in elderly patients older than 65 years of age.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, or lactose monohydrate or
• Asthma, severe, unstable, or uncontrolled or
• Eosinophilic esophagitis (inflammation of the esophagus), history of or
• Severe reaction to sublingual allergen immunotherapy, history of or
• Systemic allergic reaction, history of—Should not be used in patients with these conditions.

• Angina (severe chest pain), unstable or
• Arrhythmia (heart rhythm problem) or
• Breathing or lung problems (eg, COPD) or
• Heart attack, recent or
• Hypertension (high blood pressure), uncontrolled—It is not known if this medicine will work in patients with these conditions.

• Dental extraction or
• Mouth ulcers or thrush or
• Oral surgery—These conditions should be allowed to healed first before taking this medicine.

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 Oralair may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.