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. mixed grass pollens allergen extract 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 mixed grass pollens allergen extract 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.

Your doctor may perform an allergy skin test or blood test to make sure you are allergic to the specific pollen contained in mixed grass pollens allergen extract.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may want to give your first dose of this medicine in a clinic setting. You should be watched closely for at least 30 minutes after taking your first dose, to make sure you do not have an allergic reaction.

Mixed grass pollens allergen extract is a sublingual tablet that dissolves under your tongue. Do not chew this tablet or swallow it whole.

To take the sublingual tablet:

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil.

• Use dry hands to remove the tablet and place it in your mouth.

• Place the sublingual tablet under your tongue and allow it to dissolve completely.

• Do not swallow for at least 1 minute. Do not eat or drink anything for at least 5 minutes.

Wash your hands after handling the sublingual tablet.

A child using mixed grass pollens allergen extract should be supervised by an adult while taking this medicine.

Mixed grass pollens allergen extract is usually taken once daily throughout allergy season. For best results, start taking this medicine at least 4 months before the start of allergy season.

In some cases, you may need to take mixed grass pollens allergen extract every day all year long, for up to 3 years. Follow your doctor's dosing instructions very carefully.

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.

If you need oral surgery or dental work, or if you have a mouth injury or infection, you may need to stop using this medicine until your mouth heals. Tell your doctor if the sublingual tablets cause any mouth irritation.

Store tablets in the blister pack at room temperature, away from moisture and heat.

Usual Adult Dose for Allergic Rhinitis:

300 IR (index of reactivity) sublingually once a day

Comments:
-For sublingual use only
-For adults 18 to 65 years of age
-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).

Usual Pediatric Dose for Allergic Rhinitis:

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).

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.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Mixed grass pollens allergen extract may cause a severe allergic reaction. Stop taking the medicine and get emergency medical help if you have any of these signs of an allergic reaction:

• severe dizziness or a light-headed feeling (like you might pass out);

• fast heart rate;

• stomach pain, vomiting, diarrhea;

• hives, itching, flushing (warmth, redness, or tingly feeling);

• cough, chest tightness, wheezing, trouble breathing; or

• swelling of your face, lips, tongue, or throat.

If you stop taking mixed grass pollens allergen extract after having an allergic reaction, do not start taking the medicine again without your doctor's advice.

Mixed grass pollens allergen extract may cause serious side effects. Call your doctor at once if you have:

• severe mouth or throat irritation;

• breathing problems; or

• choking feeling, chest pain, trouble swallowing.

Common side effects of mixed grass pollens allergen extract may include:

• pain, swelling, or itching of your mouth or tongue;

• throat irritation;

• cough, sore throat, sinus pain; or

• itching in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.