Timothy grass pollen allergen extract (Under the tongue)

Grastek

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Start taking Grastek® at least 3 months before the expected onset of grass pollen season and continue taking it throughout the pollen season. It may also be taken daily for 3 years to provide a sustained effect for a fourth year in which you will not need the medicine.
• Wash your hands before and after you take the tablet.
• With dry hands, remove the tablet from the blister pack and place it under your tongue. Let it dissolve for about 1 minute before you swallow it. Do not eat or drink anything for 5 minutes after you swallow the tablet.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss one dose of this medicine, skip it and take the next dose at your normal scheduled time the next day. Do not take extra medicine to make up for a missed dose. If you miss more than one dose, contact your doctor, nurse, or pharmacist for instructions.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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

Timothy Grass Pollen Allergen Extract

Treats grass pollen allergic rhinitis.

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain or trouble swallowing
• Fast, pounding, or weak heartbeat
• Lightheadedness, dizziness, or fainting

If you notice these less serious side effects, talk with your doctor:

• Itchy ears, mouth, or tongue
• Sore throat

• Tell your doctor if you are pregnant or breastfeeding, or if you have breathing or lung problems (such as COPD), heart rhythm problems, high blood pressure, severe chest pain, or you had a recent heart attack. Tell your doctor if you have mouth ulcers, oral thrush, or recently had oral surgery or dental extraction.
• Call your doctor right away if you have trouble breathing or if your asthma becomes difficult to control.
• Ask your doctor if you should keep an emergency injection with you in case of a severe allergic reaction. If you have a severe allergic reaction, seek medical care right away and stop using this medicine.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.