Brand Names:

• Grastek

Dosage Forms:

• Tablet

Warnings:

Timothy Grass Pollen Allergen Extract can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer Timothy Grass Pollen Allergen Extract 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. Timothy 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, or in patients who may be unresponsive to epinephrine or inhaled bronchodilators (eg, those taking beta-blockers) .

Classifications:

Therapeutic—

Immunological Agent

Uses of This Medicine:

Grastek® is an allergen extract which is used as an immunotherapy to treat symptoms of grass pollen allergic rhinitis with or without conjunctivitis. This is confirmed by a positive skin test that is caused by timothy grass pollen allergen extract.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Grastek® in children 5 to 17 years of age. However, safety and efficacy have not been established in children younger than 5 years of age.

Older adults—

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

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.

Other 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.

Other interactions—

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 gelatin, mannitol, or sodium hydroxide or
• Asthma, severe, unstable, or uncontrolled or
• Eosinophilic esophagitis, history of or
• Sublingual allergen immunotherapy, history of or
• Systemic allergic reaction, severe, 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—Serious allergic reactions may be more difficult to treat 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.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Start taking Grastek® at least 3 months before the expected onset of each grass pollen season, and continue taking this medicine daily 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 do not have to take this medicine.

It is recommended to take the first dose of Grastek® in a clinic or hospital. This is to monitor you or your child for at least 30 minutes of any signs or symptoms of a severe allergic reaction. If you can tolerate the first dose of Grastek®, then you may take the succeeding doses at home.

To use:

• Wash your hands before and after taking the tablet.
• With dry hands, remove the tablet from the blister pack if you are ready to take it.
• Place the tablet immediately under the tongue where it will dissolve for about 1 minute before swallowing.
• Do not eat or drink anything for 5 minutes after taking the tablet.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For sublingual dosage form (tablets):
  • For grass pollen rhinitis:
    • Adults and children 5 to 65 years of age—One tablet (2800 BAU (bioequivalent allergy units)) once a day.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

• If you forget to take more than one dose of this medicine, contact your doctor for instructions.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swelling on the skin, and puffiness or swelling of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Your doctor may recommend that you have an emergency injection for allergic reactions available during the time of year you take this medication. If this is the case, make sure that you know how to use it properly for yourself or your child in case of a serious allergic reaction.

This medicine may increase risk of eosinophilic esophagitis. Check with your doctor right away if you or your child have severe chest pain or trouble swallowing while taking this medicine.

If you or your child have trouble breathing or if your asthma becomes difficult to control, call your doctor immediately.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Itching of the ears, mouth, or tongue

numbness or tingling feeling around the mouth

sore throat

swelling of the mouth

Less common

Chest discomfort

difficult or labored breathing

difficulty swallowing

hives or welts, itching, or skin rash

redness, swelling, or soreness of the tongue or in the mouth

runny nose

swelling of the lips

tightness in the chest

Incidence not known

Cough

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast heartbeat

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

sweating

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acid or sour stomach

dry throat

headache

heartburn

nausea

Incidence not known

Diarrhea

drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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