Grastek

Timothy grass pollen 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 timothy grass pollen allergen extract after having an allergic reaction, do not start taking the medicine again without your doctor's advice.

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 may include:

• swelling or itching of your mouth or tongue;
• throat irritation; 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.

Your doctor may perform an allergy skin test or blood test to make sure you are allergic to the specific pollen contained in this medicine.

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.

Timothy grass pollen 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 timothy grass pollen extract should be supervised by an adult while taking this medicine.

Timothy grass pollen allergen extract is usually taken once daily throughout allergy season. For best results, start taking this medicine at least 12 weeks before the start of allergy season.

In some cases, you may need to take timothy grass pollen 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 timothy grass pollen 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.

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

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.

Grass pollen extract is a prescription medication used to treat symptoms of moderate to severe seasonal grass pollen allergic rhinitis with or without conjunctivitis in patients 5 to 50 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

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.

Before taking grass pollen extract, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to grass pollen extract or to any of its ingredients
• have severe immune deficiency or an auto-immune disease

• are being treated with beta-blockers or ACE inhibitors
• have oral inflammations
• have cancer
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Take grass pollen extract exactly as prescribed.

Grass pollen extract comes in a sublingual tablet tablet form and is taken once a day, in the morning.

Take grass pollen extract on an empty stomach.

The tablet must be placed under the tongue and held there until it is completely dissolved (for at least 1 minute) and the dose is swallowed.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of grass pollen extract at the same time.

• It is recommended that the first tablet of grass pollen extract is taken under medical supervision and that the patient is monitored for 30 minutes.
• Treatment should be initiated about 4 months before the expected onset of the pollen season and must be maintained throughout the pollen season.
• Store at room temperature (15°C to 30°C).
• Store in the original package in order to protect from moisture. The tablet should remain in the sealed blister until use.
• Keep out of reach of children.

Your doctor may perform an allergy skin test or blood test to make sure you are allergic to the specific pollen contained in this medicine.

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.

Timothy grass pollen 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 timothy grass pollen extract should be supervised by an adult while taking this medicine.

Timothy grass pollen allergen extract is usually taken once daily throughout allergy season. For best results, start taking this medicine at least 12 weeks before the start of allergy season.

In some cases, you may need to take timothy grass pollen 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 timothy grass pollen 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.

Use Grastek as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Be sure your hands are dry before you touch this medicine.
• Do not take Grastek out of the blister pack until you are ready to take it. Take this medicine right away after opening the blister pack. Do not store the removed drug for future use.
• Place under tongue and let melt all the way. Do not chew, suck or swallow tablet.
• Do not swallow for at least 1 minute after putting Grastek in your mouth.
• Do not eat or drink while the tablet is melting or for 5 minutes after the tablet melts.
• Wash your hands after use.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you miss more than 1 day of taking this medicine, talk with your doctor.

Applies to timothy grass pollen allergen extract: sublingual tablet

General

The most common side effects were ear pruritus, oral pruritus, tongue pruritus, mouth edema, and throat irritation.[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Systemic allergic reactions (including anaphylaxis)
Postmarketing reports: Anaphylactic reaction, angioedema[Ref]

Respiratory

Very common (10% or more): Throat irritation (up to 22.6%)
Common (1% to 10%): Pharyngeal edema, dry throat, oropharyngeal pain, nasal discomfort, throat tightness, dyspnea, pharyngeal erythema, cough, nasal congestion, sneezing
Uncommon (0.1% to 1%): Rhinorrhea, dysphonia
Postmarketing reports: Asthma exacerbation, hoarseness, laryngitis, induced asthma exercise, decreased forced expiratory volume, hyperventilation, laryngeal discomfort, decreased oxygen saturation, decreased peak expiratory flow rate, pneumonia, respiratory distress, status asthmaticus, decreased vital capacity, wheezing[Ref]

Cardiovascular

Common (1% to 10%): Chest discomfort
Postmarketing reports: Chest pressure, increased heart rate, irregular heart rate, hypotension[Ref]

Dermatologic

Common (1% to 10%): Pruritus, urticaria
Postmarketing reports: Facial erythema, rash[Ref]

Gastrointestinal

Very common (10% or more): Oral pruritus ( up to 26.7%), Lip pruritus (up to 11.1%), mouth edema ( up to 11.1%)
Common (1% to 10%): Lip pruritus, oral paresthesia, tongue pruritus, lip swelling, swollen tongue, dyspepsia, oral hypoesthesia, nausea, oral discomfort, oral mucosal erythema, lip edema, glossitis, stomatitis, tongue disorder, tongue edema, glossodynia, dysphagia, palatal edema, glossodynia
Uncommon (0.1% to 1%): Abdominal pain, gastroesophageal reflux, mouth swelling, oral/pharyngeal itching
Postmarketing reports: Oral ulceration, ulcerative colitis exacerbation, diarrhea, eosinophilic esophagitis, oral pain, throat pruritus, vomiting[Ref]

Nervous system

Common (1% to 10%): Headache
Postmarketing reports: Altered state of consciousness, difficulty speaking, dizziness, drowsiness, tremor[Ref]

Other

Very common (10% or more): Ear pruritus (up to 12.5%)
Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Ear itching
Postmarketing reports: facial edema, sensation of foreign body, neck swelling[Ref]

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