Grass Pollen Allergen Extract (Timothy Grass)

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Itching in the ear, mouth, or tongue.
• Numbness or tingling in the mouth.
• Throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Grastek

Grass pollen-induced allergic rhinitis: Immunotherapy for the 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 timothy grass or cross-reactive grass pollens in patients 5 through 65 years of age. Not indicated for the immediate relief of allergy symptoms.

There are no dosage adjustments provided in the manufacturer’s labeling.

There are no known significant interactions.

Grass pollen allergen extract can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer 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. 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. Grass pollen allergen extract may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

Signs/symptoms of hypersensitivity; monitor patients for at least 30 minutes after administration of first dose.

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 timothy grass pollen allergen extract may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available