Usual Adult Dose for Allergic Rhinitis

1 tablet sublingually once a day

Comments:

• Treatment should be initiated at least 12 weeks before the expected onset of each grass pollen season and continued throughout the season.
• Each tablet contains 2800 bioequivalent allergy units (BAUs).
• For sustained effectiveness, consider daily use for 3 consecutive years.

Use: Treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific immunoglobulin E (IgE) antibodies for timothy grass or cross-reactive grass pollens.

Usual Pediatric Dose for Allergic Rhinitis

5 years or older: 1 tablet sublingually once a day

Comments:

• Treatment should be initiated at least 12 weeks before the expected onset of each grass pollen season and continued throughout the season.
• Each tablet contains 2800 BAUs.
• Administer to children under adult supervision.
• For sustained effectiveness, consider daily use for 3 consecutive years.

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 timothy grass or cross-reactive grass pollens.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• Timothy grass 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.
• May not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
• May not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

CONTRAINDICATIONS:

• Severe, unstable, or uncontrolled asthma
• History of any severe systemic allergic reaction
• History of any severe local reaction after taking any sublingual allergen immunotherapy
• History of eosinophilic esophagitis
• Hypersensitivity to any product ingredients

Safety and efficacy have not been established in patients younger than 5 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For sublingual use only
• Administer the first dose in a health care setting under the supervision of a physician with experience in the field.
• After receiving the first dose, observe the patient for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction.
• Administer to children under adult supervision.
• Allow the tablet to remain under the tongue until completely dissolved. Do not swallow for at least 1 minute.
• Wash hands after handling the tablet.
• Do not take the tablet with food or beverage. Food or beverage should not be taken for at least 5 minutes after taking the tablet.
• Prescribe auto-injectable epinephrine to patients and instruct them in the proper use of emergency self-injection of epinephrine.

Storage requirements:

• Protect from moisture.

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should be informed of the potential for serious hypersensitivity reactions and what to do if a reaction occurs.
• Patients with asthma should contact their health care provider immediately if their symptoms become difficult to control.