Rx Item-Grastek 2800 Bau Sublingual Tab 3X10 Bp By Alk-Abello

GRASTEK- phleum pratense pollen tablet
Merck Sharp & Dohme Corp.

WARNING: SEVERE ALLERGIC REACTIONS

GRASTEK can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. (5.1)
Do not administer GRASTEK to patients with severe, unstable or uncontrolled asthma. (4)
Observe patients in the office for at least 30 minutes following the initial dose. (5.1)
Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. (5.2)
GRASTEK may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. (5.2)
GRASTEK may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. (5.2)
1 INDICATIONS AND USAGE



GRASTEK� is an allergen extract indicated as 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. GRASTEK is approved for use in persons 5 through 65 years of age.

GRASTEK is not indicated for the immediate relief of allergic symptoms.

2 DOSAGE AND ADMINISTRATION

For sublingual use only.

2.1 Dose
One GRASTEK tablet daily.

2.2 Administration
Administer the first dose of GRASTEK in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. After receiving the first dose of GRASTEK, observe the patient for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home.

Administer GRASTEK to children under adult supervision.
Take the tablet from the blister unit after carefully removing the foil with dry hands.
Place the tablet immediately under the tongue. Allow it to remain there 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 the following 5 minutes after taking the tablet.
Initiate treatment at least 12 weeks before the expected onset of each grass pollen season and continue treatment throughout the season. For sustained effectiveness for one grass pollen season after cessation of treatment, GRASTEK may be taken daily for three consecutive years (including the intervals between the grass pollen seasons). The safety and efficacy of initiating treatment in season have not been established.

Data regarding the safety of restarting treatment after missing a dose of GRASTEK are limited. In the clinical trials, treatment interruptions for up to seven days were allowed.

Prescribe auto-injectable epinephrine to patients prescribed GRASTEK and instruct them in the proper use of emergency self-injection of epinephrine [see Warnings and Precautions (5.2)].

3 DOSAGE FORMS AND STRENGTHS

GRASTEK is available as 2800 Bioequivalent Allergy Unit (BAU) tablets that are white to off-white, circular with a debossed round detail on one side.

RX ITEM-Grastek 2800 Bau Sublingual Tab
NDC 00006-4229-30 UPC/GTIN No.3-00064-22930-1 Mfg.Part No.422930

Grastek 2800 Bau Sublingual Tab 3X10 Bp
BRAND: GRASTEK TM NDC: 52709-1501-03,52709150103 UPC: 3-52709-15013-6,352709150136 Merck & Co.

GRASS POLLEN-TIMOTHY, STD
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