Grastek

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)].

8.1        Pregnancy

        Risk Summary

        All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Available human data do not establish the presence or absence of GRASTEK-associated risks during pregnancy. 

        In two reproductive and developmental toxicity studies mice were administered Timothy grass pollen extract daily by buccal cavity at doses approximately 6.7 times the human sublingual dose. In one study doses were administered during gestation and lactation. In the other study doses were administered prior to mating and during gestation. These studies revealed no evidence of harm to the mother or the fetus due to GRASTEK (see 8.1 Data).

        Data

        Animal Data 

        A pre- and postnatal developmental study and a combined fertility/developmental toxicity study were conducted in mice. In these studies, the effect of Timothy grass (Phleum pratense) pollen allergen extract, the active component of GRASTEK, on embryo-fetal development was evaluated. In the pre- and postnatal developmental toxicity study female mice were administered Timothy grass pollen allergen extract by buccal cavity daily from day 6 of gestation to day 17 of lactation at doses approximately 6.7 times the human sublingual dose. In the combined fertility/developmental toxicity study, female mice were administered Timothy grass pollen allergen extract daily by buccal cavity administration from 14 days prior to mating and until day 15 of the gestation period (male animals were administered the same dose daily for 4 weeks before pairing and during pairing) at doses approximately 6.7 times the human sublingual dose. Fertility was normal and there were no treatment-related post-implementation losses, fetal malformations or variations.

8.2        Lactation

        Risk Summary

        It is not known if GRASTEK is excreted in human milk. Data are not available to assess the effect of GRASTEK on milk production or on the breast-fed child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GRASTEK and any potential adverse effects on the breast-fed child from GRASTEK or from the underlying maternal condition. 

8.4        Pediatric Use

        Efficacy and safety of GRASTEK have been established in children and adolescents 5 through 17 years of age. The safety and efficacy in pediatric patients below 5 years of age have not been established.

8.5        Geriatric Use

        There is no clinical trial experience with GRASTEK in patients over 65 years of age.