Odactra

2.1        Dose

One ODACTRA tablet daily.

2.2        Administration

Administer the first dose of ODACTRA in a healthcare setting under the supervision of a healthcare professional with experience in the diagnosis and treatment of allergic diseases. After receiving the first dose of ODACTRA, 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. The patient should administer ODACTRA as follows:

• Take the tablet from the blister unit after carefully removing the foil with dry hands.
  
• Place the tablet immediately under the tongue where it will dissolve within 10 seconds. 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 5 minutes after taking the tablet.

Data regarding the safety of restarting treatment after missing a dose of ODACTRA are limited. In the clinical studies, treatment interruptions for up to seven days were allowed. Prescribe epinephrine to patients prescribed ODACTRA and instruct patients (or their parents/guardians) in the proper use of epinephrine [see Warnings and Precautions ( 5.1)].

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 data on ODACTRA administered to pregnant women are insufficient to inform associated risks in pregnancy.

In an embryo/fetal developmental toxicity study performed in mice, administration of ODACTRA during gestation did not reveal adverse developmental outcomes in fetuses [see Data ( 8.1)].

Data

Animal Data

In a developmental toxicity study, the effect of ODACTRA on embryo/fetal development was evaluated in mice. Animals were administered ODACTRA subcutaneously daily from day 6 to day 17 of the gestation period at doses up to 5 times the human sublingual dose. There were no ODACTRA-related post-implantation losses, fetal malformations or variations.

8.2        Lactation

Risk Summary

It is not known whether ODACTRA is excreted in human milk. Data are not available to assess the effects of ODACTRA on the breastfed child or on milk production and excretion in the nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ODACTRA and any potential adverse effects on the breastfed child from ODACTRA or from the underlying maternal condition.

8.4        Pediatric Use

The safety and effectiveness of ODACTRA have been established in individuals 5 through 17 years of age with HDM-induced allergic rhinitis, with or without conjunctivitis. [see Adverse Reactions ( 6.1) and Clinical Studies ( 14)].

The safety and effectiveness have not been established in individuals below 5 years of age.

8.5        Geriatric Use

Safety and effectiveness have not been established in individuals older than 65 years of age.