Dosage & Administration
For sublingual use only.
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Ragwitek Prescribing Information
● RAGWITEK can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. ( 5.1)
● Do not administer RAGWITEK 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 or parents/guardians on its appropriate use, and instruct patients or parents/guardians to seek immediate medical care upon its use. ( 5.2)
● RAGWITEK may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. ( 5.2)
● RAGWITEK may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. ( 5.2)
RAGWITEK® is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. RAGWITEK is approved for use in persons 5 through 65 years of age.
RAGWITEK is not indicated for the immediate relief of allergic symptoms.
For sublingual use only.
2.1 Dose
One RAGWITEK tablet daily.
2.2 Administration
Administer the first dose of RAGWITEK 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 RAGWITEK, 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.
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 ragweed pollen season and continue treatment throughout the season. 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 RAGWITEK are limited. In the clinical trials, treatment interruptions for up to seven days were allowed.
Prescribe auto-injectable epinephrine to patients prescribed RAGWITEK and instruct them (or their parents/guardians) in the proper use of auto-injectable epinephrine [see Warnings and Precautions ( 5.2)].
RAGWITEK is available as 12 Amb a 1-Unit (Amb a 1-U) tablets that are white to off-white, circular with a debossed double hexagon on one side.
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 RAGWITEK-associated risks during pregnancy.
In an embryo/fetal developmental toxicity study, RAGWITEK subcutaneously administered to mice during gestation at doses up to approximately 3 times the human sublingual dose did not reveal adverse developmental outcomes in fetuses (see 8.1 Data).
Data
Animal Data
In a developmental toxicity study, the effect of RAGWITEK on embryo/fetal development was evaluated in mice. Animals were administered RAGWITEK subcutaneously daily from day 6 to day 15 of the gestation period at doses approximately 1 to 3 times the human sublingual dose of 12 Amb a 1-U. There were no RAGWITEK-related post-implantation losses, fetal malformations or variations.
8.2 Lactation
Risk Summary
It is not known whether RAGWITEK is excreted in human milk. Data are not available to assess the effects of RAGWITEK on the breastfed child or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RAGWITEK and any potential adverse effects on the breastfed child from RAGWITEK or from the underlying maternal condition.
8.4 Pediatric Use
Efficacy and safety of RAGWITEK have been established in children and adolescents 5 through 17 years of age. The efficacy and safety in pediatric patients below 5 years of age have not been established.
8.5 Geriatric Use
RAGWITEK is not approved for use in patients over 65 years of age because safety and efficacy have not been established.
RAGWITEK is contraindicated in patients with:
- Severe, unstable or uncontrolled asthma
- A history of any severe systemic allergic reaction
- A history of any severe local reaction after taking any sublingual allergen immunotherapy
- A history of eosinophilic esophagitis
- Hypersensitivity to any of the inactive ingredients [gelatin, mannitol, and sodium hydroxide] contained in this product [see Description ( 11)].