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RAGWITEK™ (Short Ragweed Pollen Allergen Extract)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use RAGWITEK safely and effectively. See full prescribing information for RAGWITEK.
RAGWITEK™ (Short Ragweed Pollen Allergen Extract)
Tablet for Sublingual Use
Initial U.S. Approval: 2014
WARNING: SEVERE ALLERGIC REACTIONS
See full prescribing information for complete boxed warning.
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RAGWITEK can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. (5.1)
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Do not administer RAGWITEK to patients with severe, unstable or uncontrolled asthma. (4)
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Observe patients in the office for at least 30 minutes following the initial dose. (5.1)
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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)
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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)
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RAGWITEK may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. (5.2)
INDICATIONS AND USAGE
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 adults 18 through 65 years of age. (1)
DOSAGE AND ADMINISTRATION
For sublingual use only.
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One tablet daily. (2.1)
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Initiate treatment at least 12 weeks before the expected onset of ragweed pollen season and continue treatment throughout the season. (2.2)
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Place the tablet immediately under the tongue. Allow it to remain there until completely dissolved. Do not swallow for at least 1 minute. (2.2)
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Administer the first dose of RAGWITEK under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. Observe patients in the office for at least 30 minutes following the initial dose. (2.2)
DOSAGE FORMS AND STRENGTHS
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Tablet, 12 Amb a 1-Unit (Amb a 1-U) (3)
CONTRAINDICATIONS
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Severe, unstable or uncontrolled asthma. (4)
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History of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy. (4)
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A history of eosinophilic esophagitis. (4)
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Hypersensitivity to any of the inactive ingredients contained in this product. (4)
WARNINGS AND PRECAUTIONS
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Inform patients of the signs and symptoms of serious allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur. (5.1)
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In case of oral inflammation or wounds, stop treatment with RAGWITEK to allow complete healing of the oral cavity. (5.7)
ADVERSE REACTIONS
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Adverse reactions reported in ≥5% of patients were: throat irritation, oral pruritus, ear pruritus, oral paraesthesia, mouth edema, and tongue pruritus. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 6/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
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 adults 18 through 65 years of age.
RAGWITEK is not indicated for the immediate relief of allergic symptoms.
2 DOSAGE AND ADMINISTRATION
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.
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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 in the proper use of emergency self-injection of epinephrine [see Warnings and Precautions (5.2)].
3 DOSAGE FORMS AND STRENGTHS
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.
4 CONTRAINDICATIONS
RAGWITEK is contraindicated in patients with:
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Severe, unstable or uncontrolled asthma
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A history of any severe systemic allergic reaction
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A history of any severe local reaction after taking any sublingual allergen immunotherapy
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A history of eosinophilic esophagitis
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Hypersensitivity to any of the inactive ingredients [gelatin, mannitol, and sodium hydroxide] contained in this product [see Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Severe Allergic Reactions
RAGWITEK can cause systemic allergic reactions including anaphylaxis which may be life-threatening. In addition, RAGWITEK can cause severe local reactions, including laryngopharyngeal swelling, which can compromise breathing and be life-threatening. Educate patients to recognize the signs and symptoms of these allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur. Allergic reactions may require treatment with epinephrine. [See Warnings and Precautions (5.2).]
Administer the initial dose of RAGWITEK in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases and prepared to manage a life-threatening systemic or local allergic reaction. Observe patients in the office for at least 30 minutes following the initial dose of RAGWITEK.
5.2 Epinephrine
Prescribe auto-injectable epinephrine to patients receiving RAGWITEK. Instruct patients to recognize the signs and symptoms of a severe allergic reaction and in the proper use of emergency auto-injectable epinephrine. Instruct patients to seek immediate medical care upon use of auto-injectable epinephrine and to stop treatment with RAGWITEK. [See Patient Counseling Information (17).]
See the epinephrine package insert for complete information.
RAGWITEK may not be suitable for patients with certain medical conditions that may reduce the ability to survive a serious allergic reaction or increase the risk of adverse reactions after epinephrine administration. Examples of these medical conditions include but are not limited to: markedly compromised lung function (either chronic or acute), unstable angina, recent myocardial infarction, significant arrhythmia, and uncontrolled hypertension.
RAGWITEK may not be suitable for patients who are taking medications that can potentiate or inhibit the effect of epinephrine. These medications include:
Βeta-adrenergic blockers: Patients taking beta-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, beta-adrenergic blockers antagonize the cardiostimulating and bronchodilating effects of epinephrine.
Alpha-adrenergic blockers, ergot alkaloids: Patients taking alpha-adrenergic blockers may be unresponsive to the usual doses of epinephrine used to treat serious systemic reactions, including anaphylaxis. Specifically, alpha-adrenergic blockers antagonize the vasoconstricting and hypertensive effects of epinephrine. Similarly, ergot alkaloids may reverse the pressor effects of epinephrine.
Tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and certain antihistamines: The adverse effects of epinephrine may be potentiated in patients taking tricyclic antidepressants, levothyroxine sodium, monoamine oxidase inhibitors, and the antihistamines chlorpheniramine, and diphenhydramine.
Cardiac glycosides, diuretics: Patients who receive epinephrine while taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias.
5.3 Upper Airway Compromise
RAGWITEK can cause local reactions in the mouth or throat that could compromise the upper airway [see Adverse Reactions (6.1)]. Consider discontinuation of RAGWITEK in patients who experience persistent and escalating adverse reactions in the mouth or throat.
5.4 Eosinophilic Esophagitis
Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy [see Contraindications (4)]. Discontinue RAGWITEK and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastro-esophageal symptoms including dysphagia or chest pain.
5.5 Asthma
Subjects with asthma who participated in clinical trials had asthma of a severity that required, at most, a daily low dose of an inhaled corticosteroid. RAGWITEK has not been studied in subjects with moderate or severe asthma.
Withhold immunotherapy with RAGWITEK if the patient is experiencing an acute asthma exacerbation. Reeva luate patients who have recurrent asthma exacerbations and consider discontinuation of RAGWITEK.
5.6 Concomitant Allergen Immunotherapy
RAGWITEK has not been studied in subjects who are receiving concomitant allergen immunotherapy. Concomitant dosing with other allergen immunotherapy may increase the likelihood of local or systemic adverse reactions to either subcutaneous or sublingual allergen immunotherapy.
5.7 Oral Inflammation
Stop treatment with RAGWITEK to allow complete healing of the oral cavity in patients with oral inflammation (e.g., oral lichen planus, mouth ulcers, or thrush) or oral wounds, such as those following oral surgery or dental extraction.
6 ADVERSE REACTIONS
Adverse reactions reported in ≥5% of patients were: throat irritation, oral pruritus, ear pruritus, oral paraesthesia, mouth edema, and tongue pruritus.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In 4 placebo-controlled clinical trials, 1057 subjects 18 years of age and older with short ragweed pollen-induced rhinitis, w |
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