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Important Safety Information about RAGWITEK

RAGWITEK can cause severe allergic reactions that may be life-threatening. Stop taking RAGWITEK and get medical treatment right away if you or your child has any of the following symptoms after taking RAGWITEK:
- Trouble breathing
- Throat tightness or swelling
- Trouble swallowing or speaking
- Dizziness or fainting
- Rapid or weak heartbeat
- Severe stomach cramps or pain, vomiting, or diarrhea
- Severe flushing or itching of the skin
Do not take RAGWITEK if you or your child has severe, unstable or uncontrolled asthma; had a severe allergic reaction in the past that included trouble breathing, dizziness or fainting, or rapid or weak heartbeat; had difficulty with breathing due to swelling of the throat or upper airway after using any sublingual immunotherapy before; has ever been diagnosed with eosinophilic esophagitis; or is allergic to any of the inactive ingredients contained in RAGWITEK.
For home administration of RAGWITEK, your doctor will prescribe auto-injectable epinephrine, a medicine you can inject if you or your child has a severe allergic reaction after taking RAGWITEK. Talk to your doctor or read the epinephrine patient information if you have any questions about the use of auto-injectable epinephrine.
The first dose of RAGWITEK must be taken in the doctor’s office. After taking the first tablet, you or your child will be watched for at least 30 minutes for symptoms of a serious allergic reaction.
Children and adolescents should be given each tablet of RAGWITEK by an adult who will watch for any symptoms of a serious allergic reaction.
You should tell your doctor if you or your child is taking or has recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of RAGWITEK. Ask your doctor or pharmacist for advice before taking RAGWITEK.
Stop RAGWITEK and contact your doctor if you or your child has any of the following after taking RAGWITEK: Any type of a serious allergic reaction; throat tightness that worsens or swelling of the tongue or throat that causes trouble speaking, breathing or swallowing; asthma or any other breathing condition that gets worse or heartburn, difficulty swallowing, pain with swallowing, or chest pain that does not go away or worsens. Also stop taking RAGWITEK following mouth surgery procedures (such as tooth removal) or if you or your child develop any mouth infections, ulcers or cuts in the mouth or throat.
The most commonly reported side effects in adults were itching of the mouth, lips, or tongue, swelling under the tongue, or throat irritation. These side effects, by themselves, were not dangerous or life-threatening.
The most commonly reported side effects in children and adolescents were itching of the mouth or ears, swelling of the lips, tongue, or throat, pain in the mouth, tongue, or upper abdomen, nausea, or throat irritation. These side effects, by themselves, were not dangerous or life-threatening.
Your doctor may decide that RAGWITEK is not the best treatment for you or your child if you or your child has asthma; plan to become pregnant or is breast-feeding; is unable or unwilling to administer epinephrine; or is taking certain medicines, including other allergen immunotherapy.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for RAGWITEK, including the information about severe allergic reactions, and discuss it with the doctor. The physician Prescribing Information also is available.

ISI-0004, Copyright 2021. All rights reserved, ALK-Abell ó, Inc.

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