ODACTRA, GRASTEK, and RAGWITEK are different from the type of allergy relief tablets you may get over the counter at the pharmacy. They are a type of “allergy immunotherapy”
(im-yuh-noh-thAIR-uh-pee) that you take under your tongue.
Allergy immunotherapy is a type
of prescription medicine used to
treat the underlying cause
of
allergies instead of just the
symptoms. It is made of very small
doses of what you are allergic
to
(known as an allergen). Over time,
allergy immunotherapy
can make you less sensitive to
the allergen.
By adding ODACTRA, GRASTEK,
or RAGWITEK to the allergy
medicines you already take, you
may have fewer allergy symptoms
and be able to reduce the number
of those allergy medicines.
ODACTRA, GRASTEK, and
RAGWITEK have 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.
Allergy immunotherapy
tablets may be able to help
even if you’re allergic to more
than just 1 allergen.
Talk to your doctor
to learn more.
Important Safety Information for GRASTEK®, RAGWITEK®, and ODACTRA®
GRASTEK®, RAGWITEK®, and ODACTRA® are prescription medicines used for sublingual (under the tongue) immunotherapy to treat grass pollen allergies (GRASTEK), ragweed pollen allergies (RAGWITEK), or house dust mite allergies (ODACTRA) that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes.
GRASTEK AND RAGWITEK may be prescribed for persons 5 through 65 years of age. ODACTRA may be prescribed for persons 12 through 65 years of age.
GRASTEK and RAGWITEK are taken for about 12 weeks before and during their respective pollen seasons. GRASTEK may also be taken daily for 3 years to provide a sustained effect for a fourth year in which you do not have to take GRASTEK.
GRASTEK, RAGWITEK, and ODACTRA are NOT medications that give immediate relief for allergy symptoms.
Important Safety Information about GRASTEK®, RAGWITEK®, and ODACTRA®
GRASTEK, RAGWITEK, and ODACTRA can cause severe allergic reactions that may be life-threatening. If any of these symptoms occur, stop taking GRASTEK, RAGWITEK, or ODACTRA and immediately seek medical care:
- 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 GRASTEK, RAGWITEK, or ODACTRA 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
- Are allergic to any of the inactive ingredients contained in GRASTEK, RAGWITEK, or ODACTRA
For home administration of GRASTEK, RAGWITEK, or ODACTRA, your doctor will prescribe auto- injectable epinephrine, a medicine you can inject if you or your child has a severe allergic reaction after taking GRASTEK, RAGWITEK, or ODACTRA (only indicated for persons 12 through 65 years of age). 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 GRASTEK, RAGWITEK, or ODACTRA 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 should be given each tablet of GRASTEK or 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 GRASTEK, RAGWITEK, or ODACTRA. Ask your doctor or pharmacist for advice before taking GRASTEK, RAGWITEK, or ODACTRA.
Stop taking GRASTEK, RAGWITEK, or ODACTRA and contact your doctor if you or your child have any of the following after taking GRASTEK, RAGWITEK, or ODACTRA:
- 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
Stop taking GRASTEK, RAGWITEK, or ODACTRA 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, or if you or your child have asthma or any other breathing condition that worsens, or any type of serious allergic reaction.
The most commonly reported side effects for GRASTEK and RAGWITEK were itching of the mouth, lips, or tongue, swelling under the tongue, or throat irritation.
The most commonly reported side effects for ODACTRA were throat irritation/tickle, itching in the mouth or ears, swelling of the back of the mouth, lips or tongue, tongue pain, nausea, throat swelling, stomach pain, tongue ulcer/sore on the tongue, and mouth ulcer/sore in the mouth, diarrhea, and food tastes different. These side effects, by themselves, were not dangerous or life-threatening. Typically, these common side effects begin within the first week of starting ODACTRA and may reoccur for up to two weeks. These common side effects experienced after taking the first tablet typically last up to one hour
Your doctor may decide that GRASTEK, RAGWITEK, or ODACTRA may not be the best treatment for you or your child if you or your child has asthma, depending on how severe it is; plan to become pregnant or are breast-feeding; are unable or unwilling to administer epinephrine; or are taking certain medicines, including other allergen immunotherapy. Your doctor may also decide that ODACTRA is not the best for you if you suffer from lung disease such as chronic obstructive pulmonary disease (COPD) or if you suffer from heart disease such as coronary artery disease, an irregular heart rhythm, or you have hypertension that is not well controlled.
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 GRASTEK, RAGWITEK, or ODACTRA, including the information about severe allergic reactions, and discuss it with the doctor. The physician Prescribing Information is also available for GRASTEK, RAGWITEK, and ODACTRA.
Important Safety Information for GRASTEK®, RAGWITEK®, and ODACTRA®
GRASTEK®, RAGWITEK®, and ODACTRA® are prescription medicines used for sublingual (under the tongue) immunotherapy to treat grass pollen allergies (GRASTEK), ragweed pollen allergies (RAGWITEK), or house dust mite allergies (ODACTRA) that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes.