Ragwitek

Ragweed pollen allergen extract may cause a severe allergic reaction. Stop taking the medicine and get emergency medical help if you have any of these signs of an allergic reaction:

• severe dizziness or a light-headed feeling (like you might pass out);
• fast heart rate;
• stomach pain, vomiting, diarrhea;
• hives, itching, flushing (warmth, redness, or tingly feeling);
• cough, chest tightness, wheezing, trouble breathing; or
• swelling of your face, lips, tongue, or throat.

If you stop taking ragweed pollen allergen extract after having an allergic reaction, do not start taking the medicine again without your doctor's advice.

Call your doctor at once if you have:

• severe mouth or throat irritation;
• breathing problems; or
• choking feeling, chest pain, trouble swallowing.

Common side effects may include:

• numbness, tingling, itching, or swelling in your mouth;
• swollen tongue;
• throat irritation; or
• itching in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use of Ragwitek™ is not indicated in children. Safety and efficacy have not been established.

• Merck Sharp & Dohme Corp.

Before taking ragweed pollen allergen extract, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to ragweed pollen allergen extract or to any of its ingredients

• are on concomitant allergen immunotherapy
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ragweed pollen allergen extract  falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Ragweed pollen allergen extract should be given to a pregnant woman only if clearly needed.

• Treatment should be initiated at least 12 weeks before the expected onset of ragweed pollen season and continue treatment throughout the season.
• It is recommended the first dose of ragweed pollen allergen extract is administered under the supervision of a physician. 
• Patients should be observed in the office for at least 30 minutes following the initial dose.
• Store ragweed pollen allergen extract at room temperature.
• Store in the original package until use to protect from moisture.
• Keep this and all medicines out of the reach of children.

You should not use ragweed pollen allergen extract if you have ever had an allergic reaction to similar pollen-extract medicines, or if you have:

• severe or uncontrolled asthma; or

• a history of allergic reaction that affected your esophagus (the tube that connects your mouth and stomach) and caused heartburn or trouble swallowing.

To make sure ragweed pollen allergen extract is safe for you, tell your doctor if you have:

• breathing problems;

• heart disease;

• uncontrolled high blood pressure;

• mouth sores, swollen gums, or other wounds or irritations inside your mouth;

• if you take an antidepressant or migraine headache medicine; or

• if you take medicine to treat heart problems, high blood pressure, or a prostate disorder.

FDA pregnancy category C. It is not known whether ragweed pollen allergen extract will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether ragweed pollen allergen extract passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone under 18 years old without medical advice.

This medicine is not for use in people older than 65.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Start taking Ragwitek™ at least 3 months before the expected onset of each ragweed pollen season, and continue taking this medicine daily throughout the pollen season.

It is recommended to take the first dose of Ragwitek™ in a clinic or hospital. This is to monitor you for at least 30 minutes of any signs or symptoms of a severe allergic reaction. If you can tolerate the first dose of Ragwitek™, then you may take the succeeding doses at home.

To use:

• Wash your hands before and after taking the tablet.
• With dry hands, remove the tablet from the blister pack if you are ready to take it.
• Place the tablet immediately under the tongue where it will dissolve for about 1 minute before swallowing.
• Do not eat or drink anything for 5 minutes after taking the tablet.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For sublingual dosage form (tablets):
  • For short ragweed pollen rhinitis:
    • Adults up to 65 years of age—One tablet once a day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you forget to take more than one dose of this medicine, contact your doctor for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• It is used to treat allergies caused by ragweed pollen.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Ragwitek (ragweed pollen allergen extract), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ragwitek. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Ragwitek.

Review Date: October 4, 2017