Ragwitek

Ragweed pollen allergen extract is a prescription medication used to treat short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis in adults 18 through 65 years of age.

Ragweed pollen allergen extract belongs to a group of drugs called allergy immunotherapy. These work by decreasing your body’s reaction to an allergen.

This medication comes in a sublingual tablet form and is taken once a day without food.

Common side effects of Ragweed pollen allergen extract includes throat irritation, oral pruritus, ear pruritus, oral paraesthesia, mouth edema, and tongue pruritus.

Ragweed pollen allergen extract is a prescription medication used to treat short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis in adults 18 through 65 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Merck Sharp & Dohme Corp.

Serious side effects have been reported with ragweed pollen allergen extract. See the “Ragweed Pollen Allergen Extract Precautions” section.

Common side effects of ragweed pollen allergen extract include the following:

• throat irritation
• oral pruritus
• ear pruritus
• oral paraesthesia
• mouth edema
• tongue pruritus

This is not a complete list of ragweed pollen allergen extract side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with ragweed pollen allergen extract including the following:

• Severe Allergic Reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of severe allergic reactions.
  • syncope
  • dizziness
  • hypotension
  • tachycardia
  • dyspnea
  • wheezing
  • bronchospasm
  • chest discomfort
  • cough
  • abdominal pain
  • vomiting
  • diarrhea
  • rash
  • pruritus
  • flushing
  • urticaria
• Upper Airway Compromise. Tell your healthcare provider right away if you have any persistent and escalating adverse reactions in the mouth or throat
• Eosinophilic Esophagitis. Tell your healthcare provider right away if you have some or all of the following symptoms of eosinophilic esophagitis.
  • dysphagia
  • chest pain
• Asthma. Tell your healthcare provider right away if you have asthma and you have difficulty breathing or if your asthma becomes difficult to control.
• Oral Inflammation. Tell your healthcare provider right away if you have some or all of the following symptoms of oral inflammation.
  • oral lichen planus
  • mouth ulcers
  • or thrush
  • oral wounds

Auto-injectable epinephrine may be prescribed in case there is a severe allergic reaction with ragweed pollen allergen. Ragweed pollen allergen extract may not be suitable for patients who are taking medications that can potentiate or inhibit the effect of epinephrine. These medications include:

• Beta-adrenergic blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
• Alpha-adrenergic blockers
• Ergot alkaloids
• Tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• Monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• Certain antihistamines such as chlorpheniramine (Chlor-Trimeton) and diphenhydramine (Benadryl)
• Cardiac glycosides
• Diuretics
• Levothyroxine sodium

Do not take ragweed pollen allergen extract if you:

• are allergic or hypersensitive to ragweed pollen allergen extract or to any of its ingredients
• Severe, unstable or uncontrolled asthma.
• History of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy.   
• A history of eosinophilic esophagitis.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ragweed pollen allergen extract, there are no specific foods that you must exclude from your diet when receiving this medication.

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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if ragweed pollen allergen extract crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Ragweed pollen allergen extract.

Take ragweed pollen allergen extract exactly as prescribed.

Ragweed pollen allergen extract comes in sublingual tablet form and is taken once a day without food.

Carefully remove the foil from the blister unit with dry hands, and then take the sublingual tablet immediately by placing it under the tongue where it will dissolve.  Allow it to remain there until completely dissolved. Do not swallow for at least 1 minute. Wash hands after handling the tablet. Avoid food or beverages for 5 minutes after taking the tablet.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of ragweed pollen allergen extract.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of ragweed pollen allergen extract for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis in adults 18 through 65 years of age is 12 Amb a 1-Unit per day until the end of the season.

If you take too much ragweed pollen allergen extract, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• 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.

Ragweed pollen allergen extract can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer ragweed pollen allergen extract to patients with severe, unstable or uncontrolled asthma. Observe patients in the office for at least 30 minutes following the initial dose. Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. Ragweed pollen allergen extract may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. Ragweed pollen allergen extract may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.