Ragweed pollen allergen extract

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 anf 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 of a severe allergic reaction with the administration of 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.

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.

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.

Ask your doctor before starting any new medicine or treatments, including allergy shots.

Usual Adult Dose for Allergic Rhinitis:

One tablet sublingually once a day.

Comments:
-Initiate treatment at least 12 weeks before the expected onset of each ragweed pollen season and continue treatment throughout the season.

Use: 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.

Other drugs may interact with ragweed pollen allergen extract, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble swallowing or speaking.
• Pain with swallowing.
• Heartburn.
• Chest pain or pressure, a fast heartbeat, or passing out.
• Dizziness.
• Flushing.
• Shortness of breath.
• Cough that does not go away.
• Very loose stools (diarrhea).
• Very upset stomach or throwing up.
• Stomach cramps.
• Very bad belly pain.
• Very bad mouth irritation.
• Redness or white patches in mouth or throat.
• Very bad throat irritation.

One tablet sublingually once a day.

Comments:
-Initiate treatment at least 12 weeks before the expected onset of each ragweed pollen season and continue treatment throughout the season.

Use: 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.

US BOXED WARNING:
-Short ragweed allergen can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction.
-Do not administer short ragweed allergen 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.
-May not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
-May not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available