Ragweed Allergen Extract

Ragweed Allergen Extract is a prescription medication used to treat short ragweed pollen-induced allergic rhinitis. 

• Ragweed Allergen Extract is available under the following different brand names: Ambrosia artemisiifolia, Ragwitek 

Common side effects of Ragweed Allergen Extract include:

• Numbness, tingling, itching, or swelling in the mouth,
• Swollen tongue,
• Throat irritation, and
• Itching in the ears

Serious side effects of Ragweed Allergen Extract include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Severe dizziness,
• Lightheadedness,
• Fast heart rate,
• Stomach pain,
• Vomiting,
• Diarrhea,
• Itching,
• Flushing (warmth, redness, or tingly feeling),
• Cough,
• Chest tightness,
• Wheezing,
• Trouble breathing,
• Severe mouth or throat irritation,
• Chocking feeling,
• Chest pain, and
• Trouble swallowing

Rare side effects of Ragweed Allergen Extract include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Sublingual tablet

• 12 Amb a 1-U (Approximately 12 mcg/tablet)

Allergic Rhinitis

Adult dosage

• Initiate treatment at least 12 weeks before the expected onset of ragweed pollen season and maintain dosing throughout the season
• 18-65 years: 1 tablet sublingual once a day; give 1st dose in physician’s office and observe for 30 min for allergic reactions
• Above 65 years: Not approved

Pediatric dosage

• Children below 5 years: Safety and efficacy not established
• 5-17 years: 1 tablet sublingual once a day; give 1st dose in physician’s office and observe for 30 min for allergic reactions

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ragweed Allergen Extract has no noted severe interactions with any other drugs.
• Ragweed Allergen Extract has no noted serious interactions with any other drugs.
• Ragweed Allergen Extract has no noted moderate interactions with any other drugs.
• Ragweed Allergen Extract has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Severe, unstable, or uncontrolled asthma
• History of any severe systemic or local reaction to sublingual allergen immunotherapy
• History of eosinophilic esophagitis
• Hypersensitivity to inactive ingredients (gelatin, mannitol, sodium hydroxide)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ragweed Allergen Extract?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ragweed Allergen Extract?”

Cautions

• Potential for severe allergic reaction (see Black Box Warnings and Contraindications)
• Must be prescribed way to-injectable epinephrine
• Eosinophilic esophagitis reported; consider discontinuing if severe or persistent gastroesophageal symptoms (including dysphagia or chest pain) occur
• Not studied with moderate or severe asthma or any subjects who required daily medication
• Withhold dose if patient experiencing an acute asthma exacerbation; re-evaluate patients with recurrent asthma exacerbations and consider discontinuing
• A Can cause a local reaction in the mouth or throat that could compromise the upper airway; consider discontinuing if persistent and escalating adverse reactions of mouth or throat occur
• Not studied in individuals receiving concomitant allergen immunotherapy
• Stop treatment and allow complete healing of the oral cavity in patients with oral inflammation (. g, oral lichen planus, mouth ulcers, or thrush) or oral wounds (.g, oral surgery, dental extraction)

Pregnancy and Lactation

• Available human data do not establish the presence or absence of ragweed Allergen Extract-associated risks during pregnancy
• Lactation
  • Unknown if distributed in human breast milk; caution advised