Ragwitek (ragweed pollen allergen extract)
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Fact Table
| Fact Table | |
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| Formula | Not chemically defined (standardized allergen extract from *Ambrosia artemisiifolia* pollen) |
| License | Prescription only (Rx-only immunotherapy tablet) |
| Bioavailability | Local sublingual immunological exposure; not absorbed systemically in pharmacologic sense |
| Legal status | Rx-only (US, Canada) |
| Chemical Name | Standardized allergen extract, short ragweed (*Ambrosia artemisiifolia*) |
| Elimination half-life | Not applicable (not systemically absorbed) |
| Dosage (Strength) | One sublingual tablet daily, containing 12 Amb a?1-Units; start =12?weeks before and continue throughout ragweed season |
| Pregnancy | Use only if clearly needed—discuss benefits/risks with healthcare provider |
| Brands | Ragwitek |
| Protein binding | Not applicable |
| PubChem CID | Not applicable (biological extract) |
| MedlinePlus | Not available |
| ChEBI | Not available |
| ATC code | Not assigned |
| DrugBank | Not assigned |
| KEGG | Not assigned |
| Routes of administration | Sublingual tablet |
Ragwitek is a sublingual immunotherapy tablet indicated for the treatment of short ragweed-induced allergic rhinitis, with or without conjunctivitis. It is formulated using a standardized allergen extract derived from short ragweed (Ambrosia artemisiifolia) pollen. Ragwitek is intended for use in adults aged 18 through 65 years who have a documented diagnosis of ragweed pollen allergy confirmed by a positive skin test or in vitro testing for allergen-specific IgE antibodies.
The product is designed to provide long-term relief by modulating the body's immune response to ragweed allergens, thereby reducing the severity of symptoms over time. It is taken seasonally, starting before the onset of ragweed pollen season and continuing throughout the season to build tolerance.
Directions
Ragwitek should be administered once daily by placing one tablet under the tongue and allowing it to dissolve completely. The tablet should not be chewed or swallowed. Treatment should begin approximately 12 weeks prior to the expected onset of ragweed pollen season and continue throughout the season.
The first dose must be administered in a healthcare setting under the supervision of a physician experienced in diagnosing and treating allergic diseases, due to the risk of severe allergic reactions. Patients should be observed for at least 30 minutes following administration. Subsequent doses can be taken at home, provided the patient has tolerated the first dose without serious adverse reactions.
Ingredients
Each Ragwitek tablet contains 12 Amb a 1-U (standardized units) of freeze-dried short ragweed (Ambrosia artemisiifolia) pollen extract as the active ingredient. Inactive ingredients include gelatin, mannitol, and sodium hydroxide.
Cautions
Ragwitek should be prescribed with caution in individuals with asthma, particularly those with co-existing respiratory conditions. Patients must be trained to recognize signs of systemic allergic reactions and should be prescribed an epinephrine auto-injector for emergency use. Therapy should be discontinued and medical evaluation sought if symptoms suggestive of eosinophilic esophagitis occur, such as persistent severe throat pain or difficulty swallowing.
Special consideration is required for patients with oral inflammation or mouth wounds, as these conditions may increase the risk of local adverse reactions or compromise the efficacy of treatment. Use in pregnant or lactating women should be based on a thorough risk-benefit assessment.
Contraindications
Ragwitek is contraindicated in patients with:
- Severe, unstable, or uncontrolled asthma
- A history of any severe systemic allergic reaction or severe local reaction to sublingual allergen immunotherapy
- Hypersensitivity to any of the ingredients in the formulation
- A history of eosinophilic esophagitis
It is also contraindicated in patients who are unable to receive epinephrine or those who are at increased risk of complications from epinephrine administration.
Side Effects
Common side effects associated with Ragwitek include:
- Throat irritation
- Itching in the mouth or ears
- Sneezing
- Mouth edema
- Nausea
Less common but serious side effects include:
- Systemic allergic reactions, including anaphylaxis
- Eosinophilic esophagitis
- Asthma exacerbation
Patients experiencing systemic symptoms such as dizziness, difficulty breathing, or widespread hives should seek immediate medical attention.
Frequently Asked Questions about Ragwitek (Ragweed Pollen Allergen Extract)
What is Ragwitek used for?
Ragwitek is a prescription tablet that contains ragweed pollen allergen extract. It is used to treat allergic rhinitis (hay fever) caused by short ragweed pollen in adults and children aged 5 through 65 years. It helps reduce symptoms such as sneezing, runny nose, nasal congestion, and itchy or watery eyes during ragweed pollen season.
How does Ragwitek work?
Ragwitek works through allergen immunotherapy. It exposes the body to small amounts of ragweed pollen allergen to help build tolerance and reduce allergic symptoms over time. This process helps retrain the immune system to respond less aggressively to the allergen.
How should I take Ragwitek?
Ragwitek is taken once daily by placing the tablet under the tongue and allowing it to dissolve completely. It should be taken at least 12 weeks before the start of ragweed pollen season and continued throughout the season. Do not swallow the tablet whole or take with food or drink. Hands should be dry when handling the tablet.
What are the common side effects of Ragwitek?
Common side effects include throat irritation, mouth itching or swelling, ear itching, and sneezing. These symptoms are generally mild and tend to decrease over time with continued use. Serious allergic reactions are possible and require immediate medical attention.
Can Ragwitek cause serious allergic reactions?
Yes, although rare, Ragwitek can cause severe allergic reactions, including anaphylaxis. Patients should be prescribed an epinephrine auto-injector and trained on its use. The first dose should always be taken under medical supervision to monitor for any immediate reactions.
Who should not take Ragwitek?
Ragwitek should not be used by individuals with severe, unstable asthma, a history of severe allergic reaction to ragweed pollen extract, or those with eosinophilic esophagitis. It is also not recommended for individuals with immune system problems or certain oral conditions unless advised by a healthcare provider.
Is Ragwitek safe during pregnancy or breastfeeding?
The safety of Ragwitek during pregnancy or breastfeeding has not been established. It should only be used if clearly needed and under the guidance of a healthcare provider. Discuss the potential risks and benefits with your doctor.
Can Ragwitek be taken with other allergy medications?
Yes, in some cases Ragwitek may be used along with other allergy treatments, such as antihistamines or nasal corticosteroids, especially during the early weeks of treatment. However, any combination should be discussed with your doctor to avoid interactions or side effects.
How long does it take for Ragwitek to work?
Ragwitek is designed to begin working after several weeks of daily use. It is recommended to start treatment about 12 weeks before ragweed pollen season begins for best results. Continued daily use is necessary to maintain effectiveness throughout the season.
What should I do if I miss a dose of Ragwitek?
If you miss a dose, take it as soon as you remember. If more than one dose is missed, contact your healthcare provider before resuming treatment. Missing multiple doses may increase the risk of an allergic reaction when restarting.
