Ambrosia artemisiifolia pollen

What is Ambrosia artemisiifolia pollen ?

Ambrosia artemisiifolia pollen (RAGWITEK) tablets contain pollen allergen extract from Short Ragweed (Ambrosia artemisiifolia) used as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis.

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What are the uses of this medicine?

• This medicine is used for sublingual (under the tongue) immunotherapy to treat ragweed pollen allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes.
• RAGWITEK may be prescribed for persons 5 through 65 years of age who are allergic to ragweed pollen.
• RAGWITEK is taken for about 12 weeks before ragweed pollen season and throughout ragweed pollen season.
• RAGWITEK is NOT a medication that gives immediate relief for symptoms of ragweed allergy.

How does this medicine work?

• The precise mechanisms of action of allergen immunotherapy are not known.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Severe, unstable or uncontrolled asthma
• A history of any severe systemic allergic reaction
• A history of any severe local reaction after taking any sublingual allergen immunotherapy
• A history of eosinophilic esophagitis
• Hypersensitivity to any of the inactive ingredients [gelatin, mannitol, and sodium hydroxide] contained in this product

What drug interactions can this medicine cause?

• No formal clinical drug interaction studies have been performed with RAGWITEK.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

• Initiate treatment at least 12 weeks before the expected onset of ragweed pollen season and continue treatment throughout the season.

Recommended Dosage:

• One tablet daily

Administration

• Take RAGWITEK exactly as your doctor tells you.

• RAGWITEK is a prescription medicine that is placed under the tongue.
• Take the tablet from the blister package after carefully removing the foil with dry hands.
• Place the tablet immediately under the tongue. Allow it to remain there until completely dissolved. Do not swallow for at least 1 minute.
• Do not take RAGWITEK with food or beverage. Food and beverage should not be taken for the following 5 minutes.
• Wash hands after taking the tablet.
• Take the first tablet of RAGWITEK in your doctor’s office. After taking the first tablet, you or your child will be watched for at least 30 minutes for symptoms of a serious allergic reaction.
• If you tolerate the first dose of RAGWITEK, you or your child will continue RAGWITEK therapy at home by taking one tablet every day. Children should be given each tablet of RAGWITEK by an adult who will watch for any symptoms of a serious allergic reaction.
• Take RAGWITEK as prescribed by your doctor until the end of the treatment course. If you forget to take RAGWITEK, do not take a double dose. Take the next dose at your normal scheduled time the next day. If you miss more than one dose of RAGWITEK, contact your healthcare provider before restarting.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablet, 12 Amb a 1-Unit (Amb a 1-U)

This medicine is available in fallowing brand namesː

• RAGWITEK

What side effects can this medication cause?

The most common side effects of this medicine include:

• throat irritation
• itching in the mouth or ears
• swelling of the lips
• mouth or throat
• mouth ulcer/sore in the mouth
• mouth pain
• stomach pain
• nausea

RAGWITEK can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to RAGWITEK include:

• Trouble breathing
• Throat tightness or swelling
• Trouble swallowing or speaking
• Dizziness or fainting
• Rapid or weak heartbeat
• Severe stomach cramps or pain, vomiting, or diarrhea
• Severe flushing or itching of the skin

What special precautions should I follow?

• RAGWITEK can cause systemic allergic reactions including anaphylaxis which may be life-threatening. Inform patients or parents/guardians of the signs and symptoms of serious allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur.
• RAGWITEK can cause local reactions in the mouth or throat that could compromise the upper airway. Consider discontinuation of RAGWITEK in patients who experience persistent and escalating adverse reactions in the mouth or throat.
• Stop treatment with RAGWITEK to allow complete healing of the oral cavity in patients with oral inflammation (e.g., oral lichen planus, mouth ulcers, or thrush) or oral wounds, such as those following oral surgery or dental extraction.
• RAGWITEK has not been studied in subjects with severe asthma.
• Eosinophilic esophagitis has been reported in association with sublingual tablet immunotherapy.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Available human data do not establish the presence or absence of RAGWITEK-associated risks during pregnancy.

Can this medicine be used in children?

• Efficacy and safety of RAGWITEK have been established in children and adolescents 5 through 17 years of age.
• The efficacy and safety in pediatric patients below 5 years of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• AMBROSIA ARTEMISIIFOLIA POLLEN

Inactive ingredients:

• MARINE COLLAGEN, SOLUBLE
• MANNITOL
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

• Manufactured by:

Catalent Pharma Solutions Limited, Blagrove, Swindon, Wiltshire, UK

What should I know about storage and disposal of this medication?

• Keep RAGWITEK out of the reach of children.
• Throw away any unused RAGWITEK after the expiration date which is stated on the carton and blister pack after “EXP.”
• Store RAGWITEK in a dry place at room temperature, 15ºC to 30ºC (59ºF to 86ºF), in the original package.

• Dailymed label info on Ambrosia artemisiifolia pollen
• FDA Ambrosia artemisiifolia pollen

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