Brand Names:

• Ragwitek

Dosage Forms:

• Tablet

Warnings:

Short ragweed (Ambrosia artemisiifolia) pollen extract can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer short ragweed pollen 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 or parents/guardians on its appropriate use, and instruct patients or parents/guardians to seek immediate medical care upon its use. Short ragweed pollen extract may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction or for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers .

Classifications:

Therapeutic—

Immunological Agent

Uses of This Medicine:

Ragwitek® is an allergen extract, for immunotherapy treatment of symptoms of short ragweed pollen allergic rhinitis (hay fever), with or without conjunctivitis (itching, redness, and tears in the eyes). This is confirmed by a positive skin test that is caused by short ragweed pollen allergen extract.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Ragwitek® in children younger than 5 years of age. Safety and efficacy have not been established.

Older adults—

Ragwitek® is not approved for use in patients over 65 years of age. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to gelatin, mannitol, or sodium hydroxide or
• Asthma, severe, unstable, or uncontrolled or
• Eosinophilic esophagitis, history of or
• Sublingual allergen immunotherapy, history of or
• Systemic allergic reaction, severe, history of—Should not be used in patients with these conditions.

• Angina (severe chest pain), unstable or
• Arrhythmia (heart rhythm problem) or
• Breathing or lung problems (eg, COPD) or
• Heart attack, recent or
• Hypertension (high blood pressure), uncontrolled—Serious allergic reactions may be more difficult to treat in patients with these conditions.

• Dental extraction or
• Mouth ulcers or thrush or
• Oral surgery—These conditions should be allowed to healed first before taking this medicine.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Start taking Ragwitek® at least 3 months before the expected onset of each ragweed pollen season, and continue taking this medicine daily throughout the pollen season.

It is recommended to take the first dose of Ragwitek® in a clinic or hospital. This is to monitor you for at least 30 minutes of any signs or symptoms of a severe allergic reaction. If you can tolerate the first dose of Ragwitek®, then you may take the succeeding doses at home.

To use:

• Wash your hands before and after taking the tablet.
• With dry hands, remove the tablet from the blister pack if you are ready to take it.
• Place the tablet immediately under the tongue where it will dissolve for about 1 minute before swallowing.
• Do not eat or drink anything for 5 minutes after taking the tablet.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For sublingual dosage form (tablets):
  • For short ragweed pollen rhinitis:
    • Adults and children 5 years of age and older—One tablet once a day.
    • Children younger than 5 years of age—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you forget to take more than one dose of this medicine, contact your doctor for instructions.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, skin rash, tightness in the chest, trouble breathing, or unusual tiredness or weakness. If these side effects occur, get emergency help at once.

Your doctor may recommend that you have an emergency injection for allergic reactions available during the time of year you take this medication. If this is the case, make sure that you know how to use it properly for yourself in case of a serious allergic reaction.

This medicine may increase risk of eosinophilic esophagitis. Check with your doctor right away if you have severe chest pain or trouble swallowing while taking this medicine.

If you have trouble breathing or if your asthma becomes difficult to control, call your doctor immediately.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Itching of the ears, mouth, and tongue

numbness or tingling feeling around the mouth

swelling or inflammation of the mouth

trouble breathing

upper stomach pain

Less common

Difficulty swallowing

discomfort in the chest

itching skin

redness, irritation, swelling, or soreness of the tongue or in the mouth

Incidence not known

Cough

dizziness

fast heartbeat

hives or skin rash

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

sore throat

sweating

tightness in the chest

voice changes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Dry mouth

nausea

Incidence not known

Change in taste

diarrhea

loss of taste

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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