Brand Names:

• Odactra

Dosage Forms:

• Tablet

Warnings:

Dermatophagoides farinae and Dermatophagoides pteronyssinus extracts can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer 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 parents/guardians to seek immediate medical care upon its use. Dermatophagoides farinae extract/Dermatophagoides pteronyssinus extract may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction, as well as for those who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers .

Classifications:

Therapeutic—

Immunological Agent

Uses of This Medicine:

Odactra™ is an allergen extract that is used to treat symptoms of allergic rhinitis, with or without conjunctivitis, caused by house dust mites. This medicine contains house dust mite allergen extract from Dermatophagoides farinae and Dermatophagoides pteronyssinus. It works by exposing the patient's immune system to house dust mite allergens to reduce the symptoms of hay fever.

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 Odactra™ in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of Odactra™ in the geriatric population. 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:

• Allergic reaction after taking any sublingual allergen immunotherapy or
• Allergic reaction, systemic and severe, history of or
• Asthma, severe (unstable or poorly controlled) or
• Eosinophilic esophagitis, history of—Should not be used in patients with these conditions.

• Angina, unstable or
• Arrhythmia (heart rhythm problem) or
• Heart attack, recent or
• Hypertension (high blood pressure), uncontrolled or
• Lung disease—Use with caution. May increase risk for more serious side effects.

• Mouth ulcers or
• Oral thrush or
• Oral wounds after dental surgery or tooth extraction—These conditions should be healed first before using this medicine.

Proper Use of This Medicine:

You must take your first dose of Odactra™ in a doctor's clinic or hospital. This is done to observe you for at least 30 minutes for possible allergic reactions. If the first dose is well tolerated, then you can take Odactra™ at home.

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

Your doctor will give you a medicine called epinephrine. This is to be used to relieve a severe allergic reaction. Your doctor will give you instructions on how to use it properly.

To use:

• Take the tablet from the blister unit after carefully removing the foil with dry hands.
• Place the tablet under your tongue where it will dissolve within 10 seconds.
• Avoid swallowing for at least 1 minute.
• Wash your hands after handling the tablet.
• Do not eat or drink any liquid for 5 minutes after taking the medicine.

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 oral dosage form (tablet):
  • For allergic rhinitis caused by house dust mites:
    • Adults—One tablet once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Keep the medicine in the original package until use to protect from moisture.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. 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. Call your doctor right away if you have a rash, itching, chest pain, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause sores in the mouth or throat, which can lead to difficulty with breathing. Tell your doctor right away if you have trouble breathing or swallowing.

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:

Incidence not known

Chest tightness

cough

difficulty with swallowing

dizziness

fast heartbeat

hives, itching, or skin rash

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

sores or ulcers on the tongue

unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Changes in voice

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

trouble breathing

trouble swallowing

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

Change in taste

diarrhea

itching in the ear

itching or swelling in the mouth

nausea

stomach pain

Less common

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.