Odactra

Odactra is a prescription medication used to treat allergic rhinitis (allergy symptoms), with or without pink eye, caused by house dust mites. Odactra is an allergen extract that works to prepare the immune system and prevent allergy symptoms. 

Odactra comes as a tablet that goes underneath your tongue and is normally taken once per day. The tablet should dissolve completely under the tongue before swallowing, this typically takes about a minute. Do not chew, divide, or break Odactra tablets. 

Common side effects of Odactra include itching in the mouth, itching in the ear, or swelling of the lips or tongue. 

Odactra is a prescription medication used to treat allergic rhinitis (allergy symptoms), with or without pink eye, caused by house dust mites.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Merck Sharp & Dohme Corp.

Serious side effects have been reported with Odactra. See the “Odactra Precautions” section.

Common side effects of Odactra include the following:

• throat irritation or throat tickle
• itching in the mouth
• swelling of the back of the mouth
• swelling of the lips or tongue
• nausea
• tongue pain 
• ulcers
• stomach pain 
• food tastes different 

This is not a complete list of Odactra side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been evaluated by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Odactra including the following:

• Severe allergic reactions. Life-threatening reactions can occur with Odactra and may require the use of epinephrine. The first dose of Odactra should be taken in your healthcare provider's office to ensure safety. Tell your healthcare provider right away if you have some or all of the following symptoms of severe allergic reactions.
  • fainting 
  • dizziness 
  • low blood pressure
  • fast heart rate
  • difficulty breathing or shortness of breath 
  • wheezing
  • tightening of the muscles of the lung walls
  • chest discomfort
  • cough
  • abdominal (stomach) pain
  • vomiting
  • diarrhea
  • rash
  • itching
  • flushing
  • hives
• Need for epinephrine. Auto-injectable epinephrine should be prescribed for every patient taking Odactra. Epinephrine should be used only in instances of severe allergic reaction such as face/tongue swelling, shortness of breath, or severe rash. Specific medications, such as beta blockers or tricyclic antidepressants, may interact with epinephrine, so these patients may not be suitable to take Odactra. Tell your healthcare provider about any other medications you take.
• Upper airway problems. Odactra can affect your mouth or throat and could cause breathing problems. Your doctor may stop Odactra if mouth/throat symptoms occur frequently or get worse over time. Tell your healthcare provider right away if you have symptoms of upper airway problems.
• Esophagus (throat) problems. Odactra may cause throat problems including trouble swallowing or chest pain. Your doctor will more than likely stop treatment with Odactra if damage to the tissue in your esophagus is confirmed. Tell your healthcare provider right away if you have symptoms of throat problems.
• Asthma. Odactra should not be taken during an acute asthma exacerbation. Your doctor may stop Odactra if you have frequent asthma exacerbations.  Tell your healthcare provider right away if your asthma symptoms worsen.
• Concomitant allergen immunotherapy. Odactra has not been studied with other immunotherapies and may cause an increased risk of adverse reactions if taken together. Tell your healthcare provider right away if you are taking other allergen immunotherapy.
• Oral conditions. Odactra should not be used in patients with mouth conditions such as mouth ulcers, thrush, or recent oral surgery. Tell your healthcare provider right away if you have symptoms of oral conditions.  

Do not take Odactra if you:

• are allergic to Odactra or any of its ingredients
• have severe, unstable, or uncontrolled asthma
• have a history of severe allergic reaction
• have a history of a severe local reaction after taking sublingual immunotherapy
• have a history of eosinophil esophagitis 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Odactra, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Odactra, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Odactra or any of its ingredients
• have or have had asthma 
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• currently taking other allergen immunotherapy

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Odactra. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Odactra crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Odactra.

Take Odactra exactly as prescribed.

Odactra comes as a tablet that goes underneath your tongue and is normally taken once per day. The tablet should dissolve completely under the tongue before swallowing, this typically takes about a minute. Do not chew, divide, or break Odactra tablets. Food and beverages should be avoided for at least 5 minutes after taking Odactra.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Odactra at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Odactra for the treatment of house dust mite allergies is 12 SQ-HDM (one tablet) taken underneath the toungue once a day. 

If you take too much Odactra, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away. Overdose symptoms look similar to severe allergic reaction symptoms. 

Store Odactra at room temperature 68ºF to 77ºF (20ºC to 25ºC) in the original blister package. Keep Odactra and all medications out of the reach of children. 

WARNING: SEVERE ALLERGIC REACTIONS

Odactra can cause life-threatening allergic reactions. You should not take Odactra if you have severe, unstable or uncontrolled asthma. Your doctor will observe you in the office for at least 30 minutes following the first dose of Odactra. Auto-injectable epinephrine should be given to you with training and instructions for use. Odactra may not be suitable if you have certain underlying medical conditions that may reduce your ability to survive a serious allergic reaction. Odactra may not be suitable if you are taking certain medications, such as beta blockers, because you may not respond to epinephrine or inhaled bronchodilators.