Odactra Sub Tablets
WARNING: Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.The first dose will be given in a doctor's office.Your doctor will give you another drug (epinephrine) to use in case of an allergic reaction. Someone else may have to give you the shot. Be sure you and other people who may need to give the shot know how and when to use it. Certain drugs may make epinephrine not work as well or raise the chance of side effects. This includes some drugs used to treat depression, heart problems, or high blood pressure. There are many drugs that interact with epinephrine. Talk with your doctor or pharmacist to make sure it is safe to take epinephrine with all of your drugs.Do not take this drug if you have very bad asthma or asthma that is not controlled. @ COMMON USES: It is used to treat a house dust mite allergy.
Drug Class
Allergen immunotherapy
Pharmacologic Class
Allergen extract
Pregnancy Category
Not available
FDA Approved
Mar 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Odactra is a tablet that you place under your tongue once a day. It contains tiny amounts of house dust mite allergens. By taking it regularly, your body gradually gets used to these allergens, which can help reduce your allergic reactions and symptoms like sneezing, runny nose, and itchy eyes caused by house dust mites.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. When you're ready to take your dose, remove the medication from the blister pack and place it under your tongue, allowing it to dissolve completely. Do not chew, suck, or swallow the tablet. Wait at least 1 minute before swallowing after placing the medication in your mouth. Avoid eating or drinking while the tablet is dissolving or for 5 minutes after it has dissolved. After handling the medication, wash your hands thoroughly.
Storing and Disposing of Your Medication
Store your medication in its original container at room temperature in a dry location, avoiding bathrooms. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or extra doses. If you miss 7 consecutive days of medication, contact your doctor for guidance on how to proceed.
To use this medication correctly, follow your doctor's instructions and read all the information provided. When you're ready to take your dose, remove the medication from the blister pack and place it under your tongue, allowing it to dissolve completely. Do not chew, suck, or swallow the tablet. Wait at least 1 minute before swallowing after placing the medication in your mouth. Avoid eating or drinking while the tablet is dissolving or for 5 minutes after it has dissolved. After handling the medication, wash your hands thoroughly.
Storing and Disposing of Your Medication
Store your medication in its original container at room temperature in a dry location, avoiding bathrooms. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or extra doses. If you miss 7 consecutive days of medication, contact your doctor for guidance on how to proceed.
Lifestyle & Tips
- Take the tablet immediately after removing it from the blister pack.
- Place the tablet under your tongue and allow it to dissolve completely (usually 10-20 seconds). Do not swallow for at least 1 minute.
- Do not eat or drink for at least 5 minutes after taking the tablet.
- Wash your hands after handling the tablet.
- Always carry two auto-injectable epinephrine devices (e.g., EpiPen) as instructed by your doctor, and know how to use them.
- Avoid taking Odactra if you have any cuts, sores, or inflammation in your mouth, as this may increase the risk of side effects. Wait until your mouth heals.
- Inform your doctor if you experience any severe allergic reactions or worsening asthma symptoms.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
12 SQ-HDM (standardized quality house dust mite) tablet daily, sublingually
Condition-Specific Dosing:
initialDose:
First dose should be administered in a healthcare setting under the supervision of a physician experienced in the diagnosis and treatment of allergic diseases, with equipment and personnel immediately available to treat anaphylaxis.
maintenanceDose:
Continue daily administration of 12 SQ-HDM tablet.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (approved for ages 12-17 years)
Adolescent:
12 SQ-HDM tablet daily, sublingually (for ages 12-17 years)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; unlikely to be affected due to mechanism of action
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Odactra is an allergen extract that induces an immune response to house dust mite allergens. The exact mechanisms of allergen immunotherapy are not completely understood but are thought to involve modulation of the immune system, leading to a reduction in allergic symptoms upon subsequent exposure to the allergen. This includes a shift from a Th2 to a Th1 immune response, induction of regulatory T cells, and a decrease in allergen-specific IgE, while increasing allergen-specific IgG4.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (acts locally and systemically via immune cells, not absorbed as intact drug)
Tmax:
Not applicable
FoodEffect:
Not studied; administer after removal of tablet from blister pack and placing under the tongue until dissolved.
Distribution:
Vd:
Not applicable
ProteinBinding:
Not applicable
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable
Clearance:
Not applicable
ExcretionRoute:
Not applicable
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Clinical benefit typically observed within 8-14 weeks of daily administration, with continued improvement over 1-2 years.
PeakEffect:
Not applicable (immune modulation, not a single peak effect)
DurationOfAction:
Sustained benefit after discontinuation has been observed in some studies, but long-term duration of effect after stopping treatment is not fully established.
Safety & Warnings
BLACK BOX WARNING
ODACTRA can cause severe allergic reactions that may be life-threatening. These reactions may include anaphylaxis. Administer the first dose in a healthcare setting under the supervision of a physician experienced in the diagnosis and treatment of allergic diseases, with equipment and personnel immediately available to treat anaphylaxis. Observe the patient for at least 30 minutes. Prescribe auto-injectable epinephrine to patients prescribed ODACTRA and instruct them on its proper use. Do not prescribe ODACTRA to patients with severe, unstable, or uncontrolled asthma.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Some allergic reactions can be life-threatening
Trouble swallowing or speaking
Pain when swallowing
Heartburn
Chest pain or pressure
Fast heartbeat
Passing out
Dizziness
Flushing
Shortness of breath
Cough
Severe stomach upset or vomiting
Stomach cramps
Mouth irritation or mouth sores
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Itching in the ear, mouth, or tongue
Throat pain
Throat irritation
Upset stomach
Stomach pain or diarrhea
* Change in taste
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Some allergic reactions can be life-threatening
Trouble swallowing or speaking
Pain when swallowing
Heartburn
Chest pain or pressure
Fast heartbeat
Passing out
Dizziness
Flushing
Shortness of breath
Cough
Severe stomach upset or vomiting
Stomach cramps
Mouth irritation or mouth sores
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Itching in the ear, mouth, or tongue
Throat pain
Throat irritation
Upset stomach
Stomach pain or diarrhea
* Change in taste
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Difficulty breathing or swallowing
- Wheezing or shortness of breath
- Dizziness or fainting
- Rapid or weak heartbeat
- Severe rash, hives, or itching
- Swelling of the face, lips, tongue, or throat
- Severe stomach pain, vomiting, or diarrhea
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A history of severe allergic reactions.
A diagnosis of eosinophilic esophagitis.
Any current or recent mouth-related issues, including swelling, sores, infections, mouth injuries, tooth loss, or oral surgery.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
A history of severe allergic reactions.
A diagnosis of eosinophilic esophagitis.
Any current or recent mouth-related issues, including swelling, sores, infections, mouth injuries, tooth loss, or oral surgery.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Note that this drug is not effective in relieving allergy symptoms that have already appeared. If you are experiencing allergy symptoms, consult with your doctor to discuss the best course of action.
If you have asthma and experience difficulty breathing or notice that your asthma symptoms are worsening, contact your doctor immediately.
Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of using this medication to ensure the best possible outcome for you and your baby.
Note that this drug is not effective in relieving allergy symptoms that have already appeared. If you are experiencing allergy symptoms, consult with your doctor to discuss the best course of action.
If you have asthma and experience difficulty breathing or notice that your asthma symptoms are worsening, contact your doctor immediately.
Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of using this medication to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe systemic allergic reactions (anaphylaxis)
- Exacerbation of asthma symptoms
- Severe local oral reactions
What to Do:
Seek immediate emergency medical attention. Administer auto-injectable epinephrine if available and indicated. Call 911 or your local emergency number. Call Poison Control at 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Patients with severe, unstable, or uncontrolled asthma
- Patients with a history of severe systemic allergic reaction to allergen immunotherapy
- Patients with eosinophilic esophagitis
- Patients who are unable to comply with the administration instructions (e.g., unable to hold the tablet under the tongue for the required time)
Major Interactions
- Beta-blockers (may exacerbate anaphylaxis and reduce effectiveness of epinephrine)
- Monoamine Oxidase Inhibitors (MAOIs), Tricyclic Antidepressants (TCAs), and Catechol-O-Methyltransferase (COMT) inhibitors (may potentiate effects of epinephrine)
Moderate Interactions
- Antihistamines (may mask early symptoms of systemic allergic reactions)
- Corticosteroids (may reduce the immune response to the allergen extract, but generally not a contraindication for use)
Monitoring
Baseline Monitoring
Asthma control assessment
Rationale: To ensure asthma is stable and well-controlled before initiating treatment, as uncontrolled asthma is a contraindication.
Timing: Prior to first dose
History of severe allergic reactions
Rationale: To identify patients at higher risk for adverse events.
Timing: Prior to first dose
Oral cavity examination
Rationale: To ensure no significant inflammation, wounds, or lesions that could increase systemic absorption and risk of adverse reactions.
Timing: Prior to first dose
Routine Monitoring
Symptoms of local oral reactions (e.g., oral pruritus, swelling, irritation)
Frequency: Daily, especially during initial weeks
Target: Minimal to mild
Action Threshold: Persistent, severe, or worsening symptoms may require temporary discontinuation or re-evaluation.
Symptoms of systemic allergic reactions (e.g., urticaria, angioedema, dyspnea, wheezing, dizziness)
Frequency: Daily, especially during initial weeks and with each dose
Target: Absence of symptoms
Action Threshold: Any systemic reaction requires immediate medical attention and evaluation for epinephrine administration.
Asthma control
Frequency: Regularly, as per asthma management guidelines
Target: Well-controlled
Action Threshold: Worsening or uncontrolled asthma requires immediate medical evaluation and potential discontinuation of Odactra.
Symptom Monitoring
- Oral itching
- Oral swelling
- Throat irritation
- Abdominal pain
- Nausea
- Vomiting
- Diarrhea
- Urticaria (hives)
- Angioedema (swelling of face, lips, tongue, throat)
- Dyspnea (shortness of breath)
- Wheezing
- Cough
- Chest tightness
- Dizziness
- Lightheadedness
- Fainting
- Rapid or weak pulse
- Hypotension (low blood pressure)
Special Patient Groups
Pregnancy
Limited data available. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. The FDA label states that available data are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Trimester-Specific Risks:
First Trimester:
Insufficient data
Second Trimester:
Insufficient data
Third Trimester:
Insufficient data
Lactation
No data on the presence of Odactra in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Odactra and any potential adverse effects on the breastfed infant from Odactra or from the underlying maternal condition.
Infant Risk:
Unknown
Pediatric Use
Approved for use in patients 12 through 65 years of age. Safety and effectiveness in children younger than 12 years of age have not been established.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Odactra is indicated for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, in patients 12 through 65 years of age.
- The first dose must be administered in a healthcare setting due to the risk of anaphylaxis.
- Patients must be prescribed and instructed on the use of auto-injectable epinephrine.
- Patients should be advised to avoid taking Odactra if they have any oral inflammation, sores, or wounds, and to wait until the oral cavity has healed.
- Treatment should be continued daily for at least 12 months to achieve optimal benefit, and continued for up to 3 years based on clinical response.
- Patients should be monitored for at least 30 minutes after the first dose for signs of systemic allergic reactions.
Alternative Therapies
- Other sublingual allergen immunotherapies (e.g., Oralair, Grastek, Ragwitek)
- Subcutaneous allergen immunotherapy (allergy shots)
- Symptomatic treatments (e.g., antihistamines, nasal corticosteroids, decongestants, mast cell stabilizers)
- Environmental control measures (e.g., reducing HDM exposure)
Cost & Coverage
Average Cost:
$300-$400 per 30 tablets
Insurance Coverage:
Specialty Tier (often requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it was taken, to facilitate prompt and effective treatment.