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“Before administering the first dose, providers should make sure that the patient is allergic to house dust mites either via the skin test or blood test,” says Dr. Bardelas. “After the tablet is placed under the tongue, it will dissolve in about 10 seconds. The patient should be instructed not to swallow for another minute.”
Dr. Bardelas notes that after receiving the first dose, the patient should be observed for at least 30 minutes and monitored for the development of signs and symptoms of severe systemic or local allergic reactions. If the first dose is well-tolerated, subsequent doses may be taken at home.9
“The patient may experience some irritation and itching in the mouth or throat, or mild lip swelling, but these symptoms are usually mild in the majority of cases and will resolve in 1-2 weeks after which the remaining doses should be well tolerated,” says Dr. Bardelas.
According to the ODACTRA PI, auto-injectable epinephrine should be prescribed to patients treated with ODACTRA due to the risk, albeit very low, of life-threatening allergic reactions such as severe laryngopharyngeal restriction and anaphylaxis.9
“The FDA requires that epinephrine be prescribed to patients on ODACTRA, but in the studies approximately 0.4% of study subjects required epinephrine, so serious allergic reactions with this medication are a rare occurrence,” says Dr. Bardelas. “The availability of epinephrine is a necessary precaution for both allergy injections given in the office and SLIT-tablets.”
Dr. Bardelas notes that, like other allergen immunotherapies, ODACTRA is not a fast-acting therapy and it will take time to see treatment benefits.9
“It usually takes patients 3 months to see improvements in their AR symptoms,” he says. “Treatment duration will depend on patient response. If a patient does well, we would continue treatment for at least 3 years. After 3 years, many patients will have developed immune tolerance and can do well without further use of ODACTRA.”
The safety profile of ODACTRA
It is important to set expectations with patients that adverse events may occur, which were found to be generally mild to moderate, local, and well tolerated.9 The most common solicited adverse reactions reported in ≥10% of subjects treated with ODACTRA were throat irritation/tickle, itching in the mouth, itching in the ear, swelling of the uvula/back of the mouth, swelling of the lips, swelling of the tongue, nausea, tongue pain, throat swelling, tongue ulcer/sore on the tongue, stomach pain, mouth ulcer/sore in the mouth, and taste alteration/food tastes different.9
The following symptoms may be signs of a more serious allergic reaction to ODACTRA12:
- Breathing problems
- Tightness or swelling of the throat
- Problems with swallowing or speaking
- Feeling faint or dizzy
- Weak or rapid heartbeat
- Severe itching or flushing of the skin
- Severe GI upset: stomach pain or cramps, vomiting, or diarrhea
Important considerations related to ODACTRA SLIT-tablet therapy
According to theODACTRA Medication Guide, ODACTRA should not be taken by patients who have severe, unstable or uncontrolled asthma or were in the past diagnosed with eosinophilic esophagitis, patients who experienced a severe allergic reaction in the past or those who have experienced breathing difficulty after using any sublingual immunotherapy before, and patients who are allergic to any of the inactive ingredients contained in ODACTRA (gelatin, mannitol, and sodium hydroxide).12
Prescribing information for ODACTRA recommends that treatment with ODACTRA be discontinued in patients with severe or persistent gastroesophageal symptoms including dysphagia or chest pain, patients with oral inflammation (mouth ulcers, thrush, or oral lichen planus) or oral wounds, and in patients experiencing an acute asthma exacerbation.9 As per the ODACTRA PI, treatment discontinuation should be considered in patients who experience persistent and escalating adverse effects in the throat and mouth.9
