Odactra Side Effects Center

Last updated on RxList: 4/20/2022
Odactra Side Effects Center

What Is Odactra?

Odactra House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus allergen extract tablet) is an allergen extract indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts.

What Are Side Effects of Odactra?

Common side effects of Odactra House Dust Mite include:

  • throat irritation or tickle,
  • itching in the mouth or in the ear,
  • swelling of the uvula/back of the mouth,
  • swelling of the lips or tongue,
  • nausea,
  • tongue pain,
  • throat swelling,
  • tongue ulcer/sore on the tongue,
  • stomach pain,
  • sore or ulcer in the mouth, and
  • changes in taste

Serious allergic reactions (anaphylaxis) can also occur.

Dosage for Odactra

The dose of Odactra House Dust Mite allergen extract tablet is one tablet daily. Place the tablet immediately under the tongue where it will dissolve within 10 seconds. Do not swallow for at least 1 minute.

What Drugs, Substances, or Supplements Interact with Odactra?

Odactra House Dust Mite may interact with other drugs. Tell your doctor all medications and supplements you use.

Odactra During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Odactra House Dust Mite; it is unknown how it would affect a fetus. It is unknown if Odactra House Dust Mite passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Odactra House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus allergen extract tablet) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Odactra Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In four double-blind, placebo-controlled, randomized clinical studies, a total of 1279 subjects with house dust mite-induced allergic rhinitis, with or without conjunctivitis, 18 through 65 years of age was treated with at least one dose of ODACTRA 12 SQHDM. Of subjects treated with ODACTRA in the four studies, 50% had mild to moderate asthma and 71% were polysensitized to other allergens in addition to HDM, including trees, grasses, weeds, molds, and animal danders. The study population was 88% White, 6% African American, 4% Asian and 55% female.

Study 1 (NCT01700192) was a randomized, double-blind, placebo-controlled study conducted in the US and Canada evaluating ODACTRA in 1482 subjects 12 years of age and older with house dust mite-induced allergic rhinitis with or without conjunctivitis. Of the 1482 subjects, 640 subjects 18 through 65 years of age received at least one dose of ODACTRA, with a median treatment duration of 267 days (range 1 to 368 days). 631 subjects received placebo. Placebo tablets contained the same inactive ingredients as ODACTRA without allergen extract and were packaged identically so that treatment blind/masking was maintained. Participants were monitored for unsolicited adverse events and serious adverse events (SAEs) for the duration of therapy (up to 52 weeks). Participants were monitored for solicited adverse reactions for the first 28 days following treatment initiation.

Study participants were provided side effect report cards in which they recorded the occurrence of specific solicited adverse reactions daily for the first 28 days following treatment initiation with ODACTRA or placebo. In Study 1, the most common solicited adverse reactions reported in ≥10% of subjects treated with ODACTRA were: throat irritation/tickle (67.0% vs. 20.8% placebo), itching in the mouth (61.3% vs. 14.1%), itching in the ear (51.7% vs. 11.7%), swelling of the uvula/back of the mouth (19.8% vs. 2.4%), swelling of the lips (18.0% vs. 2.7%), swelling of the tongue (15.8% vs. 2.1%), nausea (14.2% vs. 7.1%), tongue pain (14.2% vs. 3.0%), throat swelling (13.6% vs. 2.4%), tongue ulcer/sore on the tongue (11.6% vs. 2.1%), stomach pain (11.3% vs. 5.2%), mouth ulcer/sore in the mouth (10.3% vs. 2.9%), and taste alteration/food tastes different (10.0% vs. 3.6%). Table 1 summarizes all solicited adverse reactions reported within the first 28 days of treatment initiation in subjects 18 through 65 years of age using the patient-friendly term.

Table 1: Percentages of Solicited* Adverse Reactions Within 28 Days After Initiation of Treatment with ODACTRA (Study 1, Safety Analysis Set) in Patients 18 through 65 Years of Age (NCT01700192)

Adverse Reaction (Patient-Friendly Term) Study Population:
Study 1
Adverse Reactions of Any Intensity
Study Population:
Study 1
Adverse Reactions That Were Severe
ODACTRA
(N=640)
Placebo
(N=631)
ODACTRA
(N=640)
Placebo
(N=631)
Ear and labyrinth disorders
Itching in the ear 51.7% 11.7% 0.3% -
Gastrointestinal disorders
Itching in the mouth 61.3% 11.1% 0.2% -
Swelling of the uvula/back of the mouth 19.8% 2.4% - -
Swelling of the lips 18.0% 2.7% - -
Swelling of the tongue 15.8% 2.1% - -
Nausea 14.2% 7.1% - -
Tongue pain 14.2% 3.0% - -
Tongue ulcer/sore on the tongue 11.6% 2.1% - -
Stomach pain 11.3% 5.2% 0.2% -
Mouth ulcer/sore in the mouth 10.3% 2.9% - -
Diarrhea 6.9% 3.6% - -
Vomiting 2.5% 1.4% - -
Nervous system disorders
Taste alteration/food tastes different 10.0% 3.6% - -
Respiratory, thoracic and mediastinal disorders
Throat irritation/tickle 67.0% 20.8% 0.3% -
Throat swelling 13.6% 2.4% 0.2% -
In Table 1, the dashes represent no subjects.
*Solicited adverse reactions (modified from World Allergy Organization [WAO] list of local side effects of sublingual immunotherapy [SLIT]) were those reported by subjects within the first 28 days after treatment initiation.
Severe adverse reactions were those assessed by the investigator as severe in intensity, which is defined as incapacitating with inability to work or do usual activity.
The percentage of subjects reported for the patient-friendly term of "swelling of the uvula/back of the mouth" includes subjects with an enlarged uvula, palatal swelling/edema, and/or mouth swelling/edema (which can be anywhere in the mouth, not specifically back of the mouth).

In Study 1, the timing of the adverse reaction relative to exposure to ODACTRA was evaluated for 7 solicited adverse reactions (itching in the ear, itching in the mouth, swelling of the uvula/back of the mouth, swelling of the lips, swelling of the tongue, throat irritation/tickle, and throat swelling). The median time to onset of these adverse reactions following initiation of treatment with ODACTRA varied from 1 to 7 days. The median duration of these adverse reactions that occurred on the first day of treatment initiation varied from 30 to 60 minutes. These adverse reactions recurred for a median of 2 to 12 days.

In Study 1, the following unsolicited adverse events were reported in numerically more subjects treated with ODACTRA than with placebo and occurred in ≥1% of subjects 18 through 65 years of age within 28 days after initiation of treatment with ODACTRA: paresthesia oral (9.2% vs. 3.2%), tongue pruritus (4.7% vs. 1.1%), oral pain (2.7% vs. 0.6%), stomatitis (2.5% vs. 1.1%), dyspepsia (2.2% vs. 0.0%), pharyngeal erythema (2.0% vs. 0.3%), eye pruritus (1.7% vs. 1.4%), oral mucosal erythema (1.7% vs. 0.2%), upper respiratory tract infection (1.6% vs. 1.1%), sneezing (1.6% vs. 0.3%), lip pruritus (1.4% vs. 0.3%), dysphagia (1.4% vs. 0.0%), fatigue (1.3% vs. 1.0%), hypoesthesia oral (1.3% vs. 1.0%), oropharyngeal pain (1.3% vs. 0.6%), chest discomfort (1.3% vs. 0.3%), dry throat (1.3% vs. 0.3%), pruritus (1.1% vs. 1.0%), and urticaria (1.1% vs. 0.3%).

Studies 2 (NCT01454544) and 3 (NCT01644617) were randomized, double-blind, placebo-controlled studies of subjects 18 years of age and older with house dust mite-induced allergic rhinitis with or without conjunctivitis, and with or without asthma. Study 4 (NCT01433523) was a randomized, double-blind placebo-controlled study that included subjects 18 years of age and older with house dust mite-induced asthma and allergic rhinitis, with or without conjunctivitis.

Across the four clinical studies, 1279 subjects received at least one dose of ODACTRA, of whom 1104 (86%) completed at least 4 months of therapy.

The percentages of subjects in these studies who discontinued treatment because of an adverse reaction while exposed to ODACTRA or placebo were 8.1% and 3.0%, respectively. The most common adverse reactions (≥1.0%) that led to study discontinuation in subjects who received ODACTRA were throat irritation (1.5%), oral pruritus (1.3%), ear pruritus (1.1%), and mouth swelling (1.0%).

Serious adverse events were reported, 16/1279 (1.3%) among ODACTRA recipients and 23/1277 (1.8%) among placebo recipients. No deaths were reported.

Epinephrine use was reported in 5/1279 (0.4%) subjects who received ODACTRA compared to 3/1277 (0.2%) of subjects who received placebo. Of these subjects, 1 ODACTRA recipient reported a systemic allergic reaction and used epinephrine on the day of treatment initiation compared to 2 placebo recipients who reported anaphylaxis and used epinephrine 6 and 25 days after treatment initiation, respectively.

Of 1279 subjects who received ODACTRA, 34 (2.7%) reported dyspepsia compared to 0/1277 (0%) of subjects who received placebo. Twenty subjects who received ODACTRA (1.6%) reported symptoms of gastroesophageal reflux disease (GERD) compared to 3/1277 (0.2%) of subjects who received placebo.

Across 8 clinical studies conducted with different doses of ODACTRA, eosinophilic esophagitis was reported in 2/2737 (0.07%) subjects who received ODACTRA compared to 0/1636 (0%) subjects who received placebo.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ODACTRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous Tissue Disorders: erythema.

Immune System Disorders: serious systemic allergic reactions, including anaphylaxis.

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Odactra (Dermatophagoides Farinae and Dermatophagoides Pteronyssinus)

SLIDESHOW

Could I Be Allergic? Discover Your Allergy Triggers See Slideshow

© Odactra Patient Information is supplied by Cerner Multum, Inc. and Odactra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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