Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Adverse systemic reactions usually occur within minutes and consist primarily of allergic symptoms such as generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema and hypotension.
Less commonly, nausea, emesis, abdominal cramps, diarrhea and uterine contractions may occur.
Severe reactions may cause shock and loss of consciousness.
Fatalities have occurred rarely (11).
Systemic reactions occur with varying frequency in different clinics.
To some extent, the reaction rate is related to the type and dose of administered extract and to the degree of sensitivity of the patient.
Despite all precautions, occasional reactions are unavoidable.
Reports from regulatory authorities in Sweden to the Center for Biologics Evaluation and Research (CBER) indicated that several deaths have been associated with the use of mite extracts.
CBER was subsequently informed that these deaths may have been related to use by physicians or other health professionals untrained in the administration of potent allergens, rather than a product defect.
It should be noted that anaphylaxis and deaths following the injection of mite and other extracts also have been reported by the British Committee on Safety in Medicine in the British Medical Journal, 293:943,
WARNINGS Concentrated extract must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing.
All concentrates of allergenic extract are manufactured to assure high potency and therefore have the ability to cause serious local and systemic reactions, including death in sensitive patients (11).
Patients should be informed of this risk and precautions should be discussed prior to initiating immunotherapy (see PRECAUTIONS below).
Allergenic extract should be temporarily withheld from patients or the dose adjusted downward if any of the following conditions exist: 1) severe symptoms of rhinitis and/or asthma;
2) infection or flu accompanied by fever;
Like all medications, House Dust Mite, Dermatophagoides Farinae can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: