WARNINGS
This product is intended for use only by physicians who are experienced in the administration of high dose allergy injection therapy or for use under the guidance of an allergist.
Hymenoptera Venom extracts may potentially elicit a severe life-threatening systemic reaction, rarely resulting in death. (1) Therefore, emergency measures and personnel trained in their use must be available immediately in the event of such a reaction. Patients should be instructed to recognize adverse reaction symptoms, observed in the office for at least 30 minutes after skin testing or treatment, and cautioned to contact the physician's office if symptoms occur. See ADVERSE REACTION, Section 4, of this instruction for information regarding adverse event reporting.
All patients should have available an Emergency Anaphylaxis Kit containing epinephrine and be instructed in its use for emergency treatment of possible systemic reactions occurring at times after the patient has departed the testing or treatment premises. Patients with cardiovascular diseases and/or pulmonary diseases such as symptomatic unstable, steroid-dependent asthma, and/or those who are receiving cardiovascular drugs such as beta blockers, may be at higher risk for severe adverse reactions. These patients may also be more refractory to the normal allergy treatment regimen. Patients should be treated only if the benefit of treatment outweighs the risks.(1)
Patients on beta blockers may be more reactive to allergens given for testing or treatment and may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.(2)
Immunotherapy for insect sting allergy should be given to those patients who have experienced significant systemic reactions (for detailed description of symptoms see INDICATIONS AND USAGE and ADVERSE REACTIONS) from insect stings and who demonstrate hypersensitivity by skin testing with these products. The only approved method for diagnosing insect sting allergic patients for immunization is by skin testing.
This product must never be injected intravenously.
Refer also to CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and OVERDOSAGE for further discussion.
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SUMMARY
Hymenoptera Venom Products available are sterile freeze-dried venom of Honey Bee (Apis mellifera) and venom protein of Yellow Jacket (Vespula sp.), Yellow Hornet (Dolichovespula arenaria), White-Faced Hornet (Dolichovespula maculata) and Wasp (Polistes sp.). Mixed Vespid venom protein (Yellow Jacket, Yellow Hornet and White-Faced Hornet) is also available.
The reconstituted single venom products are intended for subcutaneous injection for immunotherapy and percutaneous use for diagnosis. The Mixed Vespid venom protein is for immunotherapy only, not for diagnosis. Diagnosis should be based on individual venoms.
Insect stings may induce a wide range of allergic symptoms in sensitive patients. A normal sting response is initial burning or stinging pain that may be intense and last several minutes to an hour or more. There is usually some local swelling coming on immediately and persisting for several days. The location of the sting has considerable influence on the intensity of the pain and extent of swelling. Stings on the fingers or feet produce much pain, but less swelling; whereas a sting on the head or face produces extensive swelling with variable pain.
Local reactions coming on rapidly and larger than the usual local reaction, particularly if the swelling spans both adjacent joints on the extremities, can indicate hypersensitivity. Systemic symptoms come on shortly after the sting, often within seconds to minutes. Symptoms may range from generalized flushing, itching, redness, diffuse swelling of the skin or urticarial wheals, abdominal cramps, nausea, vomiting, or incontinence of urine or stool, to faintness, blurring or loss of vision, unconsciousness, seizures, respiratory or cardiac arrest, or death. Later reactions may consist of fever, achiness, malaise, joint swelling, urticaria or other signs of vascular damage typical of serum sickness, a Type III reaction. Typical delayed Type IV reactions may also occur. (6) Rarely, other types of severe reactions to insect stings have been reported. (6) These include serum sickness, hematologic abnormalities, and neurological disorders commencing some time after a sting, and not associated with anaphylactoid reactions. These patients are not candidates for immunotherapy using insect venoms.
(1) Diagnosis
Skin testing with insect venoms is useful to demonstrate the presence of IgE antibodies which account for the patient's symptoms. (3) Patients are seldom able to identify the insect which stung them, so skin testing is used to determine the insect culprit. Dilutions of these venom products will help judge the sensitivity of the patient and whether the patient should be treated. (7)
It is not absolutely known what levels (micrograms) of venom, that elicit positive skin tests, are diagnostic of clinical sensitivity. However, patients with a history of reactions (any of three types: generalized urticaria or angioedema; respiratory difficulty due either to laryngeal edema or to bronchospasm; or vascular collapse, with or without loss of consciousness) to previous stings and a positive skin test to a venom intradermal injection of approximately 1 μg/mL had about a 60% chance of reacting again when stung by the same insect. These patients should receive venom immunotherapy. (3)
Patients with a history of reaction (any of the three reaction types described above) to previous stings, but who did not demonstrate a positive skin test reaction to venom, were considered in a previous study not to be clinically sensitive, and were not treated. (3) We cannot recommend treatment for such patients.
Another study (8) demonstrated false positive reactions when skin testing with venom concentrations of 10 μg/mL and 100 μg/mL was carried out. Thus there can be a nonspecific skin test reaction potentially due to the pharmacological action of the venom at higher concentrations.
The best statement that can be made, at present, is that patients with significant positive history (reactions of the three types described above) following an insect sting, and who do react with a positive skin test to a venom concentration of 1 μg/mL or less, are recommended for treatment. Patients who have the history described above, but who do not react to a 1 μg/mL intradermal venom skin test, cannot be recommended for treatment. At present, the data does not exist, to determine whether a patient who might react to a higher concentration, e.g., 2-10 μg/mL, is at risk from a subsequent sting or not. Since it is not known if sting-sensitive patients who subsequently lose their IgE anti-venom antibody can be resensitized by further stings, it is advisable to retest these patients after any subsequent stings. (3) However, since the level of venom-specific IgE may fall to low levels briefly after a sting, patients should not be re-tested until 2 to 4 weeks after any sting.
(2) Treatment
Immunotherapy is indicated for those patients diagnosed as sensitive (see Diagnosis above) and is accomplished by using graduated dilutions of the appropriate insect venom or venoms to control the severity of the patient's symptoms from subsequent stings.
Increasing doses of venom are given at intervals, dependent on the patient's ability to tolerate the venoms, until a maintenance dosage (100 μg per venom is recommended — 300 μg in the case of the Mixed Vespid venom protein) is reached and maintained.
Venom sensitivity differs for individual patients, thus it is not possible to provide a dosage schedule that is universally suited to all patients. The dosage schedule shown under DOSAGE AND ADMINISTRATION is a summary of the schedule used in clinical trials of our product and found suitable for the majority of patients.
In highly sensitive patients, the physician may be required to use a modified dose schedule, based on the patient's sensitivity to and tolerance of the injections. Lower initial doses and smaller dosage increments than shown under DOSAGE AND ADMINISTRATION may be necessary.
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NEWS HIGHLIGHTS
Published Studies Related to Hymenoptera Venom Products (Insect Venom)
Venom immunotherapy for preventing allergic reactions to insect stings. [2012]
CONCLUSIONS: We found venom immunotherapy using extracted insect venom
Insect anaphylaxis: addressing clinical challenges. [2011.08]
PURPOSE OF REVIEW: Few allergic reactions are as potentially life-threatening, or frightening to the patient, as anaphylaxis...
Venom immunotherapy in patients with mastocytosis and hymenoptera venom anaphylaxis. [2011.05]
Systemic mastocytosis (SM) is typically suspected in patients with cutaneous mastocytosis (CM). In recent years, the presence of clonal mast cells (MCs) in a subset of patients with systemic symptoms associated with MC activation in the absence of CM has been reported and termed monoclonal MC activation syndromes or clonal systemic MC activation syndromes.
[Hymenoptera venom allergy: new diagnostic tools and management]. [2011.04.20]
Anaphylactic reactions to hymenoptera venoms are common and, in our latitudes, mainly concern wasps and bees... This article focuses on these new laboratory tests and also reviews the management of patients experiencing an anaphylactic reaction after hymenoptera sting.
Management of occupational Hymenoptera allergy. [2011.04]
PURPOSE OF REVIEW: Certain outdoor activities show a particularly high risk for being stung by Hymenoptera species. Avoidance of such stings is preferable for preventing unwanted local or systemic sting reactions... In patients in whom local sting reactions induce symptoms of high clinical significance, an off-label use of venom immunotherapy may be discussed.
Clinical Trials Related to Hymenoptera Venom Products (Insect Venom)
Regulation of Blood Dendritic Cells During Immune Therapy for Hymenoptera Venom Allergy [Recruiting]
Dendritic cells (DC) play a key role in the pathogenesis of allergic diseases. The
regulation of blood dendritic cells in patients with hymenoptera venom allergy before and
during immune therapy is unknown.
Frequency of Hymenoptera-Stings in Patients Under Allergen-Specific Immunotherapy (SIT) [Recruiting]
In Switzerland, 3. 5% of the population are suffering from hymenoptera venom allergy. The
only causal treatment of hymenoptera alelrty is venom specific immunotherapy. There are
however several reasons, which question the relatively broad application of this expensive
treatment. That's why we aim at investigating the actual risk for hymenoptera stings in
patients undergoing allergen specific immunotherapy against hymenoptera sting allergy
Interest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy [Recruiting]
The aim of this study is to show that flow cytometry can be an accurate tool to help
physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom
allergy.
75 patients having a story of reaction to hymenoptera venom will be selected for this trial.
Blood samples will be analyzed at: inclusion visit, Week 1 visit, Week 3 visit, Week 10 and
Week 21 visit.
The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients [Recruiting]
Patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo,
fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by
mast cells. These patients have also an increased frequency of anaphylactic/anaphylactoid
reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast
media, local anesthetics or analgesics. In addition, there is increased osteoporosis in
mastocytosis patients due to the activity of mast cell mediators on osteoblasts and
osteoclasts. Symptoms of mastocytosis respond poorly to treatment with antihistamines or
other antiallergic drugs. There is currently no specific treatment for this disease with the
exception of rare cases. There are, however, some case reports suggesting that omalizumab
might decrease symptoms including hypotensive events.
The aim of the study is to investigate whether patients suffering from mastocytosis benefit
from a 6 month course of omalizumab with regard to symptoms and quality of life and whether
the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the
efficacy of omalizumab in patients with mastocytosis.
- Trial with medicinal product
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