Honey Bee Hymenoptera Venom Venomil Diagnostic Kit Honey Bee Hymenoptera Venom Venomil Maintenance Kit White Faced Hornet Hymenoptera Venom Venomil Diagnostic Kit White Faced Hornet Hymenoptera Venom Venomil Maintenance Kit Yellow Hornet Hymenoptera Venom Venomil Diagnostic Kit Yellow Hornet Hymenoptera Venom Venomil Maintenance Kit Wasp Hymenoptera Venom Venomil Diagnostic Kit Wasp Hymenoptera Venom Venomil Maintenance Kit Yellow Jacket Hymenoptera Venom Venomil Diagnostic Kit Yellow Jacket Hymenoptera Venom Venomil Maintenance Kit Mixed Vespid Hymenoptera Venom Venomil Maintenance Kit

Honey Bee Hymenoptera Venom Venomil Diagnostic Kit Honey Bee Hymenoptera Venom Venomil Maintenance Kit White Faced Hornet Hymenoptera Venom Venomil Diagnostic Kit White Faced Hornet Hymenoptera Venom Venomil Maintenance Kit Yellow Hornet Hymenoptera Venom Venomil Diagnostic Kit Yellow Hornet Hymenoptera Venom Venomil Maintenance Kit Wasp Hymenoptera Venom Venomil Diagnostic Kit Wasp Hymenoptera Venom Venomil Maintenance Kit Yellow Jacket Hymenoptera Venom Venomil Diagnostic Kit Yellow Jacket Hymenoptera Venom Venomil Maintenance Kit Mixed Vespid Hymenoptera Venom Venomil Maintenance Kit

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Honey Bee Hymenoptera Venom Venomil Diagnostic Kit Honey Bee Hymenoptera Venom Venomil Maintenance Kit White Faced Hornet Hymenoptera Venom Venomil Diagnostic Kit White Faced Hornet Hymenoptera Venom Venomil Maintenance Kit Yellow Hornet Hymenoptera Venom Venomil Diagnostic Kit Yellow Hornet Hymenoptera Venom Venomil Maintenance Kit Wasp Hymenoptera Venom Venomil Diagnostic Kit Wasp Hymenoptera Venom Venomil Maintenance Kit Yellow Jacket Hymenoptera Venom Venomil Diagnostic Kit Yellow Jacket Hymenoptera Venom Venomil Maintenance Kit Mixed Vespid Hymenoptera Venom Venomil Maintenance Kit Recall

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Questions & Answers

Side Effects & Adverse Reactions

See WARNINGS box at the beginning of this Instruction Sheet. See also PRECAUTIONS.
Venom extract must 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; (3) any evidence of an excessively large local or any generalized reaction during the initial stages of immunotherapy, or during maintenance therapy; and/or (4) insect sting prior to a scheduled injection. Do not administer venom injections during a period of symptoms following an insect sting or on the day the patient received an insect sting, since this could result in an allergen load that exceeds the patient's tolerance.
THE CONCENTRATE MUST NOT BE INJECTED AT ANY TIME UNLESS TOLERANCE HAS BEEN ESTABLISHED. DILUTE CONCENTRATED EXTRACTS WITH STERILE ALBUMIN SALINE WITH PHENOL (0.4%) FOR SKIN TESTING AND IMMUNOTHERAPY.
INJECTIONS MUST NEVER BE GIVEN INTRA VENOUSLY. Subcutaneous injection is recommended. Intracutaneous or intramuscular injections may produce large local reactions or be excessively painful. AFTER INSERTING NEEDLE SUBCUTANEOUSLY, BUT BEFORE INJECTING, ALWAYS WITHDRAW THE PLUNGER SLIGHTLY. IF BLOOD APPEARS IN THE SYRINGE, CHANGE NEEDLE AND GIVE THE INJECTION IN ANOTHER SITE.
Patients with hypersensitivity to insect venom who undergo desensitization treatment while under concomitant therapy with ACE (angiotensin-converting enzyme) inhibitors, may have an increased risk of life-threatening anaphylactic reactions. (9) Patients without insect venom hypersensitivity, who take ACE inhibitors, and are stung by insects such as bee or wasp can show such reactions as well. (10)
Two patients undergoing desensitization treatment with Hymenoptera Venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge. (11)

IF CHANGING TO A DIFFERENT LOT OR A FRESHLY RECONSTITUTED VIAL OF VENOM EXTRACT:
All extracts lose potency over time, and a fresh extract could have an effective potency that is substantially greater than that of the old extract. The first dose from the new vial should not exceed 50% of the previous dose.
IF THE VENOM EXTRACT PREVIOUSLY USED WAS FROM ANOTHER MANUFACTURER: Since manufacturing processes and sources of raw materials differ among manufacturers, the interchangeability of extracts from different manufacturers cannot be insured. The starting dose of the venom extract therefore should be greatly decreased even though the extract is the same formula and dilution. In general, a dose reduction to 50% of the previous product dose should be adequate, but each situation must be evaluated separately considering the patient's history of sensitivity, tolerance of previous injections, and other factors. If the patient tolerates a 50% decrease, the next dose could be raised to the previous dose amount. If the decrease is greater than 50%, the next dose would need to be determined by the allergist, depending on the situation. Dose intervals should not exceed one week when rebuilding dose. See DOSAGE AND ADMINISTRATION.
IF A PROLONGED PERIOD OF TIME HAS ELAPSED SINCE THE LAST INJECTION: Patients may lose tolerance for allergen injections during prolonged periods between doses. The duration of tolerance is an individual characteristic and varies from patient to patient. In general, the longer the lapse in the injection schedule, the greater dose reduction required. If the interval since last dose is over four weeks, perform skin tests to determine starting dose. See DOSAGE AND ADMINISTRATION.
IF THE PREVIOUS EXTRACT WAS OUTDATED: The dating period for allergenic extracts indicates the time that they can be expected to remain potent under refrigerated storage conditions (2° - 8°C). During the storage of extracts, even under ideal conditions, some loss of potency occurs. For this reason, extracts should not be used beyond their expiration date. If a patient has been receiving injections of an outdated extract, s/he may experience excessive local or systemic reactions when changed to a new, and possibly more potent extract. In general, the longer the material has been outdated, the greater the dose reduction necessary when starting the fresh extract.
Proper selection of the dose and careful injection should prevent most systemic reactions. It must be remembered, however, that allergenic extracts are highly potent in sensitive individuals and that systemic reactions of varying degrees of severity may occur, ranging from mild to life-threatening anaphylaxis, or even death, as described under INDICATIONS AND USAGE and ADVERSE REACTIONS. Patients should be informed of this, and the warnings and precautions should be discussed prior to immunotherapy. See PRECAUTIONS below. Systemic reactions should be treated as indicated in ADVERSE REACTIONS.
Proper selection of the dose and careful injection should prevent most systemic reactions. It must be remembered, however, that allergenic extracts are highly potent in sensitive individuals and that systemic reactions of varying degrees of severity may occur, ranging from mild to life-threatening anaphylaxis, or even death, as described under INDICATIONS AND USAGE and ADVERSE REACTIONS. Patients should be informed of this, and the warnings and precautions should be discussed prior to immunotherapy. See PRECAUTIONS below. Systemic reactions should be treated as indicated in ADVERSE REACTIONS.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

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Uses

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 demonstrated false positive reactions when skin testing with venom concentrations of 10 µg/mL and 100 µg/mL was carried out.(8) 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.

History

There is currently no drug history available for this drug.

Other Information

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.
Because of the difficulty in collecting all species of Yellow Jacket and Wasp, the venom raw materials for these two insects may vary in species composition from lot to lot. A listing of the exact species content for any particular lot of Yellow Jacket or Wasp venom protein may be obtained by calling Technical Services at Jubilant HollisterStier, (800) 992-1120.
Final containers of sterile freeze-dried venom products are sealed under vacuum. This will result in the diluting fluid being forcibly drawn into the sealed vial when the syringe needle penetrates the seal during reconstitution. See PRECAUTIONS.
Venom or venom protein is supplied in 2 mL diagnostic vials and in 2 mL vials for treatment maintenance. The chart below lists for each vial size the content of lyophilized venom or venom protein and reconstituted product, (mannitol and venom concentrations). Trace amounts of sodium chloride, potassium chloride, acetic acid and beta-alanine, as well as the constituents of the reconstituting fluid, will also be present.


Vial Size µg Venom or
Venom Protein
Reconstitution mg/mL Mannitol Venom Concentration
Single Venom
2 mL
120
1.2 mL
7.7 mg/mL
100µg/mL
Mixed Vespid
2 mL
360
1.2 mL
23.1 mg/mL
300 µg/mL
See product configuration in DOSAGE AND ADMINISTRATION Section.

Maintenance sterile freeze-dried products can be reconstituted in Sterile Albumin Saline with Phenol (which contains 0.9% NaCl, 0.4% phenol and 0.03% Human Serum Albumin) to a concentration of 100 µg/mL (300 µg/mL for Mixed Vespid venom protein). The diagnostic product should be reconstituted only with Sterile Albumin Saline with Phenol (0.4%). See DOSAGE AND ADMINISTRATION for details of dilutions for diagnosis and treatment.

Space is provided on the container label to record the date (month, day, year) venom is reconstituted. Refer to dating period shown under PRECAUTIONS. At the time of reconstitution, write the calculated reconstituted product expiration date (month, day, year) on the vial label in the space provided.

Honey Bee Hymenoptera Venom Venomil Diagnostic Kit Honey Bee Hymenoptera Venom Venomil Maintenance Kit White Faced Hornet Hymenoptera Venom Venomil Diagnostic Kit White Faced Hornet Hymenoptera Venom Venomil Maintenance Kit Yellow Hornet Hymenoptera Venom Venomil Diagnostic Kit Yellow Hornet Hymenoptera Venom Venomil Maintenance Kit Wasp Hymenoptera Venom Venomil Diagnostic Kit Wasp Hymenoptera Venom Venomil Maintenance Kit Yellow Jacket Hymenoptera Venom Venomil Diagnostic Kit Yellow Jacket Hymenoptera Venom Venomil Maintenance Kit Mixed Vespid Hymenoptera Venom Venomil Maintenance Kit Manufacturers


  • Jubilant Hollisterstier Llc
    Honey Bee Hymenoptera Venom Venomil Diagnostic Kit Honey Bee Hymenoptera Venom Venomil Maintenance Kit White Faced Hornet Hymenoptera Venom Venomil Diagnostic Kit White Faced Hornet Hymenoptera Venom Venomil Maintenance Kit Yellow Hornet Hymenoptera Venom Venomil Diagnostic Kit Yellow Hornet Hymenoptera Venom Venomil Maintenance Kit Wasp Hymenoptera Venom Venomil Diagnostic Kit Wasp Hymenoptera Venom Venomil Maintenance Kit Yellow Jacket Hymenoptera Venom Venomil Diagnostic Kit Yellow Jacket Hymenoptera Venom Venomil Maintenance Kit Mixed Vespid Hymenoptera Venom Venomil Maintenance Kit [Jubilant Hollisterstier Llc]

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