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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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)
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.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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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 |
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.
Sources
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
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Jubilant Hollisterstier Llc
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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 | Jubilant Hollisterstier Llc
(1) General
Extract of Volume Extract Concentration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Reconstitute and dilute the freeze-dried venom as directed below. Sterile Albumin Saline with Phenol (0.4%) must be used to reconstitute and dilute the venoms for skin testing and treatment.
Reconstitute the freeze-dried venoms by adding 1.2 mL Sterile Albumin Saline with Phenol (0.4%) to the vial using a sterile syringe. Swirl or rock the container to dissolve the venom completely. DO NOT SHAKE, since shaking can cause foaming.
Dilutions (see table below) must be made in Sterile Albumin Saline with Phenol (0.4%). They must be made accurately and aseptically, using sterile solutions, vials, syringes, etc., and thoroughly mixed by rocking or swirling. DO NOT SHAKE. Maintain stock solutions and dilutions constantly at 2° - 8°C.
Diluent Volume
Dilution Concentration 1 part of
100 µg/mL
+
9 parts
=
10 µg/mL
1 part of
10 µg/mL
+
9 parts
=
1 µg/mL
1 part of
1µg/mL
+
9 parts
=
0.1µg/mL
1 part of
0.1 µg/mL
+
9 parts
=
0.01 µg/mL
1 part of
0.01 µg/mL
+
9 parts
=
0.001 µg/mL
1 part of
0.001 µg/mL
+
9 parts
=
0.0001 µg/mL
As an example of the above dilution table:
Extract of Volume Extract Concentration
Diluent Volume
Dilution Concentration 0.2mL of
100 µg/mL
+
1.8mL
=
10 µg/mL
0.2mL of
10 µg/mL
+
1.8mL
=
1 µg/mL
0.2mL of
1 µg/mL
+
1.8mL
=
0.1 µg/mL
0.2mL of
0.1 µg/mL
+
1.8mL
=
0.01 µg/mL
0.2mL of
0.01 µg/mL
+
1.8mL
=
0.001 µg/mL
0.2mL of
0.001 µg/mL
+
1.8mL
=
0.0001 µg/mL
NOTE: Mixed Vespid Venom Protein concentrations will be three times that shown above.
USE OF VENOMIL DIAGNOSTIC SETS
The Venomil Diagnostic Sets from Jubilant HollisterStier contain a vial of freeze dried venom protein that when reconstituted as instructed below will contain 100 µg venom or venom protein/mL.
To use the Venomil Diagnostic set, follow these steps:
1. Open box and remove contents. Be sure to read the complete package Instruction Sheet paying particular attention to the WARNINGS, PRECAUTIONS, CONTRAINDICATIONS, and ADVERSE REACTIONS.
2. Remove the freeze-dried venom vial and one of the seven vials of diluent from the kit. Withdraw 1.3 mL of Albumin Saline with Phenol (0.4%) from the diluent vial using a 2 or 3 mL disposable syringe. Expel some Albumin Saline with Phenol (0.4%) from the syringe until exactly 1.2 mL are remaining in the syringe. The remaining Albumin Saline with Phenol (0.4%) in the diluent vial may be marked "Control" and used as a negative control for prick testing.
3. Insert the needle of the diluent syringe into the vial of venom and expel the diluent. Remove the syringe. Swirl or rock the vial to dissolve the venom completely. DO NOT SHAKE. Shaking can cause foaming of the extract.
At this point, you have completed the reconstitution of the freeze-dried venom. The reconstituted products contain 100 µg of venom or venom protein per mL. DO NOT USE THIS STRENGTH FOR INTRADERMAL SKIN TESTING. DISCARD AFTER THE DILUTIONS HAVE BEEN PREPARED.
4. Remove six vial labels from the kit and mark them: 10 µg/mL, 1 µg/mL, 0.1 µg/mL, 0.01 µg/mL, 0.001 µg/mL and 0.0001 µg/mL. Withdraw 0.2 mL of venom extract in a 1 mL syringe from the vial reconstituted in step #3. Insert the syringe needle into one vial of 1.8 mL Albumin Saline with Phenol (0.4%). Slowly expel the 0.2 mL venom into it. Swirl or rock to mix, and label 10 µg/mL.
5. Withdraw 0.2 mL of the 10 µg/mL venom extract and inject into another vial of 1.8 mL Albumin Saline with Phenol (0.4%). Mix and label 1 µg/mL.
6. The four additional dilutions should be prepared in the same manner.
(2) Diagnosis
Since the level of insect venom specific IgE may fall to low levels briefly after a reaction to a sting, patients should not be tested until 2 to 4 weeks after any sting. Skin testing should be carried out with all five individual venoms, since many patients have multiple sensitivities. (4) Mixed Vespid venom protein should be used only for therapy - not for diagnosis.
Prick testing should be done before intradermal testing to determine appropriate concentration for intradermal testing. See Intradermal Tests. Skin testing (prick and intradermal) provides information to assist in identifying those patients who are to be classified as extremely sensitive and who may not tolerate the Suggested Dose Schedule. See DOSAGE AND ADMINISTRATION, Immunotherapy CAUTION.
In both the prick and intradermal tests, a negative control test with diluent alone must be performed. A histamine positive control test is also recommended.
The flexor surface of the forearm is the usual location for skin testing. It is important that a separate sterile syringe and needle be used for each extract and each patient.
Prick Tests: Prick tests are accomplished by applying one drop of the 1 µg/mL venom extract to the forearm, and by pricking the skin through the surface of the drop with a sterile 27 gauge needle. The prick is superficial and should not draw blood.
Skin response should be assessed after approximately 15-20 minutes.
For prick tests, a positive reaction (reaction greater than diluent control) at the 1 µg/mL concentration indicates a high level of sensitivity to the test venom.
Intradermal Tests: Patients showing a positive reaction to the prick test at the 1 µg/mL concentration should begin intradermal tests at concentrations of not more than 0.0001 to 0.001 µg/mL. Patients with negative prick tests may begin intradermal tests at a concentration of 0.001 µg/mL.
A 1 mL tuberculin syringe with a short 27-gauge needle should be used to deliver a volume of 0.05 mL for intradermal testing. Introduce the needle into the superficial skin layers, bevel down, until the bevel is completely buried, then slowly inject a 0.05 mL aliquot of the venom dilution, making a small bleb.
Start intradermal tests with the most dilute solution. If after 20 minutes no skin reaction is obtained, continue the intradermal testing using ten-fold increments in the concentration until a reaction of 5-10 mm wheal and 11-20 mm erythema is obtained, or until a concentration of 1 µg/mL has been tested, whichever occurs first.
A patient should be considered sensitive to the test venom when a skin response of 5-10 mm wheal and 11-20 mm erythema (or greater) occurs at a concentration of 1 µg/mL or less, (8)providing that this reaction is greater than that of the diluent control.
(3) Immunotherapy
For proper method and route of injection, see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.
The most common site of injection is the lateral aspect of the upper arm.
Patients who have multiple venom sensitivities should be given each specific venom injection in a separate site. (Except, if the patient has sensitivities to Yellow Jacket, Yellow Hornet, and White-Faced Hornet venoms concurrently, s/he can be injected with Mixed Vespid venom protein, an equal mixture of these three vespid venoms). Note which venom preparation is injected at a specific site, so that dosage of that venom preparation can be adjusted if an excessive local reaction occurs. In patients receiving more than one venom, there is theoretically a greater risk of systemic reactions.
CAUTION: Sensitivity to venom differs from patient to patient. Thus, it is not possible to provide a dosage schedule suitable for all patients. The Suggested Dose Schedule shown below was used in
clinical trials (4)and should be suitable for a majority of patients.
IN EXTREMELY SENSITIVE PATIENTS, however, an individualized dose schedule must be employed which will be dictated by the patient's sensitivity. This individualized schedule will probably include weaker dilutions and smaller increments between doses in progressing to the maintenance level (100 µg per venom).
In identifying those patients to be classified as extremely sensitive, individuals reacting with significant skin test (wheal greater than 5 mm and erythema greater than 20 mm) at intradermal skin test concentrations of 0.01 µg/mL or less, or those patients experiencing a systemic reaction to any venom skin test concentration, should be considered highly sensitive.
Suggested Dose Schedule for a Single Venom:
Dose No. *Volume of 1 µg/mL Dose No. Volume of 10 µg/mL Dose No. Volume of 100 µg/mL 1..... ...0.05 mL 5..... ...0.05 mL 9..... ...0.05mL 2..... ...0.10 mL 6..... ...0.10 mL 10.... ...0.10mL 3..... ...0.20 mL 7..... ...0.20 mL 11.... ...0.20mL 4..... ...0.40 mL 8..... ...0.40 mL 12.... ...0.40mL 13.... ...0.60mL 14.... ...0.80mL 15.... ...1.00mL
Mixed Vespid Venom will contain three times the venom protein per mL shown in this table.
*See preceding CAUTION Section.
ALTERNATE MAINTENANCE DOSE SCHEDULE
If the above suggested dosage schedule has been followed, Dose #15 will have emptied the third vial of venom. There should now be three vials of freeze-dried venom remaining in the maintenance set. If a smaller volume maintenance dose is desired, then the remaining vials of venom may be reconstituted with 0.6 mL of Sterile Albumin Saline with Phenol (0.4%) instead of the previously recommended 1.2 mL. When 0.6 mL is used for reconstitution, the maintenance dose volume then becomes 0.5 mL instead of 1.0 mL. The 0.5 mL injection will still contain 100 micrograms of venom or venom protein.
Precautions should be taken to ensure that maintenance level injections of 0.5 mL are given only from those vials of venom that have been reconstituted with 0.6 mL of diluting fluid. Any other volume used for reconstitution will not give 100 micrograms of venom or venom protein at a dosage of 0.5 mL In proceeding with the Suggested Dose Schedule, or modified schedules (for highly sensitive patients) it is recommended that injections be given at least once per week, as in the clinical studies. (See CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). When building the dose, it is important that dose intervals not exceed one week since longer intervals may decrease the patient's tolerance of the extract.
Based on the clinical studies (4)it is suggested that if a systemic, extremely large local (10 cm or more in duration, or other severe local symptoms), or persistent and severe delayed local reaction occurs during the dose building phase, the dose at the next visit be held constant (or reduced, depending on judgment of the severity of the reaction) as was done at Study Center "A," which reported the least number of systemic reactions during the course of therapy.
It must be considered important to achieve the 100 µg per venom maintenance dose (the maintenance dose for Mixed Vespid venom protein is 300 µg), since there are no data on effectiveness of maintenance levels below 100 µg per venom. Following the achievement of maintenance level (100 µg per venom), it is recommended that a second maintenance injection be given at a 1-week interval, and a third maintenance injection at a 2-week interval. Administer the next injection at a 3-week interval, and then monthly for ongoing maintenance.
See CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE for further information regarding clinical studies on which the above recommendations are based.
The optimum duration for immunotherapy is not known, so current recommendations are that maintenance injections be continued indefinitely, year around, particularly in patients experiencing life-threatening anaphylaxis after insect stings.
PEDIATRIC USEThe dose for the pediatric population is the same as for adults. (See PRECAUTIONS).
GERIATRIC USEThe dose for elderly patients is the same as for adult patients under 65.(23) (See PRECAUTIONS).
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