Yellow Hornet Hymenoptera Venom Venomil Diagnostic Kit
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Yellow Hornet Hymenoptera Venom Venomil Diagnostic 65044-9988-01 | Jubilant | 1 kit | — | — | FDA listed | — |
| Yellow Hornet Hymenoptera Venom Venomil Diagnosticthis 65044-9962-01 | Jubilant | 1 kit | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
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- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Mar 13, 2036 |
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65044-9962-01 You're viewing this | 1 KIT in 1 TRAY (65044-9962-1) * 1.2 mL in 1 VIAL (65044-9982-2) | 1982-02-22 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full FDA label FDA SPL
🚨 Boxed Warning ▾
WARNINGS This product is intended for use only by licensed medical personnel experienced in administering allergenic extracts and trained to provide immediate emergency treatment in the event of a life-threatening reaction. 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.
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: Th…
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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 b…
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION (1) General 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. Extract of Volume Extract Concentration 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 m…
⛔ Contraindications ▾
CONTRAINDICATIONS There are no known absolute contraindications to immunotherapy using Hymenoptera Venom Products. See also PRECAUTIONS and WARNINGS . Patients showing negative intradermal skin tests to specific venoms at 1 µg/mL are not recommended for venom treatment.
Any injections, including immunotherapy, should be avoided in patients with a bleeding tendency. 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 maybe unresponsive to the usual doses of epinephrine used to treat systemic reactions .(2) Since there are differences of opinion concerning the possibility of routine immunizations exacerbating autoimmune diseases, immunotherapy should be given cautiously to patients with other immunologic diseases and only if the risk from insect stings is greater than the risk of exacerbating the underlying disorder.
⚠️ Warnings ▾
WARNINGS 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, s…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Physicians administering Hymenoptera Venom testing or treatment materials should be experienced in the treatment of severe systemic reactions (see WARNINGS box at the beginning of this Instruction Sheet). (1) Local Reactions Some erythema, swelling or pruritis at the site of injection are common, the extent varying with the patient. Excessively large, painful or persistent local reactions can occur from skin tests or immunotherapy.
Frequent application of cold, wet dressings to the area and/or the use of oral antihistamines will ameliorate the discomfort. Reactions usually subside in 24-36 hours. Large local reactions occurred in approximately 60% of the patients given immunotherapy in a clinical study.
None of the local reactions required specific treatment; however, subsequent injections in many instances were held to the previous dose or a reduced dose. Some patients had repeated large local reactions that slowed the increase in the immunotherapy dose. 4 See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION Sections.
A mild burning immediately after the injection is to be expected. This usually leaves in 10 to 20 seconds. See also WARNINGS and PRECAUTIONS regarding proper method and route of injection.
(2) Systemic Reactions Most severe systemic reactions will begin within a 30 minute time period, but systemic reactions may occur at any time after skin tests or immunotherapy. Symptoms may range from mild to life threatening from anaphylaxis as described under INDICATIONS AND USAGE . With careful attention to dosage and administration, severe systemic reactions occur infrequently, but it cannot be overemphasized that in sensitive individuals, any injection could result in anaphylactic shock.
Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions. See CLINICAL PHARMACOLOGY for clinical incidence of systemic reactions and course of action following these reactions. If a systemic or anaphylactic reaction does occur, inject 1:1000 epinephrine-hydrochloride intramuscularly or subcutaneously.
EPINEPHRINE DOSAGE ADULT: 0.3 to 0.5 mL should be injected. Repeat in 5 to 10 minutes if necessary. PEDIATRIC: The usual initial dose is 0.01 mg (mL) per kg body weight or 0.3 mg (mL) per square meter of body surface area.
Suggested dosage for infants to 2 years of age is 0.05 mL to 0.1 mL; for children 2 to 6 years, 0.15 mL; and children 6 to 12 years, 0.2 mL. Single pediatric doses should not exceed 0.3 mg (mL). Doses may be repeated as frequently as every 20 minutes, depending on the severity of the condition and the response of the patient.
After administration of epinephrine, profound shock or vasomotor collapse should be treated with intravenous fluids, and possibly vasoactive drugs. Airway patency should be insured. Oxygen should be given by mask.
Intravenous antihistamines, inhaled bronchodilators, theophylline and/or corticosteroids may be used if necessary after adequate epinephrine and circulatory support have been given. Emergency resuscitation measures and personnel trained in their use must be available immediately in the event of a serious systemic or anaphylactic reaction not responsive to the above measures [Ref. J.
Allergy and Clinical Immunology, 77(2): p.271-273, 1986]. Rarely are all of the above measures necessary; epinephrine usually produces a prompt response. However, the physician should be prepared in advance for all contingencies.
Promptness in beginning emergency treatment measures is of utmost importance. For recommendations regarding how to proceed with venom extract dose following systemic reactions, see WARNINGS , PRECAUTIONS and DOSAGE AND ADMINISTRATION . 3.
Adverse Event Reporting Report all adverse events to Jubilant HollisterStier LLC Customer Technical Services Department at 1(800) 992-1120. A voluntary adverse event reporting system for health professionals is available through the FDA MEDWATCH pr…
🔄 Drug Interactions ▾
3. DRUG INTERACTIONS 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. See WARNINGS section regarding concurrent treatment with ACE inhibitors.
Certain medications may lessen the skin test wheal and erythema responses elicited by allergens and histamine for varying time periods. Conventional antihistamines should be discontinued at least 5 days before skin testing. Long acting antihistamines should be discontinued for at least 3 weeks prior to skin testing.
(17) Topical steroids should be discontinued at the skin test site for at least 2-3 weeks before skin testing. (17, 18) Tricyclic antidepressants such as doxepin, should be withheld for at least 7 days before skin testing. (19) Topical local anesthetics may suppress the flare responses and should be avoided on skin test sites .(20) When using other drugs in patients receiving allergenic extracts, always consult the product labeling of the other drugs to determine any possible interaction with use of allergenic extracts, and specifically with stinging insect (Hymenoptera) venom extracts.
🤰 Pregnancy ▾
5. PREGNANCY (12, 21) Pregnancy Category C. Animal reproduction studies have not been conducted with Hymenoptera Venom Products.
It is also not known whether Hymenoptera Venom Products can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hymenoptera Venom Products should be given to a pregnant woman only if clearly needed. On the basis of histamine's known ability to contract uterine muscle, theoretically, a systemic reaction, whether occurring from insect sting or from venom skin testing or treatment dose, should be avoided.
Therefore, the physician must carefully consider the benefit-to-risk ratio, to both patient and fetus, of continuing venom immunotherapy during pregnancy, or performing venom skin testing, and especially of initiating a venom immunotherapy program where there is a possibility that the patient may not be able to reach the recommended maintenance dose without significant risk of a systemic reaction.
🧒 Pediatric Use ▾
7. PEDIATRIC USE Since dosage for the pediatric population is the same as for adults, the larger volumes of solution may produce excessive discomfort. Therefore, in order to achieve the total dose required, the volume of the dose may need to be divided into more than one injection per visit. A study done in children ages 4 to 17 showed no special problems with venom immunotherapy in this population. (22)
PEDIATRIC USE The dose for the pediatric population is the same as for adults. (See PRECAUTIONS ).
🧓 Geriatric Use ▾
8. GERIATRIC USE The reactions from immunotherapy can be expected to be the same in elderly patients as in younger ones. Elderly patients may be more likely to be on medication that could block the effect of epinephrine which could be used to treat serious reactions, or they could be more sensitive to the cardiovascular side effect of epinephrine because of pre-existing cardiovascular disease. (23)
GERIATRIC USE The dose for elderly patients is the same as for adult patients under 65. (23) (See PRECAUTIONS ).
🆘 Overdosage ▾
OVERDOSAGE See ADVERSE REACTIONS Section.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Diagnosis Diluted solutions of stinging insect venom injected intradermally will produce wheal and erythema reactions in patients who have significant IgE-mediated, Type I immediate hypersensitivity to stings of these insects. Treatment Repeated injections of increasing doses of insect venom extracts have been shown to ameliorate the intensity of allergic symptoms upon subsequent insect stings. (3, 4) The mechanism by which hyposensitization is achieved is not known completely.
IgG antibodies (blocking antibodies) appear in the serum of patients treated with injected venom. No direct relationship has been identified between the level of blocking antibody (or the ratio of blocking antibody to IgE antibody directed to the same venom antigens) and the degree of hyposensitization. However, patients who show protection from symptoms after stings have been found to have significant levels of specific blocking antibody.
(3, 4) Initially, after a period of immunotherapy with specific venom antigens, levels of IgE antibody may increase. (4) However, from studies carried out with other venom preparations, these levels are reported to decline after a time. (5) After maintenance level has been reached and maintained, symptoms after stings have been shown to decrease considerably.
(3, 4) It is not known if skin-sensitizing antibody can be eradicated or if the patient can be entirely cured, nor is it known how long immunotherapy must be continued. In a clinical study with Jubilant HollisterStier venom products, injections (using the Suggested Dose Schedule under DOSAGE AND ADMINISTRATION) were given once per week at one study center, and twice or more per week at another center. (4) (For further discussion, see below).
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. In the clinical trial, 97% of patients at the maintenance dosage (100 µg per venom) showed no systemic reaction following an insect sting challenge. (4) The remaining 3% had a milder reaction than noted prior to treatment.
The patients in this study reached maintenance (100 µg per venom) usually within 2 1/2 -3 1/2 months after beginning therapy. (4) Whether efficacy of therapy is influenced by the time required to reach maintenance has not yet been determined. Large local reactions occurred in approximately 60% of the patients given immunotherapy.
Some form of systemic response occurred, often repeatedly, in one-third of the patients treated in the clinical trial. (4) Only one systemic response occurred on the first dose given. The rest occurred at various times in the course of immunotherapy.
Some systemic manifestations may have occurred because of the patient's apprehension, and did not require treatment. Approximately one-fourth of the patients experiencing systemic responses were given some form of specific therapy (epinephrine, theophylline, or metaproteranol), some on several occasions. (4) In deciding the criteria for proceeding from dose to dose of the Suggested Dose Schedule (see DOSAGE AND ADMINISTRATION) , the results of the clinical study (4) should be considered.
A study center "A" reporting the least number of systemic reactions during pre-maintenance treatment held the dose constant in most of the cases where significant local reactions occurred. With the systemic reactions reported, this center held the dose the same in approximately 80% of the incidences. The treatment injections were given at this center usually once per week, and if a patient missed an appointment, the next dose was often the same as the preceding dose (depending on the previous reactivity of the patient).
Patients treated at this center reached maintenance in an average of 17-19 visits. Another study center "B", reporting a higher incidence of systemic reactions, was more regimented in f…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Jubilant HollisterStier LLC sterile freeze-dried Hymenoptera Venom Products are supplied in vacuum-sealed vials containing venom extract with mannitol as an excipient. (See the chart under DESCRIPTION or the latest Allergy Product Price List for vial sizes and content). Reconstituting fluid [Sterile Albumin Saline with Phenol (0.4%)] is supplied with the Venomil® kit, and is also available separately.
Storage: Store freeze-dried and reconstituted venom product, and venom dilutions, at 2° - 8° C, and keep at this temperature range during office use.
📋 Description ▾
DESCRIPTION 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.
💬 Information for Patients ▾
2. INFORMATION FOR PATIENTS Patients should be instructed in the recognition of adverse reactions to immunotherapy, and in particular, to the symptoms of shock. (See WARNINGS box at the beginning of this Instruction Sheet).
Patients should be made to understand the importance of a 30 minute observation period following skin testing or therapeutic injections, and be cautioned to return to the office promptly if symptoms occur after leaving. Patients should be instructed in the use of, and have available, an Emergency Anaphylaxis Kit for self-administration of epinephrine. Patients must be instructed to report any insect stings that have occurred, since a venom injection should not be given on the same day as the sting, nor during a time when the patient is still experiencing symptoms from the sting.