NDC Package 65044-9951-6 White Faced Hornet Hymenoptera Venom Multidose

65044-9951

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) DiagnosisSkin 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)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) TreatmentImmunotherapy 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.

65044995106

Jubilant Hollisterstier Llc

No

BLA103885

BLA - A product marketed under an approved Biologic License Application.

04-11-1995

08-21-2009

08-21-2009

D