Omri-Hep-B 5% IV

/ Omrix Biopharmaceuticals

10,000 IU should be administered in the unhepatic stage of Liver Transplantation followed by maximum dose of 10,000 IU administered daily for the first 5-7 days after transplantation. It is recommended that patients be tested periodically for Hepatitis B antibody levels in order to determine individual bioavailability.
It is accepted by convention that in order to prevent reinfection of graft, anti-HBsAg levels should be maintained above 100-150 mIU/ml. After an initial period of acclimation to Omri-Hep-B™ 5% IV, the interval between injections is usually 6-8 weeks but might vary from patient to patient. Prophylactic treatment and dosage should be adapted to the anti-HBsAg levels of the patient.
Administration: Should be infused intravenously at an initial rate of 0.01-0.02 ml/kg/min for 15 minutes; Infusion rate may increase gradually to a maximum of 0.08 mL/kg/min; It is recommended not to exceed a rate of 2 ml/min.

Passive immunization for the prevention of hepatitis B virus re-infection after liver transplantation.

Anaphylactic or severe systemic response to I.M. or I.V. immunoglobulin preparations. Not to be given to patients with antibodies to IgA or selective IgA deficiency.

Adequate hydration prior to the initiation of IVIG infusion is required.
Potential complications can often be avoided by ensuring that patients: Are not sensitive to human immunoglobulin by initially injecting the product slowly.
Are carefully monitored for any symptoms throughout the infusion period. In particular, patient’s naive to human immunoglobulin, patients switched from an alternative IVIG product or when there has been a long interval since the previous infusion should be monitored during the first infusion, and for the first hour after the first infusion, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration.
Certain severe adverse drug reactions may be related to the rate of infusion, therefore the recommended infusion rate given under “Dosage and Administration” section must be closely followed.
For full details see prescribing information.

Patients naive to Omri-Hep-B™ 5% IV might experience a higher frequency of minor events than those well maintained on regular therapy. These might include inflammatory reactions, manifested by a rise in temperature, chills, nausea and vomiting and appear to be related to the rate of infusion.
During or shortly after the application of intravenous immunoglobulins minor side effects such as headache, chills, dizziness, fever, vomiting, allergic reactions, nausea, athralgia, low blood pressure and moderate back pain may occur occasionally. Dyspnea and tachycardia may occur more frequently and require medical attention. Cases of reversible meningitis, nephrotoxicity isolated cases of reversible haemolytic anemia/haemolysis and rare cases of regressive cutaneous reactions, often eczema-like, have been observed with human immunoglobulin. Increase in creatininemia and/or acute renal failure have been observed.
Thrombotic events have been reported in the elderly, in patients with signs of cerebral or cardiac ischemia, and in overweight and overly volume depleted patients.
Rarely immunoglobulins may cause a fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no sensitivity to previous administrations. Slowing or stopping the infusion should allow the symptoms to disappear promptly. Thereafter the infusion may be started again using a lower infusion rate. Allergic and anaphylactic reactions necessitate immediate cessation of the infusion. Less severe reactions may be controlled with glucocorticoids and/or antihistamines.
Patients previously sensitized to certain antigens, most commonly IgA, may be at risk of immediate anaphylactoid and hypersensitivity reactions. Epinephrine should be available for the treatment of any acute anaphylactoid reaction (see Warnings and Contraindications). When severe reactions occur, treatment for shock must be initiated according to current guidelines. For this purpose see the recommendations given in the following table.
For full details see prescribing information.

Live attenuated vaccines: Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps, and varicella. After administration of this medicinal product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year. Therefore patients receiving measles vaccine should have their antibody status checked.
Interference with serological testing: Passive transmission of antibodies to erythrocyte antigen, e.g. A, B or D may interfere with some serological tests (Coombs test, haptoglobin, reticulocyte count).
Incompatibilities: Omri-Hep-B™ 5% IV should not be mixed with other medicinal products. A separate intravenous line should be used for the infusion.
Omri-Hep B™ 5% IV contains maltose which can be misinterpreted as glucose by certain types of blood glucose testing systems (for example, by systems based on GDH-PQQ or glucose-dye-oxidoreductase methods). Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific, should be used to test or monitor blood glucose levels in patients receiving maltose-containing parenteral products, including Omri-Hep B™ IV.
The product information of the blood glucose testing system, including that of the test strips, should be carefully reviewed to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the testing system to determine if the system is appropriate for use with maltose-containing parenteral products. The interference of maltose in blood glucose assays may result in falsely elevated glucose readings and, consequently, in the inappropriate administration of insulin, resulting in life threatening hypoglycaemia and death.

Pregnancy: The safety of this medical product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast feeding mothers. IVIG products have been shown to cross the placenta, increasingly after the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the fetus or neonate are to be expected.
Lactation: Breast-feeding Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate from pathogens which have a mucosal portal of entry.

Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with renal impairment.