Thromboembolic complications have been associated with the use of normal intravenous immunoglobulin. Therefore, caution is recommended especially for patients with thrombotic risk factors.
Patients must be monitored for serum anti-HBs antibody levels regularly.
Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under Method of administration under Dosage & Administration must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Certain adverse reactions may occur more frequently: in case of high rate of infusion; in patients with hypo- or agammaglobulinemia with or without IgA deficiency.
True hypersensitivity reactions are rare.
VENBIG contains 3.6 mg sodium (3.565 mg/ml) per ml. To be taken into consideration by patients on a controlled sodium diet, based on the total amount of product administered.
This medicinal product contains up to 92 mg sucrose (91.9 mg/ml) per ml. To be taken into consideration in patients at risk for acute renal failure.
VENBIG contains a small quantity of IgA. Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment with VENBIG against the potential risk of hypersensitivity reactions.
Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with immunoglobulin.
In case of renal impairment, IVIg discontinuation must be considered. While reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products containing various excipients such as sucrose, glucose and maltose, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number. In patients at risk for acute renal failure or thromboembolic adverse reactions, IVIg products must be administered at the minimum rate of infusion and dose practicable.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock must be implemented.
IVIg products can contain blood group antibodies which may act as haemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction (Coombs' test) and, rarely, haemolysis. Haemolytic anaemia may develop subsequent to IVIg therapy due to enhanced red blood (RBC) sequestration. IVIg recipients should be monitored for clinical signs and symptoms of haemolysis.
Interference with serological testing: After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patients' blood may result in misleading positive results in serological testing.
Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell antibodies, for example the antiglobulin test (Coombs' test).
Transmissible agents: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped viruses HAV.
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
It is strongly recommended that every time that VENBIG is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Effects on ability to drive and use machines: VENBIG has no or negligible influence on the ability to drive and use machines.
Fertility: Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Use in Children: No specific measures or monitoring are required.