One pre-filled syringe of 0.4 ml contains human hepatitis B immunoglobulin 200 IU.
Human protein 150 mg/ml of which at least 96 % is IgG, with a content of antibodies to hepatitis B virus surface antigen (HBs) of 500 IU/ml.
Distribution of IgG subclasses: IgG1: 59 %; IgG2: 35 %; IgG3: 3 %; IgG4: 3 %.
IgA content max. 6 mg/ml.
Excipients/Inactive Ingredients: Glycine, Water for injections.
Pharmacotherapeutic group: Specific immunoglobulins. ATC code: J06BB04.
Pharmacology: Pharmacodynamics: Fovepta contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs).
Clinical experience: In an open, randomised parallel study a single dose (200 IU, administered < 12 hours after birth) of Fovepta was administered by subcutaneous (SC) or intramuscular (IM) injection to 34 neonates (17 SC and 17 IM) of a gestational age ≥ 37+0 weeks born to HBsAg positive mothers. Serum anti-HBs concentrations ≥ 100 IU/L (primary efficacy endpoint) were found in 30/31 (16 SC vs. 17 IM) newborns. Mean anti-HBs levels were comparable with 278.1 ± 92.4 IU/L (280.2) SC vs. 294.1 ± 112.6 IU/L (260.5) IM.
Both routes of administration were considered to be effective, safe and well-tolerated.
Pharmacokinetics: Fovepta is slowly absorbed into the recipient's circulation and reaches a maximum after a delay of 2-7 days.
Fovepta has a half-life of about 3-4 weeks. This half-life may vary from patient to patient.
IgG and IgG-complexes are broken down in the reticuloendothelial system.
Toxicology: Preclinical safety data: Immunoglobulins are normal constituents of the human body, therefore toxicity testing in heterologous species is of no relevance.
In a local tolerance trial in rabbits, there was no evidence of irritation attributable to Fovepta.
No other non-clinical trials have been carried out.
Immunoprophylaxis of hepatitis B in the newborn of a hepatitis B virus carrier-mother.
Posology: Prevention of hepatitis B in the newborn, of a hepatitis B virus carrier-mother, at birth or as soon as possible after birth (at latest within 12 hours): 200 IU.
The hepatitis B immunoglobulin administration may need to be repeated until seroconversion following vaccination.
In all these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected the same day as human hepatitis B immunoglobulin, however in different sites. In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 8 IU/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/mL.
Method of administration: Fovepta should be administered via the subcutaneous or the intramuscular route.
If intramuscular administration is contraindicated (bleeding disorders), the injection can be administered subcutaneously.
Where simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites.
Consequences of an overdose are not known.
Hypersensitivity to any of the components.
Hypersensitivity to human immunoglobulins.
Ensure that Fovepta is not administered into a blood vessel, because of the risk of shock.
True hypersensitivity reactions are rare.
Fovepta 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 Fovepta 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 human immunoglobulin.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
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 virus 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 Fovepta is administered to a patient, the name and batch number of the medicinal product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Potential complications can often be avoided by ensuring that patients are carefully monitored for any symptoms throughout the injection. The patients should be observed for at least 20 minutes after administration.
Interference with serological testing: After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's 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).
Effects on ability to drive and use machines: Not relevant.
Fovepta has been studied in a clinical trial with 34 neonates. There are no robust data on the frequency of undesirable effects from this clinical trial, however, the following are known to be associated with hepatitis-B immunoglobulins: See table.
Click on icon to see table/diagram/image
For safety with respect to transmissible agents, see Precautions.
Live attenuated virus vaccines: Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps, measles and varicella for a period of 3 months. After administration of this medicinal product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines.
Special precautions for use and handling and disposal: This medicinal product should be brought to room temperature (approx. 23°C - 27°C) before use.
Solutions that are cloudy or have deposits should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: This medicinal product must not be mixed with other medicinal products.
No other preparations may be added to the Fovepta solution as any change in the electrolyte concentration or the pH may result in precipitation or denaturisation of the proteins.
Store and transport refrigerated (2°C - 8°C).
Do not freeze.
Keep the container in the outer carton in order to protect from light.
Shelf life: 2 years.
The solution should be administered immediately after opening the syringe.
J06BB04 - hepatitis B immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Soln for inj (pre-filled syringe, clear, pale yellow or light brown) 200 IU/0.4 mL x 1's.