Rabipur

/ GSK

Dosage in adults and children: The recommended single intramuscular (IM) dose is l.0 ml in individuals of all ages.
Pre-exposure Prophylaxis (PrEP)
Primary immunisation: In previously unvaccinated individuals, an initial course of pre-exposure prophylaxis consists of three doses (each of l.0 ml) administered IM on days 0, 7 and 21 (or 28).
Booster doses: The individual IM booster dose is 1.0 ml.
Rabipur may be used for booster vaccination after prior immunization with a human diploid cell rabies vaccine (HDCV).
The need of intermittent serological testing for the presence of antibody ≥ 0.5 IU/ml and the administration of booster doses should be assessed in accordance with official recommendations.
Experience shows that reinforcing doses are generally required every 2-5 years.
Post-exposure Prophylaxis (PEP)
Post exposure prophylaxis consists of:
• local treatment of the wound as soon as possible after exposure,
• a course of rabies vaccine and
• administration of rabies immunoglobulin, if indicated
The indication for post-exposure prophylaxis depends on the type of contact with the suspected rabid animal, as provided in Table 1, Recommended post-exposure prophylaxis according to type of exposure. Post-exposure immunisation should begin as soon as possible after exposure.
For recommended post-exposure prophylaxis according to type of exposure, please refer to doctor’s leaflet.
Post-exposure prophylaxis of previously unvaccinated individuals:
• 5 dose Essen regimen (1-1-1-1-1): one 1.0 ml IM injection on each of days 0, 3, 7, 14 and 28
• 4 dose modified Essen regimen (1-1-1-1): one 1.0 mL IM injection on each of days 0, 3, 7 and 14, for healthy, immunocompetent persons only.
• 4 dose Zagreb regimen (2-1-1): two 1.0 ml IM injections on day 0 (one in each of the two deltoids or thigh sites) followed by one 1.0 ml IM injection on each of days 7 and 21.
Post-exposure prophylaxis in previously vaccinated individuals: In previously vaccinated individuals, post-exposure prophylaxis consists of two doses (each of 1.0 ml) administered IM on days 0, and 3. Rabies immunoglobulin is not indicated in such cases.
Paediatric patients: Paediatric individuals receive the same 1.0 ml IM dose as adults.
Geriatric patients: Geriatric individuals receive the same 1.0 ml IM dose as adults.
Immunocompromised individuals: In immunocompromised individuals, a complete series of 5 doses according to the Essen (1-1- 1-1-1) on days 0, 3, 7,14 and 28) regimen in combination with comprehensive wound management and local infiltration of rabies immunoglobulin is required for individuals with
category II and III exposure.
See prescribing information for full details.

Active immunization against Rabies.
This includes pre-exposure prophylaxis (i.e. before possible risk of exposure to rabies), in both primary series and booster dose, and post-exposure prophylaxis (i.e. after suspected or proven exposure to rabies).
Rabipur is to be used on the basis of official recommendations.

Pre-exposure prophylaxis (PrEP): History of a severe hypersensitivity reaction to the active substance, to any of the excipients or to any of the residues.
Vaccination should be postponed in individuals with a severe febrile illness.
Post‐exposure prophylaxis (PEP): In view of the almost invariably fatal outcome of rabies, there is no contraindication to post-exposure prophylaxis.

A protective immune response may not be elicited in all vaccinees.
In case of acute diseases requiring treatment, patients should not be vaccinated until at least 2 weeks after recovery. The presence of a minor infection should not result in the deferral of vaccination.
Hypersensitivity reactions (PEP only): Anaphylactic reactions including anaphylactic shock have occurred following Rabipur vaccination. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Rabipur contains the excipient polygeline, residues of chicken proteins (e.g., ovalbumin), human serum albumin, and may contain traces of antibiotics. In instances in which individuals have developed clinical symptoms of anaphylaxis such as generalized urticaria, upper airway (lip, tongue, throat, laryngeal or epiglottal) oedema, laryngeal spasm or bronchospasm, hypotension or shock, following exposure to any of these substances, the vaccination should only be administered by personnel with the capability and facilities to manage anaphylaxis post-vaccination.
Central nervous system effects: Encephalitis and Guillain-Barré syndrome have been temporally associated with the use of Rabipur.
A patient’s risk of developing rabies must be carefully considered, before deciding to discontinue immunization.
Route of administration: Rabies vaccine must not be given by intra‐gluteal injection or subcutaneously, as the induction of an adequate immune response may be less reliable. Unintentional intravascular injection may result in systemic reactions, including shock. Do not inject intravascularly.
Anxiety-related reactions: Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stressrelated reactions, may occur in association with vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from fainting.

Anaphylactic reactions including anaphylactic shock that are very rare but clinically severe, and potentially lethal, systemic allergic reactions, can occur following Rabipur vaccination.
Mild allergic reactions to Rabipur (i.e. hypersensitivity), including rashes (very common) and urticaria (common) may occur after vaccination. These reactions are usually mild in nature and typically resolve within a few days.
Very rare cases with symptoms of Encephalitis and Guillain-Barré Syndrome have been reported following Rabipur vaccination.
In clinical trials, the most commonly reported solicited adverse reactions were injection site pain (30-85%) or injection site induration (15-35%). Most injection site reactions were not severe and resolved within 24 to 48 hours.
See prescribing information for full details.

Immunosuppressive agents can interfere with the development of an adequate response to the rabies vaccine. Therefore, it is recommended that serological responses should be monitored in such subjects, and additional doses administered as necessary.
The vaccine must not be mixed in the same syringe with other medicinal products.
If rabies immunoglobulin is indicated in addition to Rabipur vaccine, then it must be administered at an anatomical site distant to the vaccination.
Available clinical data support concomitant administration of Rabipur with inactivated Japanese encephalitis (JE) vaccine and conjugated MenACWY meningococcal vaccine in adult subjects; limited data are available in the paediatric population.
Almost all adult subjects achieved an adequate immune response (Rabies Viral Neutralizing Antibodies (RVNAs) ≥ 0.5 IU/ml) within 7 days after the end of a primary series of three injections of Rabipur when given concomitantly with inactivated JE vaccine according to the PrEP schedule by the intramuscular route. From day 57 after vaccination a decline in immune response to rabies was observed in individuals vaccinated concomitantly with JE vaccine according to the PrEP schedule and the rabies only PrEP schedule. At day 366, percentages of subjects with RVNA concentration ≥0.5 IU/mL were 76%, and 80% for vaccine groups rabies PrEP schedule /JE, and rabies PrEP schedule respectively.
All adult subjects achieved an adequate immune response (RVNAs ≥ 0.5 IU/ml) within 28 days after the end of a primary series of three injections of Rabipur when given concomitantly with conjugated MenACWY vaccine according to the recommended conventional schedule by the intramuscular route.
Concomitant vaccines should always be administrated at separate injection sites and preferably contralateral limbs.

Pregnancy: No cases of harm attributable to use of Rabipur during pregnancy have been observed.
Rabipur may be administered to pregnant women when post-exposure prophylaxis is required.
The vaccine may also be used for pre-exposure prophylaxis during pregnancy if it is considered that the potential benefit outweighs any possible risk to the foetus.
Breastfeeding: While it is not known whether Rabipur enters breast milk, no risk to the breast-feeding infant has been identified. Rabipur may be administered to breastfeeding women when postexposure prophylaxis is required.
The vaccine may also be used for pre-exposure prophylaxis in breastfeeding women if it is considered that the potential benefit outweighs any possible risk to the infant.

No symptoms of overdose are known.