HEPLISAV B Solution for injection in pre-filled syringe Ref.[28057] Active ingredients: Hepatitis B, purified antigen

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

HEPLISAV B should not be administered intravenously, subcutaneously, or intradermally.

As with all injectable vaccines, appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

As with other vaccines, the administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication for immunisation.

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia, and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury.

As with any vaccine, a protective immune response may not be elicited in all vaccinees.

Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.

HEPLISAV B will not prevent infection caused by other pathogens known to infect the liver such as hepatitis A, hepatitis C, and hepatitis E viruses.

There are very limited data on the immune response to HEPLISAV in individuals who did not mount a protective immune response to another hepatitis B vaccine.

Immunodeficiency

Immunocompromised persons may have a diminished immune response to HEPLISAV B. There are very limited data available among immunocompromised population. Attention should be given to ensure that a protective antibody level is maintained as defined by national recommendations and guidelines. See section 4.2.

Patients with chronic liver disease or with HIV infection or hepatitis C carriers should not be precluded from vaccination against hepatitis B. The vaccine could be advised since HBV infection can be severe in these patients: the HEPLISAV B vaccination should thus be considered on a case by case basis by the physician.

Renal Impairment

As pre-haemodialysis and haemodialysis patients are particularly at risk of exposure to HBV and have a higher risk of becoming chronically infected, attention should be given to ensure that a protective antibody level is maintained as defined by national recommendations and guidelines. See section 4.2.

Excipients

This medicinal product contains less than 1 mmol of sodium (23 mg) per dose, i.e. is essentially ‘sodium-free’.

There are no data on co-administration of HEPLISAV B with other vaccines, the concomitant use of HEPLISAV B with other vaccines is not recommended.

There are no data with HEPLISAV B in individuals with known or presumed exposure to HBV.

Concomitant administration of HEPLISAV B with hepatitis B immunoglobulin (HBIG) has not been studied. However, in circumstances where HEPLISAV B is administered with a standard dose of HBIG, these should be given at separate injection sites.

Pregnancy

There are a limited amount of data from the use of HEPLISAV B vaccine in pregnant women.

Animal studies do not indicate direct or indirect harmful effects of relevance to humans with respect to reproductive toxicity (see Section 5.3).

As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the foetus.

Breast-feeding

It is unknown whether HEPLISAV B is excreted in human milk. A risk to the breastfed newborns/infants cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to abstain from HEPLISAV B vaccination taking into account the benefit of breast-feeding for the child and the benefit of vaccination for the woman.

Fertility

No data on the effect of HEPLISAV B on fertility in humans are available.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Section 5.3).

HEPLISAV B may have a moderate influence on the ability to drive and use machine. Some of the effects mentioned under Section 4.8 “Undesirable Effects” (e.g., malaise) may affect the ability to drive or operate machinery.

Summary of the safety profile

The clinical trials safety profile is based on data from 9365 subjects followed in 3 pivotal studies.

In two studies, 3777 of the 9365 subjects were monitored for local and systemic post-injection reactions using diary cards for a 7-day period starting on the day of vaccination. The most common adverse reactions seen were the post-injection reactions injection site pain, headache, malaise, fatigue, myalgia and fever.

Tabulated list of adverse reactions

The frequency of adverse reactions is defined as follows: Very common: (≥1/10) Common: (≥1/100 to <1/10), Uncommon: (≥1/1000 to <1/100), Rare: (≥1/10,000 to <1/1000), Very rare: (<1/10,000).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

¹ Local and systemic adverse reactions collected using diary cards.
² Includes the individual preferred terms of nausea, vomiting, diarrhoea and abdominal pain.
³ Includes the individual preferred terms of urticaria, pruritus, rash.

Additional information in special populations

Safety data are limited in immunocompromised adults, in adults previously vaccinated for hepatitis B and in adults with chronic renal failure, including patients on haemodialysis.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.