Leitlinien & Arzneimittelsicherheit

HOS-093820 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile 4 Clinical trials involving the administration of 2,476 doses of Fendrix to 82 pre-haemodialysis and haemodialysis patients and to 713 healthy subjects  15 years of age allowed to document the reactogenicity of the vaccine. Pre-haemodialysis and haemodialysis patients The reactogenicity profile of Fendrix in a total of 82 pre-haemodialysis and haemodialysis patients was generally comparable to that seen in healthy subjects. List of adverse reactions Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being related or possibly related to vaccination have been categorised by frequency. Frequencies are reported as: Very common: (≥1/10) Common: (≥1/100 to <1/10) Uncommon: (≥1/1,000 to <1/100) Rare: (≥1/10,000 to <1/1,000) Very rare: (<1/10,000) Clinical trial data Nervous system disorders: Very common: headache Gastrointestinal disorders: Common: gastrointestinal disorder General disorders and administration site conditions: Very common: fatigue, pain Common: fever, injection site swelling, redness Unsolicited symptoms considered to be at least possibly related to vaccination were uncommonly reported and consisted of rigors, other injection site reaction and maculo-papular rash. Healthy subjects The reactogenicity profile of Fendrix in healthy subjects was generally comparable to that seen in pre- haemodialysis and haemodialysis patients. In a large double-blind randomised comparative study, healthy subjects were enrolled to receive a three dose primary course of Fendrix (N= 713) or a commercially available hepatitis B vaccine (N= 238) at 0, 1, 2 months. The most common adverse reactions reported were local reactions at the injection site. Vaccination with Fendrix induced more transient local symptoms as compared to the comparator vaccine, with pain at the injection site being the most frequently reported solicited local symptom. However, solicited general symptoms were observed with similar frequencies in both groups. Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and considered as being at least possibly related to vaccination have been categorised by frequency. Nervous system disorders: Common: headache Ear and labyrinth disorders: 5 Rare: vertigo Gastrointestinal disorders: Commo

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HOS-093816 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity after previous administration of other hepatitis B vaccines. The administration of Fendrix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection such as a cold, is not a contraindication for immunisation.

HOS-093815 · has-indication-information · PDF-Seite 2

Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).

HOS-093818 · has-interaction-information · PDF-Seite 4

No data on the concomitant administration of Fendrix and other vaccines or with specific hepatitis B immunoglobulin have been generated. If concomitant administration of specific hepatitis B immunoglobulin and Fendrix is required, these should be given at different injection sites. As no data are available for the concomitant administration of this particular vaccine with other vaccines, an interval of 2 to 3 weeks should be respected. It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited.

HOS-093819 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no data from the use of Fendrix in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Vaccination during pregnancy should only be performed if the risk-benefit ratio at individual level outweighs possible risks for the foetus. Breast-feeding There are no data from use of Fendrix during lactation. In a reproductive toxicity study in animals which included post-natal follow-up until weaning (see section 5.3), no effect on the development of the pups was observed. Vaccination should only be performed if the risk-benefit ratio at individual level outweighs possible risks for the infant. Fertility No fertility data are available.

HOS-093817 · has-warning-information · PDF-Seite 3

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine. Because of the long incubation period of hepatitis B, it is possible that subjects could have been infected before the time of immunisation. The vaccine may not prevent hepatitis B infection in such cases. The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or other pathogens known to infect the liver. As with any vaccine, a protective immune response may not be elicited in all vaccinees. A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These factors include older age, male gender, obesity, smoking, route of administration, and some chronic underlying diseases. Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of Fendrix. Additional doses may need to be considered for subjects who do not respond or have a sub-optimal response to a course of vaccinations. Since intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, this route should be avoided. Fendrix should under no circumstances be administered intradermally or intravenously. 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 3 be severe in these patients: the Hepatitis B vaccination should thus be considered on a case-by-case basis by the physician. Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents 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 from faints. This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’. 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.