Cervarix · 4.8 Undesirable effects · 1

HOS-094552 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile In clinical studies that enrolled girls and women aged from 10 up to 72 years (of which 79.2% were aged 10-25 years at the time of enrolment), Cervarix was administered to 16,142 females whilst 13,811 females received control. These subjects were followed for serious adverse events over the entire study period. In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection. In two clinical studies that enrolled males aged 10 to 18 years, 2,617 males received Cervarix and were followed-up with active safety surveillance. The most common adverse reaction observed after vaccine administration was injection site pain which occurred after 78% of all doses. The majority of these reactions were of mild to moderate severity and were not long lasting. Tabulated list of adverse reactions Adverse reactions considered as being at least 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) System Organ Class Frequency Adverse reactions Clinical trials Infections and infestations Uncommon Upper respiratory tract infection Nervous system disorders Very common Headache Uncommon Dizziness Gastrointestinal disorders Common Gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain Skin and subcutaneous tissue Common Itching/pruritus, rash, urticaria disorders Musculoskeletal and Very common Myalgia connective tissue disorders Common Arthralgia General disorders and Very common Injection site reactions including pain, redness, administration site conditions swelling, fatigue Common Fever (38°C) Uncommon Other injection site reactions such as induration, local paraesthesia Post-marketing experience Blood and lymphatic system Not known* Lymphadenopathy disorders Immune system disorders Not known* Allergic reactions (including anaphylactic and

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HOS-094548 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

HOS-094547 · has-indication-information · PDF-Seite 2

Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant ano-genital lesions (cervical, vulvar, vaginal and anal) and cervical and anal cancers causally related to certain oncogenic Human Papillomavirus (HPV) types. See sections 4.4 and 5.1 for important information on the data that support this indication. The use of Cervarix should be in accordance with official recommendations.

HOS-094550 · has-interaction-information · PDF-Seite 4

In all clinical trials individuals who had received immunoglobulin or blood-derived products within 3 months prior to the first vaccine dose were excluded. Use with other vaccines Cervarix may be administered concomitantly with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa-IPV vaccines), with no clinically relevant interference with antibody response to any of the components of either vaccine. The sequential administration of combined dTpa-IPV followed by Cervarix one month later tended to elicit lower anti-HPV-16 and anti-HPV-18 GMTs as compared to Cervarix alone. The clinical relevance of this observation is not known. Cervarix may also be administered concomitantly with meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT); with combined hepatitis A (inactivated) and hepatitis B (rDNA) vaccine (Twinrix) or with hepatitis B (rDNA) vaccine (Engerix B). 4 Administration of Cervarix at the same time as Twinrix has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens. Anti-HBs geometric mean antibody concentrations were significantly lower on co-administration, but the clinical relevance of this observation is not known since the seroprotection rates remain unaffected. The proportion of subjects reaching anti-HBs ≥ 10mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix given alone. Similar results were observed when Cervarix was given concomitantly with Engerix B with 97.9% of subjects reaching anti-HBs  10mIU/ml compared to 100% for Engerix B given alone. If Cervarix is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites. Use with hormonal contraceptive In clinical studies, approximately 60% of women who received Cervarix used hormonal contraceptives. There is no evidence that the use of hormonal contraceptives has an impact on the efficacy of Cervarix. Use with systemic immunosuppressive medicinal products See section 4.4.

HOS-094551 · has-pregnancy-information · PDF-Seite 5

Pregnancy Specific studies of the vaccine in pregnant women were not conducted. Data in pregnant women collected as part of pregnancy registries, epidemiological studies and inadvertent exposure during clinical trials are insufficient to conclude whether or not vaccination with Cervarix affects the risk of adverse pregnancy outcomes including spontaneous abortion. However, during the clinical development program, a total of 10,476 pregnancies were reported including 5,387 in women who had received Cervarix. Overall, the proportions of pregnant subjects who experienced specific outcomes (e.g., normal infant, abnormal infants including congenital anomalies, premature birth, and spontaneous abortion) were similar between treatment groups. Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Cervarix during pregnancy. Women who are pregnant or trying to become pregnant, are advised to postpone or interrupt vaccination until completion of pregnancy. Breast-feeding The effect on breast-fed infants of the administration of Cervarix to their mothers has not been evaluated in clinical studies. Cervarix should only be used during breast-feeding when the possible advantages outweigh the possible risks. Fertility No fertility data are available.

HOS-094549 · has-warning-information · PDF-Seite 3

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine. 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. Administration of Cervarix should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a cold, is not a contraindication for immunisation. The vaccine should under no circumstances be administered intravascularly or intradermally. No data are available on subcutaneous administration of Cervarix. 3 As with other vaccines administered intramuscularly, Cervarix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects. As with any vaccine, a protective immune response may not be elicited in all vaccinees. Cervarix will only protect against diseases that are caused by HPV types 16 and 18 and to some extent against diseases caused by certain other oncogenic related HPV types (see section 5.1). Therefore, appropriate precautions against sexually transmitted diseases should continue to be used. The vaccine is for prophylactic use only and has no effect on active HPV infections or established clinical disease. The vaccine has not been shown to have a therapeutic effect. The vaccine is therefore not indicated for treatment of cervical cancer or cervical intraepithelial neoplasia (CIN). It is also not intended to prevent progression of other established HPV-related lesions or existing HPV infections with vaccine or non-vaccine types (see section 5.1 “Efficacy against HPV-16/18 in women with evidence of HPV-16 or HPV-18 infection at study entry.”). Vaccination is not a substitute for routine cervical screening. Since no vaccine is 100% effective and Cervarix will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations. Duration of

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