Gardasil9 Selected Safety Information

Contraindications: Hypersensitivity to the active substances or to any of the excipients.
Individuals with hypersensitivity after previous administration of Gardasil 9 or Gardasil should not receive Gardasil 9.

Precautions/ Warnings: The decision to vaccinate an individual should take into account the risk for previous HPV exposure and potential benefit from vaccination. 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. Syncope (fainting), sometimes associated with falling, 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. Therefore, vaccinees should be observed for approximately 15 minutes after vaccination. It is important that procedures are in place to avoid injury from fainting. Vaccination should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation. As with any vaccine, vaccination with Gardasil 9 may not result in protection in all vaccine recipients. The vaccine will only protect against diseases that are caused by HPV types targeted by the vaccine. 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. Gardasil 9 does not prevent lesions due to a vaccine HPV type in individuals infected with that HPV type at the time of vaccination. Vaccination is not a substitute for routine cervical screening. Since no vaccine is 100% effective and Gardasil 9 will not provide protection against every HPV type, or against HPV infections present at the time of vaccination, routine cervical screening remains critically important and should follow local recommendations. Individuals with impaired immune responsiveness, due to either the use of potent immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may not respond to the vaccine. This vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals. There are no safety, immunogenicity or efficacy data to support interchangeability of Gardasil 9 with bivalent or quadrivalent HPV vaccines. Excipients with known effect: Sodium : This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Polysorbate 80 : This medicinal product contains 0.05 mg of polysorbate 80 in each 0.5 mL dose of suspension for injection. Polysorbates may cause allergic reactions. Most Common Adverse Events: Lymphadenopathy, Hypersensitivity, Anaphylactic reactions, Headache, Dizziness, Syncope sometimes accompanied by tonic-clonic movements, Nausea, Vomiting, Urticaria, Arthralgia, myalgia. At the injection site: pain, swelling, erythema, Pyrexia, fatigue. At the injection site: pruritus, bruising. Asthenia, chills, Malaise. Adverse reactions reported from post-marketing experience with qHPV vaccine: Injection-site cellulitis, Idiopathic thrombocytopaenic purpura, Anaphylactoid reactions, bronchospasm, Acute disseminated encephalomyelitis, Guillain-Barré syndrome.

Before initiating therapy, please consult the prescribing information.