Gardasil Selected Safety Information

GARDASIL 9 | SHORT SELECTED SAFETY INFORMATION

From PI last updated June 2018

CONTRAINDICATIONS
GARDASIL 9 is contraindicated in patients with hypersensitivity to either GARDASIL 9 or GARDASIL or any of the inactive ingredients in either vaccine. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL 9 or GARDASIL should not receive further doses of GARDASIL 9.

WARNINGS AND SPECIAL PRECAUTIONS
This vaccine should not be used interchangeably with other Human Papillomavirus (HPV) vaccines (as such use has not been studied). This vaccine should be given with caution to individuals with either thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals. Appropriate medical treatment should always be readily available in case of anaphylactic reactions following the administration of GARDASIL.

General
Vaccination with GARDASIL may not result in protection in all vaccine recipients. This vaccine is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal or anal cancers; CIN, VIN, VaIN or AIN. GARDASIL will not protect against diseases that are not caused by HPV.
Syncope (fainting) may follow any vaccination, especially in adolescents and young adults. Syncope, sometimes associated with falling, has occurred after vaccination with GARDASIL. Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of GARDASIL 9. The
decision to administer or delay vaccination, because of a current or recent febrile illness depends largely on the severity of the symptoms and their aetiology. Low-grade fever itself and mild upper respiratory infection are not generally contraindications to vaccination. Individuals with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection or other causes, may have reduced antibody response to active
immunisation.

Paediatric Use
The safety and efficacy of GARDASIL 9 have not been evaluated in children younger than 9 years.

Use in Elderly
The safety and efficacy of GARDASIL 9 have not been evaluated in individuals aged 65 years and over.

Use in Other Special Populations
The safety, immunogenicity, and efficacy of GARDASIL 9 have not been fully evaluated in HIV-infected individuals. The immunologic response to GARDASIL 9 may be diminished in
immunocompromised individuals.

INTERACTIONS
Use with Other Vaccines
Results from clinical studies indicate that GARDASIL 9 may be administered concomitantly (at a separate injection site) with Menactra [Meningococcal (Groups A, C, Y and W-135)
Polysaccharide Diphtheria Toxoid Conjugate Vaccine], Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)], and Repevax
Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine, (adsorbed, reduced antigen(s) content). No studies have been performed with OMZYTA (Measles, Mumps and Rubella) and yellow fever vaccines.

Use with Hormonal Contraceptives
In 7 269 women (16 through 26 years of age, from Protocols 001 and 002), 60,2 % used hormonal contraceptives during the vaccination period of the clinical studies. Use of
hormonal contraceptives did not appear to affect the type specific immune responses to GARDASIL 9.
Use with Steroids
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce
the immune responses to vaccines.

PREGNANCY AND LACTATION
Safety in pregnancy and lactation has not been established in well-controlled clinical studies.

SIDE EFFECTS
Very Common (≥ 1/10); Common (≥ 1/100, < 1/10); Uncommon (≥ 1/1 000, < 1/100); Rare (≥
1/10 000, < 1/1 000); Very Rare (< 1/10 000)
Nervous system disorders
Very common: Headache
Common: Dizziness
Gastrointestinal disorders
Common: Nausea
Musculoskeletal and connective tissue disorders
Common: Pain in extremity
General disorders and administration site conditions
Common: Pyrexia, fatigue
Injection site reactions
Very common: Erythema, pain and swelling
Common: Pruritus and haematoma.
Most injection site reactions were mild to moderate.
The safety profile was similar between GARDASIL 9 and GARDASIL in women, men and girls and boys.
FOR FULL PRESCRIBING INFORMATION REFER TO THE PROFESSIONAL INFORMATION APPROVED BY THE MEDICINES REGULATORY AUTHORITY.

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