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GARDASIL 9 – SELECTED SAFETY INFORMATION

Based on:
Gardasil 9 HC 3852-II-040-PI eng EMA 052021 (CARIBBEAN)

Therapeutic uses

Gardasil 9 is indicated for active immunization of individuals from the age of 9 years against the following HPV diseases:

Dosage and administration

GARDASIL 9 should be administered intramuscularly as 3 separate 0.5-mL doses according to the following schedule:

Individuals 9 to and including 14 years of age at time of first injection Gardasil 9 can be administered according to a 2-dose (0, 6 – 12 months) schedule. The second dose should be administered between 5 and 13 months after the first dose. If the second vaccine 2 dose is administered earlier than 5 months after the first dose, a third dose should always be administered.

Gardasil 9 can be administered according to a 3-dose (0, 2, 6 months) schedule. The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.

Individuals 15 years of age and older at time of first injection Gardasil 9 should be administered according to a 3-dose (0, 2, 6 months) schedule. The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.

It is recommended that individuals who receive a first dose of Gardasil 9 complete the vaccination course with Gardasil 9.

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 precautions

As for any vaccine, vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.

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, vulvar, vaginal, and anal cancer, high-grade cervical, vulvar, vaginal, and anal dysplastic lesions, or genital warts. It is also not intended to prevent progression of other established HPV-related lesions.

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

Syncope (fainting) may follow any vaccination, especially in adolescents and young adults. Syncope, sometimes associated with falling, has occurred after HPV vaccination. 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 etiology. 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 immunization.

This vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.

Use in special populations

Pregnancy should be avoided during the vaccination regimen for GARDASIL 9. Gardasil 9 can be used during breast-feeding. The safety and efficacy of GARDASIL 9 have not been evaluated in children younger than 9 years. The safety immunogenicity, and efficacy of GARDASIL 9 have not been fully evaluated in HIV-infected individuals.

Adverse reactions

The most common (>10%) vaccine-related adverse experiences were observed among recipients of GARDASIL 9 were temperature and injection-site pain, swelling, erythema, headache. And common (>1%) vaccine-related adverse experiences observed reported were pruritus, bruising, pyrexia, nausea, dizziness, pain in extremity, hematoma, and fatigue.

Post-marketing reports:

The following adverse experiences have been spontaneously reported during post-approval use of GARDASIL and may also be seen in post-marketing experience with GARDASIL9. Cellulitis, idiopathic thrombocytopenic purpura, lymphadenopathy, acute disseminated encephalomyelitis, dizziness, Guillain-Barré syndrome, headache, syncope sometimes accompanied by tonic-clonic movements; nausea, vomiting; arthralgia, myalgia; asthenia, chills, fatigue, malaise; hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria. These experiences were reported voluntarily from a population of uncertain size. It is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.

Before administering GARDASIL 9, please read the complete Prescribing Information.