GARDASIL®9

Product Information

• Name: GARDASIL®9
• Type: Human Papillomavirus 9-valent Vaccine, Recombinant
• Form: Suspension for injection
• Manufacturer: Merck Canada Inc.

Indications and Clinical Use

• Girls and Women (9 through 45 years): Prevention of infection by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, including prevention of cervical, vulvar, vaginal, and anal cancers, genital warts, and precancerous or dysplastic lesions.
• Boys and Men (9 through 26 years): Prevention of infection by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, including prevention of anal cancer, genital warts, and anal intraepithelial neoplasia.

Contraindications

• Hypersensitivity to any component of GARDASIL®9.
• Severe allergic reaction after a previous dose of GARDASIL® or GARDASIL®9.

Warnings and Precautions

• General: Vaccine may not result in protection in all vaccinees.
• Not for Treatment: Not intended to treat active external genital lesions, cancers, or dysplastic lesions caused by HPV.
• Anaphylaxis: Appropriate medical treatment should be available for rare anaphylactic reactions.
• Syncope: May occur after vaccination; observe vaccinees for 15 minutes post-vaccination.
• Routine Screening: Women should continue routine screening for cervical cancer.
• Sexual Health: Recipients should continue to use precautions against sexually transmitted diseases.

Adverse Reactions

• Common: Headache, fever, nausea, dizziness, fatigue, diarrhea, oropharyngeal pain, upper abdominal pain, local injection site reactions (pain, swelling, erythema, pruritus, bruising, hematoma, mass, hemorrhage, induration).
• Severe: Rare cases of anaphylaxis, Guillain-Barré syndrome, and syncope.

Drug Interactions

• Concomitant Vaccines: May be administered concomitantly with Menactra®, Adacel®, and Repevax® at separate injection sites.
• Hormonal Contraceptives: No effect on immune response.

Dosage and Administration

• Dosing:
  • 3-dose schedule: 0, 2, and 6 months for individuals 15 years and older or immunocompromised.
  • 2-dose schedule: 0 and 6-12 months for individuals 9-14 years of age.
• Administration: Intramuscular injection in the deltoid region of the upper arm or higher anterolateral area of the thigh. Do not inject intravascularly, subcutaneously, or intradermally.

Storage and Stability

• Store at 2° to 8°C. Do not freeze. Protect from light.

Clinical Trials and Efficacy

• Efficacy: Demonstrated high efficacy in preventing infections, cervical, vulvar, vaginal, and anal cancers, and genital warts associated with HPV types included in the vaccine.
• Safety: Evaluated in over 15,000 individuals, showing a favorable safety profile with mild to moderate adverse reactions.