human papillomavirus 9-valent vaccine: clinical use

Prescribing considerations

• Confirm previous HPV vaccination and allergy history.
• Consider previous HPV exposure and likely preventive benefit; the vaccine has no therapeutic effect on established infection or lesions.
• Postpone during acute severe febrile illness, but not routinely for a minor infection.
• Plan administration to minimise injury from syncope, particularly in adolescents.
• Use caution with thrombocytopenia, coagulation disorders or anticoagulant therapy.
• Impaired immune responsiveness may reduce immunogenicity.

Contraindications and cautions

• Hypersensitivity to the active substances or any excipient
• Hypersensitivity after previous administration of the 9-valent or quadrivalent HPV vaccine

Monitoring

• Ensure treatment for anaphylaxis is immediately available.
• Observe for fainting and protect against falls around administration.
• Record the product name and batch number for traceability.
• Continue routine cervical screening where eligible.

Clinical pharmacology

A non-infectious recombinant vaccine containing L1 virus-like particles from HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, adsorbed onto an aluminium-containing adjuvant. Protection is mediated through a type-specific humoral immune response; pharmacokinetic assessment is not applicable to vaccines of this kind.

Formulation and product differences

• Suspension for injection supplied in vial and pre-filled syringe presentations
• Contains sodium chloride, histidine, polysorbate 80, borax and water for injections
• Virus-like particles are produced in recombinant yeast cells
• The suspension requires shaking and inspection before intramuscular administration
• Must not be mixed with another medicine or vaccine in the same syringe