Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

Indications

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant is used for: Cervical, vulvar, vaginal, and anal cancer, Genital warts (condyloma acuminata), Cervical, Vulvar, Vaginal and Anal intraepithelial neoplasia caused by HPV. Girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine: Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18 Genital warts (condyloma acuminata) caused by HPV types 6 and 11 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18: Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS) Cervical intraepithelial neoplasia (CIN) grade 1 Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3 Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3 Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

Adult Dose

Adult: Injection 0.5-mL suspension for intramuscular injection at the following schedule: 0, 2 months, 6 months

Child Dose

Renal Dose

Administration

The vaccine should be administered by intramuscular injection. The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh. This vaccine must not be injected intravascularly. Neither subcutaneous nor intradermal administration has been studied. These methods of administration are not recommended.

Contra Indications

Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of the same vaccine

Precautions

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic- clonic movements and other seizure-like activity, has been reported following vaccination with this vaccine. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.

Pregnancy-Lactation

Pregnancy Specific studies of the vaccine in pregnant women were not conducted. During the clinical development program, 3,819 women (vaccine = 1,894 vs. placebo = 1,925) reported at least one pregnancy. There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in this vaccine and placebo treated individuals. These data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity. The data on in this vaccine administered during pregnancy did not indicate any safety signal. However, these data are insufficient to recommend use of in this vaccine during pregnancy. Vaccination should be postponed until completion of pregnancy. Breast-feeding In breast-feeding mothers given in this vaccine or placebo during the vaccination period of the clinical trials the rates of adverse reactions in the mother and the breast-fed infant were comparable between the vaccination and the placebo groups. In addition, vaccine immunogenicity was comparable among breast-feeding mothers and women who did not breast-feed during the vaccine administration. Therefore, in this vaccinecan be used during breast-feeding. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. No effects on male fertility were observed in rats.

Interactions

Side Effects

Side effects of Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant : The most common adverse reaction was headache. Common adverse reactions (frequency of at least 1.0% and greater than AAHS control or saline placebo) are fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising.

Mode of Action

HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Human beings develop a humoral immune response to the vaccine, although the exact mechanism of protection is unknown.