Indicated in girls and women 9 through 26 yrs of age for the prevention of the following diseases caused by 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
- Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS) caused by HPV types 6, 11, 16, and 18
- Cervical intraepithelial neoplasia (CIN) grade 1 caused by HPV types 6, 11, 16, and 18
- Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3 caused by HPV types 6, 11, 16, and 18
- Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3 caused by HPV types 6, 11, 16, and 18
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, and 18
Indicated in boys and men 9 through 26 yrs of age for the prevention of the following diseases caused by HPV types included in the vaccine:
- Anal cancer caused by HPV types 16 and 18
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, and 18
Renal Dose Adjustment
- Renal impairment: Dose adjustments not defined
Hepatic Dosage Adjustment
- Hepatic impairment: Dose adjustments not defined
See Supplemental Patient Information
- Syncope, sometimes resulting in falling with injury or sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with human papillomavirus quadrivalent vaccine. Monitor patients for 15 minutes after administration and restore cerebral perfusion by maintaining a supine or Trendelenburg position
- Anaphylaxis has been reported following administration of this vaccine. In case of anaphylactic reactions following vaccination, keep appropriate medical treatment and supervision readily available
- Human papillomavirus vaccine (quadrivalent) does not provide protection against disease from vaccine and non-vaccine HPV types to which an individual has previously been exposed through sexual activity
- This vaccine is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN
- Human papillomavirus vaccine (quadrivalent) does not protect against diseases due to HPV types not contained in the vaccine and against genital diseases not caused by HPV
- Vaccination may not result in protection in all vaccine recipients
Cautions: Use cautiously in
- Acute febrile illness
- Immunocompromised individuals
- Concomitant use of systemic immunosuppressive medications
Supplemental Patient Information
- Inform the patient, parent, or guardian of the importance of completing the immunization series unless contraindicated
- Instruct the patient, parent, or guardian that the vaccine does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Advise women who receive this vaccine to continue to undergo cervical cancer screening as per standard of care
- Advise recipients of human papillomavirus vaccine quadrivalent not to discontinue anal cancer screening if it has been recommended by a healthcare provider
Pregnancy Category:B
Breastfeeding: As per the Centers for Disease Control and Prevention and several health professional organizations, the vaccines administered to a nursing mother do not affect the safety of breastfeeding for mothers or infants. Breastfed infants developed pneumonia during the 30 days after maternal vaccination with the active quadrivalent human papillomavirus vaccine, but these effects were not thought to be vaccine related. Maternal vaccination with human papillomavirus vaccine is not a contraindication to breastfeeding. This data is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 Jan 2011). As per manufacturer's data, it is unknown whether human papillomavirus vaccine is excreted in human milk. As many drugs are excreted in human milk, manufacturer advises caution when administering to a nursing woman.
Pricing data from www.DrugStore.com in U.S.A.
- Gardasil SUSP [Syringe] (MERCK SHARP & DOHME)
3 = $875.95
6 = $1699.95
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
