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HUMAN PAPILLOMAVIRUS VACCINE: Cervarix, Gardasil

Class: Vaccine

Dosage Forms. Intramuscular Suspension: Cervarix HPV 16 L1 protein 20 mcg/0.5 mL and HPV 18 L1 protein 20 mcg/0.5 mL; Gardasil HPV 6 L1 protein 20 mcg/0.5 mL, HPV 11 L1 protein 40 mcg/0.5 mL, HPV 16 L1 protein 40 mcg/0.5 mL, and HPV 18 L1 protein 20 mcg/0.5 mL

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Common FDA Label Indication, Dosing, and Titration.

1. Human papillomavirus bivalent vaccine (HPV2; types 16 and 18): Prevention of adenocarcinoma in situ of cervix, cervical cancer prophylaxis, cervical intraepithelial neoplasia in females aged 10-25 y 3 dose series at 0, 1, and 6 mo

2. Human papillomavirus quadrivalent vaccine (HPV4; types 6, 11, 16, and 18): Prevention of adenocarcinoma in situ of cervix, cervical cancer prophylaxis, cervical intraepithelial neoplasia, anal cander prophylaxis, malignant tumor of vagina or vulva prophylaxis, intraepithelial neoplasia of the vagina or vulva, and genital warts in individuals aged 9-26 y 3 dose series at 0, 2, and 6 mo

3. Routine immunization of females is recommended at age 11-12 y with either vaccine preparation. Catch-up immunization is recommended for females aged 13-26 y.

4. Routine immunization of males is recommended at age 11-12 y with HPV4. Catch-up immunization is recommended for males aged 13-21 y. HPV4 is recommended for men who have sex with men aged 22-26 y.

Off-Label Uses. None

Drug Characteristics: Human Papillomavirus Vaccine

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Medication Safety Issues: Human Papillomavirus Vaccine

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Drug Interactions: Human Papillomavirus Vaccine

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Adverse Reactions: Human Papillomavirus Vaccine

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Efficacy Monitoring Parameters. Prevention of cervical cancer, other diseases caused by HPV.

Toxicity Monitoring Parameters. Syncope; continue routine cervical cancer screening; negative HPV test not required for vaccination.

Key Patient Counseling Points. Return to provider for all doses in the series.

Clinical Pearls. Complete the vaccine series with the same brand whenever possible. Syncope is common following vaccine administration. Observe immunized individual for 15 min following vaccine administration. Individuals already infected with HPV will not be protected by vaccine. Does not treat active HPV infection or other subtypes of HPV not included in vaccine. HPV 16, 18 causes 70% of cervical cancers; Cervarix only protects against cervical cancer. HPV 6, 11 causes 90% of genital warts; Gardasil protects against both cervical cancer and genital warts. Overall, 93% effective in preventing cervical cancer with life-long immunity.