human papillomavirus vaccine

REMS

Gardasil and Gardasil 9

Prevention of cervical, vulvar, vaginal, and anal cancers and genital warts (in females) and anal cancer and genital warts (in males).

Cervarix

Prevention of cervical cancer.

Action ⬆ ⬇

Vaccination results in antibodies to HPV viruses that are causative agents for cervical, vulvar, vaginal, and anal cancers and genital warts.

Therapeutic effects:

Prevention of cervical, vulvar, vaginal, and anal cancers and genital warts.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following IM administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(antibody response)

ROUTE	ONSET	PEAK	DURATION
IM	unknown	6 mo*	unknown

*After third vaccination.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Thrombocytopenia/bleeding disorder;
OB: Limited data available; use only if potential benefit justifies potential risk to fetus.

Use Cautiously in:

Current/recent febrile illness;
Immunosuppression may ↓ antibody response;
Lactation: Excretion into breast milk unknown;
Pedi: Children <9 yr (safety not established).

Adv. Reactions/Side Effects ⬆ ⬇

Local: injection site reactions

Neuro: fainting

Misc: ANAPHYLAXIS (RARE)

Interactions ⬆ ⬇

Drug-drug:

Immunosuppressants or antineoplastics may ↓ antibody response.

Route/Dosage ⬆ ⬇

IM (Adults and Children —males and females 9–26 yr): Gardasil and Gardasil 9: Three 0.5 mL doses at 0, 2, and 6 mo.
IM (Adults and Children —females 9–25 yr): Cervarix: Three 0.5 mL doses at 0, 2, and 6 mo.

Availability ⬆ ⬇

Sterile preparation for intramuscular administration (Gardasil): 20 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 40 mcg of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein/0.5-mL dose
Sterile preparation for intramuscular administration (Gardasil 9): 30 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 60 mcg of HPV 16 L1 protein, 40 mcg of HPV 18 L1 protein, 20 mcg of HPV 31 L1 protein, 20 mcg of HPV 33 L1 protein, 20 mcg of HPV 45 L1 protein, 20 mcg of HPV 52 L1 protein, and 20 mcg of HPV 58 L1 protein/0.5-mL dose
Sterile preparation for intramuscular administration (Cervarix): 20 mcg of HPV type 16 L1 protein and 20 mcg of HPV type 18 L1 protein

Assessment ⬆ ⬇

Assess vital signs prior to administration. Do not administer to patient with a current or recent febrile illness; low grade fever (<100°F) and mild upper respiratory infection are usually not contraindicated.
Monitor patient for 15 min following injection for fainting. Patient should remain lying down or seated to prevent falls or injury.

Implementation ⬆ ⬇

Vaccine is not intended for treatment of active genital warts or cervical cancer and will not protect from diseases not caused by HPV.
IM: Gardasil and Gardisil 9: Prefilled syringe is for single use; do not use for more than one person. Administer as supplied; do not dilute; administer full dose. Shake well prior to administration to maintain suspension of vaccine. Solution is cloudy and white; do not administer solution that is discolored or contains particulate matter. If using single-dose vial, withdraw 0.5 mL dose and administer entire contents of syringe. Administer intramuscularly in the deltoid or in the high anterolateral area of the thigh.
IM: Cervarix: Prefilled syringe is for single use; do not use for more than one person. Administer as supplied; do not dilute; administer full dose. Shake vial or syringe well before use. Solution is a turbid, white suspension; do not administer if it is discolored or contains particulate matter. The tip cap and rubber plunger of needleless prefilled syringes contain dry natural latex rubber; may cause allergic reactions in latex sensitive individuals. Vial stopper does not contain latex.

Patient/Family Teaching ⬆ ⬇

Provide information about vaccine and the importance of completing immunization series, unless contraindicated, to patient and guardian.
Inform patient that vaccine does not replace routine cervical cancer screening or prevent other sexually transmitted diseases; such screening should be continued as usual.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected. Women exposed to Gardasil or Gardisil 9 vaccine during pregnancy are encouraged to call manufacturer pregnancy registry at 800-986-8999. Women exposed to Cervarix vaccine during pregnancy are encouraged to call manufacturer pregnancy registry at 800-452-9622.
Instruct patient to report any adverse reactions to health care professional.

Evaluation/Desired Outcomes ⬆ ⬇

Prevention of cervical cancer, genital warts, cervical adenocarcinoma in situ, cervical, vulvar, anal, and vaginal intraepithelial neoplasia caused by HPV.

US Brand Names ⬆

human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant: Gardasil,

human papillomavirus bivalent (types 16 and 18) vaccine, recombinant: Cervarix,

human papillomavirus 9–valent (types 6, 11, 16, 18, 31, 33, 45, 52, and 58) vaccine, recombinant: Gardasil 9

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇