Medication Guide App

Human Papillomavirus Quadrivalent Vaccine, Recombinant

Pronunciation: PAP-i-LO-ma-VYE-rus
Class: Vaccine, viral

Trade Names

Gardasil
- Injection, suspension each 0.5 mL dose contains HPV 6 L1 protein 20 mcg, HPV 11 L1 protein 40 mcg, HPV 16 L1 protein 40 mcg, HPV 18 L1 protein 20 mcg

Pharmacology

Induces development of humoral immune responses against human papillomavirus (HPV).

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Indications and Usage

In girls and women 9 through 26 y of age, prevention of diseases caused by HPV, including cervical, vulvar, anal, and vaginal cancer (types 16 and 18), genital warts (condyloma acuminata) (types 6 and 11), and the following precancerous or dysplastic lesions (types 6, 11, 16, and 18): cervical adenocarcinoma (in situ) and cervical intraepithelial neoplasia (grade 2 and 3), vulvar intraepithelial neoplasia (grade 2 and 3), vaginal intraepithelial neoplasia (grade 2 and 3), anal intraepithelial neoplasia (grades 1, 2, and 3), and cervical intraepithelial neoplasia (grade 1); in boys and men 9 through 26 y of age, prevention of genital warts caused by HPV types 6 and 11, anal cancer caused by HPV types 16 and 18, and the following precancerous or dysplastic lesions caused by HPV (types 6, 11, 16, and 18): anal intraepithelial neoplasia grades 1, 2, and 3.

Contraindications

Hypersensitivity, including severe allergic reactions to yeast after a previous dose of HPV vaccine.

Dosage and Administration

Adults and Children 9 through 26 y of age

IM 3 separate 0.5 mL doses, with the second dose given 2 mo after the first dose and the third dose given 6 mo after the first dose.

General Advice

  • Administer the entire dose IM in the deltoid region of the upper arm or the higher anterolateral area of the thigh.
  • The prefilled syringe is for single use only and should not be used for more than 1 patient.
  • For single-use vials, a separate sterile syringe and needle must be used for each patient.
  • Use the full recommended dose of the vaccine; no dilution or reconstitution is necessary.
  • May be coadministered (at a separate injection site) with Recombivax HB , Menactra , and Adacel .
  • Do not dilute or mix with other vaccines.
  • Shake well immediately before using, which will yield a white, cloudy liquid.
  • Prior to administration, inspect visually for particulate matter and discoloration. Do not use if product has particulates or appears discolored.

Storage/Stability

Store between 36° and 46°F. Do not freeze. Protect from light. Can be out of refrigeration at or below 77°F for not more than 72 h.

Drug Interactions

Immunosuppressive therapies (eg, alkylating agents, antimetabolites, corticosteroids [used in greater than physiologic doses], cytotoxic drugs, irradiation)

Immune responses to vaccines may be reduced.

Adverse Reactions

Cardiovascular

Deep venous thrombosis, pulmonary embolus (postmarketing).

CNS

Headache (28%); dizziness (4%); insomnia, malaise (1%); syncope (including syncope associated with tonic-clonic movements and other seizure-like activity); acute disseminated encephalomyelitis, asthenia, fatigue, Guillain-Barré syndrome, motor neuron disease, paralysis, seizures, transverse myelitis (postmarketing).

EENT

Nasopharyngitis, oropharyngeal pain (3%); nasal congestion (1%).

GI

Nausea (7%); diarrhea (4%); toothache, vomiting (2%); upper abdominal pain (1%); pancreatitis (postmaketing).

Hematologic-Lymphatic

Autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, lymphadenopathy (postmarketing).

Hypersensitivity

Anaphylaxis; bronchospasm, hypersensitivity reactions including anaphylactic/anaphylactoid reactions, urticaria (postmarketing).

Local

Pain (84%); erythema, swelling (25%); bruising, pruritus (3%); hematoma (1%).

Musculoskeletal

Arthralgia/arthritis/arthropathy/reactive arthritis, myalgia (1%).

Respiratory

Cough, upper respiratory tract infection (2%).

Miscellaneous

Pyrexia (13%); autoimmune diseases, cellulitis, chills, death (postmarketing).

Precautions

Monitor

Because syncope may occur following vaccination, observe patients for 15 min after administration.


Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 9 y of age.

Immunocompromised patients

Reduced antibody response to active immunization may occur.

Limitations

Does not replace routine cervical cancer screening in girls and women; does not provide protection against disease from vaccine and nonvaccine HPV types to which patient has previous exposure through sexual activity; not intended for treatment of active genital warts, or cervical, vulvar, anal, or vaginal cancer; does not protect against diseases caused by HPV types not contained in the vaccine; protects only against those vulvar and vaginal cancers caused by HPV 16 and 18; does not protect against genital diseases not caused by HPV; may not result in protection in all vaccine recipients.

Syncope

Has been reported following vaccination with HPV; sometimes associated with tonic-clonic movements and other seizure-like activity.

Overdosage

Symptoms

Adverse reaction profile reported with overdose is comparable with recommended single doses.

Patient Information

  • Inform patient, parent, or guardian that vaccination is not a substitute for routine cervical cancer screening.
  • Inform patient that HPV vaccine has not been demonstrated to provide protection against disease from vaccine and nonvaccine HPV types to which a patient has previously been exposed through sexual activity.
  • Provide patient, parent, or guardian with required vaccine information with each vaccination.
  • Inform patient, parent, or guardian of the benefits and risks associated with vaccination.
  • Advise patient that syncope has been reported following vaccination and sometimes results in falling with injury; observation for 15 min after administration is recommended.
  • Inform patient, parent, or guardian that use is not recommended during pregnancy.
  • Advise patient, parent, or guardian of the importance of completing the immunization series.
  • Instruct patient, parent, or guardian to report any adverse reactions to health care provider.

Copyright © 2009 Wolters Kluwer Health.

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