Medication Guide App

Human Papillomavirus Bivalent Vaccine, Recombinant

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

Trade Names

Cervarix
- Injection, suspension Each 0.5 mL dose contains: 20 mcg of HPV type 16 L1 protein and 20 mcg of HPV type 18 L1 protein

Pharmacology

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

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Indications and Usage

Prevention in girls and women 10 through 25 yr of age of diseases caused by HPV types 16 and 18, including cervical cancer, cervical intraepithelial neoplasia (CIN) (grade 2 or worse) and adenocarcinoma in situ, and CIN grade 1.

Contraindications

Severe allergic reactions (eg, anaphylaxis) to any component of the vaccine.

Dosage and Administration

Women and Girls 10 to 25 yr of age

IM 3 separate 0.5 mL doses, with the second dose given 1 mo after the first dose and the third dose given 6 mo after the first dose.

General Advice

  • Administer IM in the deltoid region of the upper arm; do not inject IV, subcutaneously, or intradermally.
  • The vials and prefilled syringes are for single use only.
  • 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 in refrigerator at 36° to 46°F. Do not freeze. Discard if vaccine has been frozen.

Drug Interactions

Immunosuppressive therapies (eg, alkylating agents, antimetabolites, corticosteroids, cytotoxic drugs, irradiation)

Immune responses to vaccines may be reduced.

Adverse Reactions

Cardiovascular

Syncope (postmarketing).

CNS

Fatigue (55%); headache (53%); dizziness (2%); vasovagal reactions sometimes accompanied by tonic-clonic movements (postmarketing).

Dermatologic

Rash (10%); urticaria (7%).

EENT

Nasopharyngitis (4%); pharyngolaryngeal pain (3%); pharyngitis (2%).

GI

GI symptoms including nausea, vomiting, diarrhea, and/or abdominal pain (28%).

Genitourinary

Dysmenorrhea (2%); UTI, vaginal infection (1%).

Hypersensitivity

Anaphylactic/anaphylactoid reactions, angioedema, erythema multiform (postmarketing).

Local

Pain (92%); erythema (48%); swelling (44%); bruising, pruritus (1%).

Musculoskeletal

Myalgia (49%); arthralgia (21%); back pain (1%).

Respiratory

Upper respiratory tract infection (2%).

Miscellaneous

Pyrexia (13%); influenza (3%); chlamydia infection (2%).

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 10 yr of age.

Syncope

Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported.

Impaired immune responsiveness

Reduced antibody response to active immunization may occur.

Latex allergy

The tip cap and rubber plunger of the needleless prefilled syringe contain dry natural latex rubber that cause allergic reactions in latex-sensitive persons. The vial stopper does not contain latex.

Limitations

Does not provide protection against disease from vaccine and nonvaccine HPV types to which patient has previous exposure through sexual activity; does not protect against diseases due to HPV types not contained in the vaccine; protects only against those cervical 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.

Overdosage

Symptoms

None well documented.

Patient Information

  • Inform patient, parent, or guardian that vaccination is not a substitute for routine cervical cancer screening.
  • 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.
  • 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.
  • Inform patients that syncope has been reported following vaccination in young women, sometimes resulting in falling with injury; observation for 15 min after administration is recommended.
  • Instruct patients to inform their health care provider if they have an allergy to latex. The needleless prefilled syringe contains dry natural latex rubber.

Copyright © 2009 Wolters Kluwer Health.

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