human papillomavirus vaccine, bivalent (Rx) - Cervarix, hpv vaccine, bivalent
- Class: Vaccines, Inactivated, Viral
Adult Dosing & Uses
Cervical Cancer Prevention
Indicated for prevention of cervical precancers & cervical cancer associated with oncogenic HPV types 16 & 18
Girls & women (9-25 years old): 0.5 mL IM x3 doses at 0, 1, and 6 months (FDA approved labeled dose)
CDC recommendations
- Girls and women aged 9-26 years: 0.5 mL IM for 3 doses administered at schedule of 0, 2, and 6 mo
- CDC recommends routine vaccination at age 11 or 12 yr with either HPV2 or HPV4; may begin vaccination series as early as age 9 yr
- If age 26 y reached before vaccination series completed, remaining doses can be administered after age 26 yr
Indicated for prevention of the following diseases caused by HPV types 16 & 18
- Cervical cancer
- Cervical intraepithelial neoplasia (CIN grade 2 or worse)
- Adenocarcinoma in situ
- Cervical intraepithelial neoplasia (CIN) grade 1
Other Information
Inject IM in deltoid region of upper arm
Pediatric Dosing & Uses
Cervical Cancer Prevention
Indicated for prevention of cervical precancers and cervical cancer associated with oncogenic HPV types 16 & 18
Girls & women (9-25 years old): as adults; 0.5 mL IM x3 doses at 0, 1, and 6 months (FDA approved labeled dose)
CDC recommendations
- Girls and women aged 9-26 years: 0.5 mL IM for 3 doses administered at schedule of 0, 2, and 6 mo
- CDC recommends routine vaccination at age 11 or 12 y with either HPV2 or HPV4; may begin vaccination series as early as age 9 yr
Indicated for prevention of the following diseases caused by HPV types 16 & 18
- Cervical cancer
- Cervical intraepithelial neoplasia (CIN grade 2 or worse)
- Adenocarcinoma in situ
- Cervical intraepithelial neoplasia (CIN) grade 1
Other Information
Inject IM in deltoid region of upper arm
Drug Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Injection site pain, erythema, & inflammation
Fatigue
Headache
Myalgia
GI symptoms
Arthralgia
Contraindications & Cautions
Contraindications
Hypersensitivity
Prefilled syringes in pt w/ latex allergy
Cautions
Not recommended during pregnancy (safety not established)
Syncope may occur, observe for 15 min after administration
Tonic/clonic movements and other seizure-like activity has been reported (if associated w/ seizure, usually transient & responds to supine or Trendelenburg position)
Immunocompromised pt may have decrease response to vaccine
Do not mix with other vaccines in same syringe or vial
Pregnancy & Lactation
Pregnancy category: B
Lactation: Unknown whether distributed in breast milk; use with caution
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Duration: unknown
Mechanism of Action
Recombinant vaccine prepared from L1 protein of HPV types 16 & 18
IV & IM Information
IM Preparation
Shake vial/syringe well before withdrawal and administration
Storage
Store refrigerated be 2-8 degrees Centigrade
Do not freeze
Fine, white deposit with a clear, colorless supernatant may be observed (does not constitute deterioration)
