human papillomavirus vaccine, bivalent (Cervarix, hpv vaccine, bivalent)
Classes: Vaccines, Inactivated, Viral
Dosing and uses of Cervarix, (human papillomavirus vaccine, bivalent)
Cervical Cancer Prevention
October 21, 2016: No longer available in United States
Indicated for prevention of cervical precancers and cervical cancer associated with oncogenic HPV types 16 and 18
Girls and 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 for females at age 11 or 12 yr with either HPV2 or HPV4; may begin vaccination series as early as age 9 yr
- CDC recommends routine vaccination for females at age 13-26 yr with either HPV2 or HPV4 if not previously vaccinated
- 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
Pediatric dosage forms and strengths
Cervical Cancer Prevention
October 21, 2016: No longer available in United States
Indicated for prevention of cervical precancers and cervical cancer associated with oncogenic HPV types 16 and 18
Girls and 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 yr with either HPV2 or HPV4; may begin vaccination series as early as age 9 yr
- CDC recommends routine vaccination for females at age 13-26 yr with either HPV2 or HPV4 if not previously vaccinated
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
Cervarix, (human papillomavirus vaccine, bivalent) adverse (side) effects
>10%
Injection site pain, erythema, and inflammation
Fatigue
Headache
Myalgia
GI symptoms
Arthralgia
Warnings
Contraindications
Hypersensitivity
Prefilled syringes in patient with 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 with seizure, usually transient and responds to supine or Trendelenburg position)
Immunocompromised patient may have decrease response to vaccine
Do not mix with other vaccines in same syringe or viaL
Pregnancy and lactation
Pregnancy category: B; not recommended for use in pregnant women
Women who become pregnant after initiating the vaccination series, no intervention is needed; delay the remaining doses until completion of pregnancy
Lactation: Unknown whether distributed in breast milk; use with caution
Pregnancy categories
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 of Cervarix, (human papillomavirus vaccine, bivalent)
Mechanism of action
Recombinant vaccine prepared from L1 protein of HPV types 16 and 18
Administration
IM Preparation
Shake vial/syringe well before withdrawal and administration
IM Administration
Inject IM in deltoid region of upper arm
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)
