human papillomavirus vaccine, bivalent (Discontinued)

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Brand and Other Names:Cervarix, hpv vaccine, bivalent

Dosing & Uses

AdultPediatric

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

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
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Interactions

Interaction Checker

and human papillomavirus vaccine, bivalent

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            Adverse Effects

            >10%

            Injection site pain, erythema, and inflammation

            Fatigue

            Headache

            Myalgia

            GI symptoms

            Arthralgia

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            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

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            Pregnancy & 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.

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            Pharmacology

            Mechanism of Action

            Recombinant vaccine prepared from L1 protein of HPV types 16 and 18

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            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)

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