Cervarix (Human Papillomavirus Bivalent Vaccine) is recommended in females only. It provides immunity against infections caused by Human Papillomavirus 16 and 18 that are responsible for causing more than 70% of cervical cancer in females.

Cervarix (Human Papillomavirus Bivalent Vaccine) Uses:

• Prevention of human papillomavirus infection:

  • Prevention in females 9 to 45 years of age of the following diseases caused by oncogenic HPV types 16 and 18:
    • Cervical cancer,
    • cervical intraepithelial neoplasia (CIN) grades 1 to 3 and
    • cervical adenocarcinoma in situ
• The Canadian National Advisory Committee on Immunization (NACI) recommends routine vaccination for females between 9 and 26 years of age.
• It should not be administered in females <9 years but may be administered to females >26 years who are at ongoing risk of exposure.

Read Details about other human papillomavirus vaccines:

• Gardasil (Human Papillomavirus Quadrivalent Vaccine) - Dose, Schedule
• Gardasil 9 (Human Papillomavirus 9-Valent Vaccine) - Dose, Schedule

Cervarix (Human papillomavirus bivalent vaccine) Dose in Adults:

Cervarix (Human papillomavirus bivalent vaccine) Dose in the Prevention of human papillomavirus infection:

• IM: Females ≤45 years: 0.5 mL at 0, 1, and 6 months.
• Administer the second dose 1 to 2.5 months after the first dose; administer the third dose 5 to 12 months after the first dose.

• NACI recommendations:

  • Recommended for females ≤26 years; may be given to those ≥27 years who are at ongoing risk.

Cervarix (Human papillomavirus bivalent vaccine) Dose in Childrens

Note:

• The bivalent HPV vaccine has been discontinued from the US market;
• Use other HPV vaccines for immunization.
• According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid.

Cervarix (Human papillomavirus bivalent vaccine) for Primary immunization:

• CDC (ACIP) recommendations:

  • In a 2-dose series, the minimum interval between the first and second dose is 5 months.
  • In a 3-dose schedule, the minimum interval between the first and second doses is 4 weeks; between the second and third doses is 12 weeks; between first and third doses is 5 months.
• Non-immunocompromised patients and certain specified medical conditions:
  • Asplenia, asthma, chronic granulomatous disease, chronic liver disease, chronic lung disease, chronic renal disease, central nervous system anatomic barrier defects (eg, cochlear implant), complement deficiency, diabetes, heart disease, or sickle cell disease:
    • Children ≥9 years and Adolescents <15 years:
      • Females: 2-dose series: IM: 0.5 mL at 0, and 6 to 12 months.
      • Administer the first dose at age 11 to 12 years; for patients with any history of sexual abuse, begin vaccination at 9 years of age
    • Adolescents ≥15 years:
      • Females: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months

• Immunocompromised Conditions:

  • Immunocompromised patients including those with immunocompromising conditions that might reduce cell-mediated or humoral immunity, such as B lymphocyte antibody deficiencies, T lymphocyte complete or partial defects, HIV infection, malignant neoplasms, transplantation, autoimmune disease, or immunosuppressive therapy:
    • Children ≥9 years and Adolescents:
      • Females: 3-dose series: IM: 0.5 mL at 0, 1 to 2, and 6 months

• Manufacturer's labeling:

  • Females: Children ≥9 years and Adolescents: IM:
    • 0.5 mL per dose for a total of 3 doses.
    • Administer the second and third doses at 1 and 6 months after the initial dose.

Cervarix (Human papillomavirus bivalent vaccine) dose for Catch-up immunization: CDC (ACIP) recommendations:

Note: Do not restart the series. If doses have been given, begin the below schedule at the applicable dose number.

• Children ≥9 years and Adolescents:

  • IM: 0.5 mL per dose for a total of 2 to 3 doses (See CDC/ACIP recommendations above for 2-dose vs 3-dose schedule criteria):
    • The first dose is given on the selected date
    • The second dose is given at least 4 weeks after the first dose (for 3-dose schedule) or 5 months following the first dose (for a 2-dose schedule)
    • Third dose (for a 3-dose schedule) given at least 12 weeks following the second dose and at least 5 months following the first dose

Cervarix (Human papillomavirus bivalent vaccine) Pregnancy Risk Category: B

• Pregnant women should not be administered.
• Although there has been no causal association between exposure to the human papillomavirus vaccine and adverse pregnancy outcomes, it is recommended that the vaccine series (or the completion of the series), be delayed until the pregnancy is resolved.
• Following vaccination, the manufacturer suggests that you avoid pregnancy for at least 2 months.
• Exposure to bivalent human papillomavirus vaccine should be reported to the manufacturer at 800-387-7374.

Use of the human papillomavirus bivalent vaccination during breastfeeding

• It is not known if the vaccine is in breast milk.
• If indicated, breastfeeding mothers may be given the human papillomavirus vaccination.
• The safety of the mother and infant while breastfeeding is not affected by the administration.
• Breastfeeding infants should be vaccinated according to the recommended schedules.

Dose in Kidney Disease

No dosage adjustments provided in the manufacturer's labeling.

Dose in Liver disease:

No dosage adjustment provided in the manufacturer's labeling.

Common Side Effects of Cervarix (Human Papillomavirus Bivalent Vaccine):

• Central Nervous System:

  • Fatigue

• Local:

  • Pain At Injection Site
  • Erythema At Injection Site
  • Swelling At Injection Site

• Neuromuscular & Skeletal:

  • Myalgia
  • Arthralgia

Less Common Side Effects Of Cervarix (Human Papillomavirus Bivalent Vaccine):

• Dermatologic:

  • Urticaria
  • Injection Site Pruritus

• Genitourinary:

  • Vaginal Infection

• Infection:

  • Influenza
  • Infection

• Respiratory:

  • Nasopharyngitis
  • Pharyngolaryngeal Pain
  • Pharyngitis

Contraindications to Cervarix (Human Papillomavirus Bivalent Vaccine):

• Hypersensitivity to any ingredient of the formulation

Warnings and precautions

• Anaphylactoid/hypersensitivity reactions:

  • Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use.

• Syncope

  • Syncope can be caused by injectable vaccines. It is most common in young adults and adolescents within 15 minutes of vaccination.

• Acute illness:

  • The severity of the symptoms and the etiology determine whether or not vaccination should be administered.
  • Patients with severe or moderate acute illness should be delayed (with or with fever); patients with mild acute illness, with or without fever, should not be vaccinated.

• Bleeding disorders:

  • Patients with a history bleeding disorder (including thrombocytopenia) should be cautious. IM administration may cause bleeding/hematoma.
  • Schedule an IM injection immediately after antihemophilic therapy or similar therapy has been completed.

• Infection with human papillomavirus, HPV

  • It is not clear that HPV-infected individuals will be protected.
  • However, those who have been infected by 1 or more HPV types are protected from the disease.
  • It is not recommended for active HPV disease, abnormal Pap tests, or to treat any other diseases that are not caused by HPV vaccine type 16 or 18.

Monitoring parameters:

• Gynecologic screening exam, papillomavirus test as per current guidelines;
• screening for HPV is not required prior to vaccination, and screening for cervical cancer should continue as recommended following vaccination.
• Monitor for anaphylaxis and syncope for 15 minutes following administration.
• If seizure-like activity associated with syncope occurs, keep the patient in supine or Trendelenburg position to maintain adequate cerebral perfusion.

How to administer Cervarix (Human Papillomavirus Bivalent Vaccine)?

IM:

• Shake well prior to use.
• Do not use if discolored or if containing particulate matter, or if the syringe is cracked.
• Inject IM into the deltoid region of the upper arm.
• Do not administer IV, SubQ, or intradermally.
• Do not mix with other vaccines or injections; use separate needles and syringes for each injection.
• Vaccinate patients while seated or lying down to prevent syncope related injuries.
• When given with other age-appropriate vaccines, human papillomavirus vaccine should be given after other vaccines as it may cause more pain with injection.
• For patients at risk of bleeding following intramuscular injection, the vaccine should be administered IM only at treating clinicians' judgment.
• If the patient receives antihemophilic or other similar therapy, schedule intramuscular vaccination shortly after such therapy is administered.
• Use fine needle (23 gauge or smaller) for vaccination and apply firm pressure to the site (without rubbing) for 5 to 10 minutes.
• Educate patients about the risk of hematoma from the injection.
• Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated the same as those with clotting factor disorders.

Mechanism of action of Cervarix (Human papillomavirus bivalent vaccine):

It contains inactive human papillomavirus proteins (HPV) HPV 16 L1 and HPV18 L1, which produce neutralizing antibodies to stop cervical cancer, cervical carcinoma, and cervical neoplasia.

Efficacy:

• Females between 15 and 25 years old can be protected against HPV types 16-18-related cervical diseases by using a 95% to 99 percent effective treatment.
• Additionally, HPV 16 and 18 vaccinations may protect against 70% anogenital cancers as well as 60% of high-risk cervical precancerous lesions.

Onset:

• Seroconversion was observed at month 7

Duration:

• Unknown.
• Clinical studies followed HPV2 vaccinated participants for 10 years and found no evidence of decreased protection.

International Brand Names of Human papillomavirus Bivalent Vaccine:

• Cervarix

Human papillomavirus bivalent vaccine Brand Names in Pakistan:

No Brands Available in Pakistan.