Generic
Human Papillomavirus Bivalent
2 brands available in the market
At a glance
Human Papillomavirus Bivalent is indicated for women aged 9-45 years for preventing cervical cancer and other diseases caused by HPV types 16 and 18.
Description
Human Papillomavirus Bivalent vaccine is used for preventing diseases caused by HPV types 16 and 18. It is indicated for women aged 9-45 years. The vaccine contains recombinant L1 proteins that form virus-like particles (VLPs) and stimulate the immune system to produce antibodies. Vaccination before sexual debut is most effective, so vaccination at 9-14 years is recommended.
Indications
- Cervical cancer
- Cervical intraepithelial neoplasia Grade 2 or 3 (CIN2/3)
- Adenocarcinoma in-situ (AIS)
- Cervical intraepithelial neoplasia Grade 1 (CIN1)
- Persistent infections of HPV types 16 and/or 18
Therapeutic class
Vaccines, Anti-sera & Immunoglobulin
Pharmacological class
HPV Vaccine
Pharmacology
HPV Bivalent vaccine contains L1 proteins of HPV types 16 and 18 produced by recombinant DNA technology, which form virus-like particles (VLPs). These VLPs act as antigens and generate HPV-specific antibodies in the body.
Mechanism of action
The vaccine stimulates the immune system through virus-like particles (VLPs) to produce antibodies against HPV types 16 and 18, which prevent future infection by these viruses.
Dosage
Adult Dose (9-45 years, Female):
- 3 doses (0.5 ml each) intramuscular: 0, 1 and 6 months
- Flexible schedule: 2nd dose at 1-2 months, 3rd dose at 5-8 months
Child Dose (9-14 years, Female):
- 2 doses (0.5 ml each) intramuscular: 0 and 6 months (minimum 5 months interval)
Administration
Intramuscular injection only in the deltoid region of the upper arm. Shake well before use. Inspect the prefilled syringe content before and after shaking. Subcutaneous, intravascular or intradermal injection is prohibited. Use as soon as possible after removal from refrigeration.
Missed dose
If you miss a dose, take it as soon as possible and follow the schedule for subsequent doses. Consult your doctor.
Side effects
Common Local Reactions:
- Pain, redness, swelling at injection site
Common Systemic Reactions:
- Fever (≥37.1°C)
- Headache, fatigue, cough, muscle pain
- Nausea, diarrhea, dizziness, vomiting
Occasional Reactions:
- Hypersensitivity, allergic dermatitis, rash, pruritus
Precautions & warnings
Precautions:
- Vaccination cannot replace routine cervical cancer screening
- Review medical history before vaccination
- Prepare emergency medical measures for allergic reactions
- Observe for at least 30 minutes after each injection (to prevent syncope)
- Postpone vaccination in acute febrile illness
- Use with caution in thrombocytopenia or coagulation disorders
Contraindications
Contraindications:
- Hypersensitivity to active substances or excipients
- Symptoms of hypersensitivity after a previous dose
Drug interactions
Drug Interactions:
- Immunosuppressive therapy (corticosteroids, cytotoxic drugs) may reduce immune response
- Avoid immunoglobulin or blood products within 3 months of vaccination
- No data on interchangeability with other HPV vaccines
- Do not mix with other vaccines in the same syringe
Food interactions
No food interaction found/established.
Use in pregnancy
Use in Pregnancy: Avoid vaccination during pregnancy. Animal studies show no direct or indirect adverse effects. If pregnant or planning pregnancy, postpone vaccination and administer after pregnancy.
Use in lactation
Use in Lactation: No relevant study data for HPV vaccine. Use with caution in lactating women as many drugs are secreted in breast milk.
Pediatric use
2-dose schedule (0 and 6 months) recommended for females aged 9-14 years.
Geriatric use
No specific data for geriatric population; indicated for 9-45 years.
Renal / hepatic impairment
No specific data for renal or hepatic impairment.
Overdose effects
No information on overdose.
Storage conditions
Store at +2°C to +8°C. Transport also at +2°C to +8°C. Do not freeze. Protect from light.
Chemical structure
HPV Bivalent Vaccine