It is a vaccine indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18: ? cervical cancer, ? cervical intraepithelial neoplasia (CIN) Grade 2 or worse and adenocarcinoma in situ, and ? cervical intraepithelial neoplasia (CIN) Grade 1. it is approved for use in females 9 through 25 years of age. Limitations of Use and Effectiveness ?It does not provide protection against disease due to all HPV types. ?It has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity.
Vaccines, Anti-sera & Immunoglobulin
HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Efficacy of Human Papillomavirus Quadrivalent against anogenital diseases related to the vaccine HPV types in h uman beings is thought to be mediated by humoral immune responses induced by the vaccine, although the exact mechanism of protection is unknown.
Three doses (0.5-mL each) by intramuscular injection according to the following schedule: 0, 1, and 6 months.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
Severe allergic reactions (e.g., anaphylaxis) to any component of it
Most common side effects were pain, redness, and swelling at the injection , fatigue, headache, myalgia, gastrointestinal symptoms, and arthralgia.
Category- B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. Lactation: Unknown whether distributed in breast milk
There have been reports of administration of higher than recommended doses of Human Papillomavirus Quadrivalent. In general, the adverse event profile reported with overdose was comparable to recommended single doses of Human Papillomavirus Quadrivalent.
Store refrigerated at 2 to 8°C. Do not freeze. Protect from light. Human Papillomavirus Quadrivalent should be administered as soon as possible after being removed from refrigeration.
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