Human Papillomavirus Bivalent (Types 16 & 18)

Composition

Each dose (0.5 ml) of vaccine contains-
  • Human papillomavirus type 16 L1 protein 20 mcg
  • Human papillomavirus type 18 L1 protein 20 mcg.

Indications

Papillomavirus vaccine is indicated in females from 9 years of age onwards for the prevention of persistent infection, premalignant cervical lesions and cervical cancer (squamous cell carcinoma and adenocarcinoma) caused by oncogenic human papillomaviruses (HPV).

Pharmacology

Human Papillomavirus (HPV) type 16 and 18 cause about 70% of cervical cancer. HPV bivalent (types 16 and 18) vaccine is a non-infectious vaccine produced by recombinant technology, which contains virus-like particles (VLP) of the major capsid LI protein of oncogenic HPV types 16 and 18. Efficacy of vaccine may be mediated by the production of IgG neutralizing antibodies against the HPV-L1 capsid proteins.

Dosage & Administration

Adult: Females 10-25 yr (or between 10-45 yr in some countries): 3 doses of 0.5 ml each given at 0,1 and 6 mth, preferably administered into deltoid muscle.

Child:
Not recommended for use in girls beiow 9 yr of age.

Interaction

Immunosuppressive therapies e.g. irradiation, cytotoxic drugs and corticorsteroids may reduce a patient's immune response to the vaccine.

Contraindications

Known hypersensitivity to any component. Postpone admin in patient suffering from an acute febrile illness.

Side Effects

Injection site pain, erythema, and inflammation Fatigue, Headache, Myalgia, GI symptoms, Arthralgia

Pregnancy & Lactation

Pregnancy 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. Unknown whether distributed in breast milk

Precautions & Warnings

Observe patient for 15 min after admin as syncope, sometimes accompanied by transient tonic clonic movements and other seizure-like activity may occur during recovery. Caution in patients with thrombocytopenia or other coagulation disorders as IM admin can cause bleeding. Not to be administered by IV, SC, or intradermal route. Immunocompromised individuals may have diminished immune response to the vaccine. As vaccination will not provide protection against every HPV infection or existing HPV infections, routine cervical screening should still be performed. Not recommended for use during pregnancy; caution in lactation.

Therapeutic Class

Vaccines, Anti-sera & Immunoglobulin

Storage Conditions

Store refrigerated at 2 to 8°C. Do not freeze. Protect from light. Human Papillomavirus Bivalent should be administered as soon as possible after being removed from refrigeration.