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Generic Name

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Presentation

Indications

Adult Dosage

The primary vaccination series consists of 3 separate 0.5 ml doses administered according to the following schedule: 0, 2, 6 months.

If an alternate vaccination schedule is necessary, the second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.

The need for a booster dose has not been established.

Paediatric population: Gardasil is not recommended for use in children below 9 years of age due to insufficient data on immunogenicity, safety and efficacy.

The vaccine should be administered by intramuscular injection. The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh.

Gardasil must not be injected intravascularly. Neither subcutaneous nor intradermal administration has been studied. These methods of administration are not recommended.

It is recommended that subjects who receive a first dose of Gardasil complete the 3-dose vaccination course with Gardasi.

Child Dosage

Contra Indications

Hypersensitivity to the active substances or to any of the excipients.

Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Gardasil should not receive further doses of Gardasil.

Administration of Gardasil should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation.

Special Precautions

As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

Syncope (fainting) may follow any vaccination, especially in adolescents and young adults. Syncope, sometimes associated with falling, has occurred after vaccination with Gardasil. Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of Gardasil.

As with any vaccine, vaccination with Gardasil may not result in protection in all vaccine recipients. Gardasil will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to some limited extent against diseases caused by certain related HPV types. Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.

Gardasil has not been shown to have a therapeutic effect. The vaccine is therefore not indicated for treatment of cervical cancer, high-grade cervical, vulvar and vaginal dysplastic lesions or genital warts. It is also not intended to prevent progression of other established HPV-related lesions.

Vaccination is not a substitute for routine cervical screening. Since no vaccine is 100% effective and Gardasil will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.

There are no data on the use of Gardasil in subjects with impaired immune responsiveness. Individuals with impaired immune responsiveness, whether due to the use of potent immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may not respond to the vaccine.

This vaccine should be given with caution to individuals with thrombocytopaenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.

The duration of protection is currently unknown. Sustained protective efficacy has been observed for 4.5 years after completion of the 3-dose series. Longer term follow-up studies are ongoing.

There are no safety, immunogenicity or efficacy data to support interchangeability of Gardasil with other HPV vaccines.

Interactions

In all clinical trials, individuals who had received immunoglobulin or blood-derived products during the 6 months prior to the first vaccine dose were excluded.

Use with other vaccines

Administration of Gardasil at the same time (but, for injected vaccines, at a different injection site) as hepatitis B (recombinant) vaccine did not interfere with the immune response to the HPV types. The seroprotection rates (proportion of subjects reaching seroprotective level anti-HBs 10 mIU/ml) were unaffected (96.5% for concomitant vaccination and 97.5% for hepatitis B vaccine only). Anti-HBs geometric mean antibody titres were lower on co-administration, but the clinical significance of this observation is not known.

The concomitant administration of Gardasil with vaccines other than hepatitis B (recombinant) vaccine has not been studied.

Use with hormonal contraceptives

In clinical studies, 57.5% of women (age 16 to 26 years) who received Gardasil used hormonal contraceptives. Use of hormonal contraceptives did not appear to affect the immune response to Gardasil.

Adverse Reactions

In 5 clinical trials (4 placebo-controlled), subjects were administered Gardasil or placebo on the day of enrolment and approximately 2 and 6 months thereafter. Few subjects (0.2%) discontinued due to adverse reactions. Safety was eva luated in either the entire study population (4 studies) or in a predefined subset (one study) of the study population using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Gardasil or placebo. The subjects who were monitored using VRC-aided surveillance included 6,160 subjects (5,088 females 9 to 26 years of age and 1,072 males 9 to 15 years of age at enrolment) who received Gardasil and 4,064 subjects who received placebo.

The following vaccine-related adverse reactions were observed among recipients of Gardasil at a frequency of at least 1.0% and also at a greater frequency than observed among placebo recipients. They are ranked under headings of frequency using the following convention:

[Very Common (1/10); Common (1/100, <1/10); Uncommon (1/1,000, <1/100); Rare (1/10,000, <1/1,000); Very Rare (<1/10,000), including isolated reports]

General disorders and administration site conditions:

Very common: pyrexia.

Very common: at the injection site: erythema, pain, swelling.

Common: at the injection site: bruising, pruritus.

In addition, in clinical trials adverse reactions that were judged to be vaccine- or placebo-related by the study investigator were observed at frequencies lower than 1%:

Respiratory, thoracic and mediastinal disorders:

Very rare: bronchospasm.

Skin and subcutaneous tissue disorder:

Rare: urticaria.

Seven cases (0.06%) of urticaria were reported in the Gardasil group and 17 cases (0.18%) were seen in the adjuvant-containing placebo group.

In the clinical studies, subjects in the Safety Population reported any new medical conditions during the follow-up of up to 4 years. Among 11,778 subjects who received Gardasil and 9,686 subjects who received placebo, there were 28 cases of non-specific arthritis/arthropathy reported, 20 in the Gardasil group and 8 in the placebo group.

Post Marketing Experience

Post Marketing adverse events have been spontaneously reported for Gardasil and are not listed above.

Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure.

Blood and lymphatic system disorders: lymphadenopathy.

Immune system disorders: hypersensitivity reactions including anaphylactic/anaphylactoid reactions.

Nervous system disorders: Guillain-Barré syndrome, dizziness,headache, syncope sometimes accompanied by tonic-clonic movements.

Gastrointestinal disorders: nausea, vomiting.

Musculoskeletal and connective tissue disorders: arthralgia, myalgia.

General disorders and administration site conditions: asthenia, fatigue, malaise.

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