No information provided.

As for any vaccine, vaccination with GARDASIL may not result in protection in all vaccine recipients.

This vaccine is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN.

This vaccine will not protect against diseases that are not caused by HPV.

GARDASIL has not been shown to protect against diseases due to non-vaccine HPV types.

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.

The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. Low-grade fever itself and mild upper respiratory infection are not generally contraindications to vaccination.

Individuals with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes, may have reduced antibody response to active immunization (see PRECAUTIONS, Drug Interactions).

As with other intramuscular injections, GARDASIL should not be given to individuals with bleeding disorders such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration. If the decision is made to administer GARDASIL to such persons, it should be given with steps to avoid the risk of hematoma following the injection.

Carcinogenesis, Mutagenesis, Impairment of Fertility

GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.

GARDASIL administered to female rats at a dose of 120 mcg total protein, which corresponds to approximately 300-fold excess relative to the projected human dose, had no effects on mating performance, fertility, or embryonic/fetal survival.

Pregnancy

Pregnancy Category B:

Reproduction studies have been performed in female rats at doses up to 300 times the human dose (on a mg/kg basis) and have revealed no evidence of impaired female fertility or harm to the fetus due to GARDASIL. However, it is not known whether GARDASIL can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. GARDASIL should be given to a pregnant woman only if clearly needed. An evaluation of the effect of GARDASIL on embryo-fetal, pre- and postweaning development was conducted using rats. One group of rats was administered GARDASIL twice prior to gestation, during the period of organogenesis (gestation day 6) and on lactation day 7. A second group of pregnant rats was administered GARDASIL during the period of organogenesis (gestation day 6) and on lactation day 7 only. GARDASIL was administered at 0.5 mL/rat/occasion (approximately 300-fold excess relative to the projected human dose on a mg/kg basis) by intramuscular injection. No adverse effects on mating, fertility, pregnancy, parturition, lactation, embryo-fetal or pre- and postweaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study. In addition, there were no treatment-related effects on developmental signs, behavior, reproductive performance, or fertility of the offspring. The effect of GARDASIL on male fertility has not been studied.

In clinical studies, women underwent urine pregnancy testing prior to administration of each dose of GARDASIL. Women who were found to be pregnant before completion of a 3-dose regimen of GARDASIL were instructed to defer completion of their vaccination regimen until resolution of the pregnancy.

During clinical trials, 2266 women (vaccine = 1115 vs. placebo = 1151) reported at least 1 pregnancy each. Overall, the proportions of pregnancies with an adverse outcome were comparable in subjects who received GARDASIL and subjects who received placebo. Overall, 40 and 41 subjects in the group that received GARDASIL or placebo, respectively (3.6% and 3.6% of all subjects who reported a pregnancy in the respective vaccination groups), experienced a serious adverse experience during pregnancy. The most common events reported were conditions that can result in Caesarean section (e.g., failure of labor, malpresentation, cephalopelvic disproportion), premature onset of labor (e.g., threatened abortions, premature rupture of membranes), and pregnancy-related medical problems (e.g., pre-eclampsia, hyperemesis). The proportions of pregnant subjects who experienced such events were comparable between the vaccination groups.

There were 15 cases of congenital anomaly in pregnancies that occurred in subjects who received GARDASIL and 16 cases of congenital anomaly in pregnancies that occurred in subjects who received placebo.

Further sub-analyses were conducted to evaluate pregnancies with estimated onset within 30 days or more than 30 days from administration of a dose of GARDASIL or placebo. For pregnancies with estimated onset within 30 days of vaccination, 5 cases of congenital anomaly were observed in the group that received GARDASIL compared to 0 cases of congenital anomaly in the group that received placebo. The congenital anomalies seen in pregnancies with estimated onset within 30 days of vaccination included pyloric stenosis, congenital megacolon, congenital hydronephrosis, hip dysplasia and club foot. Conversely, in pregnancies with onset more than 30 days following vaccination, 10 cases of congenital anomaly were observed in the group that received GARDASIL compared with 16 cases of congenital anomaly in the group that received placebo. The types of anomalies observed were consistent (regardless of when pregnancy occurred in relation to vaccination) with those generally observed in pregnancies in women aged 16 to 26 years.

Pregnancy Registry for GARDASIL

Merck & Co., Inc. maintains a Pregnancy Registry to monitor fetal outcomes of pregnant women exposed to GARDASIL. Patients and health care providers are encouraged to report any exposure to GARDASIL during pregnancy by calling (800) 986-8999.

Lactation

It is not known whether vaccine antigens or antibodies induced by the vaccine are excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when GARDASIL is administered to a nursing woman.

A total of 995 nursing mothers (vaccine = 500, placebo = 495) were given GARDASIL or placebo during the vaccination period of the clinical trials. GMTs in nursing and non-nursing mothers were as follows:

The GMTs in nursing mothers were 595.9 (95% CI: 522.5, 679.5) for anti-HPV 6, 864.3 (95% CI: 754.0, 990.8) for anti-HPV 11, 3056.9 (95% CI: 2594.4, 3601.8) for anti-HPV 16, and 527.2 (95% CI: 450.9, 616.5) for anti-HPV 18. The GMTs for women who did not nurse during vaccine administration were 540.1 (95% CI: 523.5, 557.2) for anti-HPV 6, 746.3 (95% CI: 720.4, 773.3) for anti-HPV 11, 2290.8 (95% CI: 2180.7, 2406.3) for anti-HPV 16, and 456.0 (95% CI: 438.4, 474.3) for anti-HPV 18.

Overall, 17 and 9 infants of subjects who received GARDASIL or placebo, respectively (representing 3.4% and 1.8% of the total number of subjects who were breast-feeding during the period in which they received GARDASIL or placebo, respectively), experienced a serious adverse experience. None was judged by the investigator to be vaccine related.

In clinical studies, a higher number of breast-feeding infants (n = 6) whose mothers received GARDASIL had acute respiratory illnesses within 30 days post-vaccination of the mother as compared to infants (n = 2) whose mothers received placebo. In these studies, the rates of other adverse experiences in the mother and the nursing infant were comparable between vaccination groups.

Pediatric Use

The safety and efficacy of GARDASIL have not been evaluated in children younger than 9 years.

Geriatric Use

The safety and efficacy of GARDASIL have not been evaluated in adults above the age of 26 years.

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