Gardasil 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 Gardasil.
As with any vaccine, vaccination with Gardasil may not result in protection in all vaccine recipients. Also, Gardasil will only protect against diseases that are caused by HPV types 6, 11, 16 and 18. Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.
Gardasil has not been shown to have a therapeutic effect. It 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 non-vaccine HPV types, 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 Gardasil.
Gardasil should be given with caution to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an IM 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 (see Pharmacology under Actions).
Effects on the Ability to Drive or Operate Machinery: No studies on the effects on the ability to drive and use machines have been performed.
Use in pregnancy & lactation: Specific studies of Gardasil in pregnant women were not conducted. However, during the prelicensure clinical development program, 2266 women (vaccine=1115 vs placebo=1151) reported at least 1 pregnancy. Overall, the proportions of pregnancies with an adverse outcome were comparable in subjects who received Gardasil and subjects who received 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. Conversely, in pregnancies with onset >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 type of anomalies observed were consistent with those generally observed in pregnancies in women aged 16-26 years.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development (see Toxicology under Actions).
The data on Gardasil administered during pregnancy did not indicate any safety signal. However, these data are insufficient to recommend use of Gardasil during pregnancy.
Vaccination should, therefore, be postponed until after completion of pregnancy.
A total of 995 breastfeeding mothers were given Gardasil or placebo during the vaccination period of the clinical trials. The rates of adverse reactions in the mother and the breastfed infant were comparable between the vaccination and the placebo groups. In addition, vaccine immunogenicity was comparable among breastfeeding mothers and women who did not breastfeed during Gardasil administration.
Gardasil can be given to breastfeeding women.