Gardasil

Generic name: Human papillomavirus vaccine

What is Gardasil?

Gardasil is a vaccine used in girls and women 9-26 years of age for the prevention of cervical cancer and genital warts caused by human papillomavirus (HPV) types 6, 11, 16, and 18.

What is the most important information I should know about Gardasil?

This vaccine is not intended to be used for treatment of active genital warts and cervical caner. This vaccine will not protect against diseases that are not caused by HPV.

Patients with impaired immune responsiveness may have reduced antibody response to active immunization.

The safety and efficacy of Gardasil have not been evaluated in children younger than 9 years and adults above the age of 26 years.

Gardasil should not be given to individuals with bleeding disorders unless the potential benefits clearly outweigh the risk of administration.

Who should not take Gardasil?

Gardasil is contraindicated in patients who are allergic to the active substances or to any of the ingredients of the vaccine.

What should I tell my doctor before I take the first dose of Gardasil?

Tell your doctor about all prescription, over-the-counter, and herbal medication you are taking before beginning treatment with Gardasil. Also, talk to your doctor about your complete medical history, especially if you are pregnant or planning to become pregnant, and a bleeding disorder such as hemophilia.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Gardasil should be administered intramuscularly as 3 separate 0.5mL doses according to the following schedule: First dose at elected date, Second dose at 2 months after the first dose, and Third dose at 6 months after the first dose.

How should I take Gardasil?

Gardasil should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. Gardasil must not be injected intravascularly. Fainting may follow any vaccination, so patients should be observed approximately 15 minutes after administration. The prefilled syringe is for single use only and should not be used for more than 1 individual. For single-use vials a separate sterile syringe and needle must be used for each individual. Do not use the product if particulates are present or if it appears discolored. The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used. Shake well before use. Withdraw the 0.5mL dose of vaccine from the single dose vial using a sterile needle and syringe. Once the single dose vial has been penetrated, the withdrawn vaccine should be used promptly. For prefilled syringe use, inject the entire contents of the syringe.

What should I avoid while taking Gardasil?

Do not drive or engage in activities that require alertness and coordination.

What are possible food and drug interactions associated with Gardasil?

If Gardasil is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Gardasil with immunosuppressant medications.

What are the possible side effects of Gardasil?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: Injection site pain/swelling, fever, nausea, dizziness

Can I receive Gardasil if I am pregnant or breastfeeding?

The effects of Gardasil during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

What should I do if I miss a dose of Gardasil?

Contact your doctor if you miss a Gardasil dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

How should I store Gardasil?

Store at room temperature. Do not freeze. Protect from light.