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Gardasil 9

Generic Name: human papillomavirus (PAP-i-LO-ma-VYE-rus)
Brand Name: Gardasil 9

Gardasil 9 is used for:

Preventing certain diseases (eg, anal, cervical, vulvar, or vaginal cancer; genital warts; anal, cervical, vulvar, or vaginal lesions or tumors) caused by HPV infection in females 9 to 26 years old. It is also used in males 9 to 15 years old to prevent anal cancer, anal lesions or tumors, or genital warts caused by HPV infection.

Gardasil 9 is a vaccine. It works by stimulating the body to produce antibodies against HPV infection.

Do NOT use Gardasil 9 if:

  • you are allergic to any ingredient in Gardasil 9, including yeast
  • you have had an allergic reaction to a dose of another HPV vaccine

Contact your doctor or health care provider right away if this applies to you.

Before using Gardasil 9:

Some medical conditions may interact with Gardasil 9. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have or have recently had a fever
  • if you have HIV infection, cancer, a weakened immune system, or you take medicines that affect your immune system
  • if you have bleeding or blood problems (eg, hemophilia, low blood platelet levels)
  • if you are receiving radiation therapy or cancer chemotherapy
  • if you are scheduled to receive any other vaccines

Some MEDICINES MAY INTERACT with Gardasil 9. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Alkylating agents (eg, cyclophosphamide), antimetabolites (eg, fluorouracil, methotrexate), corticosteroids (eg, prednisone), or cytotoxics (eg, cisplatin) because they may decrease Gardasil 9's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gardasil 9 may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gardasil 9:

Use Gardasil 9 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Gardasil 9. Talk to your pharmacist if you have questions about this information.
  • Gardasil 9 is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • Gardasil 9 is given as a series of 3 separate injections. The first dose is given on a date chosen by you and your doctor. The second dose is given 2 months after the first dose. The third dose is given 6 months after the first dose. Be sure to keep all doctor appointments.
  • If you miss a dose of Gardasil 9, contact your doctor to reschedule your vaccine.

Ask your health care provider any questions you may have about how to use Gardasil 9.

Important safety information:

  • Fainting with jerking movements, seizure-like activity, and falling with injury has occurred following vaccination with Gardasil 9. Your doctor may ask you to sit or lie down for 15 minutes after you receive this vaccine.
  • Gardasil 9 may not provide protection against HPV infection in all recipients. Discuss any questions or concerns with your doctor.
  • Gardasil 9 is only effective against certain types of HPV. Discuss any questions or concerns with your doctor.
  • Gardasil 9 does not protect or treat patients already infected with HPV. It does not cure active genital warts; anal, cervical, vulvar, or vaginal cancer; or other lesions or tumors caused by HPV infection.
  • Gardasil 9 does not prevent or treat diseases that are not caused by HPV.
  • Continue to have regular Pap smears, routine cervical cancer screenings, or anal cancer screenings as directed by your doctor, even after you receive Gardasil 9.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gardasil 9 before you receive Gardasil 9. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Gardasil 9, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gardasil 9:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; lump at the injection site; mild fever; mild pain, redness, itching, bleeding, bruising, or swelling at the injection site; nausea; sore throat; stomach pain; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); calf or leg pain or tenderness; chest pain; chills; confusion; fainting with or without jerking movements or seizure-like activity; general feeling of being unwell; joint pain; muscle pain or weakness; seizures; severe or persistent pain, redness, swelling, or warmth at the injection site; severe stomach pain; shortness of breath; swollen glands (eg, in the neck, armpit, or groin); unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Gardasil 9:

Gardasil 9 is usually handled and stored by a health care provider. If you are storing Gardasil 9 at home, store Gardasil 9 as directed by your pharmacist or health care provider. Keep Gardasil 9 out of the reach of children and away from pets.

General information:

  • If you have any questions about Gardasil 9, please talk with your doctor, pharmacist, or other health care provider.
  • Gardasil 9 is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Gardasil 9 or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Gardasil 9. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gardasil 9. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Gardasil 9.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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