Papillomavirus Quadrivalent Vaccine (Human) (Recombinant) (Yeast) Suspension for injection

What is this medicine?

HUMAN PAPILLOMAVIRUS VACCINE (HYOO muhn pap uh LOH muh vahy ruhs vak SEEN) is a vaccine. It is used to prevent infections of four types of the human papillomavirus. This will lower your risk of getting cervical cancer, genital warts, and abnormal lesions in the genital area. You cannot get these diseases from the vaccine. This medicine does not treat cervical cancer or genital warts.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• fever or infection
• hemophilia
• HIV infection or AIDS
• immune system problems
• low platelet count
• an unusual reaction to Human Papillomavirus Vaccine, yeast, polysorbate 80, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This vaccine is for injection in a muscle on your upper arm or thigh. It is given by a health care professional. You will be observed for 15 minutes after each dose. Sometimes, fainting happens after the vaccine is given. You may be asked to sit or lie down during the 15 minutes. Three doses are given. The second dose is given 2 months after the first dose. The last dose is given 4 months after the second dose.

A patient information sheet and/or a Vaccine Information Statement will be given before each vaccination. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 9 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

All 3 doses of the vaccine should be given within 6 months. Remember to keep appointments for follow-up doses. Your health care provider will tell you when to return for the next vaccine. Ask your health care professional for advice if you are unable to keep an appointment or miss a scheduled dose.

What may interact with this medicine?

• adalimumab
• anakinra
• etanercept
• immunoglobulins
• infliximab
• medicines that suppress your immune system like medicines for cancer
• medicines that treat or prevent blood clots like warfarin
• steroid medicines like prednisone or cortisone
• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This vaccine may not fully protect everyone. This vaccine does not prevent all types of cervical cancer. Continue to have regular pelvic exams and cervical cancer screenings as directed by your doctor.

The Human Papillomavirus is a sexually transmitted disease. It can be passed by any kind of sexual activity that involves genital contact. The vaccine works best when given before you have any contact with the virus. Many people who have the virus do not have any signs or symptoms.

Tell your doctor or health care professional if you have any reaction or unusual symptom after getting the vaccine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• feeling faint or lightheaded, falls

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough
• fever
• redness, warmth, swelling, pain, or itching at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.