Human Papillomavirus Bivalent Vaccine, Injection

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KEY POINTS

• This medicine is given by injection to females 9 through 25 years of age to help prevent against cervical cancer and precancers caused by human papillomavirus.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: vaccine

Generic and brand names: human papillomavirus bivalent vaccine, injection; Cervarix

What is this medicine used for?

This medicine is given by injection (shots) to girls and women 9 through 25 years of age to help prevent against cervical cancer and precancers caused by human papillomavirus (HPV) types 16 and 18. The Advisory Committee on Immunization Practices (ACIP) recommends the HPV vaccine for females at age 11 to 12 years. The vaccine is also recommended for girls and women 13 through 26 years of age who did not get all 3 doses when they were younger.

This medicine does not treat cervical cancer. It does not prevent disease due to all types of HPV. This medicine does not protect against sexually transmitted diseases that are not caused by HPV.

What should my healthcare provider know before I take this medicine?

Before receiving this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or vaccine, or to latex
• A bleeding disorder, or if you currently take medicines that reduce the chance of blood clots forming
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection

Tell your healthcare provider if you have recently gotten any other vaccine. Also tell your provider if you currently have a fever or infection of any kind. If you are severely ill at the time the shot is scheduled, wait until you recover before getting this vaccine. If you have a mild cold or other mild infection, you may still be able to get your shot.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. This medicine is not recommended to be used during pregnancy. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine is given by a healthcare provider as a series of 3 shots:

• First dose
• 2nd dose 1 month later
• 3rd dose 6 months after the first dose

You must receive all 3 shots for the vaccine to be fully effective. Keep all appointments for shots.

What should I watch out for?

It is very important to get all shots on schedule to provide protection from this serious disease. Keep all appointments for injections and checkups.

These injections may cause pain, irritation on the skin, or a lump where you had the shot. If these symptoms don't go away in a few days, contact your healthcare provider.

These injections may make you feel dizzy or weak. They may cause fainting, especially in young girls. Your healthcare provider may ask you to sit or lie down for 15 minutes after you get this medicine. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

This vaccine does not take the place of regular Pap tests or checkups for cervical cancer. You still need regular screening.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; tightness in your chest; swelling of your lips, tongue, or throat; trouble breathing).

Serious (Report these to your healthcare provider right away.): High fever, severe dizziness or fainting, seizures, behavior changes, chest pain, fast heartbeat, swollen glands.

Other: Headache; nausea; vomiting; diarrhea; dizziness; lightheadedness; tiredness; redness, swelling, or pain at the spot where an injection has been given; mild fever; muscle aches; joint pain or stiffness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Cancer medicines such as cisplatin, hydroxyurea (Droxia, Hydrea), vinblastine, vincristine (Marqibo), and others
• Corticosteroids such as dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisone (Prednisone Intensol), and others
• Everolimus (Afinitor, Zortress)
• Immunosuppressants such as azathioprine (Azasan, Imuran), basiliximab (Simulect), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), and others
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), anakinra (Kineret), belimumab (Benlysta), leflunomide (Arava), and others
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Multiple sclerosis medicines such as fingolimod (Gilenya), natalizumab (Tysabri), teriflunomide (Aubagio), and others
• Radiation therapy

Keep a record of all vaccines received and when you received them.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.