Influenza Virus Vaccine H5N1, Injection

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KEY POINTS

• This medicine is given by injection to provide protection against the bird flu virus.
• 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: influenza virus vaccine H5N1, injection

What is this medicine used for?

This medicine is given by injection (a shot) to adults who are at increased risk of exposure to the H5N1 influenza virus. This medicine provides protection against the bird flu virus. It does not provide protection against seasonal flu.

The vaccine is not available to the general public. You can’t get it from a doctor's office. It has been purchased by the federal government for the U.S. Strategic National Stockpile. If it is ever needed, it will be distributed by the Department of Health and Human Services.

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

Before taking this medicine, tell the healthcare provider if you have ever had:

• An allergic reaction to any medicine or vaccine, or to chicken or egg products
• 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
• Guillain-Barré syndrome

Tell the healthcare provider if you currently have a fever or infection of any kind.

Females of childbearing age: Talk with the healthcare provider if you are pregnant, plan to become pregnant, or are breast-feeding. It is not known whether this medicine will harm an unborn baby. Do not breast-feed right after receiving this medicine without a healthcare provider's approval.

How do I use it?

This medicine must be given by a healthcare provider. The shot is given in the muscle of the upper arm. A second dose of the vaccine is given about 28 days later. Keep the appointment for the second shot to be sure of full protection. If the second shot is missed, call your healthcare provider to get the missed shot as soon as possible.

What should I watch out for?

For a day or two after you get the vaccine, you may feel sore where you had the shot.

This vaccine reduces your risk of getting the bird flu virus, but may not completely protect you. You still have a small chance of getting the bird flu virus even after you have had the vaccine. Talk with your healthcare provider about this.

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

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.

Other: Soreness, redness, or mild swelling where the shot was given, tiredness, muscle pain, headache, runny or stuffy nose, mild fever, diarrhea, nausea, sweating, shivering.

What products might interact with this medicine?

When you receive this medicine while you are taking 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. Tell the healthcare provider if you are taking:

• Cancer medicines such as cisplatin, doxorubicin (Doxil), hydroxyurea (Droxia, Hydrea), vinblastine, and vincristine (Marqibo)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Everolimus (Afinitor, Zortress)
• Immunosuppressants such as azathioprine (Azasan, Imuran), basiliximab (Simulect), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), tacrolimus (Astagraf, Prograf, Protopic), and temsirolimus (Torisel)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), belimumab (Benlysta), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), and leflunomide (Arava)
• 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.