Haemophilus b Vaccine Conjugate, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by injection to protect against infection from Haemophilus influenzae b (Hib) bacteria.
• This medicine may cause unwanted side effects. Tell your healthcare provider if your child has any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat your child about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: vaccine

Generic and brand names: haemophilus b conjugate vaccine, injection; ActHIB; Hiberix; PedvaxHIB

What is this medicine used for?

This medicine is given by injection (shots) to protect infants and children against infection from Haemophilus influenzae b (Hib) bacteria. This vaccine may also be given to people who:

• Have sickle cell anemia, HIV, or cancer
• Have received bone marrow transplants
• Do not have a spleen

What should my healthcare provider know before my child takes this medicine?

Before taking this medicine, tell your healthcare provider if your child has ever had:

• An allergic reaction to any medicine, vaccine, or to latex
• A bleeding disorder, or if he currently takes 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

If your child is severely ill at the time the shot is scheduled, wait until your child recovers before getting this vaccine. If your child has a mild cold or other mild infection, he may still be able to get the shot. Tell your healthcare provider if your child currently has a fever or infection of any kind.

Females of childbearing age: This medicine is not usually given to pregnant women. Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Your healthcare provider will give your child a series of these shots. The schedule of these shots depends on the brand of vaccine used and the child’s age at the time of the first dose. Usually 2 or 3 shots are given about 2 months apart. Then a booster shot is given at 12 to 15 months of age. Your healthcare provider will tell you how many shots your child will need and when he should get them. Keep all appointments for vaccinations to be sure that your child is protected. If a dose is missed, get the missed shot as soon as possible.

This vaccine may be given at the same time as other vaccines. Talk with your healthcare provider about this.

What should I watch out for?

Most people who get this vaccine do not have any problems with it. You may have mild problems such as redness, warmth, or swelling where the shot was given, or a fever. If these problems happen, they usually start within 1 day after receiving the shot. They may last 2 to 3 days. Contact your healthcare provider if these symptoms last longer or if you feel worse.

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 are unable to contact 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.): Fever over 101°F or 38.3°C; seizures; severe dizziness or fainting; gasping or trouble breathing; weakness, paralysis, or numbness in arms or legs.

Other: Diarrhea; vomiting; redness, swelling, or pain at the spot where an injection has been given; tiredness; loss of appetite; irritability; restlessness.

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.

---

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.