Respiratory Syncytial Virus Immune Globulin (Human) Solution for injection

What is this medicine?

RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN, RSV-IGIV, (RES per uh tawr ee SIN sish al VAHY ruhs i MYOON GLOB yoo lin) is used in high risk children to prevent severe cases of respiratory syncytial virus (RSV) infection. This medicine may prevent RSV or prevent the need for hospital care from an RSV infection.

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 your child has any of these conditions:

• diabetes
• heart disease
• immunoglobulin A deficiency
• kidney disease
• an unusual or allergic reaction to immune globulin, human immunoglobulin products, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as newborn 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?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• some 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?

Your condition will be monitored carefully while you are receiving this medicine.

This medicine can decrease the response to a vaccine. Extra booster doses may be needed. Talk to your doctor to see if a different vaccination schedule is needed.

This medicine is made from human blood. It may be possible to pass an infection in this medicine. Talk to your doctor about the risks and benefits of this medicine.

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
• cold, clammy skin
• extreme irritability
• fast heart rate
• fever
• lips or nails with bluish color
• pain in eyes when in light
• stiff muscles
• sudden weight gain, puffiness to face, arms, or legs
• trouble passing urine or change in the amount of urine
• unusual color pattern on skin
• unusually weak or tired
• vomiting

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

• diarrhea
• headache
• loss of appetite
• nausea
• pain at site where injected
• runny nose

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.