respiratory syncytial virus immune globulin

Do not use RSV IG without first talking to your doctor if you have

• kidney disease;

• diabetes;

• IgA deficiency; or

• had a previous allergic reaction to an immune globulin product.

You may not be able to use RSV IG, or you may require a dosage adjustment or special monitoring during treatment.

RSV IG is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use RSV IG without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether RSV IG passes into breast milk. Do not use RSV IG without first talking to your doctor if you are breast-feeding a baby.

RSV IG will be administered by intravenous (into a vein) injection by a healthcare provider in a hospital or clinic setting. If RSV IG is being administered at home, your healthcare provider will give you detailed instructions regarding administration.

RSV IG is usually administered once a month during the RSV season. Your healthcare provider will give you detailed instructions on when the medication should be administered.

Your doctor may want to perform monitoring during treatment with RSV IG to monitor progress and side effects.

Your healthcare provider will store RSV IG as directed by the manufacturer. If RSV IG is being stored at home, your healthcare provider will give you storage instructions.

Contact your healthcare provider if a dose of RSV IG is missed.

RSV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although RSV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with the doctor the risks and benefits of using RSV IG.

Treatment with immune globulin products such as RSV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify the doctor immediately if symptoms such as decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath occur. These may be signs of kidney problems.

Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of immune globulin products such as RSV IG. Notify the doctor immediately if symptoms such as severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting occur. These may be signs of AMS. Stopping treatment with the immune globulin has resulted in resolution of AMS without any lasting problems.

Notify your doctor immediately if a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to RSV IG is experienced.

Other less serious side effects may also occur. Upon injection of the medication, some patients may experience the following side effects:

• fever;

• vomiting;

• diarrhea; or

• rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

RSV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although RSV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with the doctor the risks and benefits of using RSV IG.

Treatment with immune globulin products such as RSV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify the doctor immediately if symptoms such as decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath occur. These may be signs of kidney problems.

Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of immune globulin products such as RSV IG. Notify the doctor immediately if symptoms such as severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting occur. These may be signs of AMS. Stopping treatment with the immune globulin has resulted in resolution of AMS without any lasting problems.

Vaccinations that use live strains of the virus (e.g., measles, mumps, and rubella or MMR) given during and for approximately ten months following treatment with RSV IG may not produce the desired response. Additional doses of the vaccine may be necessary to ensure effectiveness.

Vaccinations that use live strains of the virus (e.g., measles, mumps, and rubella or MMR) given during and for approximately ten months following treatment with RSV IG may not produce the desired response. Additional doses of the vaccine may be necessary to ensure effectiveness.

It is not known whether other medications will interact with RSV IG. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products during treatment with RSV IG.

Seek emergency medical attention or contact your healthcare provider if an overdose of RSV IG is suspected.

No information is available regarding an overdose of RSV IG.