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|Respiratory Syncytial Virus Immune Globulin Intravenous

RESPIRATORY SYNCYTIAL VIRUS IMMUNE GLOBULIN INTRAVENOUS (Systemic)

Some commonly used brand names are:

In the U.S.—

• RespiGam

In Canada—

• RespiGam

Another commonly used name is RSV-IGIV .

Category

• Immunizing agent (passive)

Description

Respiratory syncytial virus immune globulin intravenous (res-pi-ra-TOR-e SIN-sish-al VI-ras im-MUNE GLOB-yoo-lin IN-tra-ve-nas) (RSV-IGIV) belongs to a group of medicines known as immunizing agents. RSV-IGIV is used to prevent infection caused by respiratory syncytial virus (RSV). RSV-IGIV works by giving your body the antibodies it needs to protect it against RSV infection.

RSV infection can cause serious problems, such as pneumonia and bronchitis, which affect the lungs; and in severe cases, even death. These problems are more likely to occur in infants and young children less than 6 months of age with chronic lung disease, those born with heart problems, and those with a history of premature birth.

Onset of RSV activity usually occurs in November and continues through April or early May, with peak activity occurring from late January through mid-February. A good way to help prevent RSV infection is to get RSV-IGIV before the start of the RSV season.

RSV-IGIV is used to prevent serious lower respiratory tract infection caused by the respiratory syncytial virus (RSV) in children less than 24 months of age with breathing problems or a history of premature birth.

RSV-IGIV is to be administered only by or under the supervision of your doctor or other health care professional. It is available in the following dosage form:

• Parenteral
• Injection (U.S. and Canada)

Before Receiving This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For respiratory syncytial virus immune globulin intravenous (RSV-IGIV), the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to intramuscular or intravenous immune globulins. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding—It is not known whether RSV-IGIV passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—Children 24 months of age and older: Use is not recommended. Use is not recommended in children born with chronic heart disease. Also, too much fluid in the body is more likely to occur in infants and children with underlying lung disease.

Older adults—RSV-IGIV has been tested only in infants and young children less than 24 months of age and there is no specific information about its use in older patients.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of RSV-IGIV. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergic reaction to human immunoglobulins or
• Immunoglobulin A (IgA) deficiencies—RSV-IGIV may cause severe reactions

Proper Use of This Medicine

Make certain your health care professional knows if you are on any special diet, such as low-sodium or low-sugar diet.

Dosing—The dose of respiratory syncytial virus immune globulin intravenous (RSV-IGIV) will be different for different patients. Doses are based on body weight. The following information includes only the average doses of RSV-IGIV.

• For injection dosage form:
  • For preventing respiratory syncytial virus (RSV) infection:
    • Adults and children 24 months of age and older—Use is not recommended.
    • Infants and children younger than 24 months of age—750 milligrams (mg) per kilogram (kg) (340.9 mg per pound) of body weight injected into a vein once a month for five months.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 07/29/1998

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