Respigam

Respiratory syncytial virus immune globulin intravenous (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.

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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.

Geriatric

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.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with 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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. 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

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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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.

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.

Check with your doctor immediately if any of the following side effects occur:

• Difficulty in breathing and swallowing
• hives
• itching, especially of feet and hands
• reddening of skin, especially around ears
• swelling of eyes, face, or inside of nose
• unusual tiredness or weakness, sudden and severe
• fever of 39.2 °C (102.6 °F) or higher
• increased heart rate
• vomiting

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Applies to respiratory syncytial virus immune globulin: intravenous solution

Along with its needed effects, respiratory syncytial virus immune globulin (the active ingredient contained in RespiGam) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking respiratory syncytial virus immune globulin:

• Difficulty in breathing and swallowing
• hives
• itching, especially of feet and hands
• reddening of skin, especially around ears
• swelling of eyes, face, or inside of nose
• unusual tiredness or weakness, sudden and severe
• fever of 39.2 °C (102.6 °F) or higher
• increased heart rate
• vomiting

There are no data on the excretion of respiratory syncytial virus immune globulin into human milk.