Respigam (Intravenous)

Respiratory syncytial virus immune globulin intravenous (RSV-IGIV) is part of a group of medicines called immunizing agents. RSV-IGIV is used to prevent infections caused by respiratory syncytial virus (RSV). It works by providing your body with the antibodies needed to protect against RSV infection.

RSV infection can lead to serious issues, such as pneumonia and bronchitis, which affect the lungs. In severe cases, it can even lead to death. These complications are more likely in infants and young children under 6 months old who have chronic lung disease, those born with heart issues, and those with a history of being born prematurely.

RSV activity usually starts in November and goes through April or early May, with the highest activity between late January and mid-February. A good way to help prevent RSV infection is to receive RSV-IGIV before RSV season begins.

RSV-IGIV is used to prevent serious lower respiratory tract infections caused by RSV in children under 24 months of age who have breathing problems or a history of premature birth.

RSV-IGIV should only be given by or under the supervision of your doctor or another health care professional.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against the benefits it may provide. For this medicine, you should think about the following:

Allergies

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

Pediatric

For children 24 months of age and older: It is not recommended to use this medicine. It is also not recommended for children born with chronic heart disease. Additionally, infants and children with underlying lung disease are more likely to have too much fluid in their bodies.

Geriatric

Respigam (Intravenous) has only been tested in infants and young children less than 24 months of age, so there is no specific information about its use in older patients.

Breast Feeding

Research in women suggests that this medicine poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if there might be an interaction. In these situations, your doctor might adjust the dose, or other precautions might be necessary. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are using this medicine. The following interactions have been highlighted due to their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If your doctor prescribes both medicines, they may change the dose or how often you take one or both of them.

• Adenovirus Vaccine
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about the use of this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergic reaction to human immunoglobulins or
• Immunoglobulin A (IgA) deficiencies—Respigam (Intravenous) may cause severe reactions.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

Rare

• 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 happen 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.

In the U.S.

• Respigam

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.