Respiratory syncytial virus immune globulin, human (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 infection from 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 serious problems are more likely to happen 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 premature birth.

RSV activity typically starts in November and lasts until April or early May, with the highest activity seen from late January to 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 respiratory syncytial virus (RSV) in children under 24 months old who have breathing issues 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 will need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction 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, read the label or package ingredients carefully.

Pediatric

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

Geriatric

RSV-IGIV has only been tested in infants and young children under 24 months of age, and there is no specific information about how it works in older patients.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there is a chance of interaction. In such cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both may be the best option for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• 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 around meal times or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. Make sure to inform 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.

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.

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

Rare

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

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

Call your doctor for medical guidance about adverse 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.