In the U.S.—

In Canada—

• Immunizing agent (passive)

Palivizumab ( pal-i-VI-zu-mab) belongs to a group of medicines known as immunizing agents. Palivizumab is used to prevent infection in children and babies caused by respiratory syncytial virus (RSV). This medicine works by giving your body the antibodies it needs to protect it against RSV infection.

RSV infection can cause serious problems that affect the lungs, such as pneumonia and bronchitis, and in severe cases even can cause death. These problems are more likely to occur in infants and children younger than 6 months of age with chronic lung disease and breathing problems and in babies who were premature, and babies who were born with heart disease.

Palivizumab is used to prevent serious lower respiratory tract infection caused by the RSV.

Onset of RSV activity usually occurs in November and continues through April, but it may begin earlier or continue later in certain communities. A good way to help prevent RSV infection is to receive palivizumab before the start of the RSV season.

Palivizumab 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)

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 palivizumab, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to palivizumab. 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 palivizumab passes into breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—Studies on this medicine have been done only in children, and it has been shown to be effective in children with breathing problems and those with a history of premature birth.

Older adults—Studies on this medicine have been done only in infants and children, 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 taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Allergy to palivizumab

Dosing—

The dose of palivizumab will be different for different patients. Doses are based on body weight. If you have any questions about the proper dose of palivizumab, ask your doctor.

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 as soon as possible if any of the following side effects occur:

• More common
  • bluish color of fingernails, lips, skin, palms, or nail beds (in patients with heart disease);  Difficulty in breathing ;  ringing or buzzing in the ears;  skin rash 
  
  

• Less common or rare
  • Abdominal pain;  diarrhea;  dizziness;  fainting;  fast, slow, or irregular heartbeat;  loss of appetite ;  lump in abdomen;  nausea ;  weakness 
  
  

• Incidence not known
  • Difficult or troubled breathing;  hives or welts;  irregular, fast or slow, or shallow breathing ;  itching skin;  large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, feet, legs, sex organs ;  loss of strength or energy;  muscle pain or weakness;  redness of skin;  shortness of breath;  tightness in chest ;  unresponsiveness;  unusual weak feeling;  wheezing 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Less common or rare
  • Cough;  runny nose;  sneezing;  stuffy nose;  vomiting 
  
  

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