PALIVIZUMAB (Systemic)

Some commonly used brand names are:

In the U.S.?

• Synagis

In Canada?

• Synagis

Category

• Immunizing agent (passive)

Description

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

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

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

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

Palivizumab is to be administered only by or under the supervision of yourdoctor or other health care professional. It is available in the followingdosage form:

Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For palivizumab, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to palivizumab. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals.

Breast-feeding?It is not known whether palivizumab passes intobreast milk. However, this medicine has not been reported to cause problemsin 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 problemsand those with a history of premature birth.

Older adults?Studies on this medicine have been done only in infantsand children, and there is no specific information about its use in olderpatients.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of palivizumab. Make sure you tell your doctorif you have any other medical problems, especially:

• Allergy to palivizumab

Proper Use of This Medicine

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

Side Effects of This Medicine

Along with its needed effects, a medicine maycause 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 possibleif 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; hivesor welts; irregular, fast or slow, or shallow breathing; itching skin; large, hive-likeswelling 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; unusualweak feeling; wheezing

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

Less common or rare

Cough; runny nose; sneezing; stuffy nose; vomiting

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.