Palivizumab was initially approved by the U.S. FDA on December 14, 2004. It is used to prevent serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease.

A study published in the National Library of Medicine found that palivizumab reduced RSV hospitalisations by 55% (4.8% vs. 10.6% for placebo). It was most effective in premature infants without BPD, showing a 78% reduction in hospitalisations. The treatment was well tolerated, with no significant differences in adverse events between the palivizumab and placebo groups. Only 0.3% of children discontinued due to side effects.

Palivizumab is a monoclonal antibody designed to prevent serious RSV-related lower respiratory tract disease in high-risk children. It works by inhibiting the RSV F protein and has been shown to be safe and effective in specific patient populations.

It Prevents RSV disease in children at high risk, including:

• Children with bronchopulmonary dysplasia (BPD)
• Infants born prematurely (≤35 weeks gestational age)
• Children with hemodynamically significant congenital heart disease (CHD)

Palivizumab should be administered intramuscularly at a dose of 15 mg per kg, preferably in the anterolateral thigh. Inspect the vial for particulate matter or discolouration before use and discard if any are found. Withdraw the dose using a sterile technique and administer it immediately. For doses over 1 mL, divide the dose. Do not re-enter the vial or reuse syringes and needles to avoid infection. Always have a healthcare professional administer the drug to ensure proper technique and safety.

Side effects are unwanted symptoms caused by medicines. Even though all medicines cause side effects, not everyone gets them.

Common Side Effects of Palivizumab:

• Fever
• Rash
• Injection site reactions (e.g., pain, swelling)
• Mild hypersensitivity reactions (e.g., urticaria, pruritus)

Rare or Severe Side Effects of Palivizumab:

• Anaphylaxis (severe allergic reaction, including shock)
• Respiratory issues (e.g., dyspnea, respiratory failure, cyanosis)
• Hypotension (low blood pressure)
• Severe thrombocytopenia (low platelet count)
• Coagulation disorders (increased bleeding risk)
• Severe hypersensitivity reactions (e.g., angioedema, unresponsiveness)

• Hypersensitivity Reactions: Reported cases of anaphylaxis and anaphylactic shock (including fatal cases) after initial or re-exposure to Palivizumab. Severe hypersensitivity reactions, such as urticaria, pruritus, angioedema, dyspnea, respiratory failure, cyanosis, hypotension, and unresponsiveness, may also occur.
• Coagulation Disorders: Use Palivizumab with caution in children who have thrombocytopenia or any coagulation disorder because it is administered intramuscularly.
• RSV Diagnostic Test Interference: Palivizumab can interfere with certain RSV diagnostic tests, especially antigen detection-based assays and viral culture assays, leading to false-negative results. It does not interfere with reverse transcriptase-polymerase chain reaction (RT-PCR) based assays.

Palivizumab is for intramuscular use only. You should administer Palivizumab carefully to avoid hypersensitivity reactions. If a significant reaction occurs, stop using Palivizumab immediately and administer appropriate treatments like epinephrine, along with supportive care. 

For mild reactions, use clinical judgment to decide whether to readminister Palivizumab cautiously. Always administer Palivizumab immediately after withdrawing the dose from the single-dose vial, as it does not contain preservatives. Do not re-enter the vial, and discard any unused portion.

When using palivizumab, monitor for hypersensitivity reactions, including anaphylaxis, and prepare to treat with epinephrine if needed. Use with caution in patients with coagulation disorders due to the intramuscular route. Be aware that palivizumab can interfere with certain RSV diagnostic tests, leading to false negatives; RT-PCR is preferred for confirmation. 

Administer immediately after withdrawal from the vial and discard any unused portion. Remember, palivizumab is for the prevention of RSV, not the treatment of active infection.

1. Palivizumab, a humanised respiratory syncytial virus monoclonal antibody, reduces hospitalisation from respiratory syncytial virus infection in high-risk infants.

https://pubmed.ncbi.nlm.nih.gov/9738173/

2.https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103770s5185lbl.pdf

3. https://www.ema.europa.eu/en/medicines/human/EPAR/synagis

4. Rogovik AL, Carleton B, Solimano A, Goldman RD. Palivizumab for the prevention of respiratory syncytial virus infection.

https://pmc.ncbi.nlm.nih.gov/articles/PMC2920777/

The drug information on this page is not a substitute for medical advice, it is meant for educational purposes only. For further details consult your doctor about your medical condition to know if you are eligible to receive this treatment.