Synagis 50mg Injection is a monoclonal antibody developed to prevent severe RSV-related lower respiratory tract disease in high-risk children. It works by inhibiting the RSV F protein, blocking the virus from entering cells, and has proven to be safe and effective in specific high-risk patient populations.

Synagis 50mg Injection is used to prevent RSV infection 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)

Synagis 50mg Injection is a recombinant humanised monoclonal antibody that provides passive immunity against RSV by binding to the RSV F protein on the virus surface. This action blocks a critical step in the fusion process and prevents RSV-infected cells from fusing with neighbouring cells, thus inhibiting the spread of the virus.

Synagis 50mg Injection is generally safe when used as directed. However, inform your healthcare provider about any other medications or supplements your child is taking, as some may interact with Synagis 50mg Injection. Always follow your doctor’s instructions and seek advice before starting or stopping any other treatments.

• Store between 2°C and 8°C (36°F and 46°F) in its original container. Do not freeze. Use before expiration.
• Administer by healthcare professionals as an intramuscular injection. Use with caution in children with thrombocytopenia or coagulation disorders.
• Discontinue immediately if anaphylaxis or severe allergic reactions occur. Provide appropriate emergency treatment.
• It may interfere with certain RSV diagnostic tests (e.g., antigen detection-based assays). RT-PCR is preferred for confirmation.

Synagis 50mg Injection should be administered intramuscularly at a dose of 15 mg per kg, preferably in the anterolateral thigh. Inspect the vial for any particulate matter or discolouration before use and discard if 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. Ensure a healthcare professional administers the drug for 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 Synagis 50mg Injection:

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

Rare or severe side effects of Synagis 50mg Injection:

• Anaphylaxis (severe allergic reactions, 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)

When using Synagis 50mg Injection, monitor for hypersensitivity reactions, including anaphylaxis, and be prepared to administer epinephrine if necessary. Use with caution in patients with coagulation disorders due to the intramuscular administration. Synagis 50mg Injection may interfere with certain RSV diagnostic tests, potentially causing false negatives; RT-PCR is recommended for confirmation.

Administer Synagis 50mg Injection immediately after withdrawing from the vial and discard any unused portion. Keep in mind that Synagis 50mg Injection is intended for the prevention of RSV, not for the treatment of active infections.

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/