Precautions and Warnings With Palivizumab

To help ensure a safe treatment with palivizumab, let your child's healthcare provider know if your child has a clotting disorder, an upcoming heart surgery, or low blood platelet counts. It is also important to let the healthcare provider know about any other medications your child is taking to avoid potentially serious drug interactions with palivizumab. Other warnings and safety precautions apply to children with certain allergies.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to using palivizumab (Synagis®) if you have:
  • A bleeding or clotting disorder
  • Low blood platelet counts
  • Plans to have heart surgery
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Palivizumab Precautions and Warnings

Some warnings and precautions to be aware of prior to using this medication include the following:
  • There have been reports of severe allergic reactions occurring in children receiving palivizumab. These reactions can occur after any dose. Seek immediate medical attention if you notice any symptoms of an allergic reaction, such as:
    • Hives
    • Itching
    • Unexplained swelling of the mouth, face, lips, tongue, or throat
    • Low blood pressure
    • A bluish discoloration of the skin or lips
    • Difficulty breathing or swallowing
    • Low muscle tone or floppiness.
  • This medication should only be given as an intramuscular injection (an injection into the muscle), usually in the outer part of the thigh.
  • You may experience mild pain, redness, or swelling at the site of the injection. Contact your healthcare provider if you have a severe or persistent reaction at the injection site.
  • Palivizumab comes in single-use vials. The vials do not contain a preservative. Therefore, the injection must be administered immediately after the dose is withdrawn from the vial. Also, any medication remaining after a dose is given must be discarded. It cannot be saved for future use, or used for another dose.
  • Although this medication is approved to prevent respiratory syncytial virus (RSV), it is unknown whether palivizumab is safe or effective in children who already have an RSV infection. However, it is generally recommended that children who develop an infection continue to receive monthly palivizumab doses.
  • This product is a pregnancy Category C medication, which means it may not be safe for use during pregnancy (see Synagis and Pregnancy).
  • It is unknown if this medicine passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Synagis and Breastfeeding).
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