Clesrovimab

Clesrovimab is used to prevent lung disease caused by respiratory syncytial virus (RSV) in newborns and babies up to 12 months old who are born during or are about to enter their first RSV season.

Clesrovimab is a man-made antibody that helps protect the body against respiratory syncytial virus (RSV) infection for up to 5 months.

Clesrovimab may also be used for purposes not listed in this medication guide.

Your child should receive clesrovimab before or during the RSV season. Your healthcare provider can tell you when the RSV season begins in your area.

Clesrovimab is given as a single injection (shot) into the muscle of the leg. A healthcare provider will give this injection.

If your child has had heart surgery, they may receive another dose of this medicine.

Your child may still become infected with RSV after getting clesrovimab. Ask your child's healthcare provider what symptoms to watch for.

This medicine can change the results of some medical tests. Inform any doctor treating you that you are using clesrovimab.

Your child can receive clesrovimab at the same time as regular childhood vaccines.

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Your child should not receive clesrovimab if they have ever had a life-threatening allergic reaction to clesrovimab or any part of clesrovimab.

Tell your doctor if your child has or has ever had:

• a severe allergic reaction to antibodies known as immunoglobulins; or
• heart surgery planned during or entering their first RSV season.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of the face, lips, tongue, or throat.

Call the doctor right away if your child has:

• muscle weakness;
• trouble swallowing;
• blue lips or fingernails; or
• bluish skin color.

Common side effects of clesrovimab may include:

• rash; or
• redness or swelling where the injection was given.

This is not a complete list of side effects, and others may happen. Call your child's doctor for medical advice about side effects. You can report side effects to the FDA at 1 800 FDA 1088.

Usual Pediatric Dose for Respiratory Syncytial Virus Prophylaxis:

105 mg administered as a single IM injectionComments:-For neonates and infants born during the RSV season, administer this drug once starting from birth. -For infants born outside the RSV season, administer this drug once prior to the start of their first RSV season considering the duration of protection provided.Use: For the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season

Clesrovimab is given as a single dose and does not require daily dosing.

An overdose of clesrovimab is not likely to happen.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Other drugs may affect clesrovimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform the doctor about all other medicines your child is using.