Clesrovimab
Generic name: clesrovimab [ KLES-roe-VYE-mab ]
Brand name: Enflonsia Prefilled Syringe (cvx 332)
Dosage form: intramuscular solution (cfor 105 mg/0.7 mL)
Drug class: Antiviral monoclonal antibodies
What is 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 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.
Clesrovimab side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of the face, lips, tongue, or throat.
Call the doctor at once if your child has:
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muscle weakness;
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trouble swallowing;
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blue lips or fingernails; or
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bluish color of skin.
Common side effects of clesrovimab may include:
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rash; or
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redness or swelling where the injection was given.
This is not a complete list of side effects and others may occur. Call your child's doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.
Related/similar drugs
Warnings
Tell your doctor if you use other medicines or have other medical conditions or allergies.
Before taking this medicine
Your child should not receive clesrovimab if the child has ever had a life-threatening allergic reaction to clesrovimab or any component of clesrovimab.
Tell your doctor if your child has or has ever had:
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severe allergic reaction to antibodies called immunoglobulins; or
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a heart surgery scheduled during or entering their first RSV season.
How is clesrovimab given?
Your child should receive clesrovimab before the start of or during the RSV season. Your healthcare provider can inform you when the RSV season starts in your area.
Clesrovimab is given once as an injection (shot) into the leg muscle. A healthcare provider will give this injection.
If your child has heart surgery, your child may receive another dose of this medicine.
Your child may still get infected with RSV after receiving clesrovimab. Ask your child's healthcare provider about what symptoms to look for.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using clesrovimab.
Your child can receive clesrovimab at the same time as routine childhood vaccines.
Clesrovimab dosing information
Usual Pediatric Dose for Respiratory Syncytial Virus Prophylaxis:
105 mg administered as a single IM injection
Comments:
-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
What happens if I miss a dose?
Clesrovimab is used as a single dose and does not have a daily dosing schedule.
What happens if I overdose?
An overdose of clesrovimab is unlikely to occur.
What should I avoid while receiving clesrovimab?
Follow the doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect clesrovimab?
Other drugs may affect clesrovimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell the doctor about all other medicines your child uses.
Clesrovimab Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for clesrovimab.
Enflonsia (clesrovimab-cfor) - Merck Sharp & Dohme LLC
| Formulation type | Strength |
|---|---|
| Pre-Filled Syringe | 105 mg/0.7 mL |
View Enflonsia information in detail.
More about clesrovimab
Patient resources
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Professional resources
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Further information
- Your child's doctor or pharmacist can provide more information about clesrovimab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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