Clesrovimab

Clesrovimab is a prescription medication indicated 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 available under the following different brand names: Enflonsia, clesrovimab-cfor

Common side effects of Clesrovimab include:

• redness and swelling at the injection site
• rash

Serious side effects of Clesrovimab include:

• symptoms of serious allergic reactions may include swelling of the face, mouth, or tongue, bluish color of skin, lips, or under fingernails, difficulty swallowing or breathing, muscle weakness, unresponsiveness, severe rash, hives, or itching

Rare side effects of Clesrovimab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

Solution for IM injection

• 105 mg/0.7 mL single-dose prefilled syringe

Respiratory Syncytial Virus Prevention

Pediatric dosage

• 105 mg IM as a single dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of serious hypersensitivity reactions, including anaphylaxis, to any product component

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Clesrovimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Clesrovimab?”

Cautions

• Hypersensitivity
  • Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies
  • Initiate appropriate medications and/or supportive therapy if signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur
• RSV diagnostic test interference
  • May interfere with some immunologically based RSV diagnostic assays (ie, rapid antigen tests) as observed in laboratory studies
  • Confirmation using a reverse transcriptase polymerase chain reaction (RT-PCR) assay is recommended when rapid antigen assay results are negative and clinical observations are consistent with RSV infection
• Coadministration with routine childhood vaccines
  • Safety profile of coadministered vaccines was generally comparable to the safety profile when Clesrovimab and childhood vaccines were administered alone
  • Do not mix with vaccines in the same syringe; administer as separate injections

Pregnancy and Lactation

• Not indicated for use in females of reproductive potential
• Lactation
  • Not indicated for use in females of reproductive potential