enflonsia
Pharmaranks rates Enflonsia 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Enflonsia (Clesrovimab-Cfor) is a medication supplied as an injection, solution.
Clesrovimab-Cfor · by Merck Sharp Dohme
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Clesrovimab-Cfor
- Form
- Injectable
- Strength
- CLESROVIMAB-CFOR 105MG/0.7ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Merck Sharp Dohme
- FDA application
- BLA761432
What is Enflonsia?
From the FDA label:Clesrovimab-cfor is a respiratory syncytial virus F protein-directed fusion inhibitor. Clesrovimab-cfor is a fully human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in recombinant Chinese hamster ovary (CHO) cells. The molecular weight is approximately 149 kDa. ENFLONSIA (clesrovimab-cfor) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for intramuscular injection. Each 0.7 mL contains 105 mg of clesrovimab-cfor, arginine hydrochloride (10.33 mg), histidine (0.55 mg), L-histidine monohydrochloride monohydrate (0.74 mg), polysorbate 80 (0.14 mg), sucrose (35 mg) and water for injection (USP). The pH is 6.0.
How to use
Recommended dosage: 105 mg administered as a single intramuscular (IM) injection. ( 2.1 ) 2.1 Recommended Dosage The recommended dose for neonates and infants born during or entering their first RSV season is 105 mg administered as a single intramuscular (IM) injection. For neonates and infants born during the RSV season, administer ENFLONSIA once starting from birth. For infants born outside the RSV season, administer ENFLONSIA once prior to the start of their first RSV season considering the duration of protection provided by ENFLONSIA [see Clinical Pharmacology (12.2) ]. Infants Undergoing Cardiac Surgery with Cardiopulmonary Bypass For infants undergoing cardiac surgery with cardiopulmonary bypass during or entering their first RSV season, an additional 105 mg dose administered as an IM injection is recommended as soon as the infant is stable after surgery to ensure adequate clesrovimab-cfor serum levels. 2.2 Administration Instructions ENFLONSIA must be administered by a healthcare provider. Before injection, remove ENFLONSIA from the refrigerator and allow the prefilled syringe to come to room temperature for approximately 15 minutes. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ENFLONSIA is a clear to slightly opalescent, colorless to slightly yellow…
Side effects
Most common adverse reactions were injection-site erythema (3.8%), injection-site swelling (2.7%) and rash (2.3%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ENFLONSIA was evaluated in 2,858 infants who received ENFLONSIA in Phase 2b/3 and Phase 3 clinical trials (Trial 004 and Trial 007). Neonates and Infants Entering Their First RSV Season (Trial 004) Trial 004 was a Phase 2b/3, randomized, double-blind placebo-controlled, multisite trial conducted in early and moderate preterm infants (≥29 to <35 weeks gestational age (GA)) and late preterm and full-term infants (≥35 weeks GA). Participants were randomized 2:1 and received a single 105 mg dose of ENFLONSIA (N=2,412, including 422 early and moderate preterm infants) or saline placebo (N=1,202, including 209 early and moderate preterm infants) by IM injection. Participants were monitored for 30 minutes post-dose. Safety was assessed using an electronic diary device from Days 1 through 42 post-dose. Participants were…
Warnings
Important safety information
Hypersensitivity Including Anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies. Initiate appropriate medications and/or supportive care if such reactions occur. ( 5.1 ) 5.1 Hypersensitivity Including Anaphylaxis Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy. 5.2 RSV Diagnostic Test Interference Clesrovimab-cfor may interfere with some immunologically-based RSV diagnostic assays (i.e., 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 [see Drug Interactions (7.1) ].
Who should not take Enflonsia
ENFLONSIA is contraindicated in infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA [see Warnings and Precautions (5.1) and Description (11) ]. ENFLONSIA is contraindicated in infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA. ( 4 )
Overdose — what happens if you take too much
There is limited experience of overdose with ENFLONSIA. There is no specific treatment for an overdose with ENFLONSIA. In the event of an overdose, the infant should be monitored for the occurrence of adverse reactions and provided with symptomatic treatment as appropriate.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
7.1 Interference with Rapid Antigen Detection RSV Diagnostic Assays Clesrovimab-cfor may interfere with some immunologically-based RSV diagnostic assays (i.e., rapid antigen tests) as observed in laboratory studies. Confirmation using an RT-PCR assay is recommended when rapid antigen RSV diagnostic assay results are negative and clinical observations are consistent with RSV infection. Clesrovimab-cfor does not interfere with RT-PCR diagnostic assays [see Warnings and Precautions (5.2) ] .
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- How is Enflonsia rated?
- pharmaranks gives Enflonsia a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Enflonsia?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Enflonsia. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Enflonsia?
- Enflonsia is marketed by Merck Sharp Dohme. You can see Merck Sharp Dohme's full profile, rating, and other products on pharmaranks.
- Is Enflonsia a brand-name or generic drug?
- Enflonsia is a brand-name product with the active ingredient Clesrovimab-Cfor.
- Is Enflonsia available over the counter?
- No. Enflonsia is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Enflonsia come in?
- Enflonsia is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Enflonsia FDA-registered?
- Enflonsia is on record with the U.S. FDA under application number BLA761432. You can verify this on its official FDA label.
- Has Enflonsia been recalled by the FDA?
- Enflonsia has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Enflonsia safe?
- There's no single safe-or-not verdict. pharmaranks gives Enflonsia a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Enflonsia?
- Enflonsia's side effects are taken directly from its FDA label. From the label: Most common adverse reactions were injection-site erythema (3.8%), injection-site swelling (2.7%) and rash (2.3%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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