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Drug overview for ENFLONSIA (clesrovimab-cfor):
Generic name: CLESROVIMAB-CFOR (KLES-roe-VYE-mab)
Drug class: Antiviral Monoclonal Antibodies
Therapeutic class: Biologicals
Clesrovimab-cfor, a fully human recombinant monoclonal antibody directed against the fusion (F) surface glycoprotein of respiratory syncytial virus (RSV), is an antiviral agent.
Clesrovimab-cfor is used 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. There are no data regarding co-administration of clesrovimab-cfor with other immunoglobulin products. There are no data regarding the substitution of clesrovimab-cfor for palivizumab once prophylaxis is initiated with palivizumab for the RSV season.
Generic name: CLESROVIMAB-CFOR (KLES-roe-VYE-mab)
Drug class: Antiviral Monoclonal Antibodies
Therapeutic class: Biologicals
Clesrovimab-cfor, a fully human recombinant monoclonal antibody directed against the fusion (F) surface glycoprotein of respiratory syncytial virus (RSV), is an antiviral agent.
Clesrovimab-cfor is used 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. There are no data regarding co-administration of clesrovimab-cfor with other immunoglobulin products. There are no data regarding the substitution of clesrovimab-cfor for palivizumab once prophylaxis is initiated with palivizumab for the RSV season.
DRUG IMAGES
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The following indications for ENFLONSIA (clesrovimab-cfor) have been approved by the FDA:
Indications:
Respiratory syncytial virus pneumonia prevention
Professional Synonyms:
Respiratory syncytial virus pneumonia prophylaxis
RSV pneumonia prophylaxis
Indications:
Respiratory syncytial virus pneumonia prevention
Professional Synonyms:
Respiratory syncytial virus pneumonia prophylaxis
RSV pneumonia prophylaxis
The following dosing information is available for ENFLONSIA (clesrovimab-cfor):
No enhanced Dosing information available for this drug.
Administer clesrovimab-cfor as a single IM injection in the anterolateral aspect of the thigh; avoid gluteal region and areas near major nerve trunks/blood vessels. Clesrovimab-cfor is available as 105 mg/0.7 mL in a single-dose prefilled syringe for IM injection; the solution is clear to slightly opalescent and colorless to slightly yellow.
Do not use the prefilled syringe if there is particulate matter, discoloration, damage, a broken security seal, or if expired or dropped. Remove clesrovimab-cfor from the refrigerator and let the prefilled syringe sit at room temperature for about 15 minutes before injection. To administer clesrovimab-cfor, hold the syringe barrel and twist the tip cap counterclockwise detaching the Luer Lock adaptor or finger flange extender.
Attach a sterile Luer Lock needle by twisting clockwise until secure. Use a 22-25 gauge needle due to product viscosity. If co-administered with vaccines, inject at a separate site with a separate syringe; do not mix with vaccines or medications in the same syringe/vial.
Keep refrigerated (2-8degreesC); protect from light in original carton. Can be stored at room temperature (20-25degreesC) for up to 48 hours and then used or discarded; do not freeze or shake.
Do not use the prefilled syringe if there is particulate matter, discoloration, damage, a broken security seal, or if expired or dropped. Remove clesrovimab-cfor from the refrigerator and let the prefilled syringe sit at room temperature for about 15 minutes before injection. To administer clesrovimab-cfor, hold the syringe barrel and twist the tip cap counterclockwise detaching the Luer Lock adaptor or finger flange extender.
Attach a sterile Luer Lock needle by twisting clockwise until secure. Use a 22-25 gauge needle due to product viscosity. If co-administered with vaccines, inject at a separate site with a separate syringe; do not mix with vaccines or medications in the same syringe/vial.
Keep refrigerated (2-8degreesC); protect from light in original carton. Can be stored at room temperature (20-25degreesC) for up to 48 hours and then used or discarded; do not freeze or shake.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ENFLONSIA (clesrovimab-cfor):
There are 0 contraindications.
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Efgartigimod-alfa SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3) |
VYVGART, VYVGART HYTRULO |
| Anifrolumab/Biologic Therapies SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of anifrolumab with other biologic therapies may result in additive or synergistic effects on the immune system.(1) CLINICAL EFFECTS: Concurrent use of anifrolumab with other biologic therapies may increase the risk of serious infections.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The concurrent use of anifrolumab with other biologic therapies is not recommended.(1) DISCUSSION: The combination of anifrolumab with other biologic therapies has not been studied and is not recommended.(1) |
SAPHNELO |
| IgG Antibodies and Derivatives/Nipocalimab-aahu SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3) |
IMAAVY |
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Belimumab/Biologic Therapies SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Concurrent use of belimumab with other biologic therapies may result in additive or synergistic effects on the immune system.(1) CLINICAL EFFECTS: Concurrent use of belimumab with other biologic therapies may increase the risk of serious infections.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The concurrent use of belimumab with other biologic therapies should be approached with caution.(1) DISCUSSION: In a randomized, double-blind, placebo-controlled trial, more patients who received belimumab and rituximab experienced serious adverse events, serious infections, and post-injection systemic reactions (22.2%, 9%, and 13.2%, respectively) than patients who received belimumab with placebo (13.9%, 2.8%, 9.7%) or standard therapy (19.7%, 5.3%, 5.3%).(1) The combination of belimumab with other biologic therapies has not been studied and should be used cautiously.(1) |
BENLYSTA |
| IgG Antibodies and Derivatives/Rozanolixizumab-noli SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3) DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3) |
RYSTIGGO |
The following contraindication information is available for ENFLONSIA (clesrovimab-cfor):
Drug contraindication overview.
*Infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any of the components of clesrovimab.
*Infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any of the components of clesrovimab.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for ENFLONSIA (clesrovimab-cfor):
Adverse reaction overview.
The most frequently reported adverse reactions were injection-site erythema (3.8%), injection-site swelling (2.7%), and rash (2.3%).
The most frequently reported adverse reactions were injection-site erythema (3.8%), injection-site swelling (2.7%), and rash (2.3%).
There are 0 severe adverse reactions.
There are 3 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Injection site erythema Injection site sequelae Skin rash |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for ENFLONSIA (clesrovimab-cfor):
Safety and effectiveness of clesrovimab-cfor in preventing RSV lower respiratory tract disease have been demonstrated in neonates and infants during their first RSV season; safety and efficacy have not been established in children >12 months of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Clesrovimab-cfor is not indicated for use in females of childbearing potential.
Clesrovimab-cfor should not be used in females of childbearing potential.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ENFLONSIA (clesrovimab-cfor):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ENFLONSIA (clesrovimab-cfor)'s list of indications:
| Respiratory syncytial virus pneumonia prevention | |
| Z23 | Encounter for immunization |
| Z29.11 | Encounter for prophylactic immunotherapy for respiratory syncytial virus (RSv) |
| Z29.89 | Encounter for other specified prophylactic measures |
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