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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 immunoglobulin G1 kappa (IgG1) monoclonal antibody, is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor.
No enhanced Uses information available for this drug.
Generic name: CLESROVIMAB-CFOR (KLES-roe-VYE-mab)
Drug class: Antiviral Monoclonal Antibodies
Therapeutic class: Biologicals
Clesrovimab-cfor, a fully human immunoglobulin G1 kappa (IgG1) monoclonal antibody, is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor.
No enhanced Uses information available for this drug.
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):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Clesrovimab-cfor must be administered by a healthcare provider.
Recommended dosage of clesrovimab-cfor for neonates and infants born during or entering their first RSV season is 105 mg administered as a single IM injection.
For neonates and infants born during the RSV season, administer clesrovimab-cfor once starting from birth. For infants born outside the RSV season, administer clesrovimab-cfor once prior to the start of their first RSV season considering the duration of protection provided by clesrovimab.
See Full Prescribing Information for additional details on preparation and administration of clesrovimab-cfor prefilled syringes and for recommendations on co-administration with childhood vaccines and immunoglobulin products.
Clesrovimab-cfor must be administered by a healthcare provider.
Recommended dosage of clesrovimab-cfor for neonates and infants born during or entering their first RSV season is 105 mg administered as a single IM injection.
For neonates and infants born during the RSV season, administer clesrovimab-cfor once starting from birth. For infants born outside the RSV season, administer clesrovimab-cfor once prior to the start of their first RSV season considering the duration of protection provided by clesrovimab.
See Full Prescribing Information for additional details on preparation and administration of clesrovimab-cfor prefilled syringes and for recommendations on co-administration with childhood vaccines and immunoglobulin products.
No enhanced Administration information available for this drug.
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.
Clesrovimab-cfor is contraindicated in infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of clesrovimab.
Clesrovimab-cfor is contraindicated in infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component 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.
Most common adverse reactions were injection-site erythema (3.7%), injection-site swelling (2.7%) and rash (2.3%).
Most common adverse reactions were injection-site erythema (3.7%), 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):
The safety and effectiveness of clesrovimab-cfor have been established for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and the information on this use is discussed throughout the labeling. The safety and effectiveness of clesrovimab-cfor have not been established in children older than 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 reproductive potential.
Clesrovimab-cfor is not indicated for use in females of reproductive 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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