KEVZARA

SARILUMAB

Manufacturer: sanofi-aventis U.S. LLC

Score: 144.0

Quick Summary

KEVZARA (sarilumab) is a human recombinant monoclonal antibody used for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs), adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper, and patients with active polyarticular juvenile idiopathic arthritis (pJIA) who weigh 63 kg or greater. The drug works by binding to both soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated signaling. Important safety information includes warnings about serious infections, neutropenia, thrombocytopenia, and elevated liver enzymes. The recommended dosage is 200 mg subcutaneously once every two weeks, and dose adjustments may be necessary based on laboratory parameters and clinical response. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs)
Treatment of adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper
Treatment of patients with active polyarticular juvenile idiopathic arthritis (pJIA) who weigh 63 kg or greater

Important Safety Information

Warning

Risk of serious infections, including opportunistic infections, and neutropenia, thrombocytopenia, and elevated liver enzymes

Contraindications

Known hypersensitivity to sarilumab or any of the inactive ingredients

Adverse Reactions

Neutropenia
Thrombocytopenia
Elevated liver enzymes
Infections
Injection site reactions

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on laboratory parameters and clinical response

Rheumatoid Arthritis (RA)

Adult Dose

200 mg subcutaneously once every two weeks

Pediatric Dose

Not approved for pediatric patients weighing less than 63 kg

Polymyalgia Rheumatica (PMR)

Adult Dose

200 mg subcutaneously once every two weeks in combination with a tapering course of corticosteroids

Pediatric Dose

Not approved for pediatric patients

Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Adult Dose

Not applicable

Pediatric Dose

200 mg subcutaneously once every two weeks for patients who weigh 63 kg or greater

Special Population Considerations

Pregnancy

The limited human data with KEVZARA in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage
Monoclonal antibodies, such as sarilumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant

Nursing Mothers

No data available

Pediatric Use

KEVZARA is approved for active polyarticular juvenile idiopathic arthritis (pJIA) in pediatric patients who weigh 63 kg or greater
Use of KEVZARA in this patient population is supported by evidence from adequate and well-controlled studies of KEVZARA in adults with RA, pharmacokinetic data from adult patients with RA, and a pharmacokinetic, pharmacodynamic, dose-finding, and safety study in pediatric patients with pJIA 2 years of age and older

Geriatric Use

Of the total number of patients with RA exposed to KEVZARA in clinical studies, 450 patients (15%) were 65 years of age and over, while 48 patients (1.6%) were 75 years and over
In clinical studies, no overall differences in safety and efficacy were observed between older and younger patients