Sarilumab

1
Sarilumab
Brands

DEA Class; Rx

Common Brand Names; Kevzara

  • Interleukin Inhibitors; 
  • Monoclonal Antibodies; 
  • DMARDs, Immunomodulators

Injectable interleukin-6 (IL-6) receptor antagonist
Used for the treatment of moderate to severe rheumatoid arthritis in adults who have had an inadequate response or are intolerant to 1 or more DMARDs
Boxed warning for increased risk of developing serious infections during therapy

Indicated for adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to ≥1 disease-modifying antirheumatic drugs (DMARDs)

Indicated for adults with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper

Documented hypersensitivity to drug or inactive ingredients

  • ALT >ULN to ≤3 x ULN (38-43%)
  • AST >ULN to ≤3 x ULN (27-30%)
  • Neutropenia (7-10%)
  • ANC <1000/mm³ (4-6%)
  • Injection site erythema (4-5%)
  • Injection site pruritics (4-5%)
  • Upper respiratory tract infection (3-4%)
  • ALT >3x to 5x ULN (3-4%)
  • Urinary tract infection (3%)
  • Hypertriglyceridemia (1-3%)
  • Leukopenia (0.9-2%)

Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported (see Black Box Warnings)

GI perforations reported in clinical studies, primarily as complications of diverticulitis; GI perforation risk may be increased with concurrent diverticulitis or concomitant use of NSAIDs or corticosteroids

Immunosuppression may result in an increased risk of malignancies

Hypersensitivity reactions reported

Not recommended with active hepatic disease or hepatic impairment

Limited human data in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage

Unknown if distributed in human breast milk

Adults

200 mg/dose subcutaneously every 2 weeks; investigational doses of 400 mg IV have been used for COVID-19.

Geriatric

200 mg/dose subcutaneously every 2 weeks; investigational doses of 400 mg IV have been used for COVID-19.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

sarilumab

injectable solution (prefilled syringe)

  • 150mg/1.14mL
  • 200mg/1.14mL

injectable solution (prefilled pen)

  • 150mg/1.14mL
  • 200mg/1.14mL
DrugsAce
Logo