Label: KEVZARA- sarilumab injection, solution

  • NDC Code(s): 0024-5908-00, 0024-5908-01, 0024-5908-02, 0024-5910-00, view more
  • Packager: sanofi-aventis U.S. LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated August 22, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use KEVZARA® safely and effectively. See full prescribing information for KEVZARA. KEVZARA (sarilumab) injection, for subcutaneous ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: RISK OF SERIOUS INFECTIONS

    Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1), Adverse Reactions (6.1)]. Opportunistic infections have also been reported in patients receiving KEVZARA. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

    Avoid use of KEVZARA in patients with an active infection.

    Reported infections include:

    • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before KEVZARA use and during therapy. Treatment for latent infection should be initiated prior to KEVZARA use.
    • Invasive fungal infections, such as candidiasis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral and other infections due to opportunistic pathogens.

    Closely monitor patients for signs and symptoms of infection during treatment with KEVZARA. If a serious infection develops, interrupt KEVZARA until the infection is controlled.

    Consider the risks and benefits of treatment with KEVZARA prior to initiating therapy in patients with chronic or recurrent infection.

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  • 1 INDICATIONS AND USAGE
    1.1 Rheumatoid Arthritis (RA) KEVZARA® is indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Considerations Prior to Administration - Not Recommended for Concomitant Use with Biological DMARDS - The concurrent use of KEVZARA with biological DMARDs such as tumor necrosis ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Injection: 150 mg/1.14 mL and 200 mg/1.14 mL clear and colorless to pale-yellow solution in a single-dose pre-filled syringe. Injection: 150 mg/1.14 mL and 200 mg/1.14 mL clear and colorless to ...
  • 4 CONTRAINDICATIONS
    KEVZARA is contraindicated in patients with known hypersensitivity to sarilumab or any of the inactive ingredients [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)].
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Serious Infections - Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described elsewhere in labeling: Serious infections [see Warnings and Precautions (5.1)] Neutropenia, thrombocytopenia, elevated liver enzymes, lipid ...
  • 7 DRUG INTERACTIONS
    7.1 Use with Other Drugs - Population pharmacokinetic analyses did not detect any effect of methotrexate (MTX) on sarilumab clearance. KEVZARA has not been investigated in combination with JAK ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - The limited human data with KEVZARA in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage. Monoclonal ...
  • 11 DESCRIPTION
    Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Sarilumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No long-term animal studies have been performed to establish the carcinogenicity potential of sarilumab. Literature indicates that the ...
  • 14 CLINICAL STUDIES
    14.1 Rheumatoid Arthritis - Design of Clinical Studies in Adults with Moderately to Severely Active RA - The efficacy and safety of KEVZARA in RA were assessed in two randomized, double-blind ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    KEVZARA (sarilumab) injection is supplied as a clear and colorless to pale yellow solution in single-dose pre-filled syringes, and single-dose pre-filled pens. StrengthPackage SizeNDC ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Infections - Inform patients that KEVZARA may lower their resistance to infections ...
  • SPL UNCLASSIFIED SECTION
    REGENERON - sanofi - Manufactured by: sanofi-aventis U.S. LLC - Bridgewater, NJ 08807 - A SANOFI COMPANY - U.S. License No. 1752 - Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and - Regeneron ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - KEVZARA® (KEV-za-ra) (sarilumab) injection, for subcutaneous use - This Medication Guide has been approved by the U.S. Food and Drug AdministrationRevised: June ...
  • Instructions For UseKEVZARA® (KEV-za-ra)(sarilumab)injection, for subcutaneous useSingle-dose Pre-filled Syringe (150 mg/1.14 mL)
    Important information: KEVZARA is available as a single-dose pre-filled syringe (called "syringe" in these instructions). The pre-filled syringe contains 150 mg of KEVZARA for injection under ...
  • Instructions For UseKEVZARA® (KEV-za-ra)(sarilumab)injection, for subcutaneous useSingle-dose Pre-filled Syringe (200 mg/1.14 mL)
    Important information: KEVZARA is available as a single-dose pre-filled syringe (called "syringe" in these instructions). The pre-filled syringe contains 200 mg of KEVZARA for injection under ...
  • Instructions For UseKEVZARA® (KEV-za-ra)(sarilumab)injection, for subcutaneous useSingle-dose pre-filled pen (150 mg/1.14 mL)
    Important information: KEVZARA is available as a single-dose pre-filled pen (called "pen" in these instructions). The pre-filled pen contains 150 mg of KEVZARA for injection under the skin ...
  • Instructions For UseKEVZARA® (KEV-za-ra)(sarilumab)injection, for subcutaneous useSingle-dose pre-filled pen (200 mg/1.14 mL)
    Important information: KEVZARA is available as a single-dose pre-filled pen (called "pen" in these instructions). The pre-filled pen contains 200 mg of KEVZARA for injection under the skin ...
  • PRINCIPAL DISPLAY PANEL - 150 mg/1.14 mL Syringe Carton
    NDC 0024-5908-01 - Rx Only - KEVZARA® (sarilumab) injection - 150 mg/1.14 mL (131.6 mg/mL) 2 Single-Dose Pre-filled Syringes - For Subcutaneous Injection Use ...
  • PRINCIPAL DISPLAY PANEL - 200 mg/1.14 mL Syringe Carton
    NDC 0024-5910-01 - Rx Only - KEVZARA® (sarilumab) injection - 200 mg/1.14 mL (175.4 mg/mL) 2 Single-Dose Pre-filled Syringes - For Subcutaneous Injection Use Only ...
  • PRINCIPAL DISPLAY PANEL - 150 mg/1.14 mL Pen Carton
    NDC 0024-5920-01 - Rx Only - KEVZARA® (sarilumab) injection - 150 mg/1.14 mL (131.6 mg/mL) 2 Single-Dose Pre-filled Pens - For Subcutaneous Injection Use Only ...
  • PRINCIPAL DISPLAY PANEL - 200 mg/1.14 mL Pen Carton
    NDC 0024-5922-01 - Rx Only - KEVZARA® (sarilumab) injection - 200 mg/1.14 mL (175.4 mg/mL) 2 Single-Dose Pre-filled Pens - For Subcutaneous Injection Use ...
  • INGREDIENTS AND APPEARANCE
    Product Information