Brand Name
Kevzara
Generic Name
Sarilumab
View Brand Information FDA approval date: May 22, 2017
Classification: Interleukin-6 Receptor Antagonist
Form: Injection
What is Kevzara (Sarilumab)?
KEVZARA ® is an interleukin-6 receptor antagonist indicated for treatment of: adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs .
Approved To Treat
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Brand Information
KEVZARA (sarilumab)
WARNING: RISK OF SERIOUS INFECTIONS
Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death
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.
1DOSAGE 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 pale-yellow solution in a single-dose pre-filled pen.
2CONTRAINDICATIONS
KEVZARA is contraindicated in patients with known hypersensitivity to sarilumab or any of the inactive ingredients
3ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in labeling:
- Serious infections
- Neutropenia, thrombocytopenia, elevated liver enzymes, lipid abnormalities
- Gastrointestinal perforation
- Immunosuppression
- Hypersensitivity reactions
3.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
4DESCRIPTION
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 DNA technology in Chinese Hamster Ovary cell suspension culture.
KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen.
Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.
5HOW 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.
6PATIENT COUNSELING INFORMATION
Advise the patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
7Instructions For Use KEVZARA®(KEV-za-ra) (sarilumab) injection, for subcutaneous use Single-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 the skin (subcutaneous injection) 1 time every 2 weeks.
Do not try to inject KEVZARA until you have been shown the right way to give the injections by your healthcare provider.
Keep these instructions for future use.
If you have any further questions, ask your healthcare provider or call 1-844-KEVZARA (1-844-538-9272).
KEVZARA pre-filled syringe parts
What you will need for your injection:
- A new KEVZARA 150 mg/1.14 mL pre-filled syringe
- Alcohol wipe
- Cotton ball or gauze
- Sharps disposal container. See "
Step A: Get ready for an injection
Step B: Give the injection
Complete Step B after completing all steps in Step A "Get ready for an injection".
How should I dispose of (throw away) KEVZARA pre-filled syringes?
- Put the used syringe in an FDA-cleared sharps disposal container right away after use.
- If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
- Do not reuse the syringe.
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Important: Always keep the sharps disposal container out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
REGENERON
sanofi
sanofi
Manufactured by:
Marketed by: sanofi-aventis U.S. LLC (Morristown, NJ 07960)
KEVZARA
Issued: May 2025
8Instructions For Use KEVZARA®(KEV-za-ra) (sarilumab) injection, for subcutaneous use Single-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 the skin (subcutaneous injection) 1 time every 2 weeks.
Do not try to inject KEVZARA until you have been shown the right way to give the injections by your healthcare provider.
Keep these instructions for future use.
If you have any further questions, ask your healthcare provider or call 1-844-KEVZARA (1-844-538-9272).
KEVZARA pre-filled syringe parts
What you will need for your injection:
- A new KEVZARA 200 mg/1.14 mL pre-filled syringe
- Alcohol wipe
- Cotton ball or gauze
- Sharps disposal container. See "
Step A: Get ready for an injection
Step B: Give the injection
Complete Step B after completing all steps in Step A "Get ready for an injection"
How should I dispose of (throw away) KEVZARA pre-filled syringes?
- Put the used syringe in an FDA-cleared sharps disposal container right away after use.
- If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
- Do not reuse the syringe.
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Important: Always keep the sharps disposal container out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
REGENERON
sanofi
sanofi
Manufactured by:
Marketed by: sanofi-aventis U.S. LLC, (Morristown, NJ 07960)
KEVZARA
Issued: May 2025
9Instructions For Use KEVZARA®(KEV-za-ra) (sarilumab) injection, for subcutaneous use Single-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 (subcutaneous injection) 1 time every 2 weeks.
Do not try to inject KEVZARA until you have been shown the right way to give the injections by your healthcare provider.
Keep these instructions for future use.
If you have any further questions, ask your healthcare provider or call 1-844-KEVZARA (1-844-538-9272).
KEVZARA pre-filled pen parts
What you will need for your injection:
- An unused KEVZARA 150 mg/1.14 mL pre-filled pen
- Alcohol wipe
- Cotton ball or gauze
- Sharps disposal container. See "
Step A: Get ready for an injection
Step B: Give the injection
Complete Step B after completing all steps in Step A "Get ready for an injection"
How should I throw away (dispose of) KEVZARA pre-filled pens?
- Put the used pen in an FDA-cleared sharps disposal container right away after use.
- If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
- Do not reuse the pen.
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Important: Always keep the sharps disposal container out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
REGENERON
sanofi
sanofi
Manufactured by:
Marketed by: sanofi-aventis U.S. LLC (Morristown, NJ 07960)
KEVZARA
Issued: May 2025
10Instructions For Use KEVZARA®(KEV-za-ra) (sarilumab) injection, for subcutaneous use Single-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 (subcutaneous injection) 1 time every 2 weeks.
Do not try to inject KEVZARA until you have been shown the right way to give the injections by your healthcare provider.
Keep these instructions for future use.
If you have any further questions, ask your healthcare provider or call 1-844-KEVZARA (1-844-538-9272).
KEVZARA pre-filled pen parts
What you will need for your injection:
- An unused KEVZARA 200 mg/1.14 mL pre-filled pen
- Alcohol wipe
- Cotton ball or gauze
- Sharps disposal container. See "
Step A: Get ready for an injection
Step B: Give the injection
Complete Step B after completing all steps in Step A "Get ready for an injection"
How should I throw away (dispose of) KEVZARA pre-filled pens?
- Put the used pen in an FDA-cleared sharps disposal container right away after use.
- If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
- Do not reuse the pen.
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Important: Always keep the sharps disposal container out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
REGENERON
sanofi
sanofi
Manufactured by:
Marketed by: sanofi-aventis U.S. LLC (Morristown, NJ 07960)
KEVZARA
Issued: May 2025
11PRINCIPAL DISPLAY PANEL - 150 mg/1.14 mL Syringe Carton
NDC 0024-5908-01
KEVZARA
150 mg/1.14 mL (131.6 mg/mL)
REGENERON
Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original
If needed, patients/caregivers may store KEVZARA at room
Date removed from the refrigerator ____/____/____
ATTENTION: Enclosed Medication Guide is required for each patient
150 mg/1.14 mL
12PRINCIPAL DISPLAY PANEL - 200 mg/1.14 mL Syringe Carton
NDC 0024-5910-01
KEVZARA
200 mg/1.14 mL (175.4 mg/mL)
REGENERON
Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original
If needed, patients/caregivers may store KEVZARA at room
Date removed from the refrigerator ____/____/____
ATTENTION: Enclosed Medication Guide is required for each patient
200 mg/1.14 mL
13PRINCIPAL DISPLAY PANEL - 150 mg/1.14 mL Pen Carton
NDC 0024-5920-01
KEVZARA
150 mg/1.14 mL (131.6 mg/mL)
REGENERON
Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original
If needed, patients/caregivers may store KEVZARA at room
Date removed from the refrigerator ____/____/____
ATTENTION: Enclosed Medication Guide is required for each patient
150 mg/1.14 mL
14PRINCIPAL DISPLAY PANEL - 200 mg/1.14 mL Pen Carton
NDC 0024-5922-01
KEVZARA
200 mg/1.14 mL (175.4 mg/mL)
REGENERON
Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original
If needed, patients/caregivers may store KEVZARA at room
Date removed from the refrigerator ____/____/____
ATTENTION: Enclosed Medication Guide is required for each patient
200 mg/1.14 mL
