KEVZARA

KEVZARA- sarilumab injection, solution
sanofi-aventis U.S. LLC

1 INDICATIONS AND USAGE

KEVZARA^® is indicated for 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).

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

KEVZARA may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs.

The recommended dosage of KEVZARA is 200 mg once every two weeks given as a subcutaneous injection.

Reduce dose to 150 mg once every two weeks for management of neutropenia, thrombocytopenia and elevated liver enzymes [see Dosage and Administration (2.4), Warnings and Precautions (5.2) and Adverse Reactions (6.1)].

2.2 General Considerations for Administration

• KEVZARA initiation is not recommended in patients with an absolute neutrophil count (ANC) less than 2000 per mm³ , platelet count less than 150,000 per mm³ , or who have ALT or AST above 1.5 times the upper limit of normal (ULN) [see Dosage and Administration (2.4) and Warnings and Precautions (5.2)].
• Prior to initiating KEVZARA, test patients for latent tuberculosis (TB). If positive, consider treating for TB prior to KEVZARA use [see Warnings and Precautions (5.1)].
• Avoid using KEVZARA with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection. The concurrent use of KEVZARA with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators has not been studied.
• Avoid KEVZARA use in patients with active infections [see Warnings and Precautions (5.1)].

2.3 Important Administration Instructions

• KEVZARA is intended for use under the guidance of a healthcare professional. A patient may self-inject KEVZARA or the patient’s caregiver may administer KEVZARA. Provide proper training to patients and/or caregivers on the preparation and administration of KEVZARA prior to use according to the Instructions for Use (IFU).
• Allow the pre-filled syringe to sit at room temperature for 30 minutes prior to subcutaneous injection. Do not warm KEVZARA in any other way.
• If using a pre-filled pen, allow the pre-filled pen to sit at room temperature for 60 minutes prior to subcutaneous injection. Do not warm KEVZARA in any other way.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. KEVZARA solution should be clear and colorless to pale yellow. Do not use if the solution is cloudy, discolored or contains particles, or if any part of the pre-filled syringe or pre-filled pen appears to be damaged.
• Instruct patients to inject the full amount in the syringe or pen (1.14 mL), which provides 200 mg or 150 mg of KEVZARA, according to the directions provided in the IFU.
• Rotate injection sites with each injection. Do not inject into skin that is tender, damaged, or has bruises or scars.

2.4 Dosage Modifications for Laboratory Abnormalities or Serious Infection

If a patient develops a serious infection, hold treatment with KEVZARA until the infection is controlled.

Modify dosage in case of neutropenia, thrombocytopenia or liver enzyme elevations (see Table 1). For treatment initiation criteria, see Dosage and Administration (2.2).

Table 1: KEVZARA Dosage Modification for Neutropenia, Thrombocytopenia, or Elevated Liver Enzymes

Low Absolute Neutrophil Count (ANC) [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)]
Lab Value (cells/mm3)	Recommendation
ANC greater than 1000	Maintain current dosage of KEVZARA.
ANC 500–1000	Hold treatment with KEVZARA until ANC greater than 1000.KEVZARA can then be resumed at 150 mg every two weeks and increased to 200 mg every two weeks as clinically appropriate.
ANC less than 500	Discontinue KEVZARA.
Low Platelet Count [see Warnings and Precautions (5.2)]
Lab Value (cells/mm3)	Recommendation
50,000–100,000	Hold treatment with KEVZARA until platelets greater than 100,000.KEVZARA can then be resumed at 150 mg every two weeks and increased to 200 mg every two weeks as clinically appropriate.
Less than 50,000	If confirmed by repeat testing, discontinue KEVZARA.
Liver Enzyme Abnormalities [see Warnings and Precautions (5.2)]
Lab Value	Recommendation
ALT greater than ULN to 3 times ULN or less	Consider dosage modification of concomitant DMARDs as clinically appropriate.
ALT greater than 3 times ULN to 5 times ULN or less	Hold treatment with KEVZARA until ALT less than 3 times ULN.KEVZARA can then be resumed at 150 mg every two weeks and increased to 200 mg every two weeks as clinically appropriate.
ALT greater than 5 times ULN	Discontinue KEVZARA.

3 DOSAGE FORMS AND STRENGTHS

Injection: 150 mg/1.14 mL or 200 mg/1.14 mL colorless to pale-yellow solution in a single-dose pre-filled syringe.

Injection: 150 mg/1.14 mL or 200 mg/1.14 mL colorless to pale-yellow solution in a single-dose pre-filled pen.

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)].