KEVZARA- sarilumab injection, solution
sanofi-aventis U.S. LLC
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.
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.
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 appears to be damaged.
Instruct patients to inject the full amount in the syringe (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)].