Kevzara Dosage

Generic name: SARILUMAB 150mg in 1.14mL
Dosage form: injection, solution
Drug classes: Antirheumatics, Interleukin inhibitors

Medically reviewed by Drugs.com. Last updated on Aug 22, 2024.

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 factor (TNF) antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators has not been studied. Avoid using KEVZARA with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection.

Recommended Evaluations Prior to Treatment

Complete blood count (CBC): Treatment initiation with KEVZARA is not recommended in patients with an absolute neutrophil count (ANC) below 2000 per mm3, or platelet count below 150,000 per mm3. Monitor laboratory parameters.
Liver function tests (LFT): Treatment initiation with KEVZARA is not recommended in patients with or who have alanine transaminase (ALT) or aspartate aminotransferase (AST) above 1.5 times the upper limit of normal (ULN). Monitor laboratory parameters.
Lipid parameters (total cholesterol, LDL cholesterol, HDL cholesterol and/or triglycerides): Assess lipid parameters at baseline. Monitor laboratory parameters.
Active and latent tuberculosis infection evaluation: Prior to initiating KEVZARA, test patients for active and latent tuberculosis (TB). KEVZARA should not be administered to patients with active TB. If positive for latent infection, consider treating for TB prior to KEVZARA use.
Evaluate for infections: Avoid KEVZARA use in patients with active infections.

Recommended Dosage for Rheumatoid Arthritis

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

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

Modify the dosage as recommended in Table 1 if the patient develops neutropenia, thrombocytopenia, or liver enzyme abnormalities.

Recommended Dosage for Polymyalgia Rheumatica

The recommended dosage of KEVZARA is 200 mg once every two weeks given as a subcutaneous injection, in combination with a tapering course of systemic corticosteroids. KEVZARA can be used as monotherapy following discontinuation of corticosteroids.

Discontinue KEVZARA if the patient develops neutropenia (using ANC results obtained at the end of the dosing interval), thrombocytopenia, or liver enzyme abnormalities.

2.4 Recommended Dosage for Polyarticular Juvenile Idiopathic Arthritis

The recommended dosage of KEVZARA for patients who weigh 63 kg and greater is 200 mg once every two weeks given as a subcutaneous injection (maximum dose 200 mg). Dosage in this patient population can be achieved by administering the 200 mg/1.14 mL pre-filled syringe. The pre-filled pen is not intended for use in pediatric patients. KEVZARA is not approved in pediatric patients weighing less than 63 kg because of the lack of an appropriate dosage form.

In patients with pJIA, KEVZARA can be used alone or in combination with conventional DMARDs.

2.5 Preparation and Administration Instructions

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.

Rotate injection sites with each injection. Do not inject into skin that is tender, damaged, or has bruises or scars.

Pre-filled Pen and Pre-filled Syringe

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.
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.
The ability of pediatric patients to self-inject with the pre-filled pen has not been tested.

Dosage Modifications for Cytopenias, Abnormal Liver Enzymes, or Infections

Dosage Modifications for Patients with Rheumatoid Arthritis

Laboratory Abnormalities: Modify dosage in case of neutropenia, thrombocytopenia, or liver enzyme elevations as shown in Table 1. For treatment initiation criteria, refer to the dosage recommendations for RA.

Table 1: Dosage Modifications due to Neutropenia, Thrombocytopenia, or Elevated Liver Enzymes in Patients with Rheumatoid Arthritis
Low Absolute Neutrophil Count (ANC)
Lab Value (cells/mm3)	Recommendation
ANC greater than 1,000	Maintain current dosage of KEVZARA.
ANC 500 to 1,000	Hold treatment with KEVZARA until ANC greater than 1,000. 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
Lab Value (cells/mm3)	Recommendation
50,000 to 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
Lab Value	Recommendation
ALT or AST greater than ULN to 3 times ULN	Consider dosage modification of concomitant DMARDs as clinically appropriate.
ALT or AST greater than 3 times ULN to 5 times ULN	Hold treatment with KEVZARA until ALT or AST 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 or AST greater than 5 times ULN	Discontinue KEVZARA.

Infections: If a patient with RA develops a serious infection or an opportunistic infection, hold treatment with KEVZARA until the infection is controlled.

Dosage Modifications for Patients with Polymyalgia Rheumatica

Laboratory Abnormalities: Discontinue KEVZARA in patients with PMR who develop the following laboratory abnormalities:
- neutropenia (ANC below 1,000 per mm3 at the end of the dosing interval)
- thrombocytopenia (platelet count below 100,000 per mm3)
- AST or ALT elevations 3 times above the ULN
Dosage modifications have not been studied in patients with PMR with these conditions. For treatment initiation criteria, refer to the dosage recommendations for PMR.
Infections: If a patient with PMR develops a serious infection or an opportunistic infection, hold treatment with KEVZARA until the infection is controlled.

Dosage Modification for Patients with Polyarticular Juvenile Idiopathic Arthritis

Dose reduction of KEVZARA has not been studied in the pJIA population. Discontinue KEVZARA if ALT >5 ULN, platelet count ≤50,000 cells/mm3, neutrophil count <500 cells/mm3 associated with infection. Hold KEVZARA dosing for ALT >3 to ≤5 ULN, platelet count >50,000 to ≤100,000 cells/mm3, and neutrophil count ≥500 to <1000 cells/mm3, and until the clinical condition has been evaluated. The decision to discontinue KEVZARA should be based upon the medical assessment of the individual patient. If appropriate, the dose of concomitant methotrexate and/or other medications should be modified or discontinued.