Instructions for Sarilumab

1. Generic name: Salirumab

Product name:Kevzara

Full names: Sarilumab, Sarilumab, Kevzara

2. Indications:

1. Rheumatoid Arthritis (RA): Sarilumab is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response to or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

2. Polymyalgia rheumatica (PMR): Salirumab is suitable for the treatment of adult patients with polymyalgia rheumatica who have poor response to corticosteroids or who cannot tolerate reduction of corticosteroids.

3. Limitation of use: Avoid using salivolumab with biologicalDMARDs as it may increase the risk of immunosuppression and infection.

3. Usage and dosage:

1. Before treatment: Before treatment with Salirumab, complete blood count (CBC), liver function test (LFT), blood lipid parameters (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and/or triglycerides), active and latent tuberculosis infection should be tested.

2. Recommended dose: The recommended dose of salirumab is 200 mg subcutaneously injected once every two weeks. It can be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs. It can also be used as monotherapy after discontinuation of corticosteroids. For patients with polymyalgia rheumatica, it needs to be combined with a tapering course of systemic corticosteroids.

3. Dose adjustment: Patients with rheumatoid arthritis who develop severe infections or opportunistic infections should be treated with Salirumab until the infection is controlled. If the patient develops neutropenia (using ANC results obtained at the end of the dosing interval), thrombocytopenia, or abnormal liver enzymes, discontinue Salirumab.

4. Adverse reactions:

The most common adverse reactions observed with Salirumab in clinical studies occurred in at least 3% of patients with rheumatoid arthritis who received Salirumab in combination with DMARDs.) for neutropenia, elevated ALT, injection site erythema, upper respiratory tract infection, and urinary tract infection. Common adverse reactions occurring in ≥5% of patients with polymyalgia rheumatica treated with rilumab were neutropenia (15.3%), leukopenia (6.8%), constipation (6.8%), pruritus rash (5.1%), myalgia (6.8%), fatigue (5.1%), and injection site pruritus (5.1%).

5. Storage:

Salirumab Injection is available as a colorless to pale yellow solution in single-dose prefilled syringes and single-dose prefilled pens. Store refrigerated in the original carton at 36°F to 46°F (2°C to 8°C) to avoid light, do not freeze, and do not shake. If desired, patients/caregivers may store Salirumab in the outer carton at room temperature up to 77°F (25°C) for up to 14 days. Do not store above 77°F (25°C). Use Salirumab within 14 days after removal from the refrigerator or discard.

6. Taboo:

Sarilumab is contraindicated in patients with known hypersensitivity to sarilumab or any of the inactive ingredients. Sarilumab is contraindicated. Salirumab should not be used in patients with active tuberculosis.

7. Mechanism of action:

Salirumab binds to soluble and membrane-boundIL-6 receptors (sIL-6R and mIL-6R) and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by multiple cell types, including T and B cells, lymphocytes, monocytes, and fibroblasts. IL-6 has been shown to be involved in a variety of physiological processes, such as T cell activation, induction of immunoglobulin secretion, initiation of acute phase protein synthesis in the liver, and stimulation of hematopoietic precursor cell proliferation and differentiation. Synoviocytes and endothelial cells also produce IL-6, leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.

8. Notes:

During treatment with salivolumab, patients should pay attention to the occurrence of serious infections, gastrointestinal perforation, immunosuppression, allergic reactions, active liver disease and liver damage, and avoid concurrent use of live vaccines during treatment.

The patent drug of Salirutumab is a new type of drug for treating diseases. It is not yet on the market in China, and therefore it is not covered by medical insurance. Salirumab The common dosage form of the original drug is injection, which has been marketed overseas. The European version of specifications200mg*2 bottles is priced around 17,500 per box (The price may fluctuate due to exchange rates). There are currently no generics of Salirumab produced in other countries.