KN, a 54-year-old female, presents to the pharmacy to pick up her maintenance prescriptions. While at the counter, she expresses interest in speaking to the pharmacist about a new medication called Tyenne that she was initiated on at her most recent appointment with her rheumatologist.

PMH: Hypertension, Rheumatoid Arthritis

Labs from most recent rheumatology visit:

ANC 4,900 cells/μL (Normal 2,500-6,000 cells/μL)

Plt 328,000 cells/μL (Normal 150,000-450,000 cells/μL)

ALT 17 U/L (Normal 7-56 U/L)

AST 10 U/L (Normal 8-33 U/L)

Current medications:

Ramipril 10 mg PO QD

Methotrexate 25 mg PO QWEEK

Which of the following statement(s) is/are correct regarding Tyenne? Select all that apply.

A. Tyenne is an FDA-approved biosimilar referencing tocilizumab 

B. Tyenne is FDA-approved for the treatment of COVID-19

C. It works through inhibition of inteuleukin-6 (IL-6) receptors, leading to a reduction in cytokine and acute phase reactant production

D. Tyenne is available in intravenous and oral formulations

E. It has a boxed warning for risk of serious infections

Answer with Rationale

Rheumatoid arthritis (RA) is an autoimmune condition that primarily affects the joint and synovium, which can lead to disturbances in one’s ability to function and complete basic activities of daily living. It is one of the more common autoimmune diseases with annual incidence of approximately 40 in 100,000 people. Native American-Indian populations have the highest prevalence noted, while Southern European, Eastern Asian, and African populations have much lower prevalence. Women are twice as likely to develop the disease compared with men. Cardiovascular (CV) disease is the leading cause of death in patients with RA. Patients with RA have a higher risk of major adverse CV events, and RA disease activity is a predictor of increased CV risk. The exact etiology of RA is unknown, but treatment options are constantly being developed. It is impossible to reverse joint damage that has already occurred, even when patients are initiated on pharmacologic agents. Therefore, early aggressive treatment of RA is imperative, as it has shown to improve overall outcomes. Currently available treatment options include conventional and biologic disease-modifying antirheumatic drugs (DMARDs), as well as the Janus kinase (JAK) inhibitors tofacitinib, baricitinib, and upadacitinib. Conventional DMARDs include methotrexate, leflunomide, sulfasalazine, and hydroxychloroquine. Biologic DMARDs are further divided into two categories – tissue necrosis factor (TNF) inhibitor biologics (adalimumab, etanercept, certolizumab, golimumab, and infliximab) and non­TNF biologics (abatacept, tocilizumab, rituximab, anakinra, and sarilumab).

Answer A is correct. Tyenne is a tocilizumab biosimilar that received FDA approval on March 5, 2024. It is currently indicated for the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. A biosimilar is a biologic medication that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, called a reference product. Compared with the reference product, a biosimilar is made with the same types of living sources, is given to the patient in the same way, and has the same strength, dosage, potential treatment benefits, and potential side effects. The availability of biosimilars can provide patients with more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition. Another FDA-approved biosimilar for tocilizumab is Tofidence (tocilizumab-bavi). 

Answer B is incorrect. Actemra (tocilizumab) is FDA-approved for the management of COVID-19 in patients requiring hospitalization who are receiving systemic corticosteroids and are requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Tofidence, the previously other mentioned biosimilar for tocilizumab, is also FDA-approved for the management of COVID-19. However, Tyenne is not yet FDA-approved for the management of COVID-19 in the United States. 

Answer C is correct. Tocilizumab, a monoclonal antibody, is an antagonist of the IL-6 receptor. It binds to both soluble and membrane-bound IL-6 receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B- cells, lymphocytes, monocytes and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes, such as rheumatoid arthritis.

Answer D is incorrect. Tyenne is the first tocilizumab biosimilar to be FDA approved with both IV and SQ formulations for administration.

Answer E is correct. Patients treated with tocilizumab are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids. Reported infections include active tuberculosis, invasive fungal infections, as well as bacterial, viral, and other infections caused by opportunistic pathogens. If a serious infection develops, interrupt tocilizumab until the infection is controlled. Before starting tocilizumab therapy, patients should be tested for latent TB to ensure they are negative in order to not potentially produce active TB. 

Generic/Brand: Tocilizumab-aazg (Tyenne), Ramipril (Altace)

NAPLEX Core Competencies Covered:

• 1.2 – From patients: treatment adherence, or medication-taking behavior; chief complaint, medication history, medical history, family history, social history, lifestyle habits, socioeconomic background
• 2.1 – Pharmacology, mechanism of action, or therapeutic class
• 2.2 – Commercial availability; prescription or non-prescription status; brand, generic, or biosimilar names; physical descriptions; or how supplied
• 2.3 – Boxed warnings or REMS
• 3.5 – Drug route of administration, dosage forms, or delivery systems