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YUSIMRY (ADALIMUMAB-AQVH)
YUSIMRY (generic name: ADALIMUMAB-AQVH) is a Tumor Necrosis Factor Blocker [EPC] drug developed by COHERUS BIOSCIENCES INC. It is currently FDA-approved for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis.
YUSIMRY is a TNF-alpha inhibitor, a type of antibody that targets tumor necrosis factor. It is classified as an inhibitor and is used to treat various conditions, including those associated with tumor necrosis factor.
At a glance
| Generic name | ADALIMUMAB-AQVH |
|---|---|
| Sponsor | COHERUS BIOSCIENCES INC |
| Drug class | Tumor Necrosis Factor Blocker [EPC] |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Crohn's Disease
- Ulcerative Colitis
- Plaque Psoriasis
- Hidradenitis Suppurativa
- Uveitis
Boxed warnings
- WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including YUSIMRY are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue YUSIMRY if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before YUSIMRY use and during therapy. Initiate treatment for latent TB prior to YUSIMRY use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with YUSIMRY prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUSIMRY, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 ) ]. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [see Warnings and Precautions ( 5.2 ) ]. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions ( 5.2 ) ]. WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning . SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue YUSIMRY if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting YUSIMRY. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.
Common side effects
- Injection site reactions
- Infections (upper respiratory, sinusitis)
- Headache
- Rash
- Positive ANA titers
- ALT elevations ≥3 x ULN
Serious adverse events
- Serious infections
- Active tuberculosis
- Positive PPD conversion
- Serious opportunistic infections
- Pneumonia
- Clinical flare reaction
- Lupus-like syndrome
- Acute liver failure
- Septic arthritis
- Cellulitis
Drug interactions
- Abatacept
- Anakinra
- Live vaccines
- Methotrexate
- Rituximab followed by TNF blocker
- Other biologic products (e.g., other TNF blockers, biologic DMARDs)
- CYP450 substrates
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- YUSIMRY CI brief — competitive landscape report
- YUSIMRY updates RSS · CI watch RSS
- COHERUS BIOSCIENCES INC portfolio CI
Frequently asked questions about YUSIMRY
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Related
- Drug class: All Tumor Necrosis Factor Blocker [EPC] drugs
- Manufacturer: COHERUS BIOSCIENCES INC — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Rheumatoid Arthritis
- Indication: Drugs for Juvenile Idiopathic Arthritis
- Indication: Drugs for Psoriatic Arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing