Understanding Yuflyma (adalimumab-aaty)
Yuflyma, with the generic name adalimumab-aaty, is an FDA-approved biologic medication in the class of Tumor Necrosis Factor (TNF) alfa inhibitors. It is used to reduce pain, inflammation, and skin symptoms associated with various autoimmune conditions. It is given as a subcutaneous injection and patients can learn to self-inject.
Yuflyma is an "interchangeable biosimilar" to Humira (adalimumab). This means it is highly similar to Humira with no clinically meaningful differences and, depending on state law, may be substituted by a pharmacist for a Humira prescription without a doctor's approval.
How Yuflyma Works
Yuflyma targets and blocks TNF-alpha, a protein that promotes inflammation in autoimmune disorders where the immune system attacks the body's tissues. By neutralizing TNF, Yuflyma helps reduce inflammation and symptoms.
Approved Uses for Yuflyma
Yuflyma is FDA-approved for several inflammatory conditions in specific patient groups. A comprehensive list of approved uses can be found on {Link: Drugs.com https://www.drugs.com/yuflyma.html}.
Key Features of Yuflyma
Yuflyma is a high-concentration (100mg/mL), citrate-free formulation. It can be stored at room temperature (up to 77°F or 25°C) for up to 30 days.
Comparison: Yuflyma vs. Humira
Yuflyma is designed to have the same clinical outcome as Humira. Key differences and similarities include:
Feature | Yuflyma (adalimumab-aaty) | Humira (adalimumab) |
---|---|---|
Drug Class | TNF alfa inhibitor | TNF alfa inhibitor |
Active Ingredient | Adalimumab-aaty | Adalimumab |
FDA Approval (Initial) | May 23, 2023 | December 31, 2002 |
Interchangeable? | Yes, for all approved dosage forms and strengths | Reference Product |
Formulation | High-concentration (100mg/mL), citrate-free | Available in both original and high-concentration, citrate-free forms. |
Administration | Subcutaneous injection (prefilled syringe & auto-injector) | Subcutaneous injection (prefilled syringe & auto-injector) |
Indications | Approved for 9 inflammatory conditions | Approved for the same core inflammatory conditions |
Important Safety Information and Side Effects
BOXED WARNING: SERIOUS INFECTIONS AND MALIGNANCY Like other TNF blockers, Yuflyma carries a boxed warning about increased risk of serious infections and malignancies. Patients should be tested for latent TB before starting treatment.
Common Side Effects
Common side effects (over 10% of users) include infections (like upper respiratory infections), injection site reactions, headache, and rash.
Serious Side Effects
Seek immediate medical attention for signs of serious infection, lymphoma, heart failure, liver problems, or nerve issues. Discuss medical history, including cancer, heart failure, hepatitis B, or upcoming surgery/vaccines, with a healthcare provider.
Conclusion
Yuflyma (adalimumab-aaty), a TNF blocker and interchangeable biosimilar to Humira, offers a clinically equivalent treatment option for various autoimmune diseases. Its high-concentration, citrate-free formulation aims to improve the patient experience. Patients should discuss the benefits and risks with their doctor before starting Yuflyma.
Authoritative Link: For more detailed prescribing information, you can visit the {Link: FDA's drug database entry for Yuflyma https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s000lbl.pdf}.