Yuflyma

Approved Uses

Yuflyma is used to reduce the signs and symptoms of various autoimmune and inflammatory diseases. It is often prescribed for patients who have not responded well to other treatments. The conditions it is approved to treat include:

• Rheumatoid Arthritis: To treat moderate to severe cases in adults, helping to reduce joint pain and swelling and slow the progression of joint damage.
• Juvenile Idiopathic Arthritis: For children 2 years of age and older with moderate to severe polyarticular JIA.
• Psoriatic Arthritis: To treat adults with active psoriatic arthritis, improving physical function and reducing joint symptoms.
• Ankylosing Spondylitis: To reduce signs and symptoms in adults with this type of inflammatory arthritis affecting the spine.
• Crohn's Disease: For adults and children 6 years of age and older with moderate to severe Crohn's disease to help achieve and maintain remission.
• Ulcerative Colitis: For adults with moderate to severe ulcerative colitis when certain other medicines have not worked well enough.
• Plaque Psoriasis: For adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
• Hidradenitis Suppurativa: To treat moderate to severe cases of this chronic skin condition in adults.
• Uveitis: For adults with certain types of non-infectious inflammation in the eye (intermediate, posterior, and panuveitis).

Targeting Inflammation

Yuflyma belongs to a class of medications known as tumor necrosis factor (TNF) blockers. TNF is a protein naturally produced by the body's immune system. In a healthy person, TNF helps the body fight infections and manage inflammation.

However, in people with certain autoimmune conditions, the body produces too much TNF. This excess protein causes the immune system to attack healthy parts of the body, leading to chronic inflammation, pain, and swelling in the joints, skin, or digestive tract.

How the Medication Interacts with the Body

Yuflyma is a monoclonal antibody designed to recognize and attach to TNF-alpha molecules. Once it binds to these proteins, it prevents them from interacting with other cells in the body. This process helps to:

• Lower the overall level of inflammation.
• Reduce the physical symptoms of the disease, such as stiffness and pain.
• Help prevent further damage to bones, joints, or organs.

Because Yuflyma targets a specific part of the immune system, it is considered a biologic therapy. It does not cure the underlying condition but helps manage the immune response that causes symptoms.

Common Side Effects

Many people using this medication experience mild side effects. These often occur at the site where the medicine was injected. Common side effects include:

• Redness, itching, pain, or swelling at the injection site
• Headache
• Rash
• Nausea
• Back pain
• Sinus or upper respiratory infections

Serious Side Effects

While less common, some side effects can be serious. Contact a healthcare provider immediately if you experience:

• Signs of infection, such as fever, chills, persistent cough, or sore throat
• Unusual bruising or bleeding
• Pale skin, dizziness, or shortness of breath
• Numbness, tingling, or weakness in the arms or legs
• Vision changes
• New or worsening joint pain
• A butterfly-shaped rash on the cheeks and nose
• Yellowing of the eyes or skin, or dark urine
• Swelling of the ankles or feet

Seek emergency medical help if you have signs of a severe allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Serious Infections

Yuflyma can lower the ability of the immune system to fight infections. Some people have developed serious infections while taking this medication, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. In some cases, these infections have been fatal. Healthcare providers typically test for TB before starting treatment and monitor for signs of infection during therapy.

Cancer Risks

There is an increased risk of certain types of cancer, including lymphoma, for children and teenage patients taking TNF blockers like Yuflyma. Some people have developed a rare and serious type of cancer called hepatosplenic T-cell lymphoma, which is often fatal. This has occurred primarily in young males with Crohn's disease or ulcerative colitis who were also taking other specific medications.

Other Important Precautions

• Hepatitis B: The virus may become active again in people who carry it in their blood.
• Neurological Problems: New or worsening symptoms of demyelinating diseases, such as multiple sclerosis or Guillain-Barré syndrome, may occur.
• Blood Disorders: Rare but serious blood problems, such as a decrease in blood cells that help fight infections or stop bleeding, have been reported.
• Heart Failure: New or worsening heart failure can occur.
• Allergic Reactions: Serious allergic reactions, including anaphylaxis, are possible.
• Live Vaccines: People taking Yuflyma should not receive live vaccines.

Pregnancy

There is limited information regarding the use of Yuflyma in pregnant women. Research indicates that adalimumab, the active ingredient, crosses the placenta during the third trimester of pregnancy. This exposure may affect the immune system of the newborn. While some data do not show an increased risk of major birth defects, the evidence is not conclusive.

If you are pregnant or planning to become pregnant, discuss the potential risks and benefits of continuing treatment with your doctor. It is also important to inform the infant's healthcare provider about Yuflyma exposure before the baby receives any vaccines. Live vaccines should generally be avoided in infants for several months after the mother's last dose during pregnancy.

Breastfeeding

Yuflyma is known to pass into breast milk in very small amounts. However, it is thought that the medication is likely broken down in the infant's digestive tract and not absorbed in significant quantities. Because the long-term effects on a nursing infant are not fully understood, you should consult your healthcare provider to decide whether to continue breastfeeding while using this medication.

Available Forms

Yuflyma is supplied as a sterile, preservative-free solution for injection under the skin. It is available in the following formats:

• Prefilled Autoinjector: A device designed for subcutaneous administration that is disposed of after use.
• Prefilled Syringe: A pre-filled syringe with a needle shield, intended for injection.

These delivery systems are designed to be used by the patient or a caregiver after proper training from a healthcare provider. The medication is typically stored in a refrigerator and must be protected from light until use.

FDA Approval and Biosimilar Status

Yuflyma (adalimumab-aaty) was approved by the U.S. Food and Drug Administration (FDA) in May 2021. It is a biosimilar to Humira (adalimumab), which means it is highly similar to the reference product with no clinically meaningful differences in safety, purity, or potency.

Approved Indications

The FDA has approved Yuflyma for the treatment of several chronic inflammatory conditions in adults and some pediatric patients, including:

• Rheumatoid arthritis
• Juvenile idiopathic arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn’s disease
• Ulcerative colitis
• Plaque psoriasis

Boxed Warning

Yuflyma contains a Boxed Warning regarding the risk of serious infections and malignancy. Key safety points include:

• Serious Infections: Patients treated with Yuflyma are at increased risk for developing serious infections that may lead to hospitalization or death. These include tuberculosis (TB), bacterial sepsis, and invasive fungal infections. Patients should be tested for latent TB before starting treatment and monitored during therapy.
• Malignancy: Lymphoma and other cancers, some fatal, have been reported in children and adolescent patients treated with TNF blockers like Yuflyma.

Factors Affecting Price

The actual price a patient pays for Yuflyma is influenced by several variables:

• Insurance Coverage: Most insurance plans, including Medicare and private insurance, have different levels of coverage for biologic drugs. Your specific copayment or coinsurance will depend on your plan's formulary.
• Pharmacy Type: Because Yuflyma is a biologic, it is often dispensed through specialty pharmacies, which may have different pricing structures than standard retail pharmacies.
• Manufacturer Programs: Financial assistance, such as copay cards or patient assistance programs, may be available through the manufacturer to help lower out-of-pocket costs for eligible patients.

Biosimilar Value

As a biosimilar to Humira, Yuflyma is intended to offer a more cost-effective treatment option. Biosimilars undergo rigorous FDA evaluation to ensure they are as safe and effective as the original product while potentially reducing the financial burden on the healthcare system and patients.

Assistance and Support

Patients who are uninsured or have high out-of-pocket costs should inquire about support programs. These programs are often designed to help bridge the gap for those who meet specific clinical and financial criteria. You can check with your healthcare provider or the drug manufacturer for the most current assistance options.