Yusimry

Arthritis and Joint Conditions

Yusimry is used to reduce the signs and symptoms of several types of arthritis. These include:

• Rheumatoid arthritis: Moderate to severe cases in adults.
• Polyarticular juvenile idiopathic arthritis: Moderate to severe cases in children 2 years of age and older.
• Psoriatic arthritis: Used in adults to reduce joint pain and improve physical function.
• Ankylosing spondylitis: Used in adults to reduce symptoms of this inflammatory spine condition.

Skin Conditions

This medication is prescribed for certain chronic skin conditions, including:

• Plaque psoriasis: Moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
• Hidradenitis suppurativa: Moderate to severe cases in adults.

Bowel Diseases

Yusimry is used to treat inflammatory bowel diseases when other treatments may not have worked well enough. These include:

• Crohn's disease: Moderate to severe cases in adults and children 6 years of age and older.
• Ulcerative colitis: Moderate to severe cases in adults.

Eye Conditions

Yusimry is also used to treat non-infectious uveitis (intermediate, posterior, and panuveitis) in adults, which is a type of inflammation that affects the eye.

Targeting Inflammation

Yusimry 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. While it normally helps the body fight infections, people with certain autoimmune diseases often produce too much of it.

When TNF levels are too high, the immune system mistakenly attacks healthy tissues, leading to persistent inflammation. This inflammation is responsible for the pain, stiffness, and swelling seen in conditions such as rheumatoid arthritis, plaque psoriasis, and inflammatory bowel diseases.

How the Medication Acts

Yusimry is a monoclonal antibody, which is a type of protein designed to recognize and bind to a specific target. In this case, the medication binds directly to the excess TNF molecules in the bloodstream and tissues. By latching onto these proteins, Yusimry prevents them from attaching to healthy cells and triggering the inflammatory process.

By blocking this pathway, the medication helps to:

• Reduce swelling and pain in the joints and skin.
• Slow the progression of joint damage in inflammatory arthritis.
• Decrease inflammation in the digestive tract for those with bowel diseases.

Because Yusimry targets a specific part of the immune system rather than suppressing the entire system, it is considered a biologic therapy. It does not cure the underlying condition but helps manage the symptoms and prevent further tissue damage by keeping the inflammatory response under control.

Common Side Effects

Many people using Yusimry experience mild reactions, particularly at the site of injection. Common side effects include:

• Redness, itching, pain, or swelling where the shot was given
• Headache
• Rash
• Nausea
• Back pain

Serious Side Effects

Yusimry may cause serious side effects that require immediate medical attention. Tell your doctor right away if you notice:

• Signs of infection: Fever, chills, sweating, muscle aches, cough, shortness of breath, or warm, red, or painful skin sores.
• Nervous system issues: Numbness, tingling, dizziness, vision changes, or weakness in your legs.
• Liver problems: Feeling very tired, skin or eyes turning yellow, poor appetite, or right-sided stomach pain.
• New or worsening heart failure: Shortness of breath with exertion or while lying down, or swelling of the ankles or feet.
• Immune system reactions: Chest discomfort, joint pain, or a butterfly-shaped rash on the cheeks and nose.
• Blood problems: Fever that does not go away, bruising easily, or looking pale.

Get emergency medical help if you experience signs of a severe allergic reaction, including hives, swelling of the face or throat, or difficulty breathing.

Serious Infections

Yusimry 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. These infections may require hospitalization or lead to death.

• Testing for TB is required before starting treatment and should continue during therapy.
• Treatment should not be started if an active infection is present.

Cancer Risk

There is an increased risk of developing lymphoma or other types of cancer. Cases of a rare and fatal type of cancer called hepatosplenic T-cell lymphoma have occurred, primarily in teenage and young adult males with inflammatory bowel disease who were also using other specific medications.

Other Precautions

• Allergic Reactions: Serious allergic reactions, including anaphylaxis, can occur.
• Hepatitis B: The virus may become active again in people who carry it.
• Nervous System: New or worsening symptoms of demyelinating diseases, such as multiple sclerosis, have been reported.
• Blood Disorders: Some patients may develop low blood cell counts.
• Heart Failure: This medication may cause new or worsening heart failure.
• Vaccinations: Live vaccines should be avoided while using Yusimry.

Pregnancy

Data on the use of Yusimry during pregnancy are limited. Adalimumab, the active ingredient, is known to cross the placenta, particularly during the third trimester. This may influence the immune system of the developing fetus. Healthcare providers typically evaluate whether the benefits of treatment outweigh the potential risks to the pregnancy.

If Yusimry is used during pregnancy, it may affect the infant's ability to fight infections. It is generally advised to inform the infant's pediatrician about the exposure, as certain vaccinations, specifically live vaccines, may need to be delayed for several months after birth.

Breastfeeding

Yusimry is excreted into human breast milk in very small amounts. While it is believed that the medication is mostly destroyed in the infant's stomach and not absorbed into their bloodstream in significant quantities, the long-term effects on a nursing child are not well-established. Decisions regarding breastfeeding while using this medication should be made in consultation with a healthcare professional to weigh the benefits of breastfeeding against any potential risks.

Available Forms

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

• Prefilled Pen: A single-dose, disposable device designed for subcutaneous injection.
• Prefilled Syringe: A single-dose, disposable syringe with a fixed needle.

Each device is intended for one-time use only and should be discarded after the dose is administered.

FDA Approval Status

Yusimry (adalimumab-aqvh) is approved by the U.S. Food and Drug Administration (FDA) as a biosimilar to Humira. A biosimilar is a biological medication that is highly similar to an existing FDA-approved biological product, with no clinically meaningful differences in safety, purity, or potency.

Approved Indications

Yusimry is FDA-approved to treat several autoimmune and inflammatory conditions, including:

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

Boxed Warning

The FDA has issued a boxed warning for Yusimry regarding the following risks:

• Serious Infections: Patients are at an increased risk for developing serious infections that may lead to hospitalization or death. These include tuberculosis (TB), bacterial sepsis, and invasive fungal infections.
• Malignancy: Lymphoma and other malignancies, some of which have been fatal, have occurred in children and adolescent patients treated with tumor necrosis factor (TNF) blockers.

Insurance and Out-of-Pocket Costs

The amount you pay for Yusimry is primarily determined by your insurance plan. Most commercial insurance plans and government programs like Medicare or Medicaid provide coverage for adalimumab products, but the specific tier and co-payment amount can vary. Many insurers require prior authorization before approving coverage for this medication.

Biosimilar Savings

Yusimry is a biosimilar to the reference product Humira. Biosimilars are highly similar biological products that are typically offered at a lower cost than the original brand-name drug. Choosing a biosimilar may result in lower costs for both patients and healthcare systems.

Financial Assistance

Financial support may be available to help manage the cost of Yusimry:

• Co-pay Savings: Eligible patients with commercial insurance may be able to use a co-pay card from the manufacturer to reduce their out-of-pocket expenses.
• Patient Assistance: Programs may exist for patients who lack insurance or have limited coverage, providing the medication at a reduced cost based on financial need.

It is recommended to contact your insurance provider and the specialty pharmacy to get an accurate estimate of your specific costs.