Golimumab

Approved Uses

Golimumab is primarily used to reduce symptoms and slow the progression of various autoimmune and inflammatory diseases. It is typically prescribed for adults with the following conditions:

• Rheumatoid Arthritis: Used to treat moderate to severe cases, often in combination with methotrexate.
• Psoriatic Arthritis: Used to treat active psoriatic arthritis, either alone or with methotrexate.
• Ankylosing Spondylitis: Used to treat active cases of this inflammatory condition affecting the spine.
• Non-radiographic Axial Spondyloarthritis: Used for patients with active disease who show objective signs of inflammation.
• Ulcerative Colitis: Used for moderate to severe cases when other medications have not worked well enough or were not tolerated. It may help achieve and maintain clinical response and improve the appearance of the colon lining.

Pediatric Uses

Golimumab is also used to treat certain conditions in children, including:

• Polyarticular Juvenile Idiopathic Arthritis: Used in children 2 years of age and older with active disease.

Targeting Inflammation

Golimumab belongs to a class of drugs known as tumor necrosis factor (TNF) blockers. It works by targeting a specific protein called TNF-alpha, which is naturally produced by the immune system. While this protein is necessary for fighting infections, having too much of it can lead to chronic inflammation and damage to healthy tissues.

In conditions like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, the immune system becomes overactive and produces excessive amounts of TNF-alpha. This excess causes the pain, swelling, and stiffness associated with these diseases.

Blocking the Inflammatory Process

Golimumab is designed to find and bind to TNF-alpha proteins in the blood and on cell surfaces. By latching onto these proteins, the medication prevents them from interacting with their receptors. This action effectively blocks the inflammatory signals that would otherwise lead to:

• Joint destruction and bone erosion
• Swelling and pain in the joints or spine
• Inflammation and sores in the lining of the colon

By lowering the activity of TNF-alpha, golimumab helps to control the symptoms of autoimmune disorders and may help prevent further physical damage over time.

Common Side Effects

Many people using golimumab experience mild side effects. These may include:

• Injection site reactions: Redness, itching, pain, or swelling where the medicine was injected.
• Respiratory issues: Runny nose, sore throat, or sinus congestion.
• Digestive and neurological symptoms: Nausea, dizziness, or high blood pressure.
• Viral infections: Flu-like symptoms or cold sores.

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Signs of infection: Fever, chills, persistent cough, night sweats, or extreme tiredness.
• Heart failure: New or worsening shortness of breath, swelling of the ankles or feet, or sudden weight gain.
• Nervous system problems: Vision changes, numbness or tingling, or weakness in the arms or legs.
• Liver issues: Yellowing of the skin or eyes (jaundice), dark urine, or pain on the right side of the stomach.
• Allergic reactions: Hives, swelling of the face, lips, or tongue, and difficulty breathing.
• Lupus-like syndrome: Joint pain or a rash on the cheeks or arms that gets worse in the sun.
• Blood disorders: Easy bruising, bleeding, or looking very pale.

Serious Infections

Golimumab can weaken the immune system, increasing the risk of serious infections caused by bacteria, fungi, or viruses. These infections may lead to hospitalization or death. Testing for tuberculosis (TB) is required before starting treatment and should continue during therapy. Treatment is generally not started if an active infection is present.

Cancer Risk

There is an increased risk of developing lymphoma and other types of cancer, including skin cancer. A rare and potentially fatal type of lymphoma called hepatosplenic T-cell lymphoma has been reported in some people using TNF blockers. This risk may be higher for children and young adults.

Hepatitis B Reactivation

In people who carry the hepatitis B virus, the virus may become active again during treatment. This can lead to severe liver damage or death. Blood tests are typically used to check for hepatitis B before and during therapy.

Neurological and Heart Conditions

• Nervous System Disorders: This medication may cause or worsen conditions such as multiple sclerosis or Guillain-Barré syndrome.
• Heart Failure: New or worsening heart failure has been reported. Monitoring for symptoms like shortness of breath or swelling is necessary.

Additional Precautions

• Blood Disorders: Some individuals may experience a significant decrease in blood cells that help fight infection or stop bleeding.
• Allergic Reactions: Serious allergic reactions can occur. The needle cover on some delivery devices may contain dry natural rubber (latex), which can cause reactions in sensitive individuals.
• Vaccinations: Live vaccines should not be administered while using this medication.

Pregnancy

There is limited information regarding the safety of golimumab use in pregnant women. Research indicates that golimumab crosses the placenta and can be detected in the blood of infants born to mothers treated with the medication. This exposure may affect the infant's immune system.

If golimumab is used during pregnancy, it is important to discuss the timing of infant vaccinations with a healthcare professional. Live vaccines should generally be avoided in infants for at least six months after the mother's last dose of golimumab during pregnancy, as the medication may increase the risk of infection from the vaccine.

Breastfeeding

It is currently unknown whether golimumab passes into human breast milk or how it might affect a nursing infant. Because many medications are excreted in breast milk and have the potential for side effects, patients should consult their healthcare provider to decide whether to continue breastfeeding or use the medication.

Subcutaneous Injection

Golimumab is available for subcutaneous administration in the following delivery systems:

• Prefilled Autoinjector: A single-use device designed for injection into the tissue just under the skin.
• Prefilled Syringe: A single-use glass syringe with a fixed needle.

Intravenous Infusion

Golimumab is available as a solution for intravenous administration. This form is supplied in a single-use vial and is intended to be diluted and administered as an infusion by a healthcare provider.

FDA Approval Status

Golimumab was first approved by the U.S. Food and Drug Administration (FDA) in April 2009 as a subcutaneous injection. An intravenous formulation was subsequently approved in July 2013. It is classified as a tumor necrosis factor (TNF) blocker and is regulated as a biological product.

Approved Indications

The FDA has approved golimumab for the treatment of the following conditions in adults:

• Moderate to severe rheumatoid arthritis (in combination with methotrexate).
• Active psoriatic arthritis (alone or with methotrexate).
• Active ankylosing spondylitis.
• Moderate to severe ulcerative colitis in patients who are corticosteroid-dependent or have not responded to or tolerated other medications.

It is also approved for the treatment of active polyarticular juvenile idiopathic arthritis in pediatric patients 2 years of age and older.

Boxed Warning

Golimumab carries a Boxed Warning, the FDA's most serious warning level, 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. Healthcare providers must test patients for latent TB before starting treatment and monitor for signs of infection during therapy.
• Malignancy: Lymphoma and other malignancies, some of which have been fatal, have been reported in children and adolescent patients treated with TNF blockers.

Factors Affecting Cost

The price of golimumab is influenced by several variables, including the specific dosage required for the condition being treated and the method of administration. Because it is a biologic medication, it is generally more expensive than traditional systemic drugs.

• Insurance and Medicare: Most insurance plans cover golimumab, but they often require prior authorization. Out-of-pocket costs like deductibles and co-pays will vary by plan.
• Administration Method: The subcutaneous injection may have different costs compared to the intravenous infusion, which involves additional fees for the clinical visit and professional administration.
• Specialty Pharmacy: This medication is usually obtained through a specialty pharmacy, which coordinates delivery and may offer specialized support services.

Financial Assistance Programs

Patients may have access to financial resources to help manage the cost of treatment:

• Co-pay Savings: Manufacturers often provide co-pay cards for patients with private or commercial insurance to reduce monthly out-of-pocket expenses.
• Patient Assistance: Programs may be available for patients who are uninsured or meet specific income requirements to receive the medication at a lower cost.