Renflexis

Approved Conditions

Renflexis is used to manage symptoms and reduce inflammation in patients with specific autoimmune and inflammatory disorders. It is often prescribed when other treatments have not provided enough relief.

Digestive System Conditions

• Crohn's Disease: Used for adults and children (6 years of age and older) with moderately to severely active Crohn's disease to reduce signs and symptoms and achieve clinical remission.
• Ulcerative Colitis: Used for adults and children (6 years of age and older) with moderately to severely active ulcerative colitis to reduce symptoms and maintain remission.

Joint and Spine Conditions

• Rheumatoid Arthritis: Used in combination with methotrexate to reduce symptoms, slow the progression of structural damage, and improve physical function in adults with moderately to severely active disease.
• Ankylosing Spondylitis: Used to reduce signs and symptoms in adults with this active inflammatory condition of the spine.
• Psoriatic Arthritis: Used to reduce signs and symptoms, slow joint damage, and improve physical function in adults with active disease.

Skin Conditions

• Plaque Psoriasis: Used for adults with chronic severe plaque psoriasis who are candidates for systemic therapy (medication that works throughout the body) or phototherapy (light therapy).

Mechanism of Action

Renflexis belongs to a class of medications known as tumor necrosis factor (TNF) blockers. It works by targeting and binding to a protein called TNF-alpha, which is produced by the body's immune system.

In a healthy body, TNF-alpha helps regulate the immune response. However, in people with certain autoimmune conditions, the body produces excessive amounts of this protein. High levels of TNF-alpha lead to inflammation, which can cause pain, swelling, and damage to various parts of the body, such as the joints, skin, or digestive tract.

By binding to TNF-alpha, Renflexis prevents the protein from interacting with healthy cells. This action helps to:

• Reduce the inflammatory response.
• Decrease symptoms associated with autoimmune disorders.
• Help prevent further damage to tissues and organs.
• Induce and maintain remission in certain chronic conditions.

As a biosimilar, Renflexis is designed to be highly similar to its reference product, Remicade, and works through the same biological pathways to manage inflammation.

Common Side Effects

The most frequently reported side effects of Renflexis include:

• Upper respiratory infections, such as sinus infections or sore throat
• Headache
• Stomach pain
• Nausea
• Coughing

Infusion-Related Reactions

Some patients may experience a reaction while receiving the infusion or shortly after. Contact a healthcare provider if you notice:

• Fever or chills
• Itching or hives
• Chest pain
• Shortness of breath
• Changes in blood pressure

Serious Side Effects

Renflexis may cause serious side effects that require immediate medical attention. These include:

• Liver Problems: Symptoms may include jaundice (yellowing of the skin or eyes), dark urine, right-sided abdominal pain, or extreme tiredness.
• Heart Failure: New or worsening symptoms such as shortness of breath, swelling of the ankles or feet, or sudden weight gain.
• Nervous System Disorders: Signs include numbness, tingling, weakness in the arms or legs, tremors, or vision changes.
• Lupus-like Syndrome: This may cause joint pain or a rash on the cheeks or arms that is sensitive to sunlight.
• Blood Disorders: Seek help for a persistent fever, easy bruising, or bleeding.
• Serious Infections: Symptoms may include fever, muscle aches, or flu-like symptoms.

Serious Infections

Renflexis can lower the immune system's ability to fight infections, which may lead to serious or fatal outcomes. These include tuberculosis (TB), bacterial sepsis, and invasive fungal infections. Healthcare providers must test for TB before starting treatment and monitor for signs of infection during therapy. If a serious infection develops, treatment is typically stopped.

Malignancy and Cancer Risks

There is an increased risk of lymphoma and other cancers in children and adolescent patients treated with TNF blockers. A rare and often fatal type of cancer called hepatosplenic T-cell lymphoma has occurred in some patients, primarily young men with Crohn's disease or ulcerative colitis who were also using other immune-suppressing medications like azathioprine or 6-mercaptopurine.

Liver and Heart Health

• Liver Injury: Severe hepatic reactions, including acute liver failure and hepatitis, have been reported. Monitoring for liver enzyme changes is common, and patients should watch for symptoms like jaundice, dark urine, or abdominal pain.
• Heart Failure: Renflexis may cause new or worsening congestive heart failure. Patients with heart conditions require close monitoring, and the medication may be discontinued if heart failure symptoms appear or worsen.

Neurological and Blood Disorders

• Nervous System Problems: This medication has been associated with the onset or worsening of central nervous system demyelinating disorders, such as multiple sclerosis and Guillain-Barré syndrome.
• Blood Cell Counts: Some patients may experience a severe decrease in white blood cells, red blood cells, or platelets. This can lead to an increased risk of infection, anemia, or bruising and bleeding.

Additional Precautions

• Hepatitis B Reactivation: People who carry the hepatitis B virus may experience a reactivation of the virus while taking Renflexis.
• Hypersensitivity: Serious allergic reactions, including anaphylaxis, can occur during or after an infusion. Delayed hypersensitivity reactions, such as fever, rash, and joint pain, may also occur several days after treatment.
• Vaccinations: Patients should not receive live vaccines while being treated with Renflexis. It is recommended that pediatric patients be brought up to date with all immunizations before starting therapy.
• Autoimmunity: Treatment may result in the formation of autoantibodies and, rarely, the development of a lupus-like syndrome.

Pregnancy

Research regarding the use of Renflexis during pregnancy is limited. As a monoclonal antibody, Renflexis can cross the placenta, especially during the third trimester. This may lead to the medication being present in the newborn's system at birth, which could potentially affect the infant's immune response.

If Renflexis is used during pregnancy, it is important for the healthcare team to be aware. Infants exposed to the drug in utero may need a modified vaccination schedule. Specifically, live vaccines are generally not recommended for these infants for at least six months after birth due to the potential risk of infection.

Breastfeeding

Infliximab products have been detected in human breast milk at low concentrations. While the medication is likely broken down in the infant's digestive tract, which may limit systemic absorption, the full impact on a nursing child is not completely understood.

Individuals who are breastfeeding or planning to breastfeed should consult with their doctor to evaluate the necessity of the treatment and any potential risks to the infant.

Dosage Forms

Renflexis is supplied in the following form:

• Lyophilized powder for injection: This is a sterile, white, preservative-free powder provided in a single-dose vial.

This medication is not for self-administration. A healthcare provider must reconstitute the powder with a liquid and then further dilute it before it is administered. The final solution is given through a needle into a vein, which is called an intravenous (IV) infusion.

FDA Approval and Indications

Renflexis (infliximab-abda) was approved by the FDA in 2017 as a biosimilar to Remicade. It is approved for the treatment of several chronic inflammatory conditions in adults and, in some cases, children. These include:

• Crohn’s disease (adults and children 6 years and older)
• Ulcerative colitis (adults and children 6 years and older)
• Rheumatoid arthritis (in combination with methotrexate)
• Ankylosing spondylitis
• Psoriatic arthritis
• Plaque psoriasis

Boxed Warning

The FDA requires a boxed warning for Renflexis due to the risk of serious infections and malignancy. Patients treated with this medication are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial sepsis, and invasive fungal infections. Patients should be tested for latent TB before starting treatment and monitored during therapy.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers. Specifically, cases of hepatosplenic T-cell lymphoma have occurred, primarily in adolescent and young adult males with inflammatory bowel disease treated with these products and other immunosuppressants.

Regulatory Classification

As a biosimilar, Renflexis is highly similar to its reference product, Remicade, with no clinically meaningful differences in safety, purity, or potency. It is administered via intravenous infusion by a healthcare professional in a clinical setting.

Factors Affecting Price

Renflexis is a biosimilar medication, which is designed to be a more cost-effective alternative to the original biological product, Remicade. The total cost of treatment is influenced by several variables:

• Body Weight: The dosage is calculated based on kilograms of body weight, meaning the amount of medication needed—and the subsequent cost—will differ for each person.
• Infusion Setting: Because this medication must be administered by a healthcare professional through an intravenous (IV) line, costs include not only the drug itself but also facility fees and professional administration charges. Prices may vary between a doctor's office, an independent infusion center, or a hospital setting.
• Frequency of Doses: After the initial starting doses, maintenance infusions are typically required every six to eight weeks, which contributes to the long-term cost of therapy.

Insurance Coverage

Most private insurance plans, as well as Medicare and Medicaid, provide coverage for Renflexis. However, many insurers require prior authorization before they will approve payment. Some insurance companies may also have a preferred list of biosimilars, requiring patients to use a specific brand of infliximab to receive the highest level of coverage.

Financial Assistance Programs

For patients who are concerned about out-of-pocket expenses, financial assistance may be available. The manufacturer often provides co-pay assistance programs for patients with commercial insurance to help lower the cost of the medication. Additionally, patient assistance programs may be available for individuals who are uninsured or meet specific financial need criteria.