Inflectra

Approved Uses

Inflectra is used to treat various autoimmune and inflammatory conditions in adults and, in some cases, children. It is typically prescribed for patients who have not responded well to other medications.

Inflammatory Bowel Disease

• Crohn's Disease: For adults and children 6 years of age and older with moderately to severely active disease. It helps reduce symptoms and can induce and maintain clinical remission.
• Ulcerative Colitis: For adults and children 6 years of age and older with moderately to severely active disease to reduce symptoms and maintain remission.

Arthritis and Joint Conditions

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

Plaque Psoriasis

Inflectra is used for adults with chronic severe plaque psoriasis who are candidates for systemic therapy and when other treatments are considered less appropriate.

Mechanism of Action

Inflectra belongs to a class of medications known as tumor necrosis factor (TNF) blockers. It is a monoclonal antibody designed to target and neutralize a specific protein in the body called TNF-alpha.

TNF-alpha is naturally produced by the immune system to help fight infections. However, in people with certain autoimmune diseases, the body produces too much of this protein. Excessive levels of TNF-alpha lead the immune system to attack healthy tissues, resulting in chronic inflammation, pain, and swelling.

When Inflectra is administered, it works by:

• Binding to TNF-alpha: The medication attaches itself directly to the TNF-alpha proteins circulating in the blood and those located on cell surfaces.
• Neutralizing inflammation: By binding to these proteins, Inflectra prevents them from connecting to healthy cells and triggering the inflammatory process.
• Reducing immune activity: This action helps lower the overall activity of the immune system in specific areas of the body, such as the joints, skin, or digestive tract.

By controlling inflammation, Inflectra helps manage symptoms and can help prevent further damage to the body caused by the underlying condition.

Common Side Effects

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

• Headache
• Stomach pain or nausea
• Upper respiratory infections, such as sinus infections or a sore throat
• Cough or runny nose
• Muscle pain
• Fatigue

Serious Side Effects

Inflectra can cause serious side effects that require prompt medical evaluation. Seek help immediately for the following:

• Infusion-related reactions: Symptoms such as fever, chills, chest pain, high or low blood pressure, or shortness of breath that occur during or within 24 hours of receiving the medication.
• Infections: Fever, persistent cough, night sweats, or other signs of a new infection.
• Liver injury: Yellowing of the skin or eyes, dark urine, or severe pain in the upper right abdomen.
• Heart failure: New or worsening shortness of breath, especially when lying down, and swelling in the legs or feet.
• Nervous system problems: Numbness, tingling, weakness in any part of the body, or sudden changes in vision.
• Lupus-like syndrome: Joint pain or a skin rash on the cheeks or arms that gets worse in the sun.
• Allergic reactions: Hives, swelling of the face or throat, or difficulty breathing.

Serious Infections

Inflectra 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. Testing for TB is required before starting treatment and should continue during therapy.

Risk of Cancer

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers like Inflectra. Some patients have developed a rare and often fatal type of cancer called hepatosplenic T-cell lymphoma, primarily in adolescent and young adult males with Crohn's disease or ulcerative colitis who were also taking other immunosuppressants.

Liver and Heart Health

• Hepatotoxicity: Severe liver reactions, including liver failure and hepatitis, have occurred. Monitoring of liver enzymes is necessary.
• Hepatitis B Reactivation: The hepatitis B virus can become active again in people who carry it in their blood.
• Heart Failure: Inflectra may cause new or worsening heart failure. It should not be used at doses higher than 5 mg/kg in patients with moderate-to-severe heart failure.

Other Precautions

• Hypersensitivity: Serious allergic reactions can occur during or after the infusion. Symptoms may include hives, difficulty breathing, or chest pain. Delayed reactions, such as fever or joint pain, may also occur.
• Neurological Events: This medication has been associated with the onset or worsening of central nervous system disorders, such as multiple sclerosis or seizures.
• Blood Disorders: Some patients may experience a significant drop in blood cells that help the body fight infection or stop bleeding.
• Vaccinations: Patients should not receive live vaccines while being treated with Inflectra. Infants exposed to the drug in the womb should wait at least six months after birth before receiving live vaccines.

Pregnancy

Limited data are available regarding the use of Inflectra in pregnant women. Infliximab products, including Inflectra, are known to cross the placenta and have been detected in the serum of infants born to mothers treated with the medication. Because of this exposure, the medication may affect the immune system of the developing fetus.

If Inflectra is used during pregnancy, it is important to inform the infant's healthcare providers. Infants exposed to the drug in utero may have an increased risk of infection. It is generally recommended to wait at least six months after birth before administering live vaccines (such as the BCG vaccine) to these infants, unless otherwise directed by a physician.

Breastfeeding

Infliximab has been detected at low levels in human breast milk. While it is thought that the drug is likely broken down in the infant's digestive system and not absorbed in significant amounts, the potential for adverse effects is not fully known. The decision to breastfeed while using Inflectra should involve a discussion with a healthcare professional to weigh the benefits of breastfeeding against the mother's clinical need for the medication and any potential risks to the infant.

Available Forms

Inflectra is supplied in the following form:

• Lyophilized powder: This is a sterile, preservative-free powder contained in a single-dose vial.

This medication is intended for intravenous use only. A healthcare provider must reconstitute the powder and dilute it before it is administered as an infusion into a vein.

FDA Approval and Biosimilar Status

Inflectra (infliximab-dyyb) was approved by the FDA in 2016 as a biosimilar to Remicade (infliximab). It was the first biosimilar monoclonal antibody to receive approval in the United States. As a biosimilar, it is highly similar to the original reference product with no clinically meaningful differences in safety, purity, or potency.

Approved Indications

Inflectra is FDA-approved for the treatment of several autoimmune and inflammatory conditions in specific patient populations:

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

Boxed Warning

The FDA requires a Boxed Warning for Inflectra due to the risk of serious infections and malignancy. These risks include:

• Serious Infections: Patients treated with Inflectra 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.
• Malignancy: Lymphoma and other cancers, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers. A rare and often fatal type of cancer called hepatosplenic T-cell lymphoma has occurred in some young adults and children with inflammatory bowel disease treated with these medications.

Healthcare providers are required to monitor patients closely for signs of infection during and after treatment with Inflectra.

Factors Influencing Cost

Several factors determine the total cost of treatment with Inflectra:

• Dosage and Weight: Inflectra is typically dosed based on body weight (milligrams per kilogram). Patients who weigh more will require more medication per session, increasing the cost.
• Treatment Frequency: After the initial loading doses, maintenance infusions are usually given every 8 weeks. More frequent dosing for certain conditions can lead to higher annual costs.
• Administration Fees: Because Inflectra is administered by a healthcare professional through an intravenous (IV) infusion, the total price often includes facility fees and professional service charges from the clinic or hospital.

Insurance and Financial Assistance

Coverage for Inflectra depends on the specific health insurance plan. Many insurance providers require prior authorization before approving the medication. Patients may be responsible for deductibles, co-pays, or co-insurance amounts.

Financial assistance programs may be available to help reduce out-of-pocket expenses. These can include:

• Manufacturer Copay Cards: Eligible patients with commercial insurance may use these to lower their out-of-pocket costs.
• Patient Assistance Programs: These programs may provide the medication at little or no cost to individuals who meet specific income requirements and lack adequate insurance coverage.

Biosimilar Pricing

Inflectra is a biosimilar, meaning it is highly similar to the original biologic drug, Remicade. Biosimilars are often introduced to the market at a lower wholesale acquisition cost than the reference product to encourage competition and reduce overall healthcare spending.