Truxima

Cancer Treatment

Truxima is approved to treat several types of blood-related cancers, including:

• Non-Hodgkin Lymphoma (NHL): It is used for various forms of NHL, such as follicular lymphoma and diffuse large B-cell lymphoma. It may be used alone or in combination with other chemotherapy medications.
• Chronic Lymphocytic Leukemia (CLL): It is used alongside specific chemotherapy drugs to treat adults with this type of blood and bone marrow cancer.

Autoimmune Conditions

Truxima is also used to manage certain inflammatory and autoimmune diseases:

• Rheumatoid Arthritis (RA): It is used in combination with methotrexate for adults with moderate to severe RA who have not had an adequate response to other treatments, such as TNF antagonists.
• Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA): It is used to treat these rare conditions that cause inflammation of the blood vessels.

Targeting B-Cells

Truxima belongs to a class of medications known as monoclonal antibodies. These are laboratory-made proteins designed to mimic the way the immune system attacks harmful cells. Truxima specifically targets a protein called CD20, which is found on the surface of B-lymphocytes, also known as B-cells.

Mechanism of Action

When Truxima is infused into the body, it travels through the bloodstream and attaches itself to the CD20 protein on B-cells. Once it binds to these cells, it works in several ways to eliminate them:

• Immune System Activation: It signals other parts of the immune system to recognize and destroy the marked B-cells.
• Direct Cell Death: The binding process can trigger the B-cell to self-destruct.
• Cell Lysis: It can cause the cell membrane to break open, killing the cell.

Impact on Different Conditions

The way Truxima helps depends on the condition being treated:

• Cancers: In conditions like non-Hodgkin lymphoma and chronic lymphocytic leukemia, Truxima helps eliminate cancerous B-cells, which can slow or stop the progression of the disease.
• Autoimmune Disorders: In conditions like rheumatoid arthritis or vasculitis, the body's B-cells mistakenly attack healthy tissues. By reducing the number of these B-cells, Truxima helps decrease inflammation and prevent further damage to the body.

Because Truxima targets both healthy and diseased B-cells, the body may be more susceptible to infections while the B-cell levels are low. Over time, the body usually produces new, healthy B-cells to replace those that were destroyed.

Common Side Effects

Many people experience side effects while receiving Truxima, particularly during the first infusion. These symptoms often include:

• Fever and chills
• Nausea or diarrhea
• Headache
• Muscle or joint aches
• Feeling tired or weak
• Cold-like symptoms, such as a runny nose or sore throat
• Low white blood cell counts, which may increase the risk of infection

Serious Side Effects

Truxima can cause severe reactions that require immediate medical attention. These include:

• Infusion reactions: Severe reactions can occur during or shortly after the injection, causing hives, swelling of the face or tongue, chest pain, or difficulty breathing.
• Severe skin reactions: Painful sores, blisters, or peeling skin may develop on the body or inside the mouth.
• Hepatitis B reactivation: If you have previously had Hepatitis B, the virus can become active again, potentially leading to liver failure.
• Brain infection (PML): A rare but serious brain infection called progressive multifocal leukoencephalopathy can cause confusion, vision changes, or loss of coordination.
• Kidney problems: Some patients may experience kidney damage or failure during treatment.
• Heart problems: Truxima may cause chest pain or irregular heart rhythms.
• Bowel obstruction or perforation: Severe stomach pain or persistent vomiting may indicate a serious issue with the intestines.

Boxed Warnings

Truxima carries several boxed warnings, which are the most serious warnings issued by the FDA. These include:

• Infusion-related reactions: Severe and potentially fatal reactions can occur, typically during the first infusion. Symptoms may include hives, swelling, difficulty breathing, or chest pain.
• Progressive Multifocal Leukoencephalopathy (PML): A rare and serious brain infection caused by the JC virus. This condition can lead to severe disability or death.
• Hepatitis B Virus (HBV) Reactivation: In people who have previously had hepatitis B, the virus can become active again, leading to liver failure or death. Screening for HBV is required before starting treatment.
• Severe Mucocutaneous Reactions: Life-threatening skin and mouth reactions, such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), have been reported.

Other Serious Precautions

Tumor Lysis Syndrome (TLS)

This condition occurs when cancer cells break down quickly, releasing their contents into the bloodstream. This can cause kidney failure and abnormal heart rhythms. It is most common during the first treatment cycle.

Infections

Truxima affects the immune system and may increase the risk of serious bacterial, fungal, or viral infections. Treatment is typically not started if an active, serious infection is present.

Cardiovascular and Renal Risks

Heart problems, including chest pain, irregular heartbeats, and heart failure, may occur during or after treatment. Additionally, some patients have experienced kidney toxicity, particularly those receiving the drug for non-Hodgkin's lymphoma.

Bowel Problems

Serious abdominal issues, including blockages or tears (perforation) in the stomach or intestines, have occurred in some patients. Medical attention is necessary for symptoms like severe stomach pain or persistent vomiting.

Vaccinations

Live vaccines should not be administered shortly before or during treatment with Truxima, as the drug may reduce the vaccine's effectiveness or increase the risk of infection from the vaccine.

Pregnancy and Breastfeeding

Truxima may cause harm to an unborn baby. Effective birth control is typically recommended during treatment and for several months after the final dose. Breastfeeding is generally discouraged during treatment and for at least six months following the last dose.

Pregnancy

Truxima can cause harm to a fetus. Research indicates that rituximab products can cross the placenta and may cause a decrease in B-cells in the unborn baby. It is important to inform your doctor if you are pregnant or planning to become pregnant before starting this medication.

Individuals who can become pregnant should use effective birth control during treatment and for 12 months after the final dose of Truxima to prevent pregnancy.

Breastfeeding

It is not known if Truxima is present in human breast milk. Because of the risk of serious adverse reactions in a nursing child, it is typically recommended to avoid breastfeeding during treatment and for at least 6 months after the last dose. Consult with a healthcare professional to determine the safest options for your situation.

Available Forms

Truxima is supplied as a sterile, preservative-free solution in vials. It is intended for intravenous use only and is provided as a clear to opalescent, colorless to pale yellow liquid.

Administration

This medication is administered as an intravenous infusion into a vein by a healthcare provider in a clinical setting. Before administration, the concentrated solution from the vial is diluted into an infusion bag containing a compatible fluid.

FDA Approval and Biosimilar Status

The U.S. Food and Drug Administration (FDA) approved Truxima (rituximab-abbs) in November 2018. It is the first biosimilar to Rituxan (rituximab) to be approved in the United States. A biosimilar is a biological product that is highly similar to an already approved biological medicine, with no clinically meaningful differences in terms of safety, purity, and potency.

Approved Indications

Truxima is indicated for the treatment of several conditions in adult patients, including:

• Relapsed or refractory, low-grade or follicular, B-cell Non-Hodgkin’s Lymphoma (NHL).
• Previously untreated follicular B-cell NHL.
• Non-progressing, low-grade, B-cell NHL.
• Previously untreated diffuse large B-cell NHL.
• Chronic Lymphocytic Leukemia (CLL).
• Rheumatoid Arthritis (RA) in combination with methotrexate.
• Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA).

Boxed Warnings

Truxima carries a Boxed Warning, the FDA’s most serious warning, for the following risks:

• Infusion Reactions: Severe and fatal infusion-related reactions can occur. Most fatal reactions happen during the first infusion.
• Severe Mucocutaneous Reactions: Potentially fatal skin and mouth reactions, such as Stevens-Johnson syndrome, have occurred.
• Hepatitis B Virus (HBV) Reactivation: HBV reactivation can lead to serious liver problems, including liver failure and death. Screening for HBV is required before starting treatment.
• Progressive Multifocal Leukoencephalopathy (PML): This is a rare, serious brain infection caused by the JC virus that can lead to severe disability or death.

Factors Influencing Cost

The price of Truxima can vary significantly depending on several factors, including:

• The specific condition being treated and the required dosage.
• The frequency of the infusion sessions.
• Your health insurance plan, including deductibles and co-pays.
• The setting where you receive the infusion, such as a hospital outpatient department or a private clinic.

Biosimilar Savings

As a biosimilar to Rituxan, Truxima is designed to provide a more cost-effective treatment option. Biosimilars are highly similar to the original biologic drug but are often available at a lower list price than the reference product.

Financial Assistance

Financial support may be available for patients who meet certain eligibility criteria. This can include:

• Co-pay assistance: Programs that help reduce out-of-pocket costs for patients with commercial insurance.
• Patient assistance programs: Support for individuals who are uninsured or underinsured.

Because Truxima must be administered by a healthcare professional through an intravenous infusion, the total cost will also include fees for the medical staff and the facility where the procedure takes place. It is recommended to check with your insurance provider regarding prior authorization requirements before starting treatment.