ZELVA (rituximab) is a monoclonal antibody that is used to treat certain types of cancer and autoimmune diseases, such as non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis (GPA).
It works by targeting and destroying certain types of cells in the body, including cancer cells and immune system cells that contribute to autoimmune diseases. ZELVA is typically administered by infusion, and the vial contains the concentrated liquid form of the medication.
ZELVA (rituximab) is a monoclonal antibody that has revolutionized the treatment of certain types of cancer and autoimmune diseases. It was first approved by the US Food and Drug Administration (FDA) in 1997 and has since been used to treat millions of patients worldwide.
| ZELVA is available in some countries, including certain MENA countries, ZELVA is biosimilar to MabThera, which means that it is a version of MabThera that is similar in quality, safety, and effectiveness. Biosimilars are typically less expensive than the original medication and can increase access to treatment for patients who may not be able to afford the original medication. |
Mechanism of Action
ZELVA is a type of monoclonal antibody that targets a specific protein called CD20, which is found on the surface of certain types of cells in the body, including B lymphocytes. B lymphocytes are a type of white blood cell that plays a key role in the immune system’s response to infection and disease. In cancer and autoimmune diseases, B lymphocytes can become overactive and contribute to the development and progression of the disease.
ZELVA works by binding to CD20 on the surface of B lymphocytes and triggering their destruction by the immune system. This process is known as antibody-dependent cellular cytotoxicity (ADCC). By destroying B lymphocytes, ZELVA can help to control the symptoms of autoimmune diseases and slow the growth of cancer cells.
Indications
ZELVA is approved for the treatment of several types of cancer and autoimmune diseases, including:
1. Non-Hodgkin’s lymphoma: ZELVA is used to treat certain types of non-Hodgkin’s lymphoma, including follicular lymphoma, diffuse large B-cell lymphoma, and mantle cell lymphoma. It is typically used in combination with chemotherapy.
2. Chronic lymphocytic leukemia: ZELVA is used to treat chronic lymphocytic leukemia (CLL), a type of cancer that affects the blood and bone marrow. It is often used in combination with chemotherapy.
3. Rheumatoid arthritis: ZELVA is used to treat rheumatoid arthritis, an autoimmune disease that causes joint inflammation and damage. It is often used in combination with other medications, such as methotrexate.
4. Granulomatosis with polyangiitis (GPA): ZELVA is used to treat GPA, a rare autoimmune disease that causes inflammation of the blood vessels in the nose, sinuses, lungs, and kidneys.
Administration
ZELVA is typically administered by infusion, which involves the slow injection of the medication into a vein over a period of several hours. The dosage and frequency of ZELVA infusions vary depending on the patient’s condition and response to treatment. In some cases, ZELVA may be given as a subcutaneous injection, which is injected under the skin.
Side Effects
Like all medications, ZELVA can cause side effects, although not everyone experiences them. The most common side effects of ZELVA include:
1. Infusion reactions: These are the most common side effects of ZELVA and can include fever, chills, nausea, vomiting, headache, and rash. These symptoms typically occur during the infusion and can be managed with medications, such as antihistamines and steroids.
2. Infections: ZELVA can increase the risk of infections, including bacterial, viral, and fungal infections. Patients taking ZELVA should be monitored for signs of infection and treated promptly if an infection occurs.
3. Low blood cell counts: ZELVA can cause a decrease in the number of white blood cells, red blood cells, and platelets in the blood. This can increase the probability of getting serious health problems, such as: infection.
Uncommon (off-lable) indications
Although ZELVA is primarily approved for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis, it has been used off-label for the treatment of several other conditions.
One such condition is multiple sclerosis (MS), a chronic autoimmune disease that affects the central nervous system. Although ZELVA is not approved for the treatment of MS, it has been used off-label as an alternative to other MS medications, such as interferon beta and glatiramer acetate. Studies have shown that ZELVA can reduce the number of relapses and slow the progression of disability in patients with MS.
Another off-label use of ZELVA is in the treatment of pemphigus vulgaris, a rare autoimmune disease that causes blistering of the skin and mucous membranes. ZELVA has been shown to be effective in controlling the symptoms of pemphigus vulgaris by targeting the B lymphocytes that contribute to the disease.
ZELVA has also been used off-label in the treatment of certain types of vasculitis, a group of autoimmune diseases that cause inflammation of the blood vessels. Studies have shown that ZELVA can be effective in controlling the symptoms of vasculitis by targeting the B lymphocytes that contribute to the disease.
In addition to these off-label uses, ZELVA has also been studied for the treatment of several other conditions, including lupus nephritis, myasthenia gravis, and immune thrombocytopenic purpura. Although the results of these studies have been mixed, ZELVA continues to be studied for its potential use in the treatment of these conditions.
It is important to note that the off-label use of ZELVA is not approved by the FDA and should only be considered in consultation with a qualified healthcare professional. Off-label use of medications may carry additional risks and may not be covered by insurance. Patients considering off-label use of ZELVA should discuss the potential risks and benefits with their healthcare provider.
Precautions and Warning
Like all medications, ZELVA has certain precautions and warnings that should be considered before use. These include:
1. Serious infections: ZELVA can increase the risk of serious infections, including viral, bacterial, and fungal infections. Patients should be monitored for signs of infection during treatment and for several months following treatment.
2. Tumor lysis syndrome: ZELVA can cause tumor lysis syndrome, a condition that occurs when cancer cells break down and release their contents into the bloodstream. This can cause kidney damage, electrolyte imbalances, and other complications. Patients at risk for tumor lysis syndrome should be closely monitored during treatment.
3. Progressive multifocal leukoencephalopathy (PML): PML is a rare but serious viral infection of the brain that can occur in patients receiving immunosuppressive medications, including ZELVA. Patients should be monitored for signs of PML, including changes in vision, speech, or motor function.
4. Hepatitis B reactivation: ZELVA can cause reactivation of hepatitis B in patients who have previously been infected with the virus. Patients should be screened for hepatitis B before starting treatment with ZELVA and monitored for signs of hepatitis B reactivation during and after treatment.
5. Cardiovascular events: ZELVA has been associated with an increased risk of cardiovascular events, such as heart attacks and strokes. Patients with a history of cardiovascular disease should be closely monitored during treatment.
6. Hypersensitivity reactions: ZELVA can cause hypersensitivity reactions, including anaphylaxis, which can be life-threatening. Patients should be monitored for signs of hypersensitivity reactions during treatment.
7. Immunization: Patients receiving ZELVA should not receive live vaccines during treatment and for several months following treatment.
It is important for patients to discuss any concerns or questions about the risks and benefits of ZELVA with their healthcare provider before starting treatment. Patients should also inform their healthcare provider of any other medical conditions or medications they are taking, as they may affect the safety and effectiveness of ZELVA.
Avialability & Pricing
ZELVA is available as a prescription medication and is typically administered in a clinical setting, such as a hospital or infusion center. It is not available over-the-counter and should only be used under the supervision of a qualified healthcare professional.
The pricing of ZELVA can vary depending on several factors, such as the country of purchase, the dosage, and the frequency of administration. In the MENA, the average retail price for ZELVA is approximately $200 to 700 per 500mg vial. However, the actual cost to patients may be lower or higher depending on their insurance coverage and other factors.
Overall, the cost of ZELVA can be a barrier to treatment for some patients, particularly those without adequate insurance coverage. Patients should discuss their options for financial assistance and alternative treatments with their healthcare provider or a patient advocacy organization.
In the United States, the price of ZELVA (rituximab) can vary depending on the healthcare provider, insurance coverage, and other factors. According to some sources, the average wholesale price for a 500mg vial of ZELVA in the US is around $1,000-$1,500, but this is subject to change.
Common Side Effects
ZELVA (rituximab) is generally well-tolerated, but like all medications, it can cause side effects. Some common side effects associated with ZELVA include:
1. Infusion reactions: ZELVA is typically administered via intravenous infusion, and some patients may experience infusion reactions such as fever, chills, nausea, and headache during or shortly after the infusion.
2. Fatigue: Fatigue is a common side effect of ZELVA and may persist for several weeks after treatment.
3. Nausea and vomiting: Some patients may experience nausea and vomiting after treatment with ZELVA.
4. Infections: ZELVA can increase the risk of infections, including upper respiratory infections, urinary tract infections, and pneumonia.
5. Low blood cell counts: ZELVA can cause a decrease in the number of white blood cells, red blood cells, and platelets in the blood, which can increase the risk of infection, anemia, and bleeding.
6. Skin reactions: Some patients may develop skin reactions, such as rash or itching, after treatment with ZELVA.
7. Hypersensitivity reactions: In rare cases, ZELVA can cause hypersensitivity reactions, including anaphylaxis, which can be life-threatening.
It is important for patients to report any side effects to their healthcare provider, as they may require additional monitoring or treatment. Patients should also inform their healthcare provider if they experience any symptoms of infection, such as fever, cough, or shortness of breath, as these may be signs of a serious infection.
Some patients may experience more severe or less common side effects from ZELVA. Patients should discuss the potential risks and benefits of treatment with their healthcare provider before starting ZELVA therapy.
FAQs
1. is ZELVA A Chemotherapy?
ZELVA (rituximab) is not a traditional chemotherapy drug, but it is considered a form of cancer treatment. ZELVA is a type of immunotherapy known as a monoclonal antibody, which targets and binds to a specific protein called CD20 that is found on the surface of certain types of immune cells called B cells.
By binding to CD20, ZELVA can help to destroy cancerous B cells and reduce the size of tumors. ZELVA is commonly used to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.
While ZELVA is not classified as a traditional chemotherapy drug, it can still have some similar side effects, such as nausea, vomiting, and low blood cell counts. However, ZELVA tends to have a more targeted effect on cancer cells than traditional chemotherapy drugs, which can affect both cancerous and healthy cells.
Overall, the use of ZELVA and other immunotherapy drugs has led to significant advances in cancer treatment, offering new options for patients with certain types of cancer.
2. When does ZELVA start operating?
The timing of when ZELVA (rituximab) starts to work can vary depending on the individual and the condition being treated. In some cases, patients may experience a rapid improvement in symptoms, while in other cases, it may take several weeks or even months to see a noticeable effect.
For example, in the treatment of non-Hodgkin’s lymphoma, ZELVA is typically administered in combination with chemotherapy. In some cases, patients may experience a rapid reduction in the size of their tumors, while in other cases, it may take several cycles of treatment to achieve a significant response.
In the treatment of rheumatoid arthritis, ZELVA is typically administered once every six months. Some patients may experience an improvement in symptoms within a few weeks of treatment, while others may take several months to see a noticeable effect.
Overall, the timing of when ZELVA starts to work can depend on a variety of factors, including the condition being treated, the severity of the disease, and the individual’s response to treatment. Patients should discuss the potential timing of response with their healthcare provider before starting treatment with ZELVA.
3. Does ZELVA Cause Hair Loss?
Hair loss is not a common side effect of ZELVA (rituximab). While some cancer treatments, such as chemotherapy, can cause hair loss, ZELVA is not classified as a chemotherapy drug and is not typically associated with hair loss.
However, some patients may experience hair thinning or hair breakage as a result of other side effects of ZELVA, such as fatigue or nutritional deficiencies. Additionally, some underlying conditions that are treated with ZELVA, such as autoimmune diseases, can cause hair loss as a symptom of the disease.
If you are experiencing hair loss or other changes in your hair, it is important to discuss these symptoms with your healthcare provider to determine the underlying cause and appropriate treatment. Your healthcare provider may recommend additional tests or evaluations to determine if the hair loss is related to ZELVA treatment or another underlying condition.
ATC Code: L01FA CD20 (Clusters of Differentiation 20) inhibitors