Rituxan
Pronunciation: ri-tuk-san
Generic name: rituximab
Dosage form: injection for intravenous infusion
Drug classes: Antirheumatics, CD20 monoclonal antibodies
What is Rituxan?
Rituxan is a targeted cancer medicine given by an IV infusion that interferes with the growth and spread of cancer cells in the body. It is also used to treat other non-cancer conditions.
Rituxan is given by a healthcare professional. It is a prescription medicine used alone or in combination with other medicines to treat the following conditions:
-
non-Hodgkin's lymphoma or chronic lymphocytic leukemia in adults
- mature B-cell Non-Hodgkin's lymphoma (NHL) and mature B-cell acute leukemia (B-AL) in children aged 6 months and older
-
rheumatoid arthritis in adults
-
granulomatosis with polyangiitis and microscopic polyangiitis (rare disorders that cause inflammation of blood vessels and other tissues in the body) in adults and children 2 years of age and older
-
moderate to severe pemphigus vulgaris (a severe autoimmune reaction that causes blisters and breakdown of the skin and mucous membranes) in adults.
Rituxan is not chemotherapy, it is a type of immunotherapy called a targeted cancer treatment.
Rituxan gained FDA approval on November 26, 1997. Rituxan has 3 biosimilars: Riabni, Ruxience, and Truxima. A biosimilar is a biological product that is similar to a reference biologic (usually the originally approved product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency.
Rituxan side effects
The most common Rituxan side effects include:
- infusion-related reactions
- infections (symptoms may include fever, chills, body aches, pale skin, unusual tiredness)
- body aches
- tiredness
- low white and red blood cells
- nausea
- diarrhea
- swelling in your hands or feet
- headache, weakness
- painful urination
- muscle spasms
- depressed mood
- cold symptoms such as stuffy nose, sneezing, and sore throat.
The most common side effects in children with B-cell NHL or B-AL who receive Rituxan with chemotherapy include:
- decreased white blood cells with fever
- mouth sores
- inflammation of the upper intestine
- serious infection throughout the body and organs (sepsis)
- changes in liver function blood tests
- low level of potassium in the blood.
Other side effects reported with Rituxan include:
- aching joints during or within hours of receiving an infusion
- more frequent upper respiratory tract infections.
Serious side effects and warnings
Rituxan carries a Boxed Warning for fatal infusion-related reactions, severe skin reactions, hepatitis B virus reactivation, and a rare brain condition called progressive multifocal leukoencephalopathy (PML).
Infusion-related reactions. These are a very common side effect of Rituxan treatment. Serious infusion-related reactions can happen during your or your child’s infusion or within 24 hours after. Your healthcare provider should give you or your child medicines before your Rituxan infusion to decrease the chance of having a severe infusion-related reaction. Tell your healthcare provider or get medical help right away if you or your child get any of these symptoms during or after an infusion:
- hives (red itchy welts) or rash
- shortness of breath, difficulty breathing, or wheezing
- itching
- weakness
- swelling of your lips, tongue, throat, or face
- dizziness or feel faint
- sudden cough
- palpitations (feel like your heart is racing or fluttering)
- chest pain.
Severe skin and mouth reactions. Tell your healthcare provider or get medical help right away if you or your
child get any of these symptoms at any time during your treatment with Rituxan:
- painful sores or ulcers on your skin, lips or in your mouth
- blisters
- peeling skin
- rash
- pustules.
Hepatitis B virus (HBV) reactivation. Before you or your child receive Rituxan treatment, your healthcare
provider will do blood tests to check for HBV infection. If you or your child have had hepatitis B or are a carrier
of the hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again. Hepatitis B
reactivation may cause serious liver problems including liver failure, and death. You or your child should not
receive Rituxan if you or your child have active hepatitis B liver disease. Your healthcare provider will
monitor you or your child for hepatitis B infection during and for several months after you or your child stop
receiving Rituxan. Tell your healthcare provider right away if you or your child gets worsening tiredness, or yellowing of your or your child’s skin or white part of your eyes, during treatment.
Progressive Multifocal Leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a
virus that can happen in people who receive Rituxan. People with weakened immune systems can get
PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML.
Tell your healthcare provider right away if you or your child have any new or worsening symptoms or if anyone
close to you notice these symptoms:
- confusion
- dizziness or loss of balance
- decreased strength or weakness on one side of your body
- difficulty walking or talking
- vision problems.
Get emergency medical help if you have signs of an allergic reaction to Rituxan such as hives, difficulty breathing, swelling in your face or throat, or a severe skin reaction (symptoms may include fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
These are not all of the possible side effects of Rituxan. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088
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Before taking this medicine
Before you or your child receive Rituxan, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:
- have had a severe reaction to Rituxan or a rituximab product
- have a history of heart problems, irregular heartbeat, or chest pain
- have lung, liver, or kidney problems
- have an infection or weakened immune system
- have or have had any severe infections including:
- Hepatitis B virus (HBV)
- Parvovirus B19
- Hepatitis C virus (HCV)
- Varicella zoster virus (chickenpox or shingles)
- Cytomegalovirus (CMV)
- West Nile Virus
- Herpes simplex virus (HSV).
- have had a recent vaccination or are scheduled to receive vaccinations. You or your child should not receive certain vaccines before or during treatment with Rituxan. You should be up-to-date on any needed immunizations before starting treatment with Rituxan.
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
Rituxan may harm an unborn baby. Talk to your healthcare provider about the risks to an unborn baby if you or someone you are caring for receive Rituxan during pregnancy. If you are a female who can become pregnant your healthcare provider should do a pregnancy test to check for pregnancy before starting Rituxan.
Effective birth control (contraception) should be used during treatment with Rituxan and for 12 months after the last dose. Talk to your healthcare provider about effective birth control.
Tell your healthcare provider right away if you or your child become pregnant or think that you or your child
are pregnant during treatment with Rituxan.
Breastfeeding
Rituxan may pass into your breast milk. It is not safe to breastfeed a baby while you are using this medicine. Do not breastfeed during treatment and for 6 months after your or your child’s last dose of Rituxan.
How is Rituxan administered?
Rituxan is given by infusion through your or your child’s central catheter or through a needle placed in a vein (intravenous infusion), in you or your child’s arm. A healthcare provider will give you this injection.
- Your healthcare provider may prescribe medicines before each infusion of Rituxan to reduce infusion side effects such as fever and chills.
- Rituxan is not given daily. Your Rituxan dosing schedule will depend on the condition being treated. Follow your doctor's dosing instructions very carefully.
- Your healthcare provider should do blood tests regularly to check for side effects of Rituxan.
- Before each Rituxan treatment, your healthcare provider or nurse will ask you questions about your or your child’s general health. Tell your healthcare provider or nurse about any new symptoms.
If you need surgery, tell the surgeon ahead of time that you are using this medicine.
Call your doctor at once if you have any of these other side effects, even if they occur several months after you receive Rituxan, or after your treatment ends.
-
painful skin or mouth sores, or a severe skin rash with blistering, peeling, or pus;
-
redness, warmth, or swelling of the skin;
-
severe stomach pain, vomiting, constipation, bloody or tarry stools;
-
irregular heartbeats, chest pain or pressure, pain spreading to your jaw or shoulder;
-
tiredness or jaundice (yellowing of the skin or eyes);
-
signs of infection - fever, chills, cold or flu symptoms, cough, sore throat, mouth sores, headache, earache, pain or burning when you urinate; or
-
signs of tumor cell breakdown - confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.
What happens if I miss a dose?
Call your doctor if you miss an appointment for your Rituxan infusion.
What happens if I overdose?
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving Rituxan?
Do not receive a "live" vaccine while receiving Rituxan, and avoid coming into contact with anyone who has recently received a live vaccine.
There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and nasal flu (influenza) vaccine.
What other drugs will affect Rituxan?
Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you or your child take or have taken:
-
medicines to treat conditions such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, or psoriasis such as adalimumab, certolizumab, etanercept, golimumab, infliximab, leflunomide, methotrexate, sulfasalazine, tocilizumab, tofacitinib, and others
-
chemotherapy drugs, especially cisplatin.
This list is not complete. Other drugs may interact with rituximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Rituxan infusion ingredients
Active ingredient: rituximab
Inactive ingredients: polysorbate 80, sodium chloride, sodium citrate dihydrate, and water for injection, USP.
Who makes Rituxan infusion?
Genentech, Inc., a member of the Roche Group, makes Rituxan.
Rituxan Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Rituxan.
Rituxan (rituximab) - Genentech, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 100 mg/10 mL (10 mg/mL) |
Single-Dose Vial | 500 mg/50 mL (10 mg/mL) |
Rituxan biosimilar products
Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.
Pharmacy laws for biosimilar prescribing may vary by state
Riabni (rituximab-arrx) - Amgen Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 100 mg/10 mL (10 mg/mL) |
Single-Dose Vial | 500 mg/50 mL (10 mg/mL) |
View Riabni information in detail.
Ruxience (rituximab-pvvr) - Pfizer Ireland Pharmaceuticals
Formulation type | Strength |
---|---|
Single-Dose Vial | 100 mg/10 mL (10 mg/mL) |
Single-Dose Vial | 500 mg/50 mL (10 mg/mL) |
View Ruxience information in detail.
Truxima (rituximab-abbs) - CELLTRION, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 100 mg/10 mL (10 mg/mL) |
Single-Dose Vial | 500 mg/50 mL (10 mg/mL) |
View Truxima information in detail.
Popular FAQ
How will I feel after a Rituxan infusion?
After a Rituxan (rituximab) infusion you may experience certain side effects or adverse reactions that make you feel unwell. Common side effects include nausea, infusion-related reactions, and feeling tired. Continue reading
What are monoclonal antibodies?
Monoclonal antibodies (mAbs) are man-made proteins that mimic the natural antibodies produced by our immune systems. Monoclonal antibodies can be formulated into medicines to treat various types of illnesses, such as cancer, rheumatoid arthritis or psoriasis. Continue reading
How long does it take for Rituxan to work?
Patients treated with Rituxan may notice an early response within 7-8 weeks of treatment. Most rheumatoid arthritis patients will notice some improvement in their symptoms, such as improvement in their levels of pain and inflammation, within 16 weeks of starting treatment with Rituxan. Continue reading
What are biosimilar drugs and how do they compare to biologics?
A biosimilar is a biological product that is similar to a reference biologic (usually the originally approved product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. One example is Amjevita (adalimumab-atto), the first biosimilar approved for Humira (adalimumab) in 2016. Continue reading
Does Rituxan cause hair loss?
It’s possible for Rituxan (rituximab) to cause hair loss. This includes losing hair anywhere on your body, such as your head, legs, eyebrows, and eyelashes. Hair loss (alopecia) does not seem to be a common side effect of Rituxan. Continue reading
How does the drug Rituxan work?
Rituxan (rituximab) is a monoclonal antibody that targets the CD20 protein found on the surface of B-cells, a type of white blood cell involved in immune responses. By binding to CD20, Rituxan helps eliminate these cells, which is beneficial in treating certain cancers and autoimmune disorders. Continue reading
What is the difference between Truxima and Rituxan?
Truxima (rituximab-abbs) is a biosimilar to Rituxan (rituximab). While both drugs are CD20-directed cytolytic antibodies used to treat non-Hodgkin’s lymphoma (NHL), Rituxan has additional FDA-approved indications beyond NHL. Continue reading
What is the success rate of Rituxan (rituximab) in patients with blood cancers?
In patients with hematological or blood cancers, including non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL), Rituxan’s success is measured in a number of ways. It is measured by looking at how long patients responded to treatment (median duration of response), how long they live without their disease progressing (progression-free survival) and how many patients respond to treatment (response rate).
Rituxan treatment improves outcomes in certain patients with NHL. Adding Rituxan alongside standard therapies enhances the response patients have to treatment and improves overall outcomes, including increasing the time patients live for without experiencing a progression of their disease.
Rituxan helps to improve overall survival in certain patients with CLL and also helps to increase the time patients live for without experiencing disease progression. Adding Rituxan alongside standard therapy enhances the response patients have to therapy. Continue reading
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