Precautions
Rituxan is a cancer medicine 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 an intravenous (IV) infusion given by a healthcare professional. It is a prescription medicine used alone or in combination with other medicines to treat the following conditions:
What is Rituxan used for?
Of the 99 Rituxan-treated GPA and MPA patients in GPA/MPA Study 1, 36 (36%) were 65 years old and over, while 8 (8%) were 75 years and over. No overall differences in efficacy were observed between patients that were 65 years old and over and younger patients.
What is the average age of Rituxan treatment?
Both rituximab and methotrexate, an immune-system suppressor, were initially developed and used as anticancer drugs. Rituxan is produced by Genentech. In Europe, it’s marketed as MabThera. Who’s a good candidate for this treatment? The FDA has approved treatment with Rituxan and methotrexate:
What are rituximab and methotrexate used for?
What conditions is Rituxan used for?
Rituximab is used to treat certain types of cancer (such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia). It works by slowing or stopping the growth of cancer cells. Some brands of rituximab are also used to treat rheumatoid arthritis and can decrease joint pain and swelling.
Is Rituxan chemotherapy or immunotherapy?
Rituxan (rituximab) is a monoclonal antibody medication that treats different types of blood cancer. Rituxan is also an immunotherapy medication, meaning it helps make the immune system better at fighting cancer. Different Rituxan formulations and biosimilars are available.
Is Rituxan used to treat rheumatoid arthritis?
Rituximab is used to treat inflammatory types of arthritis, such as rheumatoid arthritis (RA) and granulomatosis with polyangiitis (GPA, also known as Wegener's Granulomatosis). For RA, rituximab is used in combination with methotrexate (MTX).
What cyclophosphamide is used for?
Cyclophosphamide is used to treat cancer of the ovaries, breast, blood and lymph system, and nerves (mainly in children). Cyclophosphamide is also used for retinoblastoma (a type of eye cancer mainly in children), multiple myeloma (cancer in the bone marrow), and mycosis fungoides (tumors on the skin).
What's the difference between Rituxan and rituximab?
Official answer. Rituxan Hycela (rituximab and hyaluronidase human) includes the same monoclonal antibody as Rituxan (rituximab), but in combination with hyaluronidase, an enzyme that helps to deliver rituximab by subcutaneous injection under the skin. The original Rituxan is given only by intravenous (IV) infusion.
Is rituximab a targeted therapy or immunotherapy?
Rituximab targets a protein called CD20 on the surface of the lymphoma cells. The antibody sticks to all the CD20 proteins it finds. This makes it easier for the cells of the immune system to pick out the marked cells and kill them. Because of the way it works, rituximab is also called a targeted immunotherapy.
What autoimmune diseases does rituximab treat?
It was originally used to treat lymphoma but is increasingly used for the treatment of autoimmune diseases. Rituximab was found to be effective in randomised controlled trials for rheumatoid arthritis, granulomatosis with polyangiitis and other antineutrophil cytoplasmic antibody-associated vasculitides.
What is the best infusion for rheumatoid arthritis?
Disease-modifying antirheumatic drugs (DMARDs) are widely regarded as the most effective infusion therapy for rheumatoid arthritis. To reduce inflammation, DMARDs target special proteins in your body or inflammatory chemicals that your body produces on a cellular level.
Is Rituxan used for lupus?
Rituximab (Rituxan, Truxima) It is used “off label” (without FDA approval) for lupus because B cells play a very important role in the disease. This medication has mixed results in lupus, but works for some patients. Rituximab dosage is one gram (1000mg) to start and at two weeks, then every 16 to 20 weeks.
Is Cytoxan used to treat lupus?
Cytoxan is a cytotoxic medication usually reserved for lupus patients with serious kidney problems who have not responded to other medications. The dosage of Cytoxan varies from person to person. It can be taken in tablet form, but more often it is given intravenously (IV) at the doctor's office.
How does cyclophosphamide work in nephrotic syndrome?
Cyclophosphamide (brand name: Cytoxan) is a medication that lowers the body's natural immunity. The immune system is thought to be involved in causing Nephrotic Syndrome. By lowering the immune system's activity, this treatment may help patients suffering from Nephrotic Syndrome.
Is cyclophosphamide a chemotherapy drug?
Cyclophosphamide (pronounced sigh-clo-fos-fah-mide) is a type of chemotherapy. It is a treatment for a number of different types of cancer. You can have cyclophosphamide on its own, or in combination with other chemotherapy drugs.
Before Taking This Medicine
Rituxan may cause a serious brain infection called progressive multifocal leukoencephalopathy (PML). This infection may be more likely if have used...
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 using this medicine, and avoid coming into contact with anyone who has recently received a live vaccine. Ther...
What Other Drugs Will Affect Rituxan?
Tell your doctor about all your current medicines and any you start or stop using, especially: 1. medicines to treat rheumatoid arthritis - adalimu...
What is Rituxan Hycela used for?
Rituxan HYCELA is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vin cristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.
What is a rituximab hycelia?
Rituxan HYCELA is a combination of rituximab and hyaluronidase human. Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD. Rituximab has a binding affinity for the CD20 antigen of approximately 8.0 nM. Rituximab is produced by mammalian cell (Chinese Hamster Ovary) suspension.
How long does it take to inject Rituxan Hycela?
Inject Rituxan HYCELA into the subcutaneous tissue of the abdomen over approximately 5–7 minutes. Never inject into areas where the skin is red, bruised, tender or hard, or areas where there are moles or scars. No data are available on performing the injection at other sites of the body.
How long does it take for a TLS to occur after rituximab?
TLS can occur within 12–24 hours after administration of a rituximab-containing product, including Rituxan HYCELA. A high number of circulating malignant cells (≥ 25,000/mm 3) or high tumor burden confers a greater risk of TLS. Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated [see Warnings and Precautions (5.8)].
How long does it take for B cells to return to normal after rituximab?
In patients treated with rituximab for hematological malignancies, B cell recovery began within 6 months of treatment and generally returned to normal levels within 12 months after completion of therapy, although in some patients this may take longer.
Can rituximab cause fetal harm?
Based on human data, rituximab-containing products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero (see Clinical Considerations). There are no available data on Rituxan HYCELA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In animal reproduction studies, intravenous administration of a rituximab product to pregnant cynomolgus monkeys during the period of organogenesis caused lymphoid B cell depletion in the newborn offspring at doses resulting in 80% of the exposure (based on AUC) of those achieved following a dose of 2 grams in humans. Reduced fetal weight and increased fetal lethality were observed following subcutaneous administration of hyaluronidase human in mice at a dose > 2700 times higher than the human dose. Comparable systemic exposure levels could occur in a pregnant patient following accidental intravenous administration of an entire vial of Rituxan HYCELA (see Data). Advise pregnant women of the potential risk to a fetus.
Can you use Rituxan Hycela subcutaneously?
Rituxan HYCELA is for subcutaneous use only. Rituxan HYCELA should only be administered by a healthcare professional with appropriate medical support to manage severe reactions that can be fatal if they occur.
What is Rituxan used for?
RITUXAN is a prescription medicine used to treat adults with: Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines. Chronic Lymphocytic Leukemia ( CLL ): with the chemotherapy medicines fludarabine and cyclophosphamide.
How long does it take for a renal failure to occur after a rituxan?
Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12-24 hours after the first infusion of RITUXAN in patients with NHL. A high number of circulating malignant cells (≥25,000/mm 3) or high tumor burden, confers a greater risk of TLS.
How long does Rituximab take to go into remission?
The study design consisted of an initial 6-month remission induction phase, and a minimum 12month follow-up phase up to a maximum of 54 months (4.5 years) in pediatric patients 2 years to 17 years of age with GPA and MPA. Patients were to receive a minimum of 3 doses of intravenous methylprednisolone (30 mg/kg/day, not exceeding 1g/day) prior to the first RITUXAN or non-U.S.licensed rituximab intravenous infusion. If clinically indicated, additional daily doses (up to three), of intravenous methylprednisolone could be given. The remission induction regimen consisted of four once weekly intravenous infusions of RITUXAN or non-U.S.-licensed rituximab at a dose of 375 mg/m 2 BSA, on study days 1, 8, 15 and 22 in combination with oral prednisolone or prednisone at 1 mg/kg/day (max 60 mg/day) tapered to 0.2 mg/kg/day minimum (max 10 mg/day) by Month 6. After the remission induction phase, patients could receive subsequent RITUXAN or non-U.S.licensed rituximab intravenous infusions on or after Month 6 to maintain remission and control disease activity.
What is the best medicine to take before a rituxan infusion?
Premedicate with acetaminophen and an antihistamine before each infusion of RITUXAN. For patients administered RITUXAN according to the 90-minute infusion rate, the glucocorticoid component of their chemotherapy regimen should be administered prior to infusion [see Clinical Studies ].
What is the molecular weight of rituximab?
Rituximab has an approximate molecular weight of 145 kD. Rituximab has a binding affinity for the CD20 antigen of approximately 8.0 nM.
Does Rituxan affect fludarabine?
Formal drug interaction studies have not been performed with RITUXAN. In patients with CLL, RITUXAN did not alter systemic exposure to fludarabine or cyclophosphamide. In clinical trials of patients with RA, concomitant administration of methotrexate or cyclophosphamide did not alter the pharmacokinetics of rituximab.
Is Rituximab a sterile drug?
Gentamicin is not detectable in the final product. Rituxan is a sterile , clear, colorless, preservative-free liquid concentrate for intravenous administration.
How long does it take for a low antibody level to show up after a rituxan?
After receiving Rituxan, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these patients with low antibody levels developed infections. People with serious infections should not receive Rituxan.
What are the symptoms of Rituxan?
Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of Rituxan: Hives (red itchy welts) or rash. Itching. Swelling of your lips, tongue, throat, or face. Sudden cough. Shortness of breath, difficulty breathing, or wheezing. Weakness.
What to tell your healthcare provider before taking Rituximab?
Before receiving Rituxan, tell your healthcare provider if you: have had a severe reaction to Rituxan or a rituximab product. have a history of heart problems, irregular heartbeat, or chest pain. have lung or kidney problems. have had an infection, currently have an infection, or have a weakened immune system.
How long after Rituxan infusion can you have a reaction?
Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of Rituxan. Your healthcare provider should give you medicines before your infusion of Rituxan to decrease your chance of having a severe infusion-related reaction.
How long does it take for Rituxan to cause TLS?
TLS can happen within 12 to 24 hours after an infusion of Rituxan. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS: nausea.
How long after Rituxan can you breastfeed?
Do not breastfeed during treatment and for at least 6 months after your last dose of Rituxan. are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken: a tumor necrosis factor (TNF) inhibitor medicine.
What are the side effects of Rituxan?
Other side effects include: aching joints during or within hours of receiving an infusion. more frequent upper respiratory tract infections. These are not all of the possible side effects with Rituxan. Call your healthcare provider for medical advice about side effects.
Where to report Rituxan side effects?
You may report side effects to the FDA at (800) FDA‐1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835‐2555. Please see the Rituxan Prescribing Information and Medication Guide including Most Serious Side Effects for additional Important Side Effect Information.
How long does it take for TLS to show up after a rituxan?
TLS can happen within 12 to 24 hours after an infusion of RITUXAN. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS: Nausea.
What to tell your healthcare provider before taking Rituximab?
Before receiving RITUXAN, tell your healthcare provider if you: Have had a severe reaction to RITUXAN or a rituximab product. Have a history of heart problems, irregular heartbeat, or chest pain. Have lung or kidney problems. Have had an infection, currently have an infection, or have a weakened immune system.
How long after a Rituxan infusion can you have a reaction?
Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of RITUXAN. Your healthcare provider should give you medicines before your infusion of RITUXAN to decrease your chance of having a severe infusion-related reaction.
What are the symptoms of a rash after a rituxan infusion?
Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of RITUXAN: Hives (red itchy welts) or rash. Itching. Swelling of your lips, tongue, throat, or face. Sudden cough. Shortness of breath, difficulty breathing, or wheezing. Weakness.
What are the side effects of Rituxan?
infections (may include fever, chills) body aches. tiredness. nausea. In patients with GPA or MPA, the most common side effects of Rituxan also include: low white and red blood cells. swelling. diarrhea. muscle spasms.
How long after a last dose of Rituxan can you breastfeed?
Do not breastfeed during treatment and for at least 6 months after your last dose of RITUXAN. Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken: a tumor necrosis factor (TNF) inhibitor medicine.
What is the best drug for relapsing remitting multiple sclerosis?
Tecfidera (dimethyl fumarate) Gilenya (fingolimod) Tysabri (natali zumab) In terms of drug discontinuation and clinical efficacy in relapsing-remitting multiple sclerosis (RRMS), Rituxan not only was the leading choice for initial treatment, but also showed the best outcomes.
What is Ocrevus used for?
Ocrevus (ocrelizumab) is an FDA-approved drug that is used for the treatment of RRMS and primary progressive multiple sclerosis (PPMS). Some people believe that Ocrevus is just a rebranded version Rituxan. They both work by targeting B cells with CD20 molecules on their surface.
Is Rituxan safe for B cells?
According to research. Trusted Source. , long-term depletion of peripheral B cells via Rituxan appears safe, but more study is needed. Side effects of Rituxan can include: infusion reactions such as rash, itching, and swelling. heart problems such as irregular heartbeats.
Is Rituxan effective for MS?
Although there haven’ t been enough comparative real-world effectiveness studies to conclusively judge Rituxan as an effective treatment for MS, positive signs suggest it might be. A study of a Swedish MS registry compared Rituxan with traditional initial disease modifying treatment choices such as.
Is Rituxan an off label drug?
Doctors sometimes prescribe Rituxan for treating multiple sclerosis (MS), although the FDA hasn’t approved it for this use. This is referred to as “off-label” drug use.
How is Rituxan given?
Rituxan is given by a drip into a vein (intravenous infusion, or IV) in a hospital setting. The dosage is two 1,000-milligram (mg) infusions separated by two weeks. The Rituxan infusion isn’t painful, but you may have an allergic-type reaction to the drug.
What to do if you are a candidate for Rituxan?
If you’re a candidate for Rituxan, read up on its effectiveness so you can make an informed decision. You’ll have to balance the benefits and potential risks versus other treatments (such as minocyline or new drugs in development ). Discuss your treatment plan options with your doctor.
How long does it take to get Rituxan?
The first infusion process may take about 4 hours and 15 minutes. Flushing the bag with a solution to make sure you get the full dose of Rituxan takes another 15 minutes. Your second infusion treatment should take about one hour less.
How many infusions of Rituximab are there?
The people who received rituximab had two infusions, two weeks apart. After 24 weeks, REFLEX found that: 51 percent of people treated with rituximab versus 18 percent treated with a placebo showed an improvement of ACR20.
What is the generic name for Rituxan?
Food and Drug Administration (FDA) in 2006 to treat rheumatoid arthritis (RA). Its generic name is rituximab. People with RA who haven’t responded to other types of treatment may use Rituxan in combination with the drug methotrexate. Rituxan is a colorless liquid given by infusion.
Can you take Rituxan with RA?
The FDA recommends against the use of Rituxan for people with RA who haven’t been treated with one or more blocking agents for TNF. Rituxan is also not recommended for people who have had hepatitis B or carry the virus, because Rituxan could reactivate hepatitis B.
Can you use Rituxan while pregnant?
if you haven’t responded positively to treatment with blocking agents for tumor necrosis factor (TNF) The FDA advises that Rituxan should be used during pregnancy only when the potential benefit to the mother outweighs any potential risk to the unborn child.
Use in Cancer
Rituximab is approved to be used in alone or with other drugs to treat adults with:
More About Rituximab
Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug.
Clinical Trials Accepting Patients
Find Clinical Trials for Rituximab - Check for trials from NCI's list of cancer clinical trials now accepting patients.
What is Rituximab used for?
Rituxan ® (rituximab), in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more TNF antagon ist therapies. Rituxan ® (rituximab), in combination with glucocorticoids, is indicated for the treatment ...
What is the most common infection with Rituxan?
The most common serious infection was pneumonia. Hypogammaglobulinemia: Hypogammaglobulinemia (IgA, IgG, or IgM below the lower limit of normal) has been observed in patients with GPA and MPA treated with Rituxan in GPA/MPA Study 1.
How long does it take for a PV to test positive for Rituximab?
Using a new ELISA assay, a total of 19/34 (56%) patients with PV treated with the Ritux 3 regimen tested positive for anti-rituximab antibodies by 18 months. The clinical relevance of anti-rituximab antibody formation in Rituxan treated PV patients is unclear.
Does Rituxan increase infection?
In 185 Rituxan-treated RA patients with active disease, subsequent treatment with a biologic DMARD, the majority of which were TNF antagonists, did not appear to increase the rate of serious infection.
Is Rituxan safe for active infections?
Rituxan is not recommended for use in patients with severe, active infections. Cardiovascular Adverse Reactions: Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving Rituxan.
Indications and Usage For Rituxan
Rituximab is used to treat certain types of cancer (such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia).
May Treat: Burkitt's lymphoma · CD20 positive non-Hodgkin's lymphoma · Chronic lymphocytic leukemia · Diffuse large B-cell lymphoma · Follicular lymphoma and more
Alternate Brand Names: Ruxience · Truxima
Drug Class: Antineoplastic - CD20 Specific Recombinant Monoclonal Antibody Agents · DMARD - B Cell Targeted Agents
Availability: Prescription Required
Pregnancy: Consult your doctor. This medication may be harmful to an unborn child.
May Treat: Burkitt's lymphoma · CD20 positive non-Hodgkin's lymphoma · Chronic lymphocytic leukemia · Diffuse large B-cell lymphoma · Follicular lymphoma and more
Alternate Brand Names: Ruxience · Truxima
Drug Class: Antineoplastic - CD20 Specific Recombinant Monoclonal Antibody Agents · DMARD - B Cell Targeted Agents
Availability: Prescription Required
Pregnancy: Consult your doctor. This medication may be harmful to an unborn child.
Lactation: This drug should not be given to breastfeeding mothers
Alcohol: Limit intake while taking this medication
Driving: May cause drowsiness or dizziness. Use caution
Manufacturer: GENENTECH, INC.
- Before use, important to read the Medication Guide
- Report hives, itching, or problems breathing to Dr
- Report change in thinking /vision/balance/speech
- Before use, important to read the Medication Guide
- Report hives, itching, or problems breathing to Dr
- Report change in thinking /vision/balance/speech
- Do not take while breast feeding or when pregnant
- Tell your doctor if you have/had liver problems
- Call MD now for changes in the amount of urine.
- Call Dr. if easy bruising or bleeding occur
- Call MD if fatigue/sore throat/infection occurs.
Rituxan Dosage and Administration
Dosage Forms and Strengths
Warnings and Precautions
Adverse Reactions
- Non–Hodgkin's Lymphoma
Rituxan is indicated for the treatment of adult patients with: 1. Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. 2. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a com… - Chronic Lymphocytic Leukemia
Rituxan, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.
Drug Interactions
- Important Dosing Information
Administer only as an Intravenous Infusion [see Dosage and Administration (2.8)]. Do not administer as an intravenous push or bolus. Rituxan should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that … - Recommended Dose for Non-Hodgkin's Lymphoma
The recommended dose is 375 mg/m2as an intravenous infusion according to the following schedules: 1. Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL Administer once weekly for 4 or 8 doses. 2. Retreatment for Relapsed or Refractory, Low-Grade …
Use in Specific Populations
- Injection: Rituxan is a colorless, clear solution for intravenous infusion: 1. 100 mg/10 mL (10 mg/mL) in a single-dose vial 2. 500 mg/50 mL (10 mg/mL) in a single-dose vial
Rituxan Description
- Infusion-Related Reactions
Rituxan can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30–120 minutes. Rituxan-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospa… - Severe Mucocutaneous Reactions
Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with Rituxan. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reacti…
Rituxan - Clinical Pharmacology
- The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: 1. Infusion-related reactions [see Warnings and Precautions (5.1)] 2. Severe mucocutaneous reactions [see Warnings and Precautions (5.2)] 3. Hepatitis B reactivation with fulminant hepatitis [see Warnings and Precautions (5.3)] 4. Progressive multifocal leukoenc…
Nonclinical Toxicology
- Formal drug interaction studies have not been performed with Rituxan. In patients with CLL, Rituxan did not alter systemic exposure to fludarabine or cyclophosphamide. In clinical trials of patients with RA, concomitant administration of methotrexate or cyclophosphamide did not alter the pharmacokinetics of rituximab.