This Rituxan Immunology Co-pay Program is only for patients with commercial insurance who have a valid prescription for a Genentech drug that has been approved by the Food and Drug Administration (FDA). Patients who pay for their prescriptions through Medicare, Medicaid, or any other federal or state government program are not eligible.
What is the generic name for rituximab?
Rituxan is a brand name for the drug rituximab. When referring to the generic medicine name rituximab, health care practitioners may use the commercial name rituxan. Rituximab is a monoclonal antibody drug. (See the “How this Medication Works” section below for further information.)
How long can you stay on rituximab?
Rituxan can provide symptom relief for up to 6 months with just one therapy (2 infusions given 2 weeks apart). Check with your doctor to see if Rituxan treatment is good for you and how long you should take it.
What is an alternative to Rituxan?
San Diego, California, December 12, 2011 Rituximab (Rituxan, Genentech) has reigned supreme as the sole medicine of its kind a monoclonal antibody that selectively targets the CD20 protein expressed on B cells for more than a decade. This activity has earned rituximab a place in the treatment of a variety of B-cell lymphomas and leukemias, as well as rheumatoid arthritis.
Now a competitor has emerged in the form of obinutuzumab, a new Genentech medication with the same particular activity. This is a humanized antibody, whereas rituximab is a chimeric product, and in preclinical testing, the new product demonstrated less proclivity for immunological reactions.
Is Rituxan chemo?
RITUXAN isn’t a type of chemotherapy. RITUXAN is an antibody treatment that can be used alone or in combination with chemotherapy. They use several methods to locate and kill the cancer-causing cells. RITUXAN binds to the CD20 protein on the surface of cancerous blood cells as well as certain healthy blood cells.
Will I lose my hair with Rituxan?
Rituxan can have both minor and severe adverse effects. Some of the most common side effects that may occur when using Rituxan are listed below. These aren’t all of the probable negative effects.
Rituxan’s adverse effects can vary depending on the ailment it’s being administered for. If you have any negative effects while taking Rituxan, talk to your doctor.
The Food and Drug Administration (FDA) keeps track of the side effects of pharmaceuticals it approves. If you’d want to report an adverse effect from Rituxan to the FDA, you can do so through MedWatch.
Mild side effects
- Urinary tract infections, bronchitis, and upper respiratory infections are examples of infections (including colds)
The majority of these adverse effects should subside within a few days or weeks. However, if they worsen or don’t go away, consult your doctor or pharmacist.
* This is only a brief list of Rituxan’s minor side effects. Consult your doctor or pharmacist for more information about other minor side effects, or go to Rituxan’s Medication Guide.
Serious side effects
Rituxan can cause serious adverse effects, however they are uncommon. If you experience any major side effects, contact your doctor straight once. If your symptoms are life-threatening or you believe you’re having a medical emergency, dial 911.
- Infusion responses that occur during or after a Rituxan treatment. Among the signs and symptoms are:
- Stevens-Johnson syndrome and toxic epidermal necrolysis are severe reactions of the skin or mucous membranes (tissue linings that are protected by mucus). Among the signs and symptoms are:
- Reactivation of the hepatitis B virus (hepatitis B flare-up). Among the signs and symptoms are:
- Progressive multifocal leukoencephalopathy (a form of central nervous system disease) is a type of central nervous system disease. Among the signs and symptoms are:
- Lympopenia and neutropenia are two different types of lymphopenia (decreased levels of certain white blood cells). Among the signs and symptoms are:
- Tumor lysis syndrome (TLS) is a situation in which a (a condition that occurs when tumor cell contents enter your bloodstream). Among the signs and symptoms are:
- Problems with the kidneys, such as producing less urine than usual. Among the signs and symptoms are:
* These adverse effects are listed in Rituxan’s boxed warnings. The FDA’s most serious warning is a boxed warning. See this page for more information “At the start of this article, there are FDA warnings.
Another major adverse effect, which is discussed in further detail below, is “Details on side effects” are as follows:
Side effects in children
Rituxan is exclusively approved to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis in children (MPA). GPA and MPA are disorders in which blood vessels in the kidneys, lungs, skin, and nose become enlarged and injured.
In clinical trials, children who received Rituxan for GPA or MPA experienced the same adverse effects as adults who received Rituxan for GPA or MPA.
Boxed warnings
Rituxan comes with multiple boxed warnings concerning the medication’s potential side effects:
The FDA’s most serious warning is a boxed warning. See the “FDA warnings” section at the beginning of this article for more information.
Allergic reaction
As with most medicines, Rituxan might cause adverse reactions in some people. It’s unclear how many participants in clinical trials who took Rituxan had an adverse reaction.
It’s unlikely that you’ll have a more severe allergic reaction, but it’s conceivable. A strong allergic reaction might cause the following symptoms:
If you develop a severe allergic response to Rituxan, contact your doctor right once. If your symptoms are life-threatening or you believe you’re having a medical emergency, dial 911.
Cough
Cough is a common side effect of Rituxan treatment. Only two groups of Rituxan users, on the other hand, experienced coughing.
- Coughing was reported as a side effect in 13% of people who took Rituxan for GPA or MPA in clinical studies.
- In instance, 11% of individuals taking the drug cyclophosphamide also reported a cough.
People with recurrent or refractory follicular lymphoma (FL) or low-grade (slow-spreading) non-Hodgkin lymphoma (NHL) coughed as well: *
- In clinical trials including persons with FL or low-grade NHL, 13% of those taking Rituxan developed a cough.
- It’s unclear how many patients who received a placebo or another medicine developed a cough. (The placebo was an infusion that included no active medication.)
If you get a cough that doesn’t go away or is troublesome while taking Rituxan, talk to your doctor. They might do tests on you to figure out what’s causing your cough. Your doctor may also be able to make suggestions to help you stop coughing.
* Rituxan is used alone to treat B-cell NHL in this case. CD20-positive carcinoma that is either low grade or FL is required. In addition, the cancer must have relapsed or become resistant to treatment. The term “relapsed” refers to the cancer returning after previous treatment. And “refractory” refers to a malignancy that hasn’t responded to other treatments. See the “Rituxan uses” section below for more information on this application of Rituxan.
Hair loss
Rituxan may cause hair loss as a side effect. Hair loss happened only in those who took Rituxan for pemphigus vulgaris in clinical studies (PV). PV is a disorder that causes significant and painful blisters on your skin and mucous membranes. The mouth, for example, is lined by mucous membranes.
Hair loss was seen in 13% of persons who had Rituxan and prednisone (Rayos) for PV. No one who took prednisone by itself experienced hair loss.
Consult your doctor if you’re on Rituxan and notice hair loss. They might be able to offer suggestions for reducing this adverse effect.
Weight gain or weight loss
Weight gain is a possible side effect of Rituxan. Only those who used the medication for NHL experienced weight increase.
People with low-grade B-cell NHL were treated with cyclophosphamide, vincristine, and prednisone in one research. After that, some persons took Rituxan, while others didn’t take any medication at all.
- People who did not take medication after chemotherapy, on the other hand, gained weight in 4% of cases.
In Rituxan clinical studies, weight loss was not observed as an adverse effect. The medicine should not induce you to lose weight on its own. However, weight loss may occur as a result of Rituxan’s adverse effects including nausea and diarrhea. Another negative effect of the drug that may cause you to lose weight is infection. This is because certain infections can cause dehydration and a reduction in food intake.
Consult your doctor if you notice any changes in your weight while taking Rituxan. They might do tests on you to figure out what’s causing the weight gain. They may also be able to offer advice on how to better control your weight.
* Rituxan is a drug that is used to treat B-cell NHL. CD20-positive malignancy with a low grade is required. The cancer must also be non-progressing, meaning it did not become worse after you tried cyclophosphamide, vincristine, and prednisone chemotherapy. See the “Rituxan uses” section below for more information on this application of Rituxan.
Rash
- Rashes were reported in 10% to 17% of patients taking Rituxan for GPA, MPA, or NHL.
- Rashes were also reported in 5% to 17% of persons who were taking other drugs for their GPA, MPA, or NHL. Cyclophosphamide, vincristine, and prednisone were among the drugs used.
A rash can be severe and cause peeling skin in some rare circumstances. Stevens-Johnson syndrome and toxic epidermal necrolysis are two disorders that can cause this. Rashes can occur as a result of infusion responses.
If you’re on Rituxan and you have a severe rash that doesn’t go away or spreads, call your doctor straight away. They’ll assist you in determining the severity of the rash and the best treatment options. In some situations, your doctor may advise you to discontinue Rituxan medication.
* Rituxan is a drug that is used to treat B-cell NHL. CD20-positive carcinoma that is either low grade or FL is required. In addition, the cancer must have relapsed or become resistant to treatment. See the Rituxan page for more information “See the “Rituxan Uses” section for further information.
Rituxan comes with a boxed warning for serious skin or mucous membrane reactions. The FDA’s most serious warning is a boxed warning. See this page for more information “At the start of this article, there are FDA warnings.
Fatigue
Rituxan may cause fatigue, which is a loss of energy. The following is what the researchers discovered:
- Fatigue is a common side effect that occurred in about 8% to 39% of persons who used Rituxan in clinical studies for GPA, MPA, NHL*, or PV.
- People who took other medications or ceased treatment altogether, on the other hand, felt weary between 6% and 21% of the time. Prednisone, cyclophosphamide, and vincristine were among the other drugs used.
Consult your doctor if you experience a lack of energy while taking Rituxan. They may be able to suggest measures to lessen the severity of this side effect.
Diarrhea
- Diarrhea was reported in 10% to 17% of those who used Rituxan for GPA, MPA, or NHL.
- In comparison, diarrhea was reported by 12% of those using cyclophosphamide for GPA or MPA. In persons with NHL, Rituxan was not matched to a placebo or another treatment.
Diarrhea could also indicate another Rituxan adverse effect, such as infection or tumor lysis syndrome.
Consult your doctor if you experience frequent, bothersome, or severe diarrhea while taking Rituxan. They may perform a blood test to determine what is causing your diarrhea. Your doctor may also be able to suggest techniques to alleviate this symptom.
Is rituximab expensive?
In 2018, the cost of two rituximab infusions (one initial loading dose and one follow-up dosage) is $19 452. (Table 1). The first dose will set you back $9812, while the second dose will set you back $9640.
What is the success rate of rituximab?
In a phase 2 trial, patients with recurrent illness were given rituximab plus bendamustine (Treanda, Cephalon). With an ORR of 92 percent, this combination was determined to be quite successful.
What Happens When You Stop rituximab?
This may result in liver failure or death. After you stop using rituximab, the risk persists for more than a month. While using rituximab, if you develop jaundice (yellowing of the skin and eyes) or viral hepatitis, contact your doctor right once.
Does rituximab lower immune system?
- When rituximab is given, it causes a large number of tumor cells to be killed (lysed) and excreted from the body. The products of the dead cells cannot be removed rapidly enough in 4-5 out of every 10,000 individuals, resulting in a disease known as tumor lysis syndrome. This is marked by a rapid deterioration in kidney function as well as a harmful accumulation or decrease in minerals like potassium, calcium, and phosphate. When the size of the tumor or the quantity of tumor cells circulating in the blood is significant, tumor lysis syndrome occurs, usually 12-24 hours after the first dosage of rituximab.
- Irregular heart rhythms and infection are two other potentially dangerous adverse effects. The uneven heart beat normally appears soon after the medicine is administered, while infection can appear anywhere from 30 days to 11 months after the treatment is stopped. Thrombocytopenia (severe reductions in red or white blood cells and platelets) is a rare side effect of rituximab therapy. The immune system is suppressed by rituximab. As a result, significant fungal, bacterial, and new or reactivated viral infections (such as hepatitis B or C, or shingles) can arise during or after rituximab treatment. In the absence of current, severe infections, rituximab is generally avoided. Within 1 to 13 weeks of starting treatment, rituximab might induce serious skin responses. If you have an allergy to mice or rats, rituximab therapy is not suggested because it is manufactured in mice or rats and may include trace levels of rat or mouse proteins that might cause serious allergic reactions.
Important Dosing Information
Only use an intravenous infusion to administer this medication. Do not use as an intravenous bolus or push.
Only a healthcare professional with proper medical support should deliver RITUXAN to address severe infusion-related reactions, which can be fatal if they occur.
Before starting RITUXAN medication, all patients should be tested for HBV infection by measuring HBsAg and anti-HBc. Before taking the first dose, get a full blood count (CBC) that includes platelets.
Obtain complete blood counts (CBC) with differential and platelet counts prior to each RITUXAN course in patients with lymphoid malignancies receiving RITUXAN monotherapy. Obtain a CBC with differential and platelet counts at weekly to monthly intervals during treatment with RITUXAN and chemotherapy, and more frequently in individuals who develop cytopenias. Obtain a CBC with differential and platelet counts at two to four month intervals in individuals with RA, GPA, or MPA while on RITUXAN treatment. After the final dose, continue to check any cytopenias until they disappear.
- Initiate the first infusion at a rate of 50 mg/hr. Increase the infusion rate by 50 mg/hr increments every 30 minutes if there is no infusion toxicity, up to 400 mg/hr.
Initiate a standard infusion at a rate of 100 mg/hr. Increase rate by 100 mg/hr increments at 30-minute intervals to a maximum of 400 mg/hr in the absence of infusion toxicity.
Patients with previously untreated follicular NHL and DLBCL can receive a 90-minute infusion in Cycle 2 with a glucocorticoid-containing chemotherapeutic regimen if they did not encounter a Grade 3 or 4 infusion-related adverse event during Cycle 1.
Begin by administering 20% of the complete dose in the first 30 minutes, followed by the remaining 80% of the total dose during the next 60 minutes. If the 90-minute infusion is tolerated in Cycle 2, the same pace can be used while giving the remainder of the treatment regimen (through Cycle 6 or 8). (through Cycle 6 or 8).
The 90-minute infusion should not be given to patients who have clinically severe cardiovascular disease or a circulating lymphocyte count of less than 5,000/mm3 before Cycle 2.
- For infusion-related reactions, stop the infusion or reduce the pace. If your symptoms improve, reduce the infusion rate to half of what it was before.
Recommended Dose For Non-HodgkinâTMs Lymphoma (NHL)
The suggested intravenous infusion dose is 375 mg/m2 according to the following schedules:
- Remission For Low-Grade Or Follicular, CD20-Positive, B-Cell NHL That Has Relapsed Or Refractory
For up to 8 doses, give on Day 1 of each chemotherapy cycle. Start RITUXAN maintenance eight weeks after finishing a rituximab product in conjunction with chemotherapy in patients who have achieved a complete or partial response. RITUXAN should be given as a single agent every 8 weeks for a total of 12 doses.
- Low-Grade, Non-progressing After First-Line CVP Chemotherapy, CD20-Positive B-Cell NHL
After 6-8 cycles of CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals for a total of 16 doses.
Recommended Dose For Chronic Lymphocytic Leukemia (CLL)
The suggested dose is 375 mg/m2 the day before FC treatment begins, followed by 500 mg/m2 on Day 1 of cycles 2-6. (every 28 days).
Recommended Dose As A Component Of Zevalin For Treatment Of NHL
- Infuse 250 mg/m2 in accordance with the Zevalin package instructions when used as part of a Zevalin treatment regimen. For complete prescribing information on the Zevalin therapy regimen, see the Zevalin package insert.
Recommended Dose For Rheumatoid Arthritis (RA)
- RITUXAN should be given in two separate 1,000 mg intravenous infusions spaced by two weeks.
- To minimize the occurrence and severity of infusion-related responses, glucocorticoids such as methylprednisolone 100 mg intravenous or its equivalent should be given 30 minutes before each infusion.
- Following then, courses should be given every 24 weeks or as needed depending on clinical evaluation, but not less frequently than every 16 weeks.
Recommended Dose For Granulomatosis With Polyangiitis (GPA) (WegenerâTMs Granulomatosis) And Microscopic Polyangiitis (MPA)
- For patients with active GPA or MPA, give RITUXAN as a 375 mg/m2 intravenous infusion once a week for four weeks.
- Glucocorticoids were given intravenously as 1,000 mg of methylprednisolone per day for 1 to 3 days, followed by oral prednisone, as per clinical practice. This regimen should begin 14 days before or with the start of RITUXAN medication and may be continued during and after the 4-week induction period.
- RITUXAN should be given in two 500 mg intravenous infusions separated by two weeks, with another 500 mg intravenous infusion every six months after that, based on clinical evaluation.
- If a rituximab product was used to treat active disease induction, start RITUXAN medication within 24 weeks of the last rituximab product infusion or depending on clinical evaluation, but no sooner than 16 weeks after the last induction infusion with a rituximab product infusion.
- Initiate RITUXAN follow-up treatment within the 4-week interval following the establishment of illness control if induction treatment of active disease was with other standard-of-care immunosuppressants.
- RITUXAN should be given as a 375 mg/m2 intravenous infusion once a week for four weeks.
- Intravenous methylprednisolone 30 mg/kg (not to exceed 1g/day) once day for 3 days prior to the first RITUXAN infusion.
- Oral steroids should be continued after intravenous methylprednisolone delivery, as per clinical practice.
- RITUXAN should be given in two 250 mg/m2 intravenous infusions separated by two weeks, with another 250 mg/m2 intravenous infusion every six months based on clinical evaluation.
- If other standard of care immunosuppressants were used to treat active disease induction, begin RITUXAN follow-up medication within 4 weeks of achieving disease control.
Recommended Dose For Pemphigus Vulgaris (PV)
- In combination with a tapering course of glucocorticoids, provide RITUXAN as two-1,000 mg intravenous infusions separated by two weeks.
At Month 12 and every 6 months afterwards, or based on clinical evaluation, give RITUXAN as a 500 mg intravenous infusion.
On relapse, provide RITUXAN as a 1,000 mg intravenous infusion, and depending on the clinical situation, consider restarting or increasing the glucocorticoid dose.
Subsequent RITUXAN infusions should be given no sooner than 16 weeks after the last infusion.
Recommended Dose For Premedication And Prophylactic Medications
Before each infusion of RITUXAN, take acetaminophen and an antihistamine. The glucocorticoid component of the patient’s chemotherapeutic treatment should be delivered prior to infusion for patients receiving RITUXAN at the 90-minute infusion rate.
Methylprednisolone 100 mg intravenously or its equivalent is indicated 30 minutes ahead to each infusion for RA, GPA, MPA, and PV patients.
Prophylaxis for Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections should be given to CLL patients during treatment and for up to 12 months after treatment, if needed.
During treatment and for at least 6 months after the last RITUXAN infusion, PCP prophylaxis is also suggested for patients with GPA and MPA. Patients with PV should consider PCP prophylaxis during and after RITUXAN treatment.
Administration And Storage
Aseptic method should be used. Prior to delivery, parenteral medication preparations should be visually examined for particle matter and discolouration. RITUXAN must be a colorless, transparent liquid. If particles or discolouration are present, do not use the vial.
To prepare RITUXAN, use a sterile needle and syringe. Withdraw the required amount of RITUXAN and dilute in an infusion bag containing either 0.9 percent Sodium Chloride, USP, or 5 percent Dextrose Injection, USP, to a final concentration of 1 mg/mL to 4 mg/mL. To mix the solution, gently invert the bag. Do not combine or dilute with any other medications. Any unused portion of the vial should be discarded.
Diluted RITUXAN infusion solutions can be kept refrigerated for up to 24 hours at 2°C to 8°C (36°F to 46°F). At room temperature, diluted RITUXAN solutions for infusion have been demonstrated to be stable for an extra 24 hours. Diluted RITUXAN solutions should be maintained refrigerated (2°C to 8°C) because they do not contain a preservative. There have been no reported incompatibilities between RITUXAN and polyvinylchloride or polyethylene bags.
Storage And Handling
RITUXAN (rituximab) injection is a clear, colorless, sterile, preservative-free solution for intravenous infusion that is delivered as follows:
Refrigerate RITUXAN vials at 2°C to 8°C (36°F to 46°F). Direct sunlight should be avoided when using RITUXAN vials. Do not freeze or shake the container.
Genentech, Inc., A Member of the Roche Group, 1 DNA Way South, San Francisco, CA 94080-4990 is the manufacturer. June 2021 (revised)