Generic Name: Rituximab Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: C

Uses

What is Rituximab 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.

Rituximab is used to treat rheumatoid arthritis and can decrease joint pain and swelling. It is also used to treat certain types of blood vessel disease (such as Wegener’s granulomatosis, microscopic polyangiitis) and can decrease the swelling of the blood vessels.

How should I take Rituximab?

Your doctor should prescribe other medications (such as acetaminophen, an antihistamine, methylprednisolone) for you to take before each treatment to help reduce side effects, such as fever and chills. Carefully follow your doctor’s instructions.

This medication is given by slow injection into a vein by a health care professional as directed by your doctor. The dosage and treatment schedule are based on your medical condition, body size, and response to treatment.

How do I store Rituximab?

Store intact vials at 2°C to 8°C (36°F to 46°F); do not freeze. Do not shake. Protect vials from direct sunlight. Solutions for infusion in NS or D5W are stable at 2°C to 8°C (36°F to 46°F) for 24 hours and at room temperature for an additional 24 hours (although because there is no preservative, the manufacturer recommends storing refrigerated).

There may be different brands of Rituximab that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Rituximab down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Rituximab?

Before using rituximab, tell your doctor or pharmacist if you are allergic to it; or to mouse protein; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: lung disease, heart problems (such as irregular heartbeat, previous heart attack), bleeding/blood disorders, current/recent infections.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Rituximab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults may be at greater risk for heart problems (such as irregular heartbeat) or lung problems while using this drug.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 1 year after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for at least 6 months after treatment is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Rituximab during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Rituximab. Rituximab is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Rituximab?

Nausea, vomiting, headache, dizziness, joint/muscle pain, weakness, or flushing may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: swelling hands/ankles/feet, increased thirst/urination, numbness/tingling of arms/legs.

Rituximab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

This medication can decrease blood cells, which can cause anemia, decrease your body’s ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: easy bleeding/bruising, black/tarry stools, vomit that looks like coffee grounds, signs of an infection (such as sore throat that doesn’t go away, fever, chills), unusual tiredness, pale skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Rituximab?

Some products that may interact with this drug are: other drugs that weaken the immune system/increase the risk of infection (such as tofacitinib, natalizumab, fingolimod).

Rituximab may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Rituximab?

Rituximab may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Rituximab?

Rituximab may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Rituximab.

What is the dose of Rituximab for an adult?

Usual Adult Dose for non-Hodgkin’s Lymphoma

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine.

FIRST INFUSION: Initiate infusion at a rate of 50 mg/hr; in the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr

SUBSEQUENT INFUSIONS:

STANDARD INFUSION: Initiate infusion at a rate of 100 mg/hr; in the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr

FOR PREVIOUSLY UNTREATED FOLLICULAR NON-HODGKIN’S LYMPHOMA (NHL) AND DIFFUSE LARGE B-CELL NHL (DLBCL) PATIENTS: If patients did not experience a Grade 3 or 4 infusion related adverse event during Cycle 1, a 90 minute infusion can be administered in Cycle 2 with a glucocorticoid-containing chemotherapy regimen:

-Initiate infusion at a rate of 20% of the total dose given in the first 30 minutes and administer the remaining 80% of the total dose over the next 60 minutes. If the 90 minute infusion is tolerated in Cycle 2, the same rate can be used for subsequent cycles.

-Patients who have clinically significant cardiovascular disease or who have a circulating lymphocyte count greater than or equal to 5000/mm3 before Cycle 2 should not be given the 90 minute infusion.

-Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

RECOMMENDED DOSE FOR NON-HODGKIN’S LYMPHOMA (NHL):

Recommended dose: 375 mg/m2 IV according to the following schedules:

-Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL: 375 mg/m2 IV once weekly for 4 or 8 doses

-Retreatment for Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL: 375 mg/m2 IV once weekly for 4 doses

-Previously Untreated, Follicular, CD20-Positive, B-Cell NHL: 375 mg/m2 IV, administered on Day 1 of each cycle of chemotherapy, for up to 8 doses. In patients with complete or partial response, initiate rituximab maintenance 8 weeks following completion of rituximab in combination with chemotherapy. Administer rituximab as a single agent every 8 weeks for 12 doses

-Non-progressing, Low-grade, CD20-positive, B-cell NHL, after first-line CVP chemotherapy: Following completion of 6 to 8 cycles of CVP chemotherapy, administer 375 mg/m2 IV once weekly for 4 doses at 6 month intervals to a maximum of 16 doses

-Diffuse Large B-Cell NHL: 375 mg/m2 on Day 1 of each cycle of chemotherapy for up to 8 infusions

RECOMMENDED DOSE AS A COMPONENT OF IBRITUMOMAB TIUXETAN THERAPY FOR TREATMENT OF NHL:

-Rituximab 250 mg/m2 should be infused within 4 hours prior to the administration of Indium-111- (In-111-) ibritumomab tiuxetan and within 4 hours prior to the administration of Yttrium-90- (Y-90-) ibritumomab tiuxetan.

-Administration of rituximab and In-111-ibritumomab tiuxetan should precede rituximab and Y-90-ibritumomab tiuxetan by 7 to 9 days.

-Refer to the ibritumomab tiuxetan package insert for full prescribing information regarding the ibritumomab tiuxetan therapeutic regimen.

Use: Non-Hodgkin’s Lymphoma (NHL):

-Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent

-Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to this drug in combination with chemotherapy, as single-agent maintenance therapy

-Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line CVP chemotherapy

-Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens

Usual Adult Dose for Rheumatoid Arthritis

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine. For RA patients, methylprednisolone 100 mg IV or its equivalent is recommended 30 minutes prior to each infusion.

-FIRST INFUSION: Initiate infusion at a rate of 50 mg/hr; in the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr

-SUBSEQUENT INFUSIONS: Initiate infusion at a rate of 100 mg/hr; in the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr

-Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

RECOMMENDED DOSE FOR RHEUMATOID ARTHRITIS (RA):

-This drug is given in combination with methotrexate

-Administer rituximab as two 1000 mg IV infusions separated by 2 weeks

-Glucocorticoids administered as methylprednisolone 100 mg IV or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion reactions

-Subsequent courses should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks

Use: Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies

Usual Adult Dose for Chronic Lymphocytic Leukemia

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine. Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

-FIRST INFUSION: Initiate infusion at a rate of 50 mg/hr; in the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr

-SUBSEQUENT INFUSIONS: Initiate infusion at a rate of 100 mg/hr; in the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr

-Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

RECOMMENDED DOSE FOR CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): 375 mg/m2 IV the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2 through 6 (every 28 days)

Use: This drug is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated CD20-positive CLL

Usual Adult Dose for Wegener’s Granulomatosus

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine. Pneumocystis jiroveci pneumonia (PCP) is recommended for patients with GPA and MPA during treatment and for at least 6 months following treatment as appropriate.

-FIRST INFUSION: Initiate infusion at a rate of 50 mg/hr; in the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr

-SUBSEQUENT INFUSIONS: Initiate infusion at a rate of 100 mg/hr; in the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr

-Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

RECOMMENDED DOSE FOR GRANULOMATOSIS WITH POLYANGIITIS (GPA) (WEGENER’S GRANULOMATOSIS) AND MICROSCOPIC POLYANGIITIS (MPA):

-Administer rituximab as a 375 mg/m2 intravenous infusion once weekly for 4 weeks

-Glucocorticoids administered as methylprednisolone 1000 mg IV per day for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of rituximab and may continue during and after the 4 week course of rituximab treatment.

-Safety and efficacy of treatment with subsequent courses of this drug have not been established

Use: This drug, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)

Usual Adult Dose for Microscopic Polyangiitis

Information for all healthcare professionals administering this drug: Administer this drug only as an IV infusion. Do not administer as an IV push or bolus. Premedicate before each infusion with acetaminophen and an antihistamine. Pneumocystis jiroveci pneumonia (PCP) is recommended for patients with GPA and MPA during treatment and for at least 6 months following treatment as appropriate.

-FIRST INFUSION: Initiate infusion at a rate of 50 mg/hr; in the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr

-SUBSEQUENT INFUSIONS: Initiate infusion at a rate of 100 mg/hr; in the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30 minute intervals, to a maximum of 400 mg/hr

-Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.

RECOMMENDED DOSE FOR GRANULOMATOSIS WITH POLYANGIITIS (GPA) (WEGENER’S GRANULOMATOSIS) AND MICROSCOPIC POLYANGIITIS (MPA):

-Administer rituximab as a 375 mg/m2 intravenous infusion once weekly for 4 weeks

-Glucocorticoids administered as methylprednisolone 1000 mg IV per day for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of rituximab and may continue during and after the 4 week course of rituximab treatment.

-Safety and efficacy of treatment with subsequent courses of this drug have not been established

Use: This drug, in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)

What is the dose of Rituximab for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Rituximab available?

Rituximab is available in the following dosage forms and strengths:

  • Intravenous solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Rituximab, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 10, 2018 | Last Modified: August 10, 2018

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