Rituximab (Intravenous Route)

Rituximab is also known under US brand name Rituxan and is used in the treatment of various strands of cancer and other autoimmune diseases.

Overview

Rituximab injection is used alone or in combination with other drugs to treat a type of cancer called non-Hodgkin's lymphoma (NHL). The drug works by helping the immune system destroy the cancerous cells. Rituximab injection is known as a monoclonal antibody.

It is is used together with cyclophosphamide and fludarabine to treat a strand of cancer known as chronic lymphocytic leukemia (CLL).

This drug is also used in combination with methotrexate to treat the symptoms of rheumatoid arthritis. It works by helping to prevent joint damage from worsening after at least one other medicine (eg etanercept, adalimumab or infliximab) has been used and was unsuccessful.

Rituximab is used in combination with steroids to treat microscopic polyangiitis (MPA) and granulomatosis with polyangiitis. These are immune disorders that cause the blood vessels to become inflamed.

This medication can only be administered directly by or under the immediate supervision of a doctor. This drug is available in the dosage form of solution for injection.

Conditions Treated

  • Resistant or Recurrent to Treatment Non-Hodgkin's Lymphoma
  • Chronic Lymphocytic Leukemia
  • Follicular Lymphoma
  • Disease of Respiratory Tract - Wegener's Granulomatosis
  • CD20 Positive Non-Hodgkin's Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Progressive Chronic Lymphocytic Leukemia
  • Rheumatoid Arthritis
  • Burkitt's Lymphoma
  • Microscopic Polyangiitis
  • Low Platelet Count and Bleeding from Immune Response
  • Waldenstrom's Macroglobulinemia
  • Thrombotic Thrombocytopenic Purpura
  • Mantle Cell Lymphoma

Type of Medicine

  • Solution

Side Effects

Along with its intended effects, the use of rituximab may produce some unwanted side effects. Not all of these side effects may appear, but if they do, you may need medical attention.

Inform your doctor or a healthcare professional urgently if you suffer from any of the following side effects whilst rituximab:

More common side effects:

  • Black, tarry stools
  • Stomach or abdominal pain
  • Bleeding gums
  • Blood in the stools or urine
  • Blurred vision
  • Swelling or bloating of the arms, face, hands, lower legs, or feet
  • Body pain or aches
  • Confusion
  • Difficulty with breathing
  • Convulsions
  • Welts or hives, itching, or rash
  • Chest pain
  • A cough or hoarseness
  • Faintness, dizziness or lightheadedness when getting up
  • Suddenly from a sitting or lying position
  • Dry mouth
  • Chills and fever
  • Ear congestion
  • Drowsiness
  • Flushed, dry skin
  • Fruit-like breath odor
  • Headache
  • Increased thirst
  • Increased hunger
  • Increased urination
  • Hands, legs, feet, or sex organs
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat
  • Lower back or side pain
  • Nausea
  • Nervousness
  • Tenderness or pain
  • Painful or difficult urination
  • Noisy breathing
  • Around the eyes and cheekbones
  • Pale skin
  • Pounding in the ears
  • Fast or slow heartbeat
  • Sore throat
  • Pinpoint red spots on the skin
  • Sneezing
  • Ulcers, sores or white spots in the mouth or on the lips
  • Sweating
  • Runny or stuffy nose
  • Swelling of the tongue or throat
  • Tightness in the chest
  • Swollen glands
  • Tingling of the hands or feet
  • Unusual bruising or bleeding
  • Troubled breathing with exertion
  • Unusual weakness or tiredness
  • Vomiting
  • Unusual weight gain or loss

Less common:

  • Blisters in the mouth
  • Crawling, burning, itching, numbness, prickling, “pins and needles”, or tingling feeling
  • Blisters on the trunk, scalp, or other areas
  • Tingling, burning, numbness or pain in the hands, arms, feet, or legs
  • Blistering, peeling, or loosening of the skin
  • Diarrhea
  • Decreased frequency and amount of urination
  • Difficulty with moving
  • Feeling empty or sad
  • Discouragement
  • Irregular heartbeat
  • Muscle or joint pain
  • Irritability
  • Loss of appetite
  • Muscle cramps
  • Loss of interest or pleasure
  • Muscle pain or stiffness
  • Pain at the injection site
  • Numbness or tingling in the hands, feet, or lips
  • Swelling, pain, or redness in the joints
  • Red, itchy lining of the eye
  • Red skin lesions, often with a purple center
  • Redness of the neck, face, arms, and occasionally, upper chest
  • Trouble sleeping
  • Stabbing pain
  • Trouble concentrating

Incidence not known

  • Blue-yellow color blindness
  • Abdominal or stomach cramps
  • Blurred vision or other change in vision
  • Dilated neck veins
  • Stinging or burning of the skin
  • Decreased vision
  • Dry cough
  • Eye pain, tearing
  • Extreme fatigue
  • Feeling of discomfort, weakness or illness
  • Nosebleed
  • Irregular breathing
  • Swollen or inflamed joints
  • Painful cold sores or blisters on the lips, nose, eyes, or genitals
  • Severe abdominal or stomach pain
  • Sensitivity of the eye to light
  • Severe vomiting, sometimes with blood
  • Stiffness, redness, swelling, or warmth around many joints
  • Sores, welting, or blisters
  • Vision loss
  • Swollen lymph glands

Some side effects that occur with rituximab usually don't need medical attention. You will find they start to ease and your body begins to adjust to the medication. If however, these side effects are bothering your daily activities, you should contact a healthcare professional or your doctor to find out ways to reduce or prevent these side effects.

More common side effects:

  • Increased cough
  • Fear
  • Loss or lack of strength
  • Throat irritation
  • Night Sweats

Less common:

  • Change in taste
  • Anxiety or agitation
  • Dry eyes
  • Feeling of constant movement of self or surroundings
  • Excessive muscle tone
  • Heartburn
  • Lightheadedness
  • Increase in body movements
  • Muscle tension
  • Sensation of spinning
  • Redness or pain at the injection site
  • Swelling of the stomach
  • Sleepiness

Remember you can report all side effects to the FDA on 1-800-FDA-1088.

Dosage

This information applies to the following strength of drug: 10 mg/mL
The final dosage of any medication will depend on a number of factors. This includes your age, height and weight, your medical history, the condition you are being treated for, the severity of the condition and what current medications you are currently taking.

Typical Adult Dose for non-Hodgkin's Lymphoma

This drug should only be administered as an IV infusion. Don't administer as a bolus or IV push. Before each infusion, premedication with an antihistamine and acetaminophen.

First infusion: The infusion should be initiated at a rate of 50 mg/hr. If there is no infusion toxicity, then increase infusion rate by 50 mg/hr increments every thirty minutes, to a maximum rate of 400 mg per hour.

Subsequent infusions:
Standard infusion: The infusion should be initiated at a rate of 100 mg/hr. If there is no infusion toxicity, increase the rate by 100 mg/hr increments at thirty-minute intervals, to a maximum rate of 400 mg per hour.

Typical Adult Dose for Rheumatoid Arthritis

This drug should only be administered as an IV infusion. Don't administer as a bolus or IV push. Before each infusion, premedication with an antihistamine and acetaminophen. For RA patients, thirty minutes prior to each infusion, it's recommended you give methylprednisolone 100 mg IV or its equivalent.

First infusion: Infusion should be given at a rate of 50 mg/hr. If no infusion toxicity is present, then increase infusion rate by 50 mg/hr increments every thirty minutes, to a maximum rate of 400 mg per hour.

Subsequent infusions: The infusion should be given at a rate of 100 mg/hr. If no infusion toxicity is present, then increase rate by 100 mg/hr increments at thirty-minute intervals, to a maximum rate of 400 mg per hour.

If infusion reactions occur, slow the infusion rate, or interrupt the infusion. Once symptoms have improved, continue the infusion at one-half the previous rate.

Recommended dose for rheumatoid arthritis (RA)

  • This drug is given alongside methotrexate
  • It should be administered as two 1000 mg IV infusions that are separated by a two week period.
  • Thirty minutes before infusion, it's recommended that glucocorticoids are administered as methylprednisolone 100 mg IV or its equivalent to reduce the possibility and severity of infusion reactions.
  • Subsequent courses should be administered every twenty-four weeks or based on clinical evaluation. This should not be any sooner than sixteen weeks.

Typical Adult Dose for Chronic Lymphocytic Leukemia

This drug should only be administered as an IV infusion. Don't administer as a bolus or IV push. Before each infusion, premedication with an antihistamine and acetaminophen. For patients with CLL during treatment, Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis are recommended for patients with CLL.

First and subsequent infusions are the same as listed above. If you have any concerns or queries then contact your doctor or health care professional for advice.

If infusion reactions occur, slow the infusion rate, or interrupt the infusion. Once symptoms have improved, continue the infusion at one-half the previous rate.

Typica Adult Dose for Wegener's Granulomatosus

This is the same administration details as above. Again if an infusion reaction occurs, then interpret the infusion or slow the infusion rate.

Not all medical treatments and combinations are given and your dose may vary. Do not be alarmed if it does not match what is noted above. Doses are tailored and individual to you, your condition and your reactions.

Interactions

Interactions between drugs can cause unwanted side effects and reduce the effectiveness of either drug. To help avoid these interactions, it's important that you let your doctor or a healthcare professional know about all the current medications you are taking and any medications you have taken in the past. This list should include all prescription and non-prescription drugs, herbal remedies and vitamins. You should also give your doctor a history of any medical conditions you have/do suffer from and any that run in the family history.

The use of this medication with any of the following drugs is not recommended. Your doctor may decide to avoid treating you with this medicine or alter some of the other medicines you are taking.

  • Mumps Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Varicella Virus Vaccine
  • Rubella Virus Vaccine, Live

The use of this medication with any of the following drugs is not usually recommended, but sometimes it may be required. If this happens, your doctor may alter the dose or frequency in which you use one or both of the medications.

  • Bacillus of Calmette and Guerin Vaccine, Live
  • Adenovirus Vaccine
  • Cholera Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Cisplatin
  • Poliovirus Vaccine, Live
  • Yellow Fever Vaccine
  • Smallpox Vaccine
  • Typhoid Vaccine

The use of this medication with any of the following drugs can cause an increased risk of side effects. However, in some cases, this combination may be the best course of treatment for you. If this happens, your doctor may alter the dose or the frequency in which you use one or both medications.

  • Influenza Virus Vaccine (Subvirion)
  • Pneumococcal Vaccine Polyvalent

A total of 127 drugs known to interact with the use of rituximab. You should let your doctor know if you are taking any of the following drugs.

  • Adenovirus vaccine
  • Adalimumab
  • Alefacept
  • Anakinra
  • Azathioprine
  • Alemtuzumab
  • Anthrax vaccine adsorbed
  • BCG
  • Canakinumab
  • Bioflavonoids / zinc glycinate
  • Candida albicans extract
  • Cholecalciferol / genistein / zinc chelazome
  • Cat's claw
  • Certolizumab
  • Cholera vaccine/live
  • Cladribine
  • Chromic chloride hexahydrate / manganese sulfate / copper sulfate / selenium / zinc sulfate
  • Clozapine
  • Coccidioidin skin test
  • Denosumab
  • Deferiprone
  • Diphtheria and tetanus toxoids
  • Efalizumab
  • Echinacea
  • Etanercept
  • Fingolimod
  • Filgrastim
  • Ganciclovir
  • Hepatitis a adult vaccine / hepatitis b adult vaccine
  • Golimumab
  • Hepatitis a pediatric vaccine/ hepatitis b pediatric vaccine
  • Histoplasmin
  • Infliximab
  • Human papillomavirus vaccine
  • Japanese encephalitis virus vaccine nakayama
  • Lyme disease vaccine
  • Leflunomide
  • Meningococcal group B vaccine
  • Mixed respiratory vaccine
  • Meningococcal polysaccharide vaccine
  • Mumps virus vaccine
  • Measels virus vaccine
  • Mumps skin test antigen
  • Natalizumab
  • Ocrelizumab
  • Niraparib
  • Olaparib
  • Palifermin
  • Omacetaxine
  • Pegfilgrastim
  • Plague vaccine
  • Phytase / zinc citrate
  • Pneumococcal 23-polyvalent vaccine
  • Pneumococcal 13-valent vaccine
  • Pneumococcal 7-valent vaccine
  • Roflumilast
  • Poliovirus vaccine, inactivated/live
  • Rotavirus vaccine
  • Sargramostim
  • Rubella virus vaccine
  • Sarilumab
  • Skin test antigens, multiple
  • Sipuleucel-T
  • Tbo-filgrastim
  • Tetanus toxoid
  • Teriflunomide
  • Tocilizumab
  • Topotecan
  • Tofacitinib
  • Ubiquinone / vitamin e
  • Valganciclovir
  • Ustekinumab
  • Varicella virus vaccine
  • Zinc acetate
  • Vitamin e
  • Zinc chloride
  • Zinc sulfate
  • Zinc gluconate
  • Zoster vaccine live/inactivated

Other interactions

If you suffer from other medical conditions, this could affect the use of this medication. Ensure you let your doctor know if you have any other medical conditions, especially:

  • Heart disease
  • Angina (chest pain), history of
  • Heart rhythm problems (eg, arrhythmia), history of
  • Infection (eg, bacteria, fungus, or virus)
  • Hepatitis B
  • Kidney disease
  • Stomach or bowel problems (eg, intestinal blockage, perforation, ulcers)—Caution should be exercised as this medication could make these conditions worse.
  • Lung problems (eg, asthma, bronchitis), history of

Warnings

Use in pediatric population

Studies have not been conducted on the relationship of age to the effects of rituximab injection on the pediatric population. Therefore efficacy and safety have not been established. Caution should be exercised.

Use in the geriatric population

Studies that have been performed have not indicated any geriatric-specific problems that could limit the effectiveness of rituximab injection in the geriatric population. However, elderly patients are more likely to have age-related lung and heart problems and infections which may require extra caution to be exercised in those older patients receiving rituximab injection.

Allergies

Before you take this medication, tell a healthcare professional or your doctor if you are allergic to it, or to mouse protein. You should let them know of any allergies you may have including to animals, preservatives, foods, dyes etc. This product could contain inactive ingredients, which could cause an allergic reaction or other problems. Speak with your doctor for further information.

Use in pregnancy and breastfeeding

This drug is under FDA pregnancy category C. During pregnancy, this drug should be used only when clearly needed as it could harm an unborn child. Discuss with your doctor reliable forms of birth control whilst using this medicine and for one year after you stop treatment. If you fall pregnant, speak with your doctor urgently about the risks and benefits associated with taking this drug.

With regards to the use of breastfeeding whilst taking this drug, it's unknown if this medication can pass into breast milk. Due to the possible risk to the infant, it is not recommended that you breastfeed while using this drug. You should not breastfeed until your treatment is complete and a blood test shows that there is no rituximab present in your body. Speak with your doctor about when it is safe to breastfeed.

This drug may make you feel dizzy and the use of marijuana or alcohol could increase dizzy spells. You should avoid taking these products whilst on this medication. Do not use machinery, drive or do anything that requires you to be alert until you can do so safely.

This drug can increase your risk of developing infections during or after treatment. These infections can be severe and lead to death. Some users have developed low levels of certain antibodies in their blood for a long period of time and developed infections. Avoid being close to people who are sick or infected whilst using this drug.Regularly wash your hands. Let your doctor know if you have lupus or other infections before you take this medication.

This can cause a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). If you have rheumatoid arthritis, the risk is higher. Speak with your doctor about the benefits and risks associated with taking this medication.

While being treated with rituximab, and after treatment is finished, don't have any vaccinations without prior approval from your doctor. If you have rheumatoid arthritis, non-live virus vaccines should be given at least four weeks before receiving this medication. Rituximab can lower your body's resistance, and there is an increased risk of your contracting the infection the vaccine is supposed to prevent.

This medication may cause a serious type of reaction that is known as tumor lysis syndrome (TLS). Your doctor may give you another medication to help prevent this.

Serious skin reactions can occur whilst take this medication. Inform your doctor urgently if you have peeling, blistering or loosening of the skin or fever or chills whilst using this medication.

Storage

Store intact vials at 36°F - 46°F (2°C - 8°C). Don't let product freeze. Don't shake product and protect vials from direct sunlight.

Summary

When used correctly, rituximab is successful in the treatment of different strands of cancer and other diseases. It may take a while to find your correct dosage before you start to see changes or improvements in conditions. Due to the high amount of reactions possible with this drug, it is important you let your doctor know about all medications and medical conditions you are currently taking and currently suffer from. This drug will be given to you in a healthcare setting. It should not be used during pregnancy and you should avoid getting pregnant for up to one-year after taking this drug. This drug should also not be used whilst breastfeeding. This drug hasn't been tested on the pediatric population.

 

Resources
Last Reviewed:
January 30, 2018
Last Updated:
January 27, 2018