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What is the Most Common Side Effect of Rituxan?

4 min read

Infusion-related reactions are a very common side effect of Rituxan, with some studies showing they occur in over 80% of patients during the first infusion [1.6.5]. So, what is the most common side effect of Rituxan and what should patients expect?

Quick Summary

An in-depth look at the side effects of Rituxan (rituximab), focusing on infusion-related reactions as the most common adverse event. It covers symptoms, management strategies, and other significant but less common risks associated with the treatment.

Key Points

  • Most Common Side Effect: Infusion-related reactions (IRRs) are the most common side effect of Rituxan, often occurring during the first treatment [1.2.5, 1.6.4].

  • Infusion Reaction Symptoms: Symptoms of IRRs typically include fever, chills, nausea, headache, itching, and rash [1.2.2, 1.2.5].

  • Management Strategy: Pre-medications like acetaminophen and antihistamines are given before the infusion to reduce the chance and severity of a reaction [1.5.1, 1.8.2].

  • Decreasing Severity: Infusion reactions generally become less frequent and severe with each subsequent infusion after the first one [1.3.3, 1.6.5].

  • Serious Risks: Rituxan has FDA boxed warnings for severe risks, including Progressive Multifocal Leukoencephalopathy (PML), Hepatitis B reactivation, and severe skin/mouth reactions [1.4.2, 1.7.2].

  • Increased Infection Risk: Due to its effect on the immune system, Rituxan increases a patient's susceptibility to bacterial, viral, and fungal infections [1.2.2, 1.7.5].

  • Patient Monitoring: Close monitoring during and after infusions is crucial to manage both common reactions and to detect rare, serious side effects early [1.8.3].

In This Article

Understanding Rituxan and Its Mechanism

Rituxan, the brand name for the medication rituximab, is a monoclonal antibody used to treat certain types of cancers and autoimmune diseases [1.6.2, 1.6.5]. It is administered as an intravenous (IV) infusion [1.4.2]. Its primary applications include non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA) [1.2.3, 1.4.2]. The medication functions by targeting the CD20 protein, which is found on the surface of immune cells called B-cells [1.6.5, 1.6.6]. By binding to this protein, Rituxan causes these B-cells to disintegrate (lyse), which helps in controlling the conditions it's prescribed for [1.6.5]. In cancers like lymphoma, this action destroys malignant cells, and in autoimmune diseases, it helps to slow down an overactive immune system by depleting B-cells [1.6.2, 1.6.5].

What is the Most Common Side Effect of Rituxan? Infusion-Related Reactions

The most frequently reported side effect of Rituxan is an infusion-related reaction (IRR) [1.2.5, 1.6.4]. These reactions are very common and can occur during the infusion or within 24 hours after it is administered [1.4.3]. Some data indicates that up to 80% of patients experience these reactions, particularly during their first treatment [1.6.5, 1.8.3]. The good news is that these reactions tend to become less frequent and less severe with subsequent infusions [1.6.5, 1.3.3].

Symptoms of an infusion-related reaction are often flu-like and can include:

  • Fever [1.2.2]
  • Chills and rigors (shaking) [1.2.2, 1.6.5]
  • Nausea [1.2.3]
  • Headache [1.2.2]
  • Itching (pruritus) and rash [1.2.5]
  • Cough [1.2.5]
  • Fatigue or weakness [1.2.3]

In most cases, these reactions are mild to moderate [1.5.1]. However, serious IRRs can occur, manifesting as shortness of breath, a significant drop in blood pressure (hypotension), chest pain, or swelling of the lips, tongue, or throat (angioedema) [1.2.5, 1.4.5]. Approximately 80% of fatal infusion reactions have been associated with the first infusion, which is why close monitoring by a healthcare team is critical [1.8.3].

Other Common Side Effects

Beyond infusion-related reactions, patients may experience other common side effects. The specific side effects can vary depending on the condition being treated [1.4.2].

  • Infections: Because Rituxan affects the immune system, it can increase the risk of infections [1.2.2]. Common infections include upper respiratory tract infections, urinary tract infections (UTIs), and bronchitis [1.4.2, 1.8.3].
  • Body Aches and Pains: General body aches, muscle spasms, and joint pain are also reported [1.2.3, 1.7.2].
  • Fatigue and Weakness: A feeling of tiredness or lack of strength (asthenia) is a common complaint [1.2.3].
  • Nausea and Diarrhea: Gastrointestinal issues like nausea and diarrhea can occur [1.2.3, 1.4.2].
  • Low Blood Counts: Rituxan can lower levels of certain blood cells, including white blood cells (neutropenia), red blood cells (anemia), and platelets (thrombocytopenia) [1.4.5].

Serious (But Less Common) Side Effects

Rituxan carries boxed warnings from the FDA for several serious, potentially life-threatening side effects [1.4.2, 1.7.2].

  • Severe Skin and Mouth Reactions: Painful sores, blisters, peeling skin, and rashes can develop, including conditions like Stevens-Johnson syndrome [1.7.2, 1.8.2]. These can occur at any time during treatment [1.2.5].
  • Hepatitis B Virus (HBV) Reactivation: For patients who have had a past hepatitis B infection, Rituxan can cause the virus to become active again, potentially leading to serious liver problems or failure [1.4.3, 1.7.2]. Patients are screened for HBV before starting treatment [1.8.2].
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious viral infection of the brain that can lead to severe disability or death [1.4.3, 1.7.2]. There is no known cure for PML [1.7.2]. Symptoms include confusion, dizziness, loss of balance, and difficulty walking or talking [1.4.3].
  • Tumor Lysis Syndrome (TLS): This can occur in cancer patients when tumor cells break down quickly, releasing their contents into the blood. This can lead to kidney failure and abnormal heart rhythms [1.7.5]. It typically happens within 12 to 24 hours of the first infusion [1.7.5].
  • Heart Problems: Rituxan can cause cardiac issues like chest pain, irregular heartbeats, and, in rare cases, heart attack [1.7.2].
  • Kidney Problems: Severe renal toxicity, sometimes fatal, has occurred, particularly in patients with NHL [1.7.2, 1.8.2].
  • Bowel Obstruction or Perforation: Especially when given with chemotherapy, Rituxan can cause severe stomach and bowel problems [1.7.2].

Comparison of Common vs. Severe Side Effects

Feature Common Side Effects Severe Side Effects
Primary Example Infusion-related reactions (fever, chills, rash) [1.2.5] Progressive Multifocal Leukoencephalopathy (PML) [1.4.3]
Frequency Very common, especially with the first infusion [1.2.5, 1.6.5] Rare [1.4.3, 1.7.2]
Typical Onset During or within 24 hours of infusion [1.4.2] Can be delayed; PML can occur up to 12 months after the last dose [1.4.2, 1.8.3]
Management Pre-medication (acetaminophen, antihistamines), slowing the infusion rate [1.5.1, 1.8.2] Immediate discontinuation of Rituxan, urgent medical care [1.8.2]
Outcome Usually resolves and lessens with subsequent doses [1.3.3] Can be life-threatening or result in permanent disability [1.7.2]

How Are Side Effects Managed?

Healthcare providers take proactive steps to manage and minimize the side effects of Rituxan. Before each infusion, patients are often given pre-medications, such as acetaminophen (Tylenol) and an antihistamine like diphenhydramine (Benadryl) [1.5.1, 1.8.2]. For some patients, a corticosteroid like methylprednisolone may also be administered [1.8.2].

During the infusion, patients are monitored closely [1.8.3]. If a reaction occurs, the medical team can slow down or temporarily stop the infusion until the symptoms resolve [1.5.1]. For more severe reactions, medications like epinephrine, additional steroids, or oxygen may be required [1.4.5]. Drinking plenty of fluids after the infusion can also help manage some of the flu-like symptoms [1.5.2]. Patients are advised to report any new or worsening symptoms to their healthcare team right away, especially signs of infection, severe skin reactions, or neurological changes [1.2.2, 1.7.1].

Conclusion

While Rituxan is an effective treatment for many serious conditions, it comes with a notable side effect profile. The most common side effect is an infusion-related reaction, characterized by fever, chills, and other flu-like symptoms, which is most prominent during the first dose but typically manageable [1.2.5, 1.6.5]. In addition to IRRs, patients should be aware of other common effects like an increased risk of infection and fatigue [1.2.2, 1.2.3]. Though rare, the risk of severe side effects such as PML, severe skin reactions, and HBV reactivation necessitates careful patient monitoring and communication [1.4.3, 1.7.2]. With proactive management strategies and close supervision by a healthcare team, the benefits of Rituxan therapy can be realized while minimizing risks.


For more detailed information, you can review the official Rituxan Medication Guide available on the manufacturer's website or the FDA's site. https://www.gene.com/download/pdf/rituxan_medguide.pdf

Frequently Asked Questions

The most common side effect is an infusion-related reaction, which can cause symptoms like fever, chills, rash, itching, and headache, especially during the first infusion [1.2.5, 1.6.4].

Most common side effects, like infusion reactions, are temporary and occur during or within 24 hours of the infusion [1.4.2]. The drug can stay in your system for 6 to 12 months, and some side effects, including the risk of infection, can persist during this time [1.4.2, 1.4.7].

While not entirely preventable, the risk and severity of infusion reactions are significantly reduced by administering pre-medications like acetaminophen and an antihistamine before treatment and by starting the infusion at a slow rate [1.5.1, 1.8.2].

Yes, weakness, fatigue (asthenia), and tiredness are commonly reported side effects of Rituxan treatment [1.2.3, 1.7.2].

PML stands for Progressive Multifocal Leukoencephalopathy. It is a rare, serious viral infection of the brain that can occur in people with weakened immune systems, including those taking Rituxan. It can lead to severe disability or death and has no known cure [1.4.3, 1.7.2].

Hair loss (alopecia) is not a common side effect of Rituxan, though it has been reported, particularly when used to treat pemphigus vulgaris in combination with other drugs [1.4.2, 1.2.3].

Rituxan works by targeting and depleting B-cells, a type of white blood cell that is part of your immune system. This suppression of the immune system can lower your ability to fight off bacterial, viral, and fungal infections [1.2.2, 1.6.5, 1.7.5].

Signs of a serious reaction include severe shortness of breath, swelling of the lips or throat, chest pain, painful skin blisters or sores, and new or worsening neurological symptoms like confusion, dizziness, or difficulty walking [1.2.5, 1.4.3, 1.7.2].

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.