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What is a bad reaction to Ocrevus?

4 min read

Infusion reactions are a common side effect of Ocrevus, with 34% to 40% of patients experiencing them in clinical trials. However, a bad reaction to Ocrevus can also involve more severe issues, including life-threatening infections and other serious medical complications.

Quick Summary

A bad reaction to Ocrevus can include serious infusion reactions, which range from mild to severe, as well as an increased risk of severe infections, including a rare but fatal brain infection called Progressive Multifocal Leukoencephalopathy (PML). Other potential serious side effects include certain cancers, liver damage, and colitis.

Key Points

  • Infusion Reactions: Common side effects during or up to 24 hours post-infusion, which can range from mild (headache, rash, fever) to severe and life-threatening (trouble breathing, chest pain).

  • Serious Infections: Ocrevus suppresses the immune system, increasing the risk of severe bacterial, viral (including herpes), fungal, and parasitic infections.

  • Progressive Multifocal Leukoencephalopathy (PML): A rare, but serious and often fatal, viral brain infection can occur, with symptoms including progressive weakness, vision issues, and changes in thinking.

  • Hepatitis B Reactivation: Patients with a history of Hepatitis B are at risk for the virus becoming active again, which can cause severe liver problems.

  • Immune-Mediated Colitis: A severe inflammation of the colon with symptoms like persistent diarrhea and stomach pain has been reported post-approval.

  • Increased Cancer Risk: Clinical trials showed a higher frequency of certain cancers, including breast cancer, in Ocrevus-treated patients compared to control groups.

  • Hypogammaglobulinemia: Decreased antibody levels can occur, potentially increasing the risk of serious infections.

In This Article

Recognizing an Ocrevus Infusion Reaction

Infusion reactions are the most common adverse event associated with Ocrevus, often occurring during or within 24 hours of an intravenous dose. To reduce the frequency and severity of these reactions, patients are typically given pre-medications, such as a steroid and antihistamine, before the infusion. While most reactions are mild to moderate, serious and life-threatening cases, including bronchospasm and anaphylaxis, have been reported.

Common Infusion Reaction Symptoms

  • Skin: Itching, rash, hives, or flushing.
  • Head/Neck: Headache, throat irritation, or pain.
  • Gastrointestinal: Nausea.
  • Other: Fatigue, dizziness, or fever.

Severe Infusion Reaction Symptoms

Prompt medical attention is required for severe reactions. Symptoms include:

  • Respiratory: Shortness of breath, trouble breathing, wheezing, or chest tightness.
  • Circulatory: Fast or irregular heartbeat.
  • Swelling: Swelling of the throat or mouth.
  • Other: Feeling faint or dizzy.

Serious Infections and Immunosuppression

Because Ocrevus works by targeting certain B-cells in the immune system, it can weaken the body's ability to fight off infections. This increases the risk for serious, and sometimes fatal, bacterial, viral, and fungal infections. It is critical to contact a healthcare provider immediately if you develop any signs of an infection, and treatment may be delayed until the infection has resolved.

Types of Ocrevus-Related Infections

  • Respiratory Infections: Upper respiratory tract infections (like the common cold) and lower respiratory tract infections (like bronchitis) are frequently reported.
  • Herpes Infections: The risk of herpes virus infections, including oral herpes and herpes zoster (shingles), is increased. In rare, serious cases, these can affect the central nervous system.
  • Hepatitis B Reactivation: In patients with a history of Hepatitis B, the virus can become active again, potentially leading to liver failure. All patients are screened for Hepatitis B before starting Ocrevus.
  • Progressive Multifocal Leukoencephalopathy (PML): This is a rare and often fatal viral brain infection. It is caused by the JC virus and typically only occurs in immunocompromised individuals. PML symptoms develop over days to weeks and warrant immediate medical evaluation.

Potential Increased Risk of Cancer

An increased risk of certain cancers, particularly breast cancer, was observed in clinical trials for Ocrevus. While rare, patients should be aware of this potential risk and follow standard cancer screening guidelines as recommended by their doctor. Any new lumps, pain, or changes in breast tissue should be reported.

Immune-Mediated Colitis and Other Adverse Reactions

Postmarketing reports have indicated rare cases of immune-mediated colitis in patients treated with Ocrevus. This can cause severe abdominal pain and bloody diarrhea. Patients experiencing new or persistent gastrointestinal symptoms should be evaluated promptly. Additionally, Ocrevus can cause a decrease in immunoglobulins (antibodies), which can further increase the risk of serious infections.

Recognizing a Bad Reaction to Ocrevus: Symptom Comparison

Type of Reaction Characteristic Symptoms When to Seek Medical Attention
Mild Infusion Reaction Headache, mild rash, nausea, fatigue, itching Inform healthcare provider at your next visit if persistent or bothersome.
Severe Infusion Reaction Trouble breathing, chest tightness, fast heartbeat, swelling of the throat Seek immediate medical attention.
Infection Fever, chills, persistent cough, sores that don't heal Contact healthcare provider, who may delay your next dose.
PML (Brain Infection) Weakness on one side, clumsiness, vision changes, confusion, memory issues Seek immediate medical attention.
Colitis Severe abdominal pain, bloody diarrhea Seek immediate medical attention.

What to Do If You Experience a Bad Reaction

  1. During the Infusion: If you notice any signs of an infusion reaction, no matter how mild, immediately inform your healthcare provider. They can adjust the infusion rate or provide additional medication to manage the symptoms.
  2. After the Infusion: Infusion reactions can occur up to 24 hours later. If you experience any symptoms, especially severe ones, contact your healthcare provider right away or seek emergency medical help.
  3. Regarding Infections: The risk of infection is ongoing due to the drug's effect on your immune system. If you develop a fever, chills, cough, or any other signs of infection, contact your healthcare team promptly. They may advise delaying your next dose.
  4. Know the Warning Signs: Stay vigilant for symptoms of rare but serious conditions like PML, colitis, or cancer. Being proactive and communicating any new or worsening symptoms to your doctor is vital.

Conclusion

While Ocrevus is an effective treatment for multiple sclerosis, it is important for patients and caregivers to be aware of the potential for serious adverse reactions. Common infusion reactions can be managed with pre-medication and monitoring during the infusion, but more severe reactions like serious infections, including PML, colitis, and potential cancer risk, require careful monitoring and prompt medical attention. Patients should maintain open communication with their healthcare team to safely manage these risks throughout their treatment. For more information, you can visit the official Ocrevus website at https://www.ocrevus.com/patient/safety-and-side-effects.html.

Frequently Asked Questions

You should seek immediate medical attention. Severe infusion reactions can involve difficulty breathing, chest pain, swelling of the throat, and a fast heartbeat. Inform your healthcare team or go to the nearest emergency room.

Contact your healthcare provider if you have a fever, chills, a persistent cough, or sores that do not heal. These can be signs of a serious infection that requires evaluation and may necessitate delaying your next dose.

Symptoms of PML include new or worsening neurological signs like progressive weakness on one side of the body, vision disturbances, clumsiness, confusion, or changes in thinking and personality. You must contact your doctor immediately if these symptoms appear.

Yes, infusion reactions can happen for up to 24 hours after your infusion. It is important to monitor for symptoms like headache, rash, or nausea and call your doctor if they occur or are severe.

Before each infusion, you will receive pre-medications, such as a steroid and antihistamine, to reduce the risk of an infusion reaction. You will also be monitored closely during and for at least an hour after the infusion.

In clinical trials, an increased risk of certain cancers, including breast cancer, was observed. It is recommended to follow standard cancer screening guidelines and discuss this risk with your doctor.

Be alert for signs such as severe stomach pain, persistent diarrhea, or bloody stools. If you experience these symptoms, your doctor should evaluate you promptly to determine if it is immune-mediated colitis.

If you have a history of Hepatitis B (HBV), the virus can reactivate during or after Ocrevus treatment, potentially causing serious liver problems, including liver failure or death. Your doctor will screen you for HBV before starting treatment.

References

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Medical Disclaimer

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