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What are the problems with Fasenra? A Comprehensive Overview

3 min read

While Fasenra (benralizumab) is an effective add-on maintenance treatment for severe eosinophilic asthma and EGPA, it is not without its challenges. A significant reported issue is its high cost, with some patients citing a major financial burden despite effective symptom control. Furthermore, like all medications, it carries a risk of side effects, ranging from common, mild reactions to rare, serious allergic responses.

Quick Summary

Fasenra presents potential problems including common side effects like headache and sore throat, rare but serious allergic reactions, limitations such as not treating acute asthma attacks, possible waning effectiveness, significant cost barriers, and management requirements for patients transitioning from corticosteroids.

Key Points

  • Common Side Effects: Headache and sore throat are the most frequently reported adverse reactions associated with Fasenra use.

  • Serious Allergic Reactions: Although rare, Fasenra can cause severe allergic reactions, including anaphylaxis and angioedema, which can occur hours or days after an injection.

  • Significant Cost: High cost and potential financial burden are major concerns for many patients, impacting access and affordability of the medication.

  • Not for Acute Attacks: Fasenra is not a rescue medication and will not stop an asthma attack that has already started, necessitating the use of a quick-relief inhaler for sudden symptoms.

  • Corticosteroid Management: Systemic or inhaled corticosteroids should not be stopped abruptly after starting Fasenra; any dose reduction must be gradual and supervised by a physician.

  • Potential for Waning Effectiveness: Some patient reports suggest that Fasenra's effectiveness may decrease over time, though clinical studies do not universally confirm this observation.

  • Infection Risk: There is a potential influence on the immune response to parasitic infections, so pre-existing helminth infections should be treated before starting Fasenra.

In This Article

Understanding the Most Common Problems with Fasenra

Fasenra (benralizumab) is a monoclonal antibody used to treat severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA). Despite its therapeutic benefits, a number of problems associated with Fasenra have been documented in clinical trials and patient reports. These issues can be broadly categorized into adverse reactions, limitations, effectiveness issues, and financial concerns.

Common Side Effects and Injection Site Reactions

Clinical studies have identified several common side effects associated with Fasenra therapy. The most frequently reported issues are headaches and sore throats (pharyngitis). Other less common but reported side effects include fever, back pain, and flu-like symptoms. While these effects are generally mild and temporary, they can be bothersome for some individuals.

Injection site reactions are another frequently reported problem, occurring at the location where the medication is administered subcutaneously. These reactions are often mild and can include:

  • Pain or stinging sensation
  • Redness or discoloration of the skin
  • Swelling and itching
  • Bruising or a small lump

These reactions can be mitigated by ensuring the autoinjector pen has warmed to room temperature before use and by rotating injection sites. However, persistent or worsening injection site issues should be discussed with a healthcare provider.

Serious Allergic and Immune System Problems

Though rare, some problems with Fasenra can be serious and life-threatening. The most significant of these are severe allergic (hypersensitivity) reactions, including anaphylaxis and angioedema. These reactions can occur hours or even days after an injection, requiring immediate medical attention. Symptoms may include:

  • Swelling of the face, mouth, and tongue
  • Difficulty breathing
  • Dizziness or fainting
  • Rash and hives

Patients with a known hypersensitivity to benralizumab should not use Fasenra. While there have been concerns about immune-modulating drugs increasing the risk of malignancies, long-term studies have not identified any unexpected trends suggesting a cancer risk with Fasenra. Another immune-related consideration is that Fasenra might interfere with the body's response to parasitic (helminth) infections, so pre-existing infections should be treated before starting Fasenra.

Limitations and Effectiveness Concerns

An important problem with Fasenra is that it is not intended for the treatment of acute asthma symptoms or severe asthma attacks (exacerbations). Patients should be instructed to continue using their rescue medication, such as an albuterol inhaler, for sudden breathing problems. Seeking medical advice is necessary if asthma symptoms worsen despite using Fasenra.

Another limitation concerns the use of systemic or inhaled corticosteroids. These medications should not be stopped abruptly after starting Fasenra, as this can trigger withdrawal symptoms or unmask other underlying conditions. Dosage reductions, if appropriate, must be done gradually under a doctor's supervision.

Some patient reviews suggest a potential problem with waning effectiveness over time, with individuals reporting a gradual decrease in symptom control after the first year of treatment. This highlights the variation in individual responses to biologic medications.

Cost and Access Barriers

For many patients, the most significant problem with Fasenra is its high cost. As a brand-name biologic, it can present a considerable financial burden, even with insurance. This cost can limit access for many individuals, as reported in a patient input summary by the National Institutes of Health. These financial strains can also affect caregivers who may have to give up careers or face significant costs.

Comparison of Common vs. Serious Problems

Feature Common Problems Serious Problems
Incidence Fairly common Rare
Onset Short-term, usually within hours to days of injection Can be immediate or delayed (hours to days)
Examples Headache, sore throat, injection site reaction Anaphylaxis, angioedema
Management Often resolves on its own; can be managed with over-the-counter pain relievers or cold compresses Requires immediate medical attention; may necessitate discontinuing Fasenra
Typical Outcome Mild and temporary Potentially life-threatening

Conclusion

Fasenra offers a valuable treatment option for individuals with severe eosinophilic asthma or EGPA by targeting and reducing eosinophils. However, prospective patients and healthcare providers must be aware of the range of potential problems. These include common but manageable side effects like headaches and injection site reactions, the rare but serious risk of hypersensitivity reactions, and important limitations regarding its use for acute symptoms and steroid management. Cost and access remain a significant barrier for many, affecting the feasibility of long-term treatment. Thoroughly discussing these concerns with a healthcare provider is essential for weighing the benefits against the risks and managing expectations regarding long-term efficacy. For more detailed prescribing information, refer to the Fasenra website for healthcare providers.

Frequently Asked Questions

The most commonly reported side effects of Fasenra are headache and sore throat (pharyngitis). Other common issues include fever and reactions at the injection site, such as pain, redness, or swelling.

Yes, Fasenra can cause severe allergic (hypersensitivity) reactions, including anaphylaxis and angioedema, which can be life-threatening. These can happen hours or days after an injection and require immediate medical attention.

No, Fasenra is an add-on maintenance treatment and is not used to treat acute asthma symptoms or attacks. A fast-acting rescue inhaler should be used for sudden breathing problems.

Patients should not stop taking their corticosteroids abruptly after starting Fasenra. Any dose reduction must be done gradually and only under the supervision of a healthcare provider.

Some individual patient reviews suggest that Fasenra's effectiveness may wane over time. However, clinical studies on long-term use have found consistent safety and efficacy, though individual responses can vary.

Fasenra is a costly medication, and the financial burden is a significant problem reported by many patients. Cost can often impact a patient's access to the medication.

Important warnings include a potential influence on the body's immune response to parasitic infections, so pre-existing infections should be treated. Patients should also be monitored for signs of worsening asthma.

The data on Fasenra use during pregnancy is insufficient, and it is unknown if it passes into breast milk. The risks and benefits should be discussed with a doctor, and pregnant patients can enroll in a pregnancy exposure registry.

References

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Medical Disclaimer

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