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How Often Can You Get a ZILRETTA Injection in the Knee?

3 min read

According to the official prescribing information, the efficacy and safety of repeat administration of Zilretta have not been demonstrated, leading to a single-dose indication. While this statement guides clinical practice, some patients may still explore further injections based on clinical trials and consultation with their healthcare provider.

Quick Summary

Zilretta is officially indicated as a single intra-articular injection for knee osteoarthritis pain, with repeat use not formally proven safe or effective. Repeat administration is considered cautiously in clinical practice based on individual patient response and provider discretion.

Key Points

  • Single-Dose Indication: Zilretta is officially indicated as a single intra-articular injection for knee osteoarthritis pain.

  • Limited Repeat-Dose Data: A Phase 3b clinical trial evaluated repeat administration finding similar efficacy to the initial dose but with a higher rate of mild to moderate joint pain after the subsequent injection.

  • Timing of Subsequent Doses: Any consideration for another injection would occur only after the pain has returned.

  • Risk of Repeated Corticosteroids: The caution for repeating Zilretta injections aligns with general concerns about frequent corticosteroid injections, which carry risks for joint cartilage and bone health over time.

  • Consult a Professional: The decision for repeat administration is complex and must be made by a healthcare provider on a case-by-case basis.

  • Not a Long-Term Strategy: Given the limited data on repeated use, Zilretta is not intended as a long-term, cyclical treatment.

In This Article

Before discussing how often one might receive a Zilretta injection in the knee, it is important to understand that information provided is for general knowledge only and should not be taken as medical advice. Always consult with a healthcare provider before making any decisions about your treatment.

Zilretta (triamcinolone acetonide extended-release injectable suspension) is a long-acting intra-articular corticosteroid for managing knee osteoarthritis pain. Its extended-release technology provides sustained pain relief for months from a single injection. However, the guidance on repeat dosing differs from standard cortisone shots, prompting questions from patients and providers.

The Official Guidance on Zilretta Administration

The FDA approved Zilretta for a single intra-articular knee injection. The official prescribing information states that "the efficacy and safety of repeat administration of ZILRETTA have not been demonstrated". This differs from immediate-release corticosteroid injections, where repeat administration is more common, within limits.

This single-dose approval means that coverage for Zilretta is often for one treatment per knee. Providers weigh the benefits of extended relief against the limited data on repeating the treatment.

Clinical Trial Evidence for Repeat Administration

The manufacturer has studied repeat administration. A Phase 3b trial gave a second injection if pain returned.

Key findings included:

  • Similar Efficacy: The second injection showed similar improvements in pain as the first.
  • Increased Arthralgia: Mild to moderate joint pain was more common after the second dose (16%) than the first (6%).
  • Safety Not Fully Characterized: The study data was "insufficient to fully characterize the safety of repeat administration". More research is needed on the long-term effects of multiple injections.

This trial offers some evidence for considering a repeat injection but highlights the need for careful patient selection and monitoring.

Comparison: Zilretta vs. Standard Corticosteroid Injections

Feature Zilretta (Extended-Release Triamcinolone Acetonide) Standard Corticosteroid (e.g., Immediate-Release Triamcinolone)
Dosing Frequency Officially indicated as a single dose; repeat use not demonstrated safe or effective. May be considered based on clinical judgment. Typically limited to a certain number of times per year in the same joint to minimize risks.
Active Ingredient Triamcinolone Acetonide Triamcinolone Acetonide or other corticosteroids
Release Mechanism Extended-release microsphere technology provides sustained relief over months. Immediate release, offering shorter-term relief (weeks to a few months).
FDA Label Includes a specific limitation regarding repeat use. Standard approval for intra-articular injection; dosing frequency is managed by clinical guidelines.
Considerations for Repeat Dose Requires careful weighing of limited repeat-dose safety data, individual response, and potential for increased arthralgia. Balancing the need for pain relief with the risk of cumulative side effects on joint structures.

Risks of Repeated Steroid Injections

Caution with repeat Zilretta injections relates to the general risks of multiple intra-articular corticosteroid injections. Risks for standard steroid shots include:

  • Cartilage Damage: Frequent injections can accelerate cartilage loss.
  • Bone Health: Long-term use can negatively affect bone density.
  • Tendinopathy: Potential weakening of tendons.
  • Infection: A small risk with any injection.

Considering Zilretta's long-lasting effect, the potential cumulative effects of repeat dosing are important, especially with limited long-term safety data.

What to Consider When Repeat Injections are an Option

If you responded well to a single Zilretta injection and your pain returned, your doctor might consider another dose after a careful assessment. This involves:

  • Timing: Repeat injections were studied after pain returned. Waiting for pain to recur is key.
  • Severity of Symptoms: The extent of pain return is a major factor.
  • Overall Treatment Plan: Repeat injections should be part of a broader strategy, not a sole long-term solution. Your provider may discuss other therapies or surgery.
  • Monitoring: Your doctor will monitor your response and any side effects, particularly the increased arthralgia seen with further doses.

Conclusion

While Zilretta is effective for knee osteoarthritis pain with a single dose, how often can you get a ZILRETTA injection in the knee? has a nuanced answer. Repeat dose safety and efficacy are not demonstrated according to the FDA, though a clinical trial showed generally good short-term results with some concerns. A decision for a repeat injection requires careful consultation with a healthcare professional. For more detailed information, consult the official FDA package insert.

Frequently Asked Questions

The official product label states that the safety and efficacy of repeat Zilretta administration have not been demonstrated. While a clinical trial has explored repeat injections, the decision to proceed must be made by your healthcare provider after a careful assessment of your condition.

In clinical trials, a single Zilretta injection significantly reduced knee pain for three months. Some patients may experience relief for a longer period, up to five or six months.

Zilretta uses an extended-release microsphere technology that is different from standard cortisone shots, which are immediate-release. Because of this novel mechanism, the long-term effects of repeating the dose were not fully characterized in initial studies, leading to the cautionary label.

Potential risks of repeated intra-articular steroid injections include acceleration of cartilage degradation, negative effects on bone health, and weakening of joint-supporting tissues. These risks are a key consideration when deciding on repeat Zilretta injections.

Insurance coverage for repeat Zilretta injections varies by provider and plan. Some policies may specifically state that coverage is limited to a single injection per knee, citing the lack of demonstrated safety for repeated use. It is essential to check with your insurance provider.

If you are not a candidate for a repeat Zilretta injection, your doctor may suggest other treatments for osteoarthritis pain. These can include physical therapy, weight management, oral medications, hyaluronic acid injections, or, for severe cases, surgical options.

In 2019, the FDA approved a label update that removed the statement 'not intended for repeat administration' and replaced it with 'the efficacy and safety of repeat administration have not been demonstrated'. This was intended to clarify, not change, the primary single-dose indication, emphasizing that while repeat dosing was studied, long-term safety is not fully characterized.

References

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Medical Disclaimer

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