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Xiaflex:Understanding and Managing Potential Mild to Severe Adverse Reactions

Treating the off-label use of Xiaflex: Understanding and Addressing Potential Mild to Severe Adverse Reactions

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Xiaflex: Managing potential side effects, from mild to severe
Xiaflex: Managing potential side effects, from mild to severe

Xiaflex:Understanding and Managing Potential Mild to Severe Adverse Reactions

Xiaflex, a medication used to treat Peyronie's disease and Dupuytren's contracture in adults, comes with a variety of side effects. It's essential for patients to be aware of these potential risks before undergoing treatment.

Common Side Effects

The most frequent side effects of Xiaflex include:

  • Small collections of blood under the skin at the injection site (hematoma)
  • Swelling at the injection site or along the penis
  • Burning sensation
  • Dizziness
  • Headache
  • Reduced sensation (hypoesthesia)
  • Tingling (paresthesia)

In addition, back pain reactions, including sudden severe lower back pain that may radiate to legs, feet, chest, and arms, have been noted after injection for Peyronie’s disease.

Mild Side Effects

Mild side effects reported with Xiaflex treatment include:

  • Flu-like symptoms
  • Sinusitis
  • Injection site reactions such as cellulitis and lymphangitis

Serious Side Effects

Serious injuries, such as penile fracture (corporal rupture), can occur with Xiaflex treatment for Peyronie’s disease. Symptoms of corporal rupture require immediate medical attention and may include severe bleeding under the skin, severe bruising and swelling of the skin, sudden loss of erection, popping sound or sensation during an erection, pain in the penis, difficulty urinating or blood in the urine.

Hypersensitivity reactions, including severe allergic reactions like anaphylaxis, manifesting as hives, swollen face, breathing difficulties, chest pain, low blood pressure, dizziness or fainting, are also possible. Other serious immunologic responses such as thrombocytopenia (low platelet count) have been reported, although less common.

Back pain associated with spasms severe enough to impair walking is a serious but typically short-lived reaction.

Important Considerations

Due to these potential risks, Xiaflex treatment for Peyronie’s disease is restricted to a REMS (Risk Evaluation and Mitigation Strategy) program. It's crucial for patients to discuss any concerns about their health conditions, medications, or alcohol consumption with their doctor before starting treatment.

In summary, common side effects are mostly local injection site swelling and bruising; mild effects include flu-like symptoms and minor infections; serious side effects involve penile fracture, severe allergic reactions, and significant back pain. Patients should be closely monitored, particularly for signs of serious adverse events.

If you notice any symptoms of penile fracture or other serious injury to the penis, contact your doctor right away or call 911 or your local emergency number. For mild symptoms of an allergic reaction, call your doctor right away. For serious symptoms, immediately call 911 or your local emergency number.

[1] FDA Prescribing Information for Xiaflex. (n.d.). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125220s000lbl.pdf [2] Xiaflex (collagenase clostridium histolyticum) injection, for intralesional use. (2018, July 11). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208529s000lbl.pdf [3] Xiaflex (collagenase clostridium histolyticum) injection, for intralesional use. (2018, July 11). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208528s000lbl.pdf [4] Xiaflex (collagenase clostridium histolyticum) injection, for intralesional use. (2018, July 11). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208527s000lbl.pdf [5] Xiaflex (collagenase clostridium histolyticum) injection, for intralesional use. (2018, July 11). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208526s000lbl.pdf

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