Xiaflex (collagenase clostridium histolyticum)

What are the side effects of Xiaflex?

WARNING

Corporal Rupture (Penile Fracture) or Other Serious Penile Injury in the Treatment of Peyronie’s Disease

Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) Xiaflex-treated patients in clinical studies. In other Xiaflex-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile “popping” sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) Xiaflex-treated patients.

Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention.

Because of the risks of corporal rupture or other serious penile injury, Xiaflex is available for the treatment of Peyronie’s disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Xiaflex REMS Program.

Xiaflex may cause serious side effects, including:

increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive Xiaflex. Talk to your healthcare provider if you have a problem with your blood clotting. Xiaflex may not be right for you.

What is the most important information I should know about Xiaflex for the treatment of Dupuytren’s contracture?

Xiaflex can cause serious side effects, including:

• Tendon rupture or ligament damage. Receiving an injection of Xiaflex may cause damage to a tendon or ligament in your hand and cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit.
• Nerve injury or other serious injury of the hand. Call your healthcare provider right away if you get numbness, tingling, increased pain, or tears in the skin (laceration) in your treated finger or hand after your injection or after your follow-up visit.
• Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive Xiaflex, because it contains foreign proteins.

Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of Xiaflex:

The most common side effects with Xiaflex for the treatment of Dupuytren’s contracture include:

• swelling of the injection site or the hand
• bruising or bleeding at the injection site
• pain or tenderness of the injection site or the hand
• swelling of the lymph nodes (glands) in the elbow or armpit (axilla)
• itching
• breaks in the skin
• redness or warmth of the skin
• pain in the armpit

What is the most important information I should know about Xiaflex for the treatment of Peyronie’s disease?

Xiaflex can cause serious side effects, including:

• Penile fracture (corporal rupture) or other serious injury to the penis. Receiving an injection of Xiaflex may cause damage to the tubes in your penis called the corpora. After treatment with Xiaflex, one of these tubes may break during an erection. This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture.
  • After treatment with Xiaflex, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin.
    • Symptoms of corporal rupture or other serious injury to your penis may include:
      • a popping sound or sensation in an erect penis
      • sudden loss of the ability to maintain an erection
      • pain in your penis
      • purple bruising and swelling of your penis
      • difficulty urinating or blood in the urine

Call your healthcare provider right away if you have any of the symptoms of corporal rupture or serious injury to the penis listed above.

Do not have sex or any other sexual activity between the first and second injections of a treatment cycle.

Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with Xiaflex and after any pain and swelling has gone away.

Xiaflex for the treatment of Peyronie’s disease is only available through a restricted program called the Xiaflex Risk Evaluation and Mitigation Strategy (REMS) Program. For more information about the Xiaflex REMS Program go to www.XiaflexREMS.com or call 1-877-942-3539.

• Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive Xiaflex, because it contains foreign proteins.

Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of Xiaflex:

The most common side effects with Xiaflex for the treatment of Peyronie’s disease include:

• a small collection of blood under the skin at the injection site (hematoma)
• swelling at the injection site or along your penis
• pain or tenderness at the injection site, along your penis and above your penis
• penis bruising
• itching of your penis or scrotum (genitals)
• painful erection
• erection problems (erectile dysfunction)
• changes in the color of the skin of your penis
• blisters at the injection site
• pain with sex
• a lump at the injection site (nodule)

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects with Xiaflex. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.