XIAFLEX Potential side effects

XIAFLEX Potential side effects

Although XIAFLEX^® has been proven to be safe and effective in controlled clinical trials, it is still important to know about the potential side effects.

Serious side effects

In clinical trials, serious side effects with XIAFLEX^® occurred in 0.6% of 1,082 patients studied.

The types of serious side effects associated with XIAFLEX^® include:

• Tendon or ligament damage. Receiving an injection of XIAFLEX^® may damage 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 doctor right away if you have trouble bending your injected finger (toward 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 doctor if you get numbness, tingling, or increased pain in your treated finger or hand after your injection or after your follow-up visit.
• Allergic reactions. Allergic reactions can happen in people who take XIAFLEX^® because it contains foreign proteins. Call your doctor right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX^®:
  – hives
  – swollen face
  – breathing trouble
  – chest pain

Most common side effects

The side effects most often seen with XIAFLEX^® are:

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

Before receiving XIAFLEX^®, tell your doctor if you have had an allergic reaction to a previous XIAFLEX^® injection, or have a bleeding problem or any other medical conditions. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Be sure to tell them if you use blood thinners such as aspirin, clopidogrel (Plavix^®), prasugrel hydrochloride (Effient^®), or warfarin sodium (Coumadin^®).

About XIAFLEX^®

XIAFLEX^® (collagenase clostridium histolyticum) is a prescription medicine used to treat adults with Dupuytren’s contracture when a “cord” can be felt. Over time, the thickening of this cord in your hand can cause one or more fingers to bend toward your palm, so that you cannot straighten them. XIAFLEX^® helps to break down the cord that is causing the finger to be bent. XIAFLEX^® should be injected into the cord by a healthcare provider who is experienced in injection procedures of the hand and treating people with Dupuytren’s contracture.

IMPORTANT SAFETY INFORMATION

XIAFLEX^® can cause serious side effects, including:

• Tendon 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 if you get numbness, tingling, or increased pain in your treated finger or hand after your injection or after your follow-up visit.
• Allergic Reactions. Allergic reactions can happen in people who have received an injection of 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^®: hives; swollen face; breathing trouble; or chest pain.

Before receiving XIAFLEX^®, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX^® injection, or have a bleeding problem or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Be sure to tell them if you use blood thinners such as aspirin, clopidogrel (Plavix^®), prasugrel hydrochloride (Effient^®), or warfarin sodium (Coumadin^®).

Common side effects with XIAFLEX^® include: swelling of the injection site or the hand, bleeding or bruising at the injection site; and pain or tenderness of the injection site or the hand, swelling of the lymph nodes (glands) in the elbow or underarm, itching, breaks in the skin, redness or warmth of the skin, and pain in the underarm.

Please see Full Prescribing Information and Medication Guide.