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.

How XIAFLEX® is administered

How XIAFLEX^® is administered

XIAFLEX^® (collagenase clostridium histolyticum) is an injection that is given directly into the Dupuytren's cord. You can get treated right in your doctor's office. Please read the XIAFLEX^®Medication Guide before you receive XIAFLEX^® and each time you get an injection.

XIAFLEX^® injection

Injecting XIAFLEX^®

• First, your doctor will clean the area
• The cord that is causing your finger to bend will be injected with a small needle
• Once the injection is over, your doctor will provide a bandage to cover your hand

If you have more than one cord and your specialist thinks it is appropriate, the next cord that you have may be treated with XIAFLEX^® at a later time.

Tip: Limit moving and using the treated finger after the injection. Keep the injected hand elevated until bedtime. Your finger may straighten on its own before you see the doctor, but do not try to push it into a straighter position

Next day follow-up with your hand specialist

• You will return to your doctor for a finger extension about 24 hours after your XIAFLEX^® injection(s). In this part of the procedure, your doctor will carefully unbend your finger to "break" the cord and try to straighten the finger. Many patients feel or hear a popping or cracking sound. (Some say it is like the sound of knuckles cracking.)

Tip: After the finger extension visit, your doctor will give you a splint to wear at night to help keep your finger straight. You may also be shown finger exercises to do at home.

• Follow your doctor's instructions about when you can start doing your normal activities with the injected hand

30-day follow-up with your specialist

• After about 30 days have passed, you should see your doctor for a progress check
• Because individual results will vary, your doctor may suggest repeating the XIAFLEX^® treatment cycle (Steps 1, 2 and 3) up to 3 times for each Dupuytren's cord

Prepare for your XIAFLEX® consultation

Prepare for your XIAFLEX^® consultation

If you have been diagnosed with Dupuytren’s contracture and have a cord that can be felt, XIAFLEX^®may be an effective non-surgical choice to treat your condition. However, there are some situations in which you may not be able to take advantage of this option. See the list below of points, which you should discuss with your doctor, to see if XIAFLEX^® is the best choice for you.

What should I tell my healthcare provider before starting treatment with XIAFLEX^®?

XIAFLEX^® may not be right for you. Before receiving XIAFLEX^®, tell your healthcare provider if you:

• have had an allergic reaction to a previous XIAFLEX^® injection
• have a bleeding problem
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if XIAFLEX^® will harm your unborn baby
• are breastfeeding. It is not known if XIAFLEX^® passes into your breast-milk. Talk to your healthcare provider about the best way to feed your baby if you receive XIAFLEX^®

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you use:

• a blood thinner medicine such as aspirin, clopidogrel (Plavix^®), prasugrel hydrochloride (Effient^®), or warfarin sodium (Coumadin^®). If you are told to stop taking a blood thinner before your XIAFLEX^®injection, your healthcare provider should tell you when to restart the blood thinner.