Xiaflex is made from a mixture of proteins derived from a certain bacteria.

Xiaflex is used to treat Dupuytren's contracture in adults. This condition causes an abnormal thickening of the tissue in the palm of the hand. This condition may get worse over time and form a "cord" in your palm, causing a permanent bend in your finger.

Xiaflex is also used to treat a related condition called Peyronie's disease in adult men. This condition causes scar tissue or "plaque" to develop under the skin of the penis, resulting in an abnormal curving of the penis during erection.

Xiaflex is available for Peyronie's disease only from a certified pharmacy under a special program called Xiaflex REMS. You must be registered in the program and understand the risks of taking this medicine.

Before you receive Xiaflex, tell your doctor if you have a bleeding or blood clotting disorder, such as hemophilia.

Xiaflex can damage a nerve, tendon, or ligament in the hand the medicine is injected into. After the swelling from your injection goes down, call your doctor if you have numbness, tingling, increased pain, trouble bending your finger toward your wrist, or if you have new or worsened movement problems in your treated hand.

Xiaflex may also damage the erectile tissues inside a man's penis, which could require surgery to correct. Call your doctor right away if you have bruising and swelling of your penis, pain when you urinate, blood in the urine, sudden erection problems, or a "popping" sound or sensation in your penis during an erection.

Before taking this medicine

You should not use Xiaflex if you are allergic to collagenase clostridium histolyticum. This medicine should not be used to treat Peyronie's disease that affects the urethra (the tube for passing urine out of your bladder).

Stop using Xiaflex and call your doctor at once if you have ever has:

• a bleeding or blood clotting disorder, such as hemophilia;

• received Xiaflex to treat another condition; or

• any other medical problems.

It is not known if collagenase clostridium histolyticum will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using Xiaflex.

Xiaflex is injected directly into the "cord" of the affected hand or into a "plaque" of the penis. A healthcare provider will give you this injection. Follow your doctor's instructions very carefully.

For Dupuytren's contracture:

• Do not bend or straighten the fingers of the treated hand until your doctor tells you to.

• Keep the treated hand elevated until bedtime.

• You may need to wear a splint on your hand for a short time to keep your fingers straight. You may also need to perform daily finger exercises.

• One to 3 days after injection into your hand, your doctor will need to examine the hand to see if your condition has improved.

For Peyronie's disease:

• Your penis may need to be wrapped in a bandage for a short time after each injection. Follow your doctor's instructions about how long to wear the bandage.

• One to 3 days after your second Xiaflex injection, your doctor will perform a stretching procedure to help straighten the curve in your penis.

• You may also need to perform gentle exercises to stretch and straighten the penis at home. Carefully follow all directions about how to perform these exercises.

• You should not have any sexual activity between the first and second Xiaflex injections and for at least 4 weeks after your second injection and after any pain or swelling in your penis has gone away.

Usual Adult Dose of Xiaflex for Dupuytren's Contracture:

0.58 mg injected into a palpable cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint

Comments:
-This drug should be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of patients with Dupuytren's contracture.
-Up to 2 joints in the same hand may be treated during a treatment visit. Two palpable cords affecting 2 joints may be injected or one palpable cord affecting 2 joints in the same finger may be injected at 2 locations during a treatment visit. If a patient has other palpable cords with contractures of MP or PIP joints, these cords may be injected at other treatment visits approximately 4 weeks apart.
-Approximately 24 to 72 hours following an injection, a finger extension procedure should be performed if a contracture persists. Consult manufacturer product information or local protocol for information on the finger extension procedure.
-Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals.
-Up to 2 cords in the same hand may be injected at a treatment visit. If a patient has other cords with contractures, those cords should be injected at another treatment visit.
-Vital signs should be monitored and appropriate equipment should be available to address any severe local or systemic reactions including the potential for anaphylaxis that may occur following injection.

Usual Adult Dose of Xiaflex for Peyronie's Disease:

0.58 mg injected into the target plaque once on each of two days, 1 to 3 days apart

Comments:
-This drug should be administered by a healthcare provider experienced in the treatment of male urological diseases, who has completed required training for use of this drug in the treatment of Peyronie's disease.
-A treatment cycle consists of 2 injection procedures and a penile modeling procedure.
-For each plaque causing the curvature deformity, up to 4 treatment cycles may be administered. Each treatment cycle may be repeated at approximately 6 week intervals. If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if further treatment is not indicated, then subsequent treatment cycles should not be administered.
-The safety of more than one treatment course for Peyronie's disease is not known.

You should not use Xiaflex if you are allergic to collagenase clostridium histolyticum. This medicine should not be used to treat Peyronie's disease that affects the urethra (the tube for passing urine out of your bladder).

Stop using Xiaflex and call your doctor at once if you have ever has:

• a bleeding or blood clotting disorder, such as hemophilia;

• received Xiaflex to treat another condition; or

• any other medical problems.

It is not known if collagenase clostridium histolyticum will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using Xiaflex.

Call your doctor for instructions if you miss an appointment for your Xiaflex injection.

In a medical setting an overdose would be treated quickly.

Avoid any strenuous activity using the treated hand until your doctor tells you to resume normal activities.

Avoid situations where you may strain your stomach muscles, such as straining during bowel movements.

Get emergency medical help if you have signs of an allergic reaction to Xiaflex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Collagenase clostridium histolyticum can damage a nerve, tendon, or ligament in the hand the medicine is injected into. Call your doctor at once if you have:

• fever, chills, increased redness, or swelling;

• numbness, or tingling in the treated finger; or

• trouble bending the injected finger after the swelling decreases.

Xiaflex may also damage the erectile tissues inside a man's penis, which could require surgery to correct. Call your doctor right away if you have:

• bruising and swelling of your penis;

• pain when you urinate, blood in the urine;

• sudden erection problems; or

• a "popping" sound or sensation in your penis during an erection.

Also call your doctor at once if you have:

• sudden back pain, chest pain, or problems walking after an injection; or

• feeling like you might pass out (even while lying down).

Common Xiaflex side effects may include:

• swelling, bruising, bleeding, pain, or tenderness where the medicine was injected;

• swollen glands in your elbow or underarm;

• itching, redness, or warmth of the skin;

• cracked skin;

• underarm pain;

• pain or tenderness in your treated hand;

• bruising of the penis or scrotum, erection problems; or

• discoloration of the skin on your penis, bruising or blisters where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• a blood thinner - warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may interact with collagenase clostridium histolyticum, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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