Brand Name(s):

Xiaflex^®

IMPORTANT WARNING

For men receiving collagenaseClostridium histolyticuminjection for treatment of Peyronie's disease:

Serious injury to the penis, including penile fracture (corporal rupture), has been reported in patients receivingClostridium histolyticuminjection for treatment of Peyronie's disease. Surgery may be required to treat the injury, but in some cases the damage may be permanent. If you experience any of the following symptoms, call your doctor immediately: a popping sound or sensation in an erect penis; sudden inability to maintain an erection; pain in the penis; bruising, bleeding, or swelling of the penis; difficult urination; or blood in the urine.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with collagenaseClostridium histolyticumand each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of receiving collagenaseClostridium histolyticuminjection.

WHY is this medicine prescribed?

CollagenaseClostridium histolyticuminjection is used to treat Dupuytren's contracture (a painless thickening and tightening of tissue [cord] beneath the skin in the palm of the hand, which may make it difficult to straighten one or more fingers) when a cord of tissue can be felt upon examination. CollagenaseClostridium histolyticuminjection is also used to treat Peyronie's disease (a thickening of tissue [plaque] inside the penis that causes the penis to curve). CollagenaseClostridium histolyticuminjection is in a class of medications called enzymes. In people with Dupuytren's contracture, it works by helping to break down the cord of thickened tissue and allows the finger(s) to be straightened. In people with Peyronie's disease, it works by helping to break down the plaque of thickened tissue and allows the penis to be straightened.

HOW should this medicine be used?

CollagenaseClostridium histolyticuminjection comes as a powder to be mixed with a liquid and injected by a doctor. If you are receiving collagenaseClostridium histolyticumto treat Dupuytren's contracture, your doctor will inject the medicine into a cord just under the skin in the affected hand. If you are receiving collagenaseClostridium histolyticumto treat Peyronie's disease, your doctor will inject the medicine into the plaque that is causing your penis to curve. Your doctor will choose the best place to inject the medication in order to treat your condition.

If you are receiving treatment for Dupuytren's contracture, do not bend or straighten the fingers of the injected hand or put pressure on the injected area after your injection. Keep the injected hand elevated until bedtime. You must return to your doctor's office on the day after your injection. Your doctor will check your hand, and possibly move and extend the finger to help break up the cord. Ask your doctor when you can expect to see improvement, and call your doctor if your condition does not improve during the expected time. Your doctor may need to give you additional injections if your condition does not improve. Do not perform strenuous activity with the injected hand until your doctor tells you that you can do so. Your doctor will probably tell you to wear a splint every night (at bedtime) for up to 4 months after the injection. Your doctor may also tell you to do finger exercises each day. Follow the directions of your doctor carefully and ask the doctor to explain any part you do not understand.

If you are receiving treatment for Peyronie's disease, your doctor will inject collagenaseClostridium histolyticuminto your penis, followed by a second injection 1 to 3 days after the first injection You must return to your doctor's office 1 to 3 days after your second injection. Your doctor will gently move and stretch your penis (penile modeling procedure) to help straighten your penis. Your doctor will also tell you to gently stretch and straighten your penis at home for 6 weeks afterward. Follow the directions of your doctor carefully and ask the doctor to explain any part you do not understand. Avoid sexual activity for at least 2 weeks after your last injection and after pain and swelling have gone away. Your doctor may need to give you additional treatment cycles.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before receiving collagenase Clostridium histolyticum injection,

tell your doctor and pharmacist if you are allergic to collagenase Clostridium histolyticum injection, collagenase ointment (Santyl), any other medications, or any of the ingredients in collagenase Clostridium histolyticum injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin), aspirin (more than 150 mg per day), clopidogrel (Plavix), and prasugrel (Effient). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had a bleeding condition or any other medical condition. Also, tell your doctor if you have previously received collagenase Clostridium histolyticum injection to treat another condition.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving collagenase Clostridium histolyticum injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your doctor or pharmacist any questions you have about collagenaseClostridium histolyticuminjection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2014.