Collagenase, Clostridium histolyticum (kol-AJ-e-nase klos-TRID-ee-um his-toe-LIT-ik-um)

Treats Dupuytren contracture and Peyronie disease.

Brand Name(s):

Xiaflex

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into your hand or penis.
• A nurse or other health provider will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Dupuytren contracture:
  • Do not try to move or massage the cord, bend, or extend the fingers of the injected hand, or do heavy activity using your hand to prevent more injury.
  • Your doctor may put a splint on your hand after giving this medicine. Wear the splint at bedtime for up to 4 months. Do finger bending and extending exercises as instructed by your doctor.
• Peyronie disease:
  • Do not have sex or have any sexual activity between the first and second injections of a treatment cycle, and for at least 4 weeks after the second injection of a treatment cycle and after pain and swelling has gone away.
  • Avoid situations that may cause straining your stomach muscles (including straining during bowel movements).

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how collagenase, Clostridium histolyticum works. Tell your doctor if you are using blood thinners (including high-dose aspirin or warfarin).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a blood clotting problem.
• This medicine may cause the following problems:
  • Tendon rupture or other serious injury to the affected finger or hand
  • Fracture of or other serious injury to the penis
  • Bleeding or bruising at the injection site
  • Back pain reactions after receiving the injection
• Fainting or near fainting may occur after you receive this medicine. Check with your doctor right away if you feel dizzy or faint. You may lie down until your symptoms go away.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dizziness or fainting
• Fever or chills
• Rapid weight gain, swelling of your hands, ankles, or feet
• Severe bruising or bleeding at the injection site
• Severe lower back pain moving to your legs, feet, arms, or chest
• Peyronie disease: Popping sound or sensation in an erect penis, sudden loss of an erection or painful erection, blood in your urine or trouble urinating

If you notice these less serious side effects, talk with your doctor:

• Redness, pain, itching, bleeding, swelling, or tenderness at or around the injection site
• Swollen, painful, or tender glands in your neck or armpit

If you notice other side effects that you think are caused by this medicine, tell your doctor

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