Generic name: collagenase clostridium histolyticum (KOL a JEN ase klos TRID ee um HIS toe LIT ik um)
Brand name: Xiaflex
Drug class: Miscellaneous uncategorized agents
Xiaflex (collagenase clostridium histolyticum) 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 receiving this medicine
You should not use Xiaflex if you are allergic to collagenase clostridium histolyticum. Xiaflex should not be used to treat Peyronie's disease that affects the urethra (the tube for passing urine out of your bladder).
To make sure Xiaflex is safe for you, tell your doctor if you have:
- a bleeding or blood clotting disorder, such as hemophilia; or
- if you take a blood thinner such as warfarin (Coumadin, Jantoven).
FDA pregnancy category B. Xiaflex is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether collagenase clostridium histolyticum passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby while using Xiaflex.
Xiaflex pregnancy and breastfeeding warnings (more detail)
How is Xiaflex given?
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 dosing instructions very carefully.
For Dupuytren's contracture:
- Xiaflex is usually given in a treatment cycle of 1 to 3 injections given 4 weeks apart.
- After your injection, do not touch or put pressure on the treated area of the hand for the rest of the day. 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, especially at night. You may also need to perform daily finger exercises. Follow your doctor's instructions.
- One to 3 days after injection into your hand, your doctor will need to examine the hand to see if your condition has improved.
- If you still have the cord, your doctor may try to break it by extending your treated finger.
Call your doctor if you have trouble bending the treated finger after the swelling goes down.
For Peyronie's disease:
- Xiaflex is usually given in a treatment cycle of 2 injections given 1 to 3 days apart.
- 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 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 every day for 6 weeks. Carefully follow all directions about how to perform these exercises.
- You should not have any sexual activity for at least 2 weeks after your second injection if the first injection caused any pain or swelling in your penis.
Usual Adult Dose of Xiaflex for Dupuytren's Contracture:
0.58 mg as a single injection into the target cord, followed by a finger extension procedure approximately 24 hours later to facilitate disruption of the cord in those individuals who did not experience spontaneous disruption, and up to two follow-up injections at 4 week intervals, if necessary.
Additional cords are to be handled sequentially
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Xiaflex injection.
What happens if I overdose?
Since Xiaflex is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid before and after receiving Xiaflex?
After your injection for Dupuytren's contracture, do not flex or extend the fingers of your treated hand until you visit your doctor again. Extending your fingers may cause the medicine to spread away from the treatment area, making it less effective. Avoid any strenuous activity using the treated hand until your doctor tells you to resume normal activities.
Avoid sexual activity during your treatment for Peyronie's disease. Your doctor will tell you when it is safe to resume sexual activity.
Xiaflex side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Xiaflex: hives; chest pain, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
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
- 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.
Also call your doctor at once if you have:
- signs of infection such as fever, chills, redness or swelling;
- severe pain, itching, or other irritation; 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;
- mild 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 Xiaflex 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.
What other drugs can affect Xiaflex?
Other drugs may interact with collagenase clostridium histolyticum, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.