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Xiaflex is a medicine used to treat Dupuytren's contracture when a "cord" can be felt. Xiaflex is also used to treat adult men with Peyronie's disease who have a "plaque" that can be felt that causes a curve in the penis. Xiaflex is administered directly into the "cord" or "plaque" by your healthcare provider.
Xiaflex may only be available under a special restricted distribution program called the Xiaflex REMS Program. Your healthcare provider will explain this program to you.
How does this medication work?
For Dupuytren's contracture, Xiaflex works by helping to break down the cord of thickened tissue and allows the finger(s) to be straightened. For Peyronie's disease, Xiaflex works by helping to break down the plaque of thickened tissue and allows the penis to be straightened.
What are the beneficial effects of this medication and when should I begin to have results?
Dupuytren's contracture: In studies, many people were able to achieve straight or nearly straight fingers and improve the range of motion of the affected finger.
Peyronie's disease: In studies, men who were treated with Xiaflex experienced a significant improvement in the curve of their erections, compared to men who did not receive Xiaflex.
When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's instructions.
How do I know it is working?
You may notice an improvement in your symptoms. Your healthcare provider may also ask you questions to assess how well your symptoms are controlled with treatment.
The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.
Xiaflex can cause penile fracture or other serious injury to the penis. After treatment with Xiaflex, one of the tubes in the penis may break during an erection. This is called a corporal rupture or penile fracture, and may require surgery to fix the damaged area. Blood vessels may also break, causing blood to collect under the skin. Symptoms may include a popping sound or sensation in an erect penis, sudden loss of the ability to maintain an erection, pain in your penis, purple bruising and swelling of your penis, or difficulty urinating or blood in the urine. Call your healthcare provider right away if you have any of these symptoms. Because of these risks, Xiaflex may only be available through the Xiaflex REMS Program.
More common side effects may include: swelling of the injected hand, injection-site bleeding or reaction, pain, bruise.
More common side effects may include: penis swelling, pain, or hematoma.
Less common side effects of Xiaflex may include:
Tendon rupture or ligament damage in your hand, with symptoms such as trouble bending your injected finger (towards the wrist) after the swelling goes down, or if you have problems using your treated hand after your follow-up visit.
Nerve injury or other serious injuries of the hand, with symptoms such as numbness, tingling, increased pain, or tears in the skin.
Serious allergic reactions, with symptoms such as hives, face swelling, trouble breathing, chest pain, low blood pressure, dizziness, or fainting.
Increased chance of bleeding.
Your healthcare provider will not administer Xiaflex to you if you are allergic to it or any of its ingredients.
Your healthcare provider will not administer Xiaflex to you if your treatment of Peyronie's plaque involves the urethra (the tube that your urine passes through).
Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Xiaflex. Also, talk to your healthcare provider about your complete medical history, especially if you have bleeding problems, received Xiaflex to treat another condition, or are pregnant, plan to become pregnant, or are breastfeeding.
The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.
Adults: Your healthcare provider will prescribe the appropriate dose for you.
Your healthcare provider will administer Xiaflex to you.
Your healthcare provider will show you how to gently stretch your penis the right way. You should do this 3 times a day for 6 weeks after each treatment cycle. Your healthcare provider will also show you how to gently straighten your penis. You should do this 1 time a day for 6 weeks after each treatment cycle.
Your healthcare provider will tell you when you can resume sexual activity after each treatment cycle.
If you experience severe pain or swelling of the penis, severe purple bruising, difficulty urinating or blood in the urine, or sudden loss of the ability to maintain an erection, notify your healthcare provider immediately.
Your healthcare provider may provide you with a splint to wear on the treated finger. Wear the splint at bedtime for up to 4 months. Keep the injected hand elevated until bedtime.
Follow your healthcare provider's instructions about when you can start doing your normal activities with the injected hand. Do finger exercises each day, as instructed by your healthcare provider.
If you experience signs of an infection (such as fever, chills, increasing redness or swelling), trouble bending the finger after the swelling goes down, or other changes, notify your healthcare provider immediately.
Do not miss any scheduled follow-up appointments with your healthcare provider.
Do not bend or straighten the finger of the injected hand until your healthcare provider tells you to.
Do not try to straighten the treated finger yourself.
Do not have sex or any other sexual activity between the first and second injections of a treatment cycle.
Do not have sex or have any other sexual activity for at least 2 weeks after the second injection of a treatment cycle with Xiaflex and after any pain and swelling has gone away.
If Xiaflex is used with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your healthcare provider before combining Xiaflex with blood thinners (such as warfarin).
The effects of Xiaflex during pregnancy and breastfeeding are unknown. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
Xiaflex should be given under special circumstances determined by your healthcare provider. If you miss your scheduled dose, contact your healthcare provider for advice.
Your healthcare provider will store this medication for you.
In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
National Poison Control#: Call 1-800-222-1222
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