Xiaflex was approved in 2010 for the treatment of Dupuytren’s contracture. Dupuytren’s contracture is a condition where nodules form under the skin in the palm of the hand. These nodules thicken and form cords that pull the affected finger down toward the palm. It affects hand and finger movement and usually involves the ring finger and little finger.
In 2013, Xiaflex was approved to treat Peyronie’s Disease. Peyronie’s disease is a disorder that affects the penis. A collagen plaque forms under the skin of the penis. This can cause the penis to curve and can cause pain and difficulty forming an erection.
According to studies, Xiaflex improved both Dupuytren’s contracture and Peyronie’s disease.
Below are common questions and answers about Xiaflex and whether it may be a good treatment option for you.
How Does It Work?
In both Dupuytren’s contracture and Peyronie’s disease, excess collagen plaques or cords form and restrict movement. Xiaflex dissolves these collagen plaques and cords to help restore normal movement and function.
How Do I Take It?
Xiaflex is given by a health care provider. For Dupuytren’s contracture, you will receive an injection into the cord. After the injection, you should limit the use and movement of the affected fingers. You will return to your health care provider’s office in 1 to 3 days following your injection, where they will perform a finger extension procedure. You will be required to wear a splint at bedtime and will complete exercises several times a day. If the cord still remains, you may receive up to three injections per cord, each four weeks apart. Ask your health care provider when you can return to normal activity.
For Peyronie’s disease, you may receive up to four treatment cycles. Each treatment cycle includes two injections one to three days apart, followed by a penile modeling procedure one to three days after the second injection. Treatment cycles are separated by 6 weeks. Your provider will determine how many treatment cycles are needed. You will be required to perform daily stretching and straightening exercises for 6 weeks after each modeling procedure.
How Was It Studied for Dupuytren’s Contracture?
The effect of Xiaflex on Dupuytren’s contracture was studied in two clinical trials. To be included in these studies, people had to have a palpable cord with at least a 20-degree contracture. They also were unable to place the affected hand or finger flat on the table.
People in these studies were over the age of 18, with an average age of about 63. The majority were male, and everyone was White.
People in these studies were injected with either Xiaflex or a placebo. One day after the injection, the cords were manipulated in order to try to break the cords. People could receive up to three injections per joint, 30 days apart. They had to wear a splint at bedtime and perform daily finger extension exercises. Successful treatment was a reduction in the primary contracture to within 5 degrees of full extension.
What Are the Benefits Based on Studies for Dupuytren’s Contracture?
Reduction in contracture. In the first study, 64% of all primary joints treated with Xiaflex had treatment success compared to about 7% with a placebo. In the second study, 44% of people treated with Xiaflex had treatment success compared to 5% with a placebo.
Increased range of motion. People treated with Xiaflex saw greater improvements in their range of motion compared to placebo. In the first study, those treated with Xiaflex saw their range of motion increase by an average of 37 degrees, compared to 4 degrees with placebo. In the second study, Xiaflex improved range of motion by an average of 35 degrees, while the placebo improved by only 8 degrees.
The majority had clinical improvement. Clinical improvement was considered at least a 50% reduction in contracture. In the first study, 85% of people using Xiaflex had clinical improvement compared to 12% with a placebo. In the second study, 78% of people using Xiaflex had clinical improvement compared to 14% with a placebo
Early treatment is better. Results showed that people with less severe contracture responded better than those with severe contracture.
How Was It Studied for Peyronie’s Disease?
People were included in these studies if they had at least a 30-degree curvature deformity of the penis. The degree of curvature of people in the study ranged from 30 degrees to 90 degrees.
People in these studies were between the ages of 23 to 84, with an average age of 58. Ninety-seven percent were White and 3% were Black. The average degree of penis curvature was about 50%, and about 50% had a history of erectile dysfunction.
People in these studies received either Xiaflex or a placebo. They received two injections, which were one to three days apart. One to three days after the second injection, they underwent a penis remodeling procedure where the penis would be stretched and elongated. This treatment cycle was repeated every 6 weeks for up to four treatment cycles. People in these studies had to also perform the penis remodeling procedure daily at home between cycles.
The study looked at the percentage change at week 52 in the curvature deformity. It also looked at the change in the Bother score at week 52. The Bother score was a patient questionnaire that rated erection pain, erection appearance, and the impact of Peyronie’s disease on their sex life.
What Are the Benefits Based on Studies for Peyronie’s Diseases?
Improvement in curvature. In both studies, treatment with Xiaflex improved the curvature of the penis better than placebo. In the first study, Xiaflex changed the curvature by 35%. Placebo improved the curvature by about 18%. In the second study, Xiaflex improved the curvature by about 33%, and placebo improved the curvature by 22%.
Average change of 17 degrees. Treatment with Xiaflex improved the curvature by an average of 17 degrees. Placebo saw a 9-degree improvement.
Improvement in Bother score. In both studies, Xiaflex decreased the Bother score greater than the placebo. Before treatment, the average Bother score ranged from 7.4 to 8.2. In the first study, Xiaflex decreased the score by 2.8 points whereas the placebo decreased the score by 1.6 points. In the second study, Xiaflex decreased the score by 2.6 points versus 1.5 points with the placebo.
When Can I Expect Results?
For Dupuytren’s contracture, some people had treatment success after one treatment at 30 days. Others may require three injections and 90 days before improvement is seen. In studies, half of people had treatment success by day 56 to 57 of treatment.
For Peyronie’s disease, some people started to see an improvement after the first treatment cycle. The greatest benefit was seen after the fourth treatment cycle. Talk to your health care provider if you do not notice an improvement in three months.
How Can I Prevent and Manage Side Effects?
In both Dupuytren’s contracture and Peyronie’s disease, side effects mostly occurred at the injection area and were mild to moderate in severity.
Xiaflex can cause fainting in both Dupuytren’s contracture and Peyronie’s disease. In most cases, fainting occurred right after the injection or within 1 to 2 days of the injection. Pain was the most common reason for fainting. If you feel dizzy or as though you may faint, you should lie down until you feel better.
In Dupuytren’s contracture, the most common side effects were swelling of the hands, bruising, and pain. In studies, most side effects were mild to moderate and went away in about 2 weeks. An over-the-counter (OTC) pain reliever such as acetaminophen may help with pain.
Xiaflex can cause severe damage to the hand including tendon, ligament, and nerve damage. Surgery may be required. Tell your health care provider if you have any of the following symptoms.
- Trouble using your hand after the follow-up visit
- Trouble bending your finger after the swelling has gone
- Numbness or tingling
- Signs of an infection
- Cuts or tears in the skin
In Peyronie’s disease, the most common side effects were bruising, swelling, and pain in the penis. These symptoms should go away in two to four weeks. Over-the-counter (OTC) pain relievers such as acetaminophen may help with mild to moderate pain.
Although rare, Xiaflex can cause severe damage to the penis including penile fracture. When the penis is erect, the damaged inner tissue may rupture. This is a medical emergency and you should seek care right away. The injection may also cause blood to pool below the skin surface. In severe cases, this can lead to tissue death (necrosis) and may require surgery.
Call your health care provider right away if you develop any of the following symptoms:
- Severe pain or swelling of the penis
- A popping sound or sensation in the penis
- Severe purple bruising on the penis
- Trouble urinating (peeing)
- Blood in the urine (pee)
- Suddenly unable to maintain an erection
- Signs of an infection
Back pain may also occur after Xiaflex injections for Peyronie’s disease. The pain may be mild or severe but usually only lasts about 15 minutes. The pain may spread to the legs, chest, and arms. You may develop muscle spasms and it may be difficult to walk. Tell your health care provider if you develop severe pain or have trouble walking.
What Type of Drug Interactions Can Happen?
Xiaflex can increase your risk of bleeding, so you should avoid other medicines that increase this risk. Tell your health care provider about all medicines you take including anticoagulants such as Xarelto and warfarin and antiplatelet medicines like clopidogrel.
What Are the Aftercare Instructions?
Dupuytren’s contracture
You should elevate your hand after the injection until bedtime. You should avoid strenuous activity including flexing or extending the fingers. You should also avoid manipulating the injected cord.
After the finger extension procedure, your health care provider will give you a splint to wear for up to 4 months. They will also give you finger flexion and extension exercises to do daily.
Peyronie’s disease
Your health care provider will teach you how to perform gentle remodeling exercises.
You should avoid sex between the first and second injections of each treatment cycle. You should avoid sex for at least 4 weeks after the second injection of a treatment cycle and until the pain and swelling have gone away. You should also avoid using a vacuum erection device.
You should avoid straining during bowel movements. Make sure you are drinking enough fluids and eating a healthy diet with plenty of fiber. An over-the-counter stool softener may also help.
What Do I Need to Do to Get It?
Xiaflex for Peyronie’s disease is only available under the Xiaflex REMS program because of the severe side effect risk. Providers must be certified and trained in order to give Xiaflex.
If you are receiving Xiaflex for Dupuytren’s contracture, your hand specialist should also be trained on how to use Xiaflex.
Is There Any Cost Assistance Available?
A copay assistance program is available for eligible people. Eligibility depends on your current prescription and medical coverage. Eligible people may be able to pay as little as $0 out of pocket for Xiaflex.
For Dupuytren’s contracture, visit www.Xiaflex-savings.com or call 877-942-3539 for more information.
For coverage and cost questions about Peyronie's disease, call Endo Advantage at 800-743-2382.
