Xiaflex

Xiaflex is a prescription medication used for the treatment of Dupuytren’s contracture, a progressive hand disease that can affect a person’s ability to straighten and properly use their fingers. It is also used to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.

Xiaflex is a biologic medicine (made from the protein product of a living organism). It is believed to work for Peyronie’s disease by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature deformity. It works to treat Dupuytren's contracture by breaking the cord of tissue that is causing the finger to be bent.

Xiaflex is a prescription medication used to treat:

• adults with Dupuytren’s contracture (a condition in which tissue under the skin in the palm of the hand tightens and thickens into a painless "cord" that may make it difficult to move the fingers)
• Peyronie's disease (a condition in which a plaque (lump) in the penis forms caused by scar tissue that develops under the skin of the penis, resulting in a curvature deformity of at least 30 degrees upon erection)

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

• Auxilium Pharmaceuticals, Inc.

Common side effects with Xiaflex include:

• swelling of the injection site or the hand
• bleeding or bruising at the injection site
• pain or tenderness of the injefction site or the hand
• swelling of the lymph nodes (glands) in the elbow or underarm
• itching
• breaks in the skin
• redness or warmth of the skin
• pain in the underarm

These are not all of the possible side effects with Xiaflex. Tell your healthcare provider about any side effect that bothers you or does not go away.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you use:

• a blood thinner medicine such as aspirin,
• clopidogrel (Plavix),
• prasugrel hydrochloride (Effient),
• or warfarin sodium (Coumadin). 

If you are told to stop taking a blood thinner before your Xiaflex injection, your healthcare provider should tell you when to restart the blood thinner.

Xiaflex can cause serious side effects, including:

1. Tendon rupture or ligament damage. Receiving an injection of Xiaflex may cause damage to a tendon or ligament in your hand and cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit.
2. Nerve injury or other serious injury of the hand. Call your healthcare provider right away if you get numbness, tingling, or increased pain in your treated finger or hand after your injection or after your follow-up visit.
3. Allergic Reactions. Allergic reactions can happen in people who take Xiaflex because it contains foreign proteins.

Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of Xiaflex:

• hives
• swollen face
• breathing trouble
• chest pain

Treatment of Peyronie's Disease

When prescribed for the treatment of Peyronie’s disease, Xiaflex is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) because of the risks of serious adverse reactions, including penile fracture (rupture of one of the penile bodies within the penile shaft, also known as corporal rupture) and other serious penile injury.

Xiaflex for the treatment of Peyronie’s disease should be administered by a health care professional who is experienced in the treatment of male urological diseases. The REMS requires participating health care professionals to be certified within the program by enrolling and completing training in the administration of Xiaflex treatment for Peyronie’s disease. The REMS also requires health care facilities to be certified within the program and ensure that Xiaflex is dispensed only for use by certified health care professionals.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xiaflex there are no specific foods that you must exclude from your diet when receiving Xiaflex.

Before receiving Xiaflex, tell your healthcare provider if you:

• have had an allergic reaction to a previous Xiaflex injection.
• have a bleeding problem (e.g. hemophilia)
• have any other medical conditions.
• are pregnant or plan to become pregnant.
• are breastfeeding. 

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
 
This medication falls into category B. There are no well-done studies that have been done in humans with Xiaflex. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Xiaflex passes into your breastmilk. Talk to healthcare provider about the best way to feed your baby if you receive Xiaflex.

Treatment of Dupuytren’s Contracture

• Your healthcare provider will inject Xiaflex into the cord that is causing your finger to bend.
• After an injection of Xiaflex, your affected hand will be wrapped with a bandage. You should limit moving and using the treated finger after the injection.
• Do not bend or straighten the fingers of the injected hand until your healthcare provider says it is okay. This will help prevent the medicine from leaking out of the cord.
• Do not try to straighten the treated finger yourself.
• Keep the injected hand elevated until bedtime.

Call your healthcare provider right away if you have:

• signs of infection after your injection, such as fever, chills, increased redness, or swelling
• numbness or tingling in the treated finger
• trouble bending the injected finger after the swelling goes down

Return to your healthcare provider’s office as directed on the day after your injection. During this first follow-up visit, if you still have the cord, your healthcare provider may try to extend the treated finger to “break” the cord and try to straighten your finger. Your healthcare provider will provide you with a splint to wear on the treated finger.

• Wear the splint as instructed by your healthcare provider at bedtime to keep your finger straight.
• Do finger exercises each day, as instructed by your healthcare provider.
• Follow your healthcare provider’s instructions about when you can start doing your normal activities with the injected hand.

Treatment of Peyronie's Disease

A treatment course for Peyronie’s disease consists of a maximum of four treatment cycles. Each treatment cycle consists of two Xiaflex injection procedures (in which it is injected directly into the collagen-containing structure of the penis) and one penile modeling procedure performed by the health care professional.

The effects of overdose of Xiaflex are unknown. It is possible that multiple simultaneous or excessive doses of Xiaflex may cause more severe local effects including serious adverse reactions (e.g., tendon ruptures) than the recommended doses. Supportive care and symptomatic treatment are recommended in these circumstances.

Xiaflex is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.