All About Xiaflex

What is Xiaflex?

If you have Dupuytren’s contracture or Peyronie’s disease, your doctor may suggest treatment with Xiaflex. This is a prescription medication used to treat these two conditions in adults in certain situations.

For more information, see the “What is Xiaflex used for?” section below.

Xiaflex basics

The active ingredient in Xiaflex is collagenase clostridium histolyticum. (An active ingredient is what makes a drug work.) It is a biologic drug, which means it’s made from parts of living organisms.

The drug is not available in a generic or biosimilar form. Biosimilars are like generic drugs. But unlike generics, which are made for nonbiologic drugs, biosimilars are made for biologic drugs.

Xiaflex comes as a powder in a vial. A healthcare professional will use the powder to make a liquid solution for injection.

Keep reading to learn more about Xiaflex, including the drug’s dosage, cost, side effects, and more.

What is the dosage of Xiafex injections?

Your doctor will recommend the dosage of Xiaflex that’s right for you. Below are commonly used dosages, but the dosage you receive will be determined by your doctor.

Form and strength

Xiaflex comes as a powder in a vial. A healthcare professional will use the powder to make a liquid solution for injection. The powder comes in one strength: 0.9 mg.

Recommended dosages

The recommended Xiaflex dosage depends on whether the drug is used to treat Dupuytren’s contracture or Peyronie’s disease. (For more about the use of the drug for these conditions, see the “What is Xiaflex used for?” section below.)

Xiaflex dosage for Dupuytren’s contracture

For treating Dupuytren’s contracture, each cord of tissue in the hand may receive up to three Xiaflex injections. A healthcare professional will give you these injections in doctor’s office or other healthcare setting. If you receive more than one injection in a cord, the injections should be at least 4 weeks apart.

If you have more than one cord, you may have injections in up to two cords in the same hand during the same appointment. You’ll receive injections at separate appointments if you have more than two cords in the same hand. Your doctor can tell you how often you’ll need to have injections of Xiaflex.

Xiaflex dosage for Peyronie’s disease

For treating Peyronie’s disease, Xiaflex is given in treatment cycles.

Each treatment cycle consists of two Xiaflex injections, with 1 to 3 days between injections. Each plaque (area of scar tissue in the penis) may receive up to a maximum of four treatment cycles (eight Xiaflex injections).

If you have more than one cycle of treatment, the cycles will be scheduled so that they occur about every 6 weeks.

Questions about Xiaflex’s dosing

Below are some common questions about Xiaflex’s dosing.

• What if I miss a dose of Xiaflex? If you miss an appointment to receive a Xiaflex injection, immediately contact your doctor’s office to reschedule your appointment.
• Will I need to receive Xiaflex long term? No, because there are a maximum number of Xiaflex injections you may receive. Your doctor will recommend how many you should receive based on your condition.
• How long does Xiaflex take to work? It can depend on the condition it’s used to treat. Xiaflex may dissolve a cord causing Dupuytren’s contracture within 1 to 3 days, but this isn’t the case for everyone. Xiaflex can take up to several weeks and multiple treatments to fully work for Dupuytren’s contracture or Peyronie’s disease. Your doctor can provide more information about how long Xiaflex may take to work and possible recovery time.

What do Xiaflex injections cost?

Costs of prescription drugs such as Xiaflex can vary depending on many factors, such as whether you have insurance.

If you have questions about how to pay for your prescription, talk with your doctor. A copay assistance program may help you save on the cost of Xiaflex injections if you have insurance. For more information, see the program brochure or call 877-942-3539.

You can also check out this article to learn more about saving money on prescriptions.

What are Xiaflex’s side effects?

Like most drugs, Xiaflex may cause mild or serious side effects. The lists below describe some of the more common side effects that Xiaflex may cause. These lists don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

• your age
• other health conditions you have
• other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Xiaflex. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a list of some of the mild side effects that Xiaflex can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Xiaflex’s prescribing information.

Mild side effects of Xiaflex that have been reported in people receiving the drug to treat Dupuytren’s contracture include:

• swelling or bruising, usually in the affected hand
• injection site reactions, including pain, discoloration, and warmth
• pain in the affected finger
• pain or swelling in the lymph nodes
• breaks in the skin of the injected hand
• mild allergic reaction*

Mild side effects of Xiaflex that have been reported in people receiving the drug to treat Peyronie’s disease include:

• hematoma (pooling of blood under the skin) at the site where Xiaflex is injected
• injection site reactions, including pain, blistering, and swelling
• bruising, itching, pain, or tenderness affecting the penis
• erectile dysfunction (ED)
• painful erection
• pain during sex
• changes to the skin color of the penis
• mild allergic reaction*

* To learn more about this side effect, see the “Allergic reaction” section below.

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Xiaflex can occur, but they aren’t common. If you have serious side effects from Xiaflex, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Xiaflex may vary depending on the condition it’s used to treat. The following have been reported with Dupuytren’s contracture:

• serious reactions at or around the site where Xiaflex is injected, such as tendon rupture

Serious side effects that have been reported with Peyronie’s disease include:

• sudden, brief back pain
• boxed warning: risk of penile fracture and other serious penis injury*

The following may occur when Xiaflex is used for either condition:

• fainting up to 2 days after receiving a Xiaflex injection, which could result in injury from falls
• severe allergic reaction†

* For more information, see the “What should be considered before starting Xiaflex?” section.
† To learn more about this side effect, see the “Allergic reaction” section below.

Allergic reaction

Some people may have an allergic reaction to Xiaflex. But this side effect was rare in studies of the drug.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (temporary warmth, discoloration, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, usually in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Xiaflex. But if you think you’re having a medical emergency, call 911 or your local emergency number.

What is Xiaflex used for?

Xiaflex is a prescription medication used to treat Dupuytren’s contracture and Peyronie’s disease in adults in certain situations. The following sections describe these uses.

Xiaflex for Dupuytren’s contracture

Xiaflex is prescribed to treat Dupuytren’s contracture in adults. For this purpose, the person with the condition must have a cord of tissue that can be felt in the palm of their hand.

Dupuytren’s contracture occurs when nodules (lumps) of tissue form under the skin of the palm. These nodules develop thick cords that extend into one or more fingers. The cords can tighten, causing the joints in affected fingers to bend and become difficult to straighten.

Xiaflex is injected directly into the cord or cords in the hand to break them down.

Xiaflex for Peyronie’s disease

Xiaflex can be prescribed to treat Peyronie’s disease in adult males* if:

• there is a plaque (area of scar tissue) in the penis that can be felt, and
• the penis has a curve of at least 30 degrees

With Peyronie’s disease, one or more plaques develop under the skin of the penis. They appear as flat, hard lumps. Other symptoms of Peyronie’s disease include:

• erectile dysfunction (ED), including painful or soft erections
• curved penis, mainly when the penis is erect
• trouble having or enjoying sex due to the curve in the penis
• anxiety or depression related to the condition
• penis pain, especially with an erection

Xiaflex is injected directly into the penis plaque, where it works by breaking down the plaque. As part of treatment, your doctor will instruct you on exercises you’ll do to gently stretch and strengthen your penis.

* In this article, we use the term “male” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.

What are some frequently asked questions about Xiaflex?

Find answers to some commonly asked questions about Xiaflex.

What alternative medications are available for Xiaflex?

Alternative medications are available to treat the same conditions as Xiaflex.

Alternative medications and supplements for treating Dupuytren’s contracture include:

• steroid injections, such as triamcinolone (Kenalog)
• vitamin E

Alternative medications for treating Peyronie’s disease include:

• interferon alfa-2b (Intron A)
• verapamil (Calan SR)
• colchicine (Colcrys)
• pentoxifylline
• aminobenzoate potassium

Some of the treatments listed above are used off-label for these conditions. Off-label drug use means to use a drug for a purpose that has not been approved by the Food and Drug Administration (FDA). The FDA regulates the testing and approval of drugs, but not how doctors use drugs to treat conditions in patients. So your doctor can prescribe a drug off-label if they think it’s the best option for your care.

To learn more about the risks and benefits of these treatments compared with Xiaflex for your condition, talk with your doctor or pharmacist.

Are there before and after photos available that show Xiaflex treatment results?

Yes, the drugmaker’s website has some before and after photos showing Xiaflex treatment results. These are photos of people who received the drug to treat Dupuytren’s contracture.

Your doctor may be able to provide before and after photos showing results of the drug for treating Peyronie’s disease.

Keep in mind that not everyone has the same results from Xiaflex treatment. How effectively and safely the drug works will vary from person to person. Your doctor can tell you more about the risks and benefits of Xiaflex treatment for your condition.

How is Xiaflex given?

Your doctor will explain how Xiaflex will be given to you. They’ll also explain how much of the drug you’ll receive and how often.

Receiving Xiaflex injections

Xiaflex comes as a powder in a vial. A healthcare professional will use the powder to make a liquid solution for injection.

How you receive Xiaflex injections depends on the condition you’re receiving the drug to treat.

Xiaflex injections for Dupuytren’s contracture

For treating Dupuytren’s contracture, a healthcare professional will inject Xiaflex into the cord that is causing your finger to bend. If you have more than one cord, you may receive up to two injections in your hand at each appointment.

Each cord in your hand may be treated with up to three Xiaflex injections, with at least 4 weeks between each injection.

After the healthcare professional injects Xiaflex, they’ll wrap your hand in a bandage. This is to limit the movement of the treated hand and finger or fingers. It’s important that you do not bend or straighten any treated fingers until your doctor says it’s safe to do so. This keeps Xiaflex from leaking out of the cord.

You’ll also need to keep the treated hand elevated for a time, except while you sleep. Your doctor will let you know how long you’ll need to do this.

Xiaflex injections for Peyronie’s disease

For treating Peyronie’s disease, a healthcare professional will inject Xiaflex into the plaque (scar tissue) that is causing your penis to curve.

Xiaflex treatment for Peyronie’s disease consists of cycles. You may receive up to four cycles of treatment. If you have more than one cycle, the cycles will be scheduled so that they occur about every 6 weeks.

During each cycle, you’ll receive two injections, 1 to 3 days apart. Xiaflex must be injected into an erect penis. Your healthcare professional may inject a medication called alprostadil into your penis to cause an erection.

After the injections

After each injection, the healthcare professional may wrap your penis in a bandage. It’s important that you follow their instructions about when to remove the bandage.

You’ll see your doctor 1 to 3 days after your second injection. During this appointment, they’ll try to stretch the plaque and straighten your penis.

For 6 weeks after each injection, you’ll need to gently stretch your penis three times per day. Your doctor will show you the correct way to do so. The medication guide for Xiaflex also contains instructions for these stretches.

During treatment, if you get an erection without sexual activity, it’s recommended that you gently straighten your penis. Your doctor can show you how to do this.

Between injections and after injections, it’s recommended that you avoid sexual activity for a certain amount of time. For more information, see the “What should be considered before starting Xiaflex?” section below.

Receiving Xiaflex with other drugs

For treating Peyronie’s disease, Xiaflex must be injected into an erect penis. Your healthcare professional may inject a medication called alprostadil into your penis to cause an erection.

Xiaflex isn’t given with other medications to treat Dupuytren’s contracture.

Questions for your doctor

You may have questions about Xiaflex and your treatment plan. It’s important to discuss all your concerns with your doctor.

Here are a few tips that might help guide your discussion:

• Before your appointment, write down questions such as:
  • How will Xiaflex affect my body, mood, or lifestyle?
• Bring someone with you to your appointment if doing so will help you feel more comfortable.
• If you don’t understand something related to your condition or treatment, ask your doctor to explain it to you.

Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So don’t be afraid to ask questions or offer feedback on your treatment.

What should be considered before starting Xiaflex?

Before starting treatment with Xiaflex, it’s important to discuss certain considerations with your doctor. This includes any medications you take or medical conditions you may have. Doing so will help your doctor determine whether Xiaflex is a safe and effective treatment option for you.

Interactions

Taking a medication with certain vaccines, foods, and other things can affect how the medication works. These effects are called interactions.

Before starting Xiaflex treatment, be sure to tell your doctor about all medications you take, including prescription and over-the-counter kinds. Also, describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Xiaflex.

For information about drug-condition interactions, see the “Other warnings” section below.

Interactions with drugs or supplements

Xiaflex can interact with several kinds of drugs. These drugs include anticoagulants (blood thinners) such as warfarin (Jantoven) and apixaban (Eliquis).

Your doctor or pharmacist can tell you more about these interactions and any others that may occur with Xiaflex.

Boxed warning

Xiaflex has a boxed warning. This is a serious warning from the Food and Drug Administration (FDA) about drug effects that may be dangerous.

In rare cases, treatment with Xiaflex for Peyronie’s disease can result in penile fracture (rupture of certain tissue in the penis) and other serious penis injury. Symptoms can include:

• bloody urine
• trouble urinating
• penis pain
• hematoma (pooling of blood under the skin) in the penis
• sudden “popping” sound in an erect penis
• sudden erectile dysfunction (ED)

What may help

If you’re receiving Xiaflex to treat Peyronie’s disease and you experience any of the symptoms listed above, contact your doctor immediately.

To lower the risk of injury to your penis, it’s important not to have sexual activity for much of a Xiaflex treatment cycle. Specifically, you should:

• Avoid sexual activity between the first and second Xiaflex injections during a treatment cycle.
• Avoid sexual activity after the second Xiaflex injection of a treatment cycle for at least 4 weeks. You should also wait until any pain and swelling in your penis has gone away.

In addition, only certain doctors may prescribe Xiaflex through a Risk Evaluation and Mitigation Strategy (REMS) program. This is a drug safety program that the FDA requires for certain drugs. It’s designed to ensure those drugs are used only when their benefits outweigh their risks. To learn more about the Xiaflex REMS program, call 877-313-1235 or visit the program’s website.

Because of the risk of injury, doctors will usually avoid prescribing Xiaflex to treat Peyronie’s disease if the plaque involves the urethra. (The urethra is a tube that carries urine out of the body.) In such cases, they’ll likely recommend other treatment options.

Other warnings

Xiaflex may not be right for you if you have certain medical conditions. These are known as drug-condition interactions. Other factors may also affect whether Xiaflex is a good treatment option for you.

Talk with your doctor about your health history before you receive Xiaflex. Factors to consider include those in the list below.

Blood clotting problem. People with blood clotting problems, such as hemophilia, have a higher risk of bleeding or bruising at Xiaflex injection sites. People who take anticoagulants (blood thinners) also have a higher risk of this side effect.

If you have a blood clotting problem or take a blood thinner, tell your doctor before starting Xiaflex treatment. This can help them determine whether Xiaflex is safe for you to receive or if another treatment option may be a better choice for you.

Allergic reaction. If you’ve had an allergic reaction to Xiaflex or any of its ingredients, your doctor will likely not prescribe Xiaflex. Ask them what other medications are better options for you.

Xiaflex and alcohol

There’s no known interaction between alcohol and Xiaflex.

If you have questions about consuming alcohol with any medications you take, talk with your doctor or pharmacist.

Pregnancy and breastfeeding

Xiaflex hasn’t been studied during pregnancy, so it’s not known whether the drug is safe to use in someone who is pregnant. It’s also not known whether it’s safe to breastfeed while receiving the medication.

To learn more about your treatment options if you’re pregnant or breastfeeding, or planning to become pregnant or breastfeed, talk with your doctor.