Q: What is Xiaflex used for?

Xiaflex is used to treat Dupuytren's contracture and Peyronie's disease .

Q: How does Xiaflex work?

Mechanism of Action Xiaflex contains two types of enzymes known as collagenases. These enzymes are specifically designed to target and break down collagen, a protein that provides structure to tissues in the body. When collagen builds up excessively, it can form hard cords or plaques that restrict movement or cause physical deformities. Targeting Collagen Buildup The medication is injected directly into the area where the collagen has thickened. Once injected, the enzymes work together to dissolve the collagen fibers. This process helps to: Soften and weaken the thickened cord in the palm for those with Dupuytren's contracture. Break down the hard plaque that causes curvature in those with Peyronie's disease. By breaking down these structures, Xiaflex allows the affected area to become more flexible. Following the injection, a healthcare provider may perform a manual procedure to help stretch or straighten the area, further improving the range of motion.

Q: What are the active ingredients in Xiaflex?

The active ingredient in Xiaflex is collagenase Clostridium histolyticum .

Q: What are the side effects of Xiaflex?

Common side effects of Xiaflex may include: swelling bruising pain at injection site Always consult with a healthcare professional about potential side effects.

Q: What drug class is Xiaflex?

Xiaflex belongs to the collagenase enzyme drug class.

Q: What is the dosage of Xiaflex and how do I take it?

Administration Xiaflex must be administered by a healthcare provider who is specifically trained in the procedure. It is given as an injection directly into the collagen cord in the hand or the plaque in the penis. Your doctor may apply a local anesthetic to numb the area before the injection. Treatment for Dupuytren's Contracture For the treatment of Dupuytren's contracture, the injection is placed into the cord that is causing the finger to bend. Following the injection, you will likely return to the doctor's office one to three days later. During this follow-up visit, the doctor may perform a finger extension procedure to help break the cord and straighten the finger. Treatment for Peyronie's Disease Treatment for Peyronie's disease is typically administered in cycles. A single treatment cycle usually involves: Two separate injections spaced one to three days apart. A follow-up visit one to three days after the second injection for a penile modeling procedure performed by the doctor. These cycles are generally repeated every several weeks as determined by your healthcare provider. Missed Appointments Because this medication is administered in a clinical setting on a specific schedule, it is important to keep all appointments. If you miss a scheduled injection or follow-up procedure, contact your healthcare provider immediately to reschedule.

Q: Is Xiaflex safe during pregnancy and breastfeeding?

Pregnancy It is not known whether Xiaflex can cause harm to an unborn baby or affect reproductive capacity. There are no adequate and well-controlled studies of Xiaflex in pregnant women, and animal reproduction studies have not been performed. While Xiaflex is injected locally and typically does not reach significant levels in the bloodstream, patients should discuss the potential risks and benefits with their healthcare provider if they are pregnant or planning to become pregnant. Breastfeeding It is unknown if Xiaflex passes into breast milk or if it could affect a nursing child. Because many drugs are excreted in human milk, caution is recommended when administering this medication to a person who is breastfeeding. Individuals should consult with their doctor to determine if the benefits of treatment outweigh any potential risks to the infant while nursing.

Q: What forms and strengths does Xiaflex come in?

Dosage Forms Xiaflex is supplied as a sterile, preservative-free powder in a vial. It is intended for reconstitution, which means it must be mixed with a liquid before it can be used. Packaging and Preparation The medication is typically provided in a kit that includes: Lyophilized Powder: A concentrated, freeze-dried form of the medication. Sterile Diluent: A specific liquid used to dissolve the powder for injection. Xiaflex is administered as an intralesional injection, meaning it is injected directly into the target tissue by a trained healthcare professional in a clinical setting. Each vial of powder and diluent is intended for a single use only, and any unused portion must be discarded after the procedure.

Q: What is the FDA approval status of Xiaflex?

FDA Approval History Xiaflex (collagenase clostridium histolyticum) was first approved by the U.S. Food and Drug Administration (FDA) in February 2010 for the treatment of Dupuytren's contracture in adults with a palpable cord. In December 2013, the FDA expanded its approval to include the treatment of adult men with Peyronie's disease who have a palpable plaque and a curvature deformity of at least 30 degrees at the start of therapy. Boxed Warning The FDA has issued a boxed warning for Xiaflex regarding the risk of corporal rupture (penile fracture) or other serious penile injuries when the drug is used to treat Peyronie's disease. These injuries can occur if the medication is injected into certain structures of the penis other than the target plaque. REMS Program Because of the risks of serious injury, Xiaflex is only available through a restricted distribution program called the Xiaflex Risk Evaluation and Mitigation Strategy (REMS). The requirements of this program include: Healthcare providers must be certified with the REMS program by completing training on the administration of the drug. Healthcare facilities must be certified and ensure that the drug is only dispensed for use by certified providers. The drug must only be administered by healthcare professionals trained in the management of the specific conditions it treats. Other Regulatory Considerations Xiaflex is a biological product. There are currently no approved generic or biosimilar versions of this medication. The FDA continues to monitor the safety of the product through post-marketing reports, which have included warnings about the risk of hypersensitivity reactions, including anaphylaxis, and the risk of tendon rupture when used for Dupuytren's contracture.

Question 1

What is Xiaflex?

Accepted Answer

Xiaflex is a biologic medication composed of a mixture of enzymes called collagenases. These enzymes are derived from the bacterium Clostridium histolyticum and are designed to target and break down collagen, a structural protein found in connective tissues.

When collagen accumulates excessively, it can cause tissues to thicken and harden. Xiaflex works by dissolving these collagen deposits to help restore normal tissue structure and flexibility.

Question 2

What is Xiaflex used for?

Accepted Answer

Xiaflex is used to treat Dupuytren's contracture and Peyronie's disease.

Question 3

How does Xiaflex work?

Accepted Answer

Mechanism of Action

Xiaflex contains two types of enzymes known as collagenases. These enzymes are specifically designed to target and break down collagen, a protein that provides structure to tissues in the body. When collagen builds up excessively, it can form hard cords or plaques that restrict movement or cause physical deformities.

Targeting Collagen Buildup

The medication is injected directly into the area where the collagen has thickened. Once injected, the enzymes work together to dissolve the collagen fibers. This process helps to:

Soften and weaken the thickened cord in the palm for those with Dupuytren's contracture.
Break down the hard plaque that causes curvature in those with Peyronie's disease.

By breaking down these structures, Xiaflex allows the affected area to become more flexible. Following the injection, a healthcare provider may perform a manual procedure to help stretch or straighten the area, further improving the range of motion.

Question 4

What are the active ingredients in Xiaflex?

Accepted Answer

The active ingredient in Xiaflex is collagenase Clostridium histolyticum.

Question 5

What are the side effects of Xiaflex?

Accepted Answer

Common side effects of Xiaflex may include:

swelling
bruising
pain at injection site

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Xiaflex?

Accepted Answer

Xiaflex belongs to the collagenase enzyme drug class.

Question 7

What is the dosage of Xiaflex and how do I take it?

Accepted Answer

Administration

Xiaflex must be administered by a healthcare provider who is specifically trained in the procedure. It is given as an injection directly into the collagen cord in the hand or the plaque in the penis. Your doctor may apply a local anesthetic to numb the area before the injection.

Treatment for Dupuytren's

Contracture

For the treatment of Dupuytren's contracture, the injection is placed into the cord that is causing the finger to bend. Following the injection, you will likely return to the doctor's office one to three days later. During this follow-up visit, the doctor may perform a finger extension procedure to help break the cord and straighten the finger.

Treatment for Peyronie's

Disease

Treatment for Peyronie's disease is typically administered in cycles. A single treatment cycle usually involves:

Two separate injections spaced one to three days apart.
A follow-up visit one to three days after the second injection for a penile modeling procedure performed by the doctor.

These cycles are generally repeated every several weeks as determined by your healthcare provider.

Missed Appointments

Because this medication is administered in a clinical setting on a specific schedule, it is important to keep all appointments. If you miss a scheduled injection or follow-up procedure, contact your healthcare provider immediately to reschedule.

Question 8

Is Xiaflex safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

It is not known whether Xiaflex can cause harm to an unborn baby or affect reproductive capacity. There are no adequate and well-controlled studies of Xiaflex in pregnant women, and animal reproduction studies have not been performed.

While Xiaflex is injected locally and typically does not reach significant levels in the bloodstream, patients should discuss the potential risks and benefits with their healthcare provider if they are pregnant or planning to become pregnant.

Breastfeeding

It is unknown if Xiaflex passes into breast milk or if it could affect a nursing child. Because many drugs are excreted in human milk, caution is recommended when administering this medication to a person who is breastfeeding.

Individuals should consult with their doctor to determine if the benefits of treatment outweigh any potential risks to the infant while nursing.

Question 9

What forms and strengths does Xiaflex come in?

Accepted Answer

Dosage Forms

Xiaflex is supplied as a sterile, preservative-free powder in a vial. It is intended for reconstitution, which means it must be mixed with a liquid before it can be used.

Packaging and Preparation

The medication is typically provided in a kit that includes:

Lyophilized Powder: A concentrated, freeze-dried form of the medication.
Sterile Diluent: A specific liquid used to dissolve the powder for injection.

Xiaflex is administered as an intralesional injection, meaning it is injected directly into the target tissue by a trained healthcare professional in a clinical setting. Each vial of powder and diluent is intended for a single use only, and any unused portion must be discarded after the procedure.

Question 10

What is the FDA approval status of Xiaflex?

Accepted Answer

FDA Approval History

Xiaflex (collagenase clostridium histolyticum) was first approved by the U.S. Food and Drug Administration (FDA) in February 2010 for the treatment of Dupuytren's contracture in adults with a palpable cord. In December 2013, the FDA expanded its approval to include the treatment of adult men with Peyronie's disease who have a palpable plaque and a curvature deformity of at least 30 degrees at the start of therapy.

Boxed Warning

The FDA has issued a boxed warning for Xiaflex regarding the risk of corporal rupture (penile fracture) or other serious penile injuries when the drug is used to treat Peyronie's disease. These injuries can occur if the medication is injected into certain structures of the penis other than the target plaque.

REMS Program

Because of the risks of serious injury, Xiaflex is only available through a restricted distribution program called the Xiaflex Risk Evaluation and Mitigation Strategy (REMS). The requirements of this program include:

Healthcare providers must be certified with the REMS program by completing training on the administration of the drug.
Healthcare facilities must be certified and ensure that the drug is only dispensed for use by certified providers.
The drug must only be administered by healthcare professionals trained in the management of the specific conditions it treats.

Other Regulatory Considerations

Xiaflex is a biological product. There are currently no approved generic or biosimilar versions of this medication. The FDA continues to monitor the safety of the product through post-marketing reports, which have included warnings about the risk of hypersensitivity reactions, including anaphylaxis, and the risk of tendon rupture when used for Dupuytren's contracture.

Question 11

What should I know about Xiaflex and cost?

Accepted Answer

Factors Influencing Cost

The overall expense for Xiaflex treatment involves several components beyond the price of the medication itself:

Medication Price: The cost of the vial is a primary factor. Because Xiaflex is a specialized biologic, it typically has a high list price.
Administration Fees: Xiaflex must be administered by a healthcare professional who has been specifically trained in the injection technique. Patients will incur costs for the office visit and the medical procedure.
Treatment Cycles: The number of injections needed varies by patient. For Dupuytren's contracture, multiple injections may be needed if the cord persists. For Peyronie's disease, a full treatment course typically involves multiple injection cycles.

Insurance and Prior Authorization

Most private insurance plans and Medicare cover Xiaflex for its FDA-approved uses. However, insurance companies often require prior authorization, which means the healthcare provider must prove the treatment is medically necessary before the insurer agrees to pay. Patients should check their specific plan details to understand their deductibles, copayments, or coinsurance responsibilities.

Financial Assistance

Financial assistance programs may be available to help eligible patients manage out-of-pocket costs. These often include:

Copay Cards: For patients with commercial insurance, the manufacturer may offer programs to reduce the cost of the medication.
Patient Assistance Programs: Patients who are uninsured or meet certain income requirements may be eligible for assistance to receive the medication at a lower cost or for free.

It is recommended that patients contact their insurance provider and the healthcare facility's billing department for a comprehensive cost estimate before starting treatment.

Xiaflex

📋Overview

How It Works

Uses

Active Ingredients

Common Side Effects

Warnings & Precautions

Dosage

Pregnancy & Breastfeeding

Frequently Asked Questions

📚References

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