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Xiaflex

Generic name: collagenase clostridium histolyticumKOL-a-JEN-ase-klos-TRID-ee-um-HIS-toe-LIT-ik-um ]
Drug class: Miscellaneous uncategorized agents

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 23, 2023.

What is Xiaflex?

Xiaflex is made from a mixture of proteins derived from a certain bacteria.

Xiaflex is used to treat Dupuytren's contracture in adults. This condition causes an abnormal thickening of the tissue in the palm of the hand. This condition may get worse over time and form a "cord" in your palm, causing a permanent bend in your finger.

Xiaflex is also used to treat a related condition called Peyronie's disease in adult men. This condition causes scar tissue or "plaque" to develop under the skin of the penis, resulting in an abnormal curving of the penis during erection.

Xiaflex is available for Peyronie's disease only from a certified pharmacy under a special program called Xiaflex REMS. You must be registered in the program and understand the risks of taking this medicine.

Warnings

Before you receive Xiaflex, tell your doctor if you have a bleeding or blood clotting disorder, such as hemophilia.

Xiaflex can damage a nerve, tendon, or ligament in the hand the medicine is injected into. After the swelling from your injection goes down, call your doctor if you have numbness, tingling, increased pain, trouble bending your finger toward your wrist, or if you have new or worsened movement problems in your treated hand.

Xiaflex may also damage the erectile tissues inside a man's penis, which could require surgery to correct. Call your doctor right away if you have bruising and swelling of your penis, pain when you urinate, blood in the urine, sudden erection problems, or a "popping" sound or sensation in your penis during an erection.

Before taking this medicine

You should not use Xiaflex if you are allergic to collagenase clostridium histolyticum. This medicine should not be used to treat Peyronie's disease that affects the urethra (the tube for passing urine out of your bladder).

Stop using Xiaflex and call your doctor at once if you have ever has:

It is not known if collagenase clostridium histolyticum will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using Xiaflex.

How is Xiaflex given?

Xiaflex is injected directly into the "cord" of the affected hand or into a "plaque" of the penis. A healthcare provider will give you this injection. Follow your doctor's instructions very carefully.

For Dupuytren's contracture:

For Peyronie's disease:

Dosing information

Usual Adult Dose of Xiaflex for Dupuytren's Contracture:

0.58 mg injected into a palpable cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint

Comments:
-This drug should be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of patients with Dupuytren's contracture.
-Up to 2 joints in the same hand may be treated during a treatment visit. Two palpable cords affecting 2 joints may be injected or one palpable cord affecting 2 joints in the same finger may be injected at 2 locations during a treatment visit. If a patient has other palpable cords with contractures of MP or PIP joints, these cords may be injected at other treatment visits approximately 4 weeks apart.
-Approximately 24 to 72 hours following an injection, a finger extension procedure should be performed if a contracture persists. Consult manufacturer product information or local protocol for information on the finger extension procedure.
-Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals.
-Up to 2 cords in the same hand may be injected at a treatment visit. If a patient has other cords with contractures, those cords should be injected at another treatment visit.
-Vital signs should be monitored and appropriate equipment should be available to address any severe local or systemic reactions including the potential for anaphylaxis that may occur following injection.

Usual Adult Dose of Xiaflex for Peyronie's Disease:

0.58 mg injected into the target plaque once on each of two days, 1 to 3 days apart

Comments:
-This drug should be administered by a healthcare provider experienced in the treatment of male urological diseases, who has completed required training for use of this drug in the treatment of Peyronie's disease.
-A treatment cycle consists of 2 injection procedures and a penile modeling procedure.
-For each plaque causing the curvature deformity, up to 4 treatment cycles may be administered. Each treatment cycle may be repeated at approximately 6 week intervals. If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if further treatment is not indicated, then subsequent treatment cycles should not be administered.
-The safety of more than one treatment course for Peyronie's disease is not known.

collagenase clostridium histolyticum

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Xiaflex injection.

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving Xiaflex?

Avoid any strenuous activity using the treated hand until your doctor tells you to resume normal activities.

Avoid situations where you may strain your stomach muscles, such as straining during bowel movements.

Xiaflex side effects

Get emergency medical help if you have signs of an allergic reaction to Xiaflex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Collagenase clostridium histolyticum can damage a nerve, tendon, or ligament in the hand the medicine is injected into. Call your doctor at once if you have:

Xiaflex may also damage the erectile tissues inside a man's penis, which could require surgery to correct. Call your doctor right away if you have:

Also call your doctor at once if you have:

Common Xiaflex side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs can affect Xiaflex?

Tell your doctor about all your other medicines, especially:

This list is not complete. Other drugs may interact with collagenase clostridium histolyticum, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Xiaflex Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Xiaflex.

Qwo (collagenase clostridium histolyticum-aaes) - Endo Global Aesthetics Limited
Formulation type Strength
Single-Dose Vial .92 mg
Single-Dose Vial 1.84 mg

View Qwo information in detail.

Xiaflex (collagenase clostridium histolyticum) - Auxilium Pharmaceuticals, Inc.
Formulation type Strength
Single-Dose Vial 0.9 mg

Popular FAQ

How long does it take for Xiaflex to work?

Xiaflex starts to work within 30 days for some people with Dupuytren’s Contracture, but some people may have to wait up to 90 days to see a result. Up to 39% report an improvement after 30 days which increases to up to 64% by 90 days. When Xiaflex is used to treat Peyronie’s Disease, it may take several months for it to start working although some improvements may be noticed within the first month or two. Maximal effects may not be seen for at least 24 weeks. Trials reported on outcomes at 52 weeks. Continue reading

How long does it take to recover after a Xiaflex injection?

It takes at least a week for your hand to recover after a Xiaflex injection for Dupuytren's contracture, in some people it may take 2 to 4 weeks before they can fully use their hand again, especially if you have skin tears which will need daily wound care. If you have had a Xiaflex injection for Peyronie’s disease, the recovery time varies depending on how much pain or swelling is present but generally takes 2 to 4 weeks. You should not have sex or have any other sexual activity between the 2 injections of a treatment cycle and for at least 4 weeks after the second injection of a treatment cycle. Continue reading

How painful are Xiaflex injections?

Unfortunately, a Xiaflex injection can be a painful process with one study in patients with Dupuytren contracture (DC) reporting 29% of people reporting serious or very intense pain, 30% moderate pain, and 41% reporting slight or inconsequential pain during needle insertion and Xiaflex injection. Continue reading

View more FAQ

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xiaflex only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.