Consumer Information for: XIAFLEX

What the medication is used for

For Dupuytren’s Contracture

XIAFLEX is a prescription medicine used to treat two different conditions:

adults with Dupuytren’s contracture when a “cord” can be felt.
adult men with Peyronie’s disease who have a “plaque” that can be felt and a curve in their penis greater than 30 degrees when treatment is started.

Use for treating Dupuytren’s contracture is described in this medication information. Use for treating Peyronie’s disease is described in a separate information guide.

For Peyronie’s Disease

XIAFLEX is a prescription medicine used to treat two different conditions:

adult men with Peyronie’s disease who have a “plaque” that can be felt and a curve in their penis greater than 30 degrees when treatment is started.
adults with Dupuytren’s contracture when a “cord” can be felt.

Use for treating Peyronie’s disease is described in this medication information. Use for treating Dupuytren’s contracture is described in a separate information guide

What it does

For Dupuytren’s Contracture

In people with Dupuytren’s contracture, there is a thickening of the skin and tissue in the palm of your hand that is not normal. Over time, this thickened tissue can form a cord in your palm. This causes one or more of your fingers to bend toward the palm, so you cannot straighten them. The proteins in XIAFLEX help to “break” the cord of tissue that is causing the finger to be bent.

For Peyronie’s Disease

In men with Peyronie’s disease, there is scar tissue called plaque that forms inside the penis. It can make the penis bend upward or to the side. The proteins in XIAFLEX help to “break” the plaque that is causing the penis to be bent.

When it should not be used

For Dupuytren’s Contracture

Do not use XIAFLEX if:

you have had an allergic reaction to XIAFLEX or any of its ingredients. See the “What are the ingredients in XIAFLEX” section above for a list of all ingredients in XIAFLEX.

For Peyronie’s Disease

Do not use XIAFLEX if:

you have had an allergic to XIAFLEX or any of its ingredients. See the “What are the ingredients in XIAFLEX” sections above for a list of ingredients in XIAFLEX.
you have been told by your health professional that the Peyronie’s plaque to be treated involves the tube that your urine passes through (urethra).

What the medicinal ingredient is

collagenase clostridium histolyticum

What the non-medicinal ingredients are

hydrochloric acid, sucrose, and tromethamine. The sterile diluent contains calcium chloride dehydrate, and sodium chloride

What dosage form it comes in

Vials with 0.9 mg lyophilized powder for solution.

Warnings and precautions

For Dupuytren’s Contracture

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take XIAFLEX. Talk about any health conditions or problems you may have, including if you experience:

Tendon or ligament damage: Receiving an injection of XIAFLEX may cause damage to a tendon or ligament in your hand and can cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your health professional 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.
Nerve injury or other serious hand injury of the hand: Call your health professional if you get numbness, tingling, or increased pain in your treated finger or hand after your injection or after your follow-up visit.
Allergic reactions: Allergic reactions can happen in people who take XIAFLEX because it contains foreign proteins. Call your health professional 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.

Other warnings you should know about:
Before receiving XIAFLEX, tell your health professional if you:

have had an allergic reaction to a previous XIAFLEX injection
have a bleeding problem
have received XIAFLEX to treat another condition
have any other medical condition
are pregnant or plan to become pregnant. It is unknown if XIAFLEX will harm your unborn baby.
are breastfeeding. It is not known if XIAFLEX passes into your breast milk. Talk to your health professional about the best way to feed your baby if you receive XIAFLEX.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

For Peyronie’s Disease

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take XIAFLEX. Talk about any health conditions or problems you may have, including if you experience:

Penile fracture (corporal rupture) or other serious injury to the penis.

Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX, one of the tubes may break during an erection. This is called corporal rupture or penile fracture. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture.
Other serious injury could include broken blood vessels in your penis, causing blood to collect under the skin (hematoma). A procedure may be required to drain the blood from under the skin.
Symptoms of a corporal rupture or other serious injury to your penis may include:

a popping sound or sensation in an erect penis
sudden loss of the ability to maintain an erection
pain in your penis
purple bruising and swelling of your penis
difficulty urinating or blood in the urine

Do not have sex or any other sexual activity between the first and second injections of a treatment cycle. Do not have sex or any other sexual activity for at least 4 weeks

Allergic reactions:

Other warnings you should know about:
XIAFLEX may not be right for you. Before receiving XIAFLEX, tell your health professional if you:

have had an allergic reaction to a previous XIAFLEX injection
have a bleeding problem
have received XIAFLEX to treat another condition
have any other medical condition

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

The following may interact with XIAFLEX:

blood thinner medicines such as acetylsalicylic acid clopidogrel (PLAVIX®), prasugrel hydrochloride (EFFIENT®), or warfarin sodium (COUMADIN®). If you are told to stop taking a blood thinner before your XIAFLEX injection, your health professional should tell you when to restart the blood thinner.
antibiotics or cancer medicines containing tetracycline, anthracycline, anthraquinone, or their derivatives

Proper use of this medication

For Dupuytren’s Contracture

How to take XIAFLEX:
XIAFLEX should be injected into a cord by a health professional who is skilled in injection procedures of the hand and treating people with Dupuytren’s contracture.

Your health professional 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 health professional 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 health professional 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 health professional’s office as directed 24-72 hours after your injection. During this first follow-up visit, if you still have the cord, your health professional may try to extend the treated finger to “break” the cord and try to straighten your finger. Your health professional will provide you with a splint to wear on the treated finger. Wear the splint as instructed at bedtime to keep your finger straight. Do finger exercises each day, as instructed. Follow your health professional’s instructions about when you can start doing your normal activities with the injected hand.

For Peyronie’s Disease

How to take XIAFLEX
XIAFLEX should be injected into the plaque by a health professional who is skilled in injection procedures and experienced in treating men with Peyronie’s disease. Your health professional will inject XIAFLEX into the plaque that is causing your penis to bend.

XIAFLEX is given as part of a treatment cycle. In each treatment cycle, you will receive an injection of XIAFLEX, followed by a second injection 1 to 3 days later.

After each injection of XIAFLEX, your penis may be wrapped with a bandage. Your health professional will tell you when to take the bandage off.
1 to 3 days after your second injection of XIAFLEX in a treatment cycle, you will need to return to your health professional’s office to learn two manual procedures that will

help stretch your penis (see “How to gently stretch your penis”), and
help straighten your penis (see “How to gently straighten your penis”).

Your health professional will tell you when to come back to learn these procedures.

Your health professional will tell you when you can resume sexual activity after each treatment cycle.

Your health professional will also tell you when to come back if more treatment cycles are needed.

Tell your healthcare provider right away if you have trouble stretching or straightening your penis, or if you have pain or other concerns.

1) How to gently stretch your penis:
Following the instructions provided by your health professional and described below, gently stretch your penis 3 times a day for 6 weeks after each treatment cycle. Only stretch your penis if your penis is not hard (erect).

With 1 hand, hold the tip of your penis with your fingers. With your other hand, hold the base of your penis with your fingers (See Figure A).
Gently pull your penis away from your body to its full length and hold the stretch for 30 seconds.
Let go of the tip of your penis and let your penis return to its normal length.

(Figure A)

2) How to gently straighten your penis:
Following the instructions provided by your health professional and described below, gently straighten your penis 1 time a day for 6 weeks after each treatment cycle. Only straighten your penis if you have an erection that happens without any sexual activity (spontaneous erection). Bending your penis should not cause any pain or discomfort.

With one hand hold your penis. With your other hand, gently bend your penis in the opposite direction of the curve (See Figure B). Hold the penis in this more straightened position for 30 seconds, then let go.

(Figure B)

Usual Dose

For Dupuytren’s Contracture

The usual dose of XIAFLEX is 0.58 mg per injection into a palpable cord.

For Peyronie’s Disease

The usual dose of XIAFLEX is 0.58mg per injection into a Peyronie’s plaque.

Overdose

If you think you have received too much XIAFLEX, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

For Dupuytren’s Contracture

Treatment with XIAFLEX is managed by a health professional. Contact your health professional if you missed a treatment visit or the contracture persists in your finger.

For Peyronie’s Disease

Treatment with XIAFLEX is managed by a health professional. Contact your health professional if you missed a treatment visit or the curvature persists in your penis.

Side effects and what to do about them

For Dupuytren’s Contracture

These are not all the possible side effects you may feel when taking XIAFLEX. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

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 injection 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

Serious side effects, how often they happen and what to do about them
Symptom / effect	Talk with your doctor, nurse, or pharmacist only if severe	Talk with your doctor, nurse, or pharmacist in all cases	Stop taking drug and get immediate medical help
RARE
Trouble bending the treated finger after the swelling goes down		✔
Numbness or tingling in the treated finger		✔
Skin tears		✔
Inflammation of lymphatic channels (lymphangitis) with symptoms including enlarged lymph nodes, and reddened skin with raised borders, tender and warm, usually accompanied by a red streak		✔
Allergic reaction such as hives, swollen face, breathing trouble, chest pain		✔

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

For Peyronie’s Disease

These are not all the possible side effects you may feel when taking XIAFLEX. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

The most common side effects include:

swelling, pain, itching, and/or blisters in the penis or at the injection site
lump or nodule may form at the injection site
painful erections, or erection problems, and/or pain with sex

Serious side effects, how often they happen and what to do about them
Symptom / effect	Talk with your doctor, nurse, or pharmacist only if severe	Talk with your doctor, nurse, or pharmacist in all cases	Stop taking drug and get immediate medical help
RARE
Allergic reaction such as hives, swollen face, breathing trouble, chest pain	✔
Hematoma: bleeding or bruising at the injection site, or collection of blood outside the blood vessel
Penile fracture/corporal rupture or other serious injury to the penis: may include popping sound/sensation indicating penile fracture, sudden loss of the ability to maintain an erection, pain in your penis , purple bruising and swelling of your penis, difficulty urinating or blood in the urine

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:

Online at MedEffect;
By calling 1-866-234-2345 (toll-free);
By completing a Consumer Side Effect Reporting Form and sending it by:

Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program

MedEffect

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about XIAFLEX:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the distributor’s, Paladin Labs Inc, website www.paladinlabs.com or by calling 1-888-867-7426.

This leaflet was prepared by Endo Ventures Ltd., Dublin 4, Ireland.

Last Revised June 6, 2019

Language selection

WxT Language switcher

WxT Search form