WARNINGS
What is the most important information I should know about XIAFLEX for the treatment of Dupuytren’s contracture?
XIAFLEX may cause serious side effects, including:
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.
Nerve injury or other serious injury of the hand. After finger procedures, some people developed tears in the skin (lacerations), and local skin and soft-tissue necrosis (death of skin cells). Some lacerations and necrosis required skin grafting, or other surgery including amputation. Call your healthcare provider right away if you get numbness, tingling, increased pain, or tears in the skin (laceration) in your treated finger or hand after your injection or after your follow-up visit.
Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive 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
low blood pressure
dizziness or fainting
Fainting: Fainting or near fainting can happen in people who receive XIAFLEX, especially following finger procedures.
If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away
Who should not receive XIAFLEX?
Do not receive XIAFLEX if you:
are allergic to collagenase clostridium histolyticum, or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of this Medication Guide for a complete list of ingredients in XIAFLEX.
Talk to your healthcare provider before receiving this medicine if you have any of these conditions.
USES
XIAFLEX is a prescription medicine used to treat adults with Dupuytren’s contracture when a “cord” can be felt.
It is not known if XIAFLEX is safe and effective in children under the age of 18.
HOW TO USE
How will I receive XIAFLEX?
XIAFLEX should be injected into a cord by a healthcare provider who is experienced in injection procedures of the hand and treating people with Dupuytren’s contracture. If you have more than 1 contracture, your healthcare provider may give you 2 injections in 1 of your hands during your visit.
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 to keep 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 1 to 3 days 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.
XIAFLEX may cause serious side effects, including:
See “What is the most important information I should know about XIAFLEX for the treatment of Dupuytren’s contracture?”
increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you.
The most common side effects with XIAFLEX for the treatment of Dupuytren’s contracture include:
swelling of the injection site or the hand
bruising or bleeding at the injection site
pain or tenderness of the injection site or the hand
swelling of the lymph nodes (glands) in the elbow or armpit (axilla)
itching
breaks in the skin
redness or warmth of the skin
pain in the armpit
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
General information about the safe and effective use of XIAFLEX.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about XIAFLEX. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about XIAFLEX that is written for health professionals.
What are the ingredients in XIAFLEX?
Active ingredient: collagenase clostridium histolyticum
Inactive ingredients: hydrochloric acid, sucrose, and tromethamine. The diluent contains: calcium chloride dihydrate in 0.9% sodium chloride.
OVERDOSE
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 than the recommended doses including serious adverse reactions in the injected area (e.g., tendon ruptures or corporal ruptures dependent on the injection site). Supportive care and symptomatic treatment are recommended in these circumstances.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Prior to reconstitution, the vials of XIAFLEX and diluent should be stored in a refrigerator at2-degrees C to 8-degrees C (36-degrees F to 46-degress F). Do not freeze.
The reconstituted XIAFLEX solution can be kept at room temperature (20-degrees C to 25-degrees C/68-degrees F to 77-degrees F) for up to 1 hour or refrigerated at 2-degrees C to 8-degrees C (36-degrees F to 46-degrees F) for up to 4 hours prior to administration.
NOTES
Medication Guide: revision date 04/2024
Prescribing Information: revision date 08/2022
Anticoagulant drugs: XIAFLEX should be used with caution in patients receiving concomitant anticoagulants (except for low-dose aspirin).
What should I tell my healthcare provider before receiving XIAFLEX?
Before receiving XIAFLEX, tell your healthcare provider if you:
have had an allergic reaction to a XIAFLEX injection in the past
have a bleeding problem
have received XIAFLEX to treat another condition
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if XIAFLEX will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if XIAFLEX passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive XIAFLEX.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Using XIAFLEX with certain other medicines can cause serious side effects.
Especially tell your healthcare provider if you take:
medicines to thin your blood (anticoagulants). 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.
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine
