Xiaflex

Generic Name: collagenase clostridium histolyticum (COL-a-geh-nase klo-STRID-ee-um his-toe-LIT-ik-um)
Brand Name: Xiaflex

Xiaflex is used for:

Treating Dupuytren contracture with a palpable cord.

Xiaflex is a collagenase enzyme. It works by helping to break down the collagen in the cord, which allows the fingers to straighten.

Do NOT use Xiaflex if:

• you are allergic to any ingredient in Xiaflex

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Xiaflex:

Some medical conditions may interact with Xiaflex. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a bleeding problem

Some MEDICINES MAY INTERACT with Xiaflex. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Medicines that thin the blood (eg, aspirin, clopidogrel, prasugrel, warfarin) because the risk of bleeding or bruising at the injection site may be increased
• Anthracyclines (eg, doxorubicin), anthraquinone, or tetracyclines (eg, doxycycline) because they may decrease Xiaflex's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xiaflex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xiaflex:

Use Xiaflex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Xiaflex comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Xiaflex refilled.
• Xiaflex is given as an injection at your doctor's office, hospital, or clinic.
• Your doctor will wrap your affected hand with a bandage after you receive your injection.
• Limit motion of the treated finger and keep the treated hand elevated until bedtime.
• Do not bend or straighten the fingers of your hand until your doctor tells you to. This will help prevent the medicine from leaking out of the cord.
• Do NOT try to straighten the finger yourself.
• If you miss your dose of Xiaflex, contact the doctor to set up a new appointment.

Ask your health care provider any questions you may have about how to use Xiaflex.

Important safety information:

• You will need to return to your doctor's office the day after you receive Xiaflex for an examination of the treated hand. Your doctor may also need to straighten your finger. Do not try to straighten the finger yourself.
• Do not perform normal or strenuous activities with the treated hand until your doctor tells you otherwise.
• You will need to wear a splint at bedtime for up to 4 months after you receive Xiaflex.
• Your doctor will give you exercises for the treated hand. Discuss any questions that you may have about these exercises with your doctor.
• Rarely, some patients have had serious effects on other tissues of the treated hand (eg, tendon or ligament problems, nerve problems). Tell your doctor right away if you have numbness, tingling, or increased pain in the treated finger or hand after your injection or after your follow-up visit. Also tell your doctor if you have trouble bending your treated finger after the swelling goes down or if you have problems using the treated hand after your follow-up visit.
• Xiaflex should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xiaflex while you are pregnant. It is not known if Xiaflex is found in breast milk. If you are or will be breast-feeding while you use Xiaflex, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xiaflex:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild swelling or pain of the lymph nodes in the elbow or underarm; pain, redness, bruising, or mild bleeding at the injection site; swelling, pain, or tenderness of the treated hand; warmth or redness of the skin.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness or pain in the chest; swelling of the mouth, face, lips, or tongue); breaks in the skin or skin tears; fainting; numbness, tingling, or other unusual sensation in the treated hand; severe or persistent bleeding at the injection site; severe pain in the treated area; symptoms of infection (eg, fever, chills, swelling, redness); trouble bending the treated finger after the swelling goes down; trouble using the treated hand.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Xiaflex is handled and stored by a health care provider. Keep Xiaflex out of the reach of children and away from pets.

General information:

• If you have any questions about Xiaflex, please talk with your doctor, pharmacist, or other health care provider.
• Xiaflex is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Xiaflex or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Xiaflex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Xiaflex. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Xiaflex.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.