Uses of Collagenase:

• It is used to treat cords formed in patients with Dupuytren's contracture.
• It is used to treat Peyronie's disease.

What do I need to tell my doctor BEFORE I take Collagenase?

For all uses of collagenase (systemic):

• If you are allergic to collagenase (systemic); any part of collagenase (systemic); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

Peyronie's disease:

• If you have Peyronie's disease and the plaque to be treated is in the urethra (the tube that urine passes through).

This is not a list of all drugs or health problems that interact with collagenase (systemic).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take collagenase (systemic) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Collagenase?

For all uses of collagenase (systemic):

• Tell all of your health care providers that you take collagenase (systemic). This includes your doctors, nurses, pharmacists, and dentists.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

Peyronie's disease:

• Do not have sex or any other sex action for at least 4 weeks after the second dose and until any pain and swelling have gone away.
• Do not use a vacuum erection device while you use collagenase (systemic).
• Try to avoid things that lead to straining your stomach muscles while you use collagenase (systemic). This includes things like straining during a bowel movement.

How is this medicine (Collagenase) best taken?

Use collagenase (systemic) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

For all uses of collagenase (systemic):

• It is given as a shot.

Dupuytren's contracture:

• Do not bend or straighten the fingers of your treated hand until your doctor tells you it is okay.
• Do not try to straighten your treated finger.
• Keep your treated hand raised until bedtime on the first day.
• You will need to go back to your doctor's office 1 to 3 days after the injection.
• You will be given a splint to wear on the treated finger at bedtime for up to 4 months.
• Do your finger exercises each day.
• Do not start normal actions with the treated hand until doctor tells you it is okay.

Peyronie's disease:

• You will need to go back to your doctor's office 1 to 3 days after the second injection in a treatment cycle. Make sure you know when to return to the office.
• Your doctor will give you a patient guide that tells you how to stretch and form your penis at home. Read it carefully.
• Follow how and when to stretch your penis after each cycle as your doctor has told you.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all uses of collagenase (systemic):

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Chest pain.
• Dizziness or passing out.
• Very bad swelling or pain of hands or feet.
• A burning, numbness, or tingling feeling that is not normal.
• Bleeding.

Dupuytren's contracture:

• Damage to a tendon or ligament causing the tendon or ligament to be weak or break has happened with collagenase (systemic). Surgery may be needed to fix this. Call your doctor right away if you are not able to bend the treated finger after the swelling goes down or if you have any problems using your treated hand.
• Nerve problems and skin tears have happened with collagenase (systemic). Call your doctor right away if you have numbness, tingling, more pain, or breaks in the skin of the treated finger or hand after you get the shot or after your doctor visit.

What are some other side effects of Collagenase?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

For all uses of collagenase (systemic):

• Irritation or swelling where the shot was given.
• Pain where the shot was given.
• Bruising.

Dupuytren's contracture:

• Swollen gland in the elbow or armpit.
• Pain in the armpit.
• Swelling, warmth, or redness of the skin.

Peyronie's disease:

• Mild pain in the penis. OTC pain drugs may help.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Collagenase?

• If you need to store collagenase (systemic) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time collagenase (systemic) is refilled. If you have any questions about collagenase (systemic), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.