- This drug may harm the tubes in the penis. This damage may not go away. It may cause them to break during an erection. This drug may also cause blood vessels in the penis to break. This may cause blood to collect under the skin. Call your doctor right away if you are not able to keep an erection all of a sudden. Call your doctor right away if you have pain, bruising, or swelling of the penis; a popping sound or feeling in an erect penis; trouble passing urine; or blood in the urine.
- You may only get this drug through the Xiaflex REMS program.
- It is used to treat cords formed in patients with Dupuytren’s contracture.
- It is used to treat Peyronie’s disease.
- If you have an allergy to collagenase or any other part of this drug.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have Peyronie’s disease and the plaque to be treated is in the urethra (the tube that urine passes through).
- Tell dentists, surgeons, and other doctors that you use this drug.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
- Do not have sex or any other sex action for at least 2 weeks after the second dose and until any pain and swelling have gone away.
- 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 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.
- Very bad dizziness or passing out.
- Very bad swelling or pain of hands or feet.
- A burning, numbness, or tingling feeling that is not normal.
- Damage to a tendon or ligament causing the tendon or ligament to be weak or break has happened with this drug. 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 this drug. 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.
- Irritation or swelling where the shot was given.
- Pain where the shot was given.
- Swollen gland in the elbow or armpit.
- Pain in the armpit.
- Swelling, warmth, or redness of the skin.
- Mild pain in the penis. OTC pain drugs may help.
- It is given as a shot.
- Your doctor will give this drug.
- 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 the next day.
- 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.
- 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.
- Call the doctor to find out what to do.
- This drug will be given to you in a hospital or doctor’s office. You will not store it at home.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- 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 a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.
- This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled.
- 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.
If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.