REGRANEX- becaplermin gel
Smith & Nephew, Inc.
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MEDICATION GUIDE REGRANEX®(RE–GRANʹ–IX) (becaplermin) gel |
Important:REGRANEX is for use on the skin only (topical). Do not use REGRANEX near or in your mouth, eyes, or vagina. |
What is the most important information I should know about REGRANEX? REGRANEX may cause serious side effects, including: Risk of cancer.Cancers have happened in areas away from the REGRANEX application site. You and your healthcare provider should carefully consider whether you will use REGRANEX if you have cancer. |
What is REGRANEX? REGRANEX is a prescription medicine that is used with good ulcer care practice for the treatment of diabetic sores (ulcers) of your legs or feet that are deeper than just your skin, in people who have good blood supply to the legs and feet. It is not known if REGRANEX is effective for the treatment of pressure ulcers or ulcers that are due to poor blood flow (circulation). It is not known if REGRANEX is safe and effective in children under 16 years of age. |
Who should not use REGRANEX? Do not use REGRANEXif you have a cancer at the application site. |
Before using REGRANEX, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. |
How should I use REGRANEX? Read the Instructions for Use for detailed information about the right way to apply REGRANEX.
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What are the possible side effects of REGRANEX? REGRANEX may cause serious side effects.
The most common side effect of REGRANEXis red skin rashes. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Smith & Nephew, Inc. at 1-800-441-8227. |
How should I store REGRANEX?
Keep REGRANEX and all medicines out of the reach of children. |
General information about the safe and effective use of REGRANEX Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REGRANEX for a condition for which it was not prescribed. Do not give REGRANEX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about REGRANEX that is written for health professionals. |
What are the ingredients in REGRANEX? Active ingredient:becaplermin Inactive ingredients:carboxymethylcellulose sodium, acetic acid, lysine hydrochloride, metacresol, methylparaben, propylparaben, sodium acetate, sodium chloride and purified water. Manufactured and marketed by: Smith & Nephew, Inc., Fort Worth, TX 76109 U.S. Gov’t License # 2004 REGRANEX ®is a registered trademark of Smith & Nephew, Inc. Part No. 141125-0819 |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 08/2019