Regranex

Regranex is a prescription medication used to treat diabetic ulcers. Regranex belongs to a group of drugs called human platelet-derived growth factors. These work by helping to repair and replace dead skin and other tissues, attracting cells that repair wounds, and helping to close and heal the ulcer. 

This medication comes in a gel form to be applied to the skin and is usually used once a day until the ulcer is healed. 

Common side effects of Regranex include skin rashes.

Regranex is a prescription medication used to treat ulcers (sores) on the feet, ankles, or legs in people who have diabetes. Regranex must be used along with other ulcer care practices such as removal of dead tissue by a healthcare professional and treatment of infections.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Healthpoint Biotherapeutics

Serious side effects have been reported with Regranex. See the "Drug Precautions" section.

Common side effects of Regranex include skin rashes.

This is not a complete list of Regranex side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you apply other medicines to diabetic ulcers of your legs or feet. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Regranex including the following: 

• People who use 3 or more tubes of Regranex may have an increased risk of death from cancer.

Do not use Regranex if you:

• are allergic to Regranex or any of its ingredients
• have poor blood flow to your lower legs and feet
• have cancer or a skin tumor at the area where you apply the product

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Regranex, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Regranex, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Have cancer
• Have poor blood flow to your legs and feet
• Have allergies to any of the ingredients in Regranex gel
• Have any other medical conditions
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Regranex falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Regranex should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Regranex crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Regranex.

Use Regranex gel exactly as prescribed.

Regranex comes as a gel to be applied to the skin and is used once a day until the ulcer is healed.

Regranex gel is used for skin ulcers only. Do not use Regranex in your mouth, eyes, or vagina.

It is important to use Regranex gel together with a program for ulcer care determined by your doctor.

To apply Regranex gel:

• Wash your hands well first
• Carefully measure out the amount of gel your doctor told you to use.
• Squeeze the amount of gel needed on to a clean, firm, non-absorbable surface like wax paper. Do not let the tip of the tube touch the ulcer or any other surface. Close tube tightly after each use and store in refrigerator.
• Using a clean cotton swab, tongue depressor, or similar application aid, spread the gel in a thin layer over the surface of the ulcer.
• Cover the area with a saline-moistened gauze dressing.
• After about 12 hours, gently rinse the ulcer with saline or water to remove the rest of the gel. Cover the ulcer with a new saline-moistened gauze dressing. Do not apply any more gel.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The amount of Regranex gel to be applied will vary depending upon the size of your ulcer. Your doctor will measure your ulcer to calculate the amount of gel you need to use. 

Your doctor or wound care giver will check your ulcer every 1 or 2 weeks to determine if the amount of gel used needs to be changed.

If you use too much Regranex, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Regranex is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep this and all medicines out of the reach of children.

Store Regranex gel in the refrigerator (36°F to 46°F). Do not freeze it.

Regranex gel should not be used after the expiration date on the bottom end of the tube.

Throw away any Regranex gel that is out of date or no longer needed for your treatment.

Warning: Increased Rate of Mortality Secondary to Malignancy

An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of Regranex Gel in a postmarketing retrospective cohort study. Regranex Gel should only be used when the benefits can be expected to outweigh the risks. Regranex Gel should be used with caution in patients with known malignancy.