REGRANEX (Page 3 of 4)

14.2 Lack of Efficacy in Pressure Ulcers and Venous Stasis Ulcers

In a randomized, double-blind study of REGRANEX (100 mcg/g once daily for 16 weeks) in subjects with Stage III or IV pressure ulcers, the incidence of complete ulcer closure was 15% (28/189) in the REGRANEX group and 12% (22/190) in the vehicle control group. This difference was not statistically significant.

In two small, randomized, double-blinded studies of REGRANEX (100 mcg/g once daily for 16 weeks) in subjects with venous stasis ulcers, the combined incidence of complete ulcer closure was 46% (30/65) in the REGRANEX group and 39% (26/67) in the vehicle control group. This difference was not statistically significant.

14.3 Observational Studies to Evaluate Cancer Development and Mortality

The observational studies described below do not involve random allocation of treatments. They are susceptible to bias and confounding.

A retrospective study using medical claims database to assess cancer incidence with up to 6 years of follow-up observed development of 28 cancers and 8 cancer deaths in the REGRANEX exposed cohort (n = 1,622) and 43 cancers and 8 cancer deaths in the matched comparator cohort not exposed to REGRANEX (n = 2,809). The rate ratio for incident cancer comparing the REGRANEX-exposed cohort to the unexposed comparator cohort was 1.2 (95% CI, 0.7 -1.9). The rate ratio for cancer mortality comparing the REGRANEX-exposed cohort to the unexposed comparator cohort was 1.8 (95% CI, 0.7 -4.9). The rate ratio comparing patients exposed to three or more tubes of REGRANEX to those not exposed was 5.2 (95% CI, 1.6 -17.6) [ see Adverse Reactions (6.2) ].

A retrospective study using medical claims from the Veteran Affairs health care database with up to 11 years of follow-up among patients without prior cancer observed 197 cancer deaths in the REGRANEX exposed cohort (n = 6,429) and 206 cancer deaths in the matched comparator cohort not exposed to REGRANEX (n = 6,429), resulting in a hazard ratio of 0.9 (95% CI, 0.8-1.2). The hazard ratio for cancer mortality comparing patients exposed to three or more tubes of REGRANEX to those not exposed was 1.0 (95% CI, 0.7 -1.5). The hazard ratio for incident cancer in a smaller cohort (1,507 REGRANEX-exposed and 1,507 unexposed patients) comparing patients exposed to REGRANEX to those not exposed was 1.1 (95% CI, 0.8-1.4).

A second retrospective study using medical claims from the Veteran Affairs health care database with up to 11 years of follow-up among patients with prior cancer observed 87 cancer deaths in the REGRANEX-exposed cohort (n = 477) and 340 cancer deaths in the matched comparator cohort not exposed to REGRANEX (n = 1,756), resulting in a hazard ratio of 0.9 (95% CI, 0.7-1.2). The hazard ratio for cancer mortality comparing patients exposed to three or more tubes of REGRANEX to those not exposed was 0.9 (95% CI, 0.6 -1.2).

16 HOW SUPPLIED/STORAGE AND HANDLING

REGRANEX (0.01%) is clear, colorless to straw-colored and is available in multi-use tubes in the following size:

15 g tube NDC 50484-810-15

Store refrigerated at 2° – 8° C (36° – 46°F). Do not freeze.

17 PATIENT COUNSELING INFORMATION

  • Advise patients and caregivers to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) and follow the step-by-step instructions for REGRANEX application in the Instructions for Use.
  • Counsel patients to review and discuss any questions or concerns with their healthcare provider before starting REGRANEX and at regular intervals while receiving REGRANEX.
  • Advise patients that it is important to use REGRANEX together with a good ulcer care program, including a strict non-weight-bearing program.
  • Advise patients to store REGRANEX in the refrigerator and not to freeze REGRANEX.

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

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 REGRANEX if you have a cancer at the application site.

Before using REGRANEX, tell your healthcare provider about all of your medical conditions, including if you:

  • have cancer.
  • are pregnant or plan to become pregnant. It is not known if REGRANEX will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if REGRANEX passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with REGRANEX.

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.

  • Use REGRANEX together with good ulcer care, as prescribed by your healthcare provider. This includes following your healthcare provider’s instructions about not putting weight (non-weight bearing) on the affected leg and foot.
  • Use REGRANEX exactly as your healthcare provider tells you to use it.
  • The amount of REGRANEX you will apply will depend on the size of your ulcer. Your healthcare provider should check the size of your ulcer every 1 to 2 weeks. Your healthcare provider may change the amount of REGRANEX to be applied to your ulcer as the size of your ulcer changes.

What are the possible side effects of REGRANEX?

REGRANEX may cause serious side effects.

  • See “What is the most important information I should know about REGRANEX?”
  • Application site reactions. Tell your healthcare provider if you have any skin reactions such as burning sensation at the site of application during treatment with REGRANEX. Your healthcare provider may temporarily stop or completely stop treatment with REGRANEX if you have skin reactions.

The most common side effect of REGRANEX is 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?

  • Store REGRANEX in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Do not freeze REGRANEX.
  • Do not use REGRANEX after the expiration date on the bottom (sealed end) of the tube.
  • Throw away your REGRANEX that is out of date or no longer needed for your treatment.

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, glacial acetic acid, l-lysine hydrochloride, m-cresol, methylparaben, propylparaben, sodium acetate trihydrate, sodium chloride, and water for injection.

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

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.