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REGRANEX

(becaplermin) Gel, 0.01%

About REGRANEX

Engineered for growth

Recombinant platelet-derived growth factor (PDGF) therapy for diabetic neuropathic ulcers

REGRANEX gel is the only FDA-approved PDGF for the treatment of diabetic neuropathic ulcers, formulated to act as a first-line treatment following effective ulcer care.

The prevalence of diabetes is rising, with an estimated 15% of patients likely to experience a diabetic foot ulcer (DFU).1-3 85% of diabetes-related lower extremity amputations are preceded by a DFU4, yet it is estimated that 85% of those amputations can be prevented.3

Shown to achieve faster healing and a greater incidence of wound closure

In clinical studies, using REGRANEX gel as part of effective ulcer care:

avaerage 6 weeks closure earlier Helped to achieve wound closure an average 6 weeks earlier than placebo gel*5

 

Achieved a 50% incidence of wound closure at 20 weeks Significantly increased the incidence of complete closure by 43%, when compared to placebo gel**5

 

stimulate the recruitment and proliferation of cells Shown to help stimulate the recruitment and proliferation of cells involved in wound repair6

 

Patients could save money Patients could save up to $200 with our Copay Assistance Program***. Help achieve patient savings in a few simple steps.

Aim to achieve a greater incidence of wound closure

Administer REGRANEX gel as an adjunct to effective ulcer care when:

  • The wound bed is free of necrotic tissue, and extends into the subcutaneous tissue and beyond6
  • Adequate blood flow is present and infection has been controlled6
  • Pressure has been redistributed6
  • The patient and/or caregiver has shown an understanding of good foot care6

Principles and treatment to promote good care for ulcer wounds

Add REGRANEX gel to standard care protocols for good ulcer wound care.

The principles of effective ulcer care include:

Debridement Debridement – remove necrotic tissue and calluses to facilitate drainage and stimulate healing.7 Consider using Collagenase SANTYL◊ Ointment, indicated for debriding chronic dermal ulcers.

Infection Control Infection control – reduce bacterial burden to restore a stable bacterial balance.7

 

Redistribute pressure to reduce incidence of ulceration Off-loading – redistribute plantar pressure,7 which can reduce the incidence of ulceration.8

 

other factors Other factors – ensure adequate blood flow, controlled blood sugar levels and a proper moisture balance in the wound.9,10

 

Other wound management solutions

PICO PICO Single Use Negative Pressure Wound Therapy System

 

 

 

SANTYL  Collagenase SANTYL Ointment is indicated for debriding chronic dermal ulcers.

 

 

T.I.M.E.  Implement a systematic, holistic and multidisciplinary approach to daily clinical practice with the T.I.M.E. clinical decision support tool (CDST)11,12

 


 *Multi-center, double-blind, parallel-group placebo-controlled trial of 382 patients with type 1 or type 2 diabetes. p=0.013
**Multi-center, double-blind, parallel-group placebo-controlled trial of 382 patients with type 1 or type 2 diabetes. p=0.007
**Subject to the Copay Assistance Card Terms and Conditions below and on the back of the card.

Important safety information

Indications: REGRANEX (becaplermin) gel 0.01% ("REGRANEX") is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.

Contraindications: REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application.

Warnings and Precautions: Malignancies distant from the site of application have occurred in REGRANEX users in a clinical study and in postmarketing use. REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers. The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans. REGRANEX is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.

Adverse Reactions: In clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care). In a retrospective follow-up study, eight of 291 subjects (2.7%) from the REGRANEX group, and two of 200 subjects (1%) from the placebo group were diagnosed with cancers during the follow-up period. An increased rate of death from systemic malignancies in patients dispensed three or more tubes of REGRANEX, observed in one of three retrospective postmarketing studies. Other adverse reactions that have been reported include a burning sensation, and erythema at the site of application. The risk information provided herein is not comprehensive. To see the complete prescribing information, please see the FDA-approved product labeling, here:

Indications: Collagenase SANTYL Ointment (“SANTYL”) is indicated for debriding chronic dermal ulcers and severely burned areas.

Contraindications: SANTYL is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase.

Warnings and Precautions: The optimal pH range of collagenase is 6 to 8. Higher or lower pH conditions will decrease the enzyme’s activity and appropriate precautions should be taken. The enzymatic activity is also adversely affected by certain detergents, and heavy metal ions such as mercury and silver which are used in some antiseptics. As such, the wound should be properly cleansed prior to application of SANTYL. Debilitated patients should be closely monitored for systemic bacterial infections because of the theoretical possibility that debriding enzymes may increase the risk of bacteremia. A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when SANTYL was not confined to the wound. SANTYL is not indicated for wound closure. Discontinue use of SANTYL after granulation tissue is well-established.

Adverse Reactions: No allergic sensitivity or toxic reactions have been noted in clinical use when used as directed. The risk information provided herein is not comprehensive. To see the complete Prescribing Information, please see the FDA-approved product labelling, here: https://www.santyl.com/pdf/SANTYL-PI.pdf

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

 

References:
1. Frykberg RG, Zgonis T, Armstrong DG, et al; American College of Foot and Ankle Surgeons. Diabetic foot disorders: a clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006;45(5 Suppl):S1-S66.
2. Huang ES, Basu A, O’Grady M, Capretta JC. Projecting the future diabetes population size and related costs for the US. Diabetes Care. 2009;32:2225-2229.
3. International Working Group on the Diabetic Foot. Time to act. Available at: https://www.worlddiabetesfoundation.org/sites/default/files/Diabetes%20and%20Foot%20care_Time%20to%20act.pdf. Accessed May 9, 2017.
4. Boulton AJ. The diabetic foot: grand overview, epidemiology and pathogenesis. Diabetes Metab Res Rev. 2008;24 Suppl 1:S3-S6.
5. Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998;21:822-827.
6. REGRANEX gel Prescribing Information.
7. Edmonds M, Foster AV, Vowden P. Wound bed preparation for diabetic ulcers. In: Moffatt C, ed. European Wound Management Association (EWMA). Position Document: Wound Bed Preparation in Practice. London, England: MEP Ltd; 2004:6-11.
8. Steed DL, Attinger C, Colaizzi T, et al. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006;14:680-692.
9. Adeshara KA, Diwan AG, Tupe RS. Diabetes and complications: cellular signalling pathways, current understanding and targeted therapies. Curr Drug Targets. 2016;17:1309-1328.
10. Kirsner RS. The standard of care for evaluation and treatment of diabetic foot ulcers. The University of Michigan Medical School. The University of Michigan Health System’s Educational Services for Nursing. Barry University School of Podiatric Medicine 2010. Available at: http://www.barry.edu/includes/docs/continuing-medical-education/diabetic.pdf. Accessed May 5, 2017.
11. Ousey K, Gilchrist B, Jaimes H. Understanding clinical practice challenges: a survey performed with wound care clinicians to explore wound assessment frameworks. Wounds International. 2018;9(4):58-62.
12. Moore Z, Dowsett C, Smith G, et al. TIME CDST: an updated tool to address the current challenges in wound care. J Wound Care. 2019;28(3):154-161. Available at: Journal of Wound Care.

How REGRANEX Works

How REGRANEX works

Understanding REGRANEX gel in practice for diabetic neuropathic ulcers

REGRANEX gel features endogenous platelet-derived growth factor (PDGF) therapy, shown to initiate the healing process by attracting repair cells to the wound.1 PDGF works to:

  • Stimulate fibroblast proliferation to increase the growth of granulation tissue2
  • Increase the rate of re-epithelialization and revascularization2
  • Promote collagen production2

REGRANEX gel in practice – patient case studies

Case study 1: 50-year old male with recurrent diabetes-related foot ulcers**

Day 1 – Ulcer sharp debrided and REGRANEX gel treatment applied. Patient off-loaded with a postoperative shoe and crutches

Day 17 – sharp debrided and REGRANEX gel treatment continued (same applied on day 7)

Day 27 – REGRANEX gel treatment discontinued and covered with suitable dressing or gauze.

Case study 2: DFU patient discharged from ER with REGRANEX after debridement 

Day 1 – Ulcer measurement: 3cm x 2.5cm x 0.2cm

Day 34 – Ulcer measurement: 2cm x 1cm x 0.1cm

Day 71 – Wound resolved in 2.4 months following initial sharp debridement, REGRANEX gel and off-loading.

The stages of wound healing

Stage 1: Homeostasis - clotting and vascular response

Platelets release PDGF to initiate the chemotaxis of neutrophils, macrophages, smooth muscle cells and fibroblasts.1

Stage 2: Inflammation

Neutrophils remove foreign material, bacteria, non-functional host cells, and damaged matrix components from the wound site. Fixed tissue monocytes are activated to become macrophages, releasing PDGF and TGF-ß to further attract fibroblasts and smooth muscle cells to the wound. Macrophages remove non-functional host cells, bacteria, damaged matrix, and foreign debris.1

Stage 3 – Proliferation – epithelial healing, contraction and scar formation

Fibroblasts, recruited by PDGF, produce the new matrix needed to restore structure and function to injured tissue. Fibroblasts attach to the cables of the provisional fibrin matrix and begin to produce collagen.1

Stage 4 – Scar remodelling*

Continued synthesis and degradation of extracellular matrix (ECM) components to establish a new skin matrix.1 Collagenase enzymes break collagen into smaller fragments, then the ECM is rebuilt to provide strength to mature scar tissue.1

How to break the cycle of inflammation3

Ongoing, daily debridement can help break the cycle of inflammation by removing macroscopic and microscopic necrotic tissue from diabetic foot ulcers and other types of chronic wound.4

SANTYL Collagenase SANTYL◊ Ointment is indicated for debriding chronic dermal ulcers.  



*Because REGRANEX gel is indicated for diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond, it is not indicated for use during this phase of healing.5

** 50-year-old male with type 2 diabetes, peripheral neuropathy, peripheral artery disease, left fifth toe amputation for osteomyelitis, stenting of right and left external iliac arteries. Recurrent left foot ulcers for 3-4 years. Fully ambulatory in post-op shoe with cut-out under ulcer.

***Patient was presented to ER with DFU. Angiogram to determine vascularity. A week later, sharp debridement was performed. Patient was then discharged to home care with REGRANEX gel, three days post-debridement with forefoot offloading wedge shoe. Home health nurse monitored patient until seen four weeks later.

Important safety information

Indications: REGRANEX (becaplermin) gel 0.01% ("REGRANEX") is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.

Contraindications: REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application.

Warnings and Precautions: Malignancies distant from the site of application have occurred in REGRANEX users in a clinical study and in postmarketing use. REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers. The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans. REGRANEX is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.

Adverse Reactions: In clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care). In a retrospective follow-up study, eight of 291 subjects (2.7%) from the REGRANEX group, and two of 200 subjects (1%) from the placebo group were diagnosed with cancers during the follow-up period. An increased rate of death from systemic malignancies in patients dispensed three or more tubes of REGRANEX, observed in one of three retrospective postmarketing studies. Other adverse reactions that have been reported include a burning sensation, and erythema at the site of application. The risk information provided herein is not comprehensive. To see the complete prescribing information, please see the FDA-approved product labeling, here

Indications: Collagenase SANTYL Ointment (“SANTYL”) is indicated for debriding chronic dermal ulcers and severely burned areas.

Contraindications: SANTYL is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase.

Warnings and Precautions: The optimal pH range of collagenase is 6 to 8. Higher or lower pH conditions will decrease the enzyme’s activity and appropriate precautions should be taken. The enzymatic activity is also adversely affected by certain detergents, and heavy metal ions such as mercury and silver which are used in some antiseptics. As such, the wound should be properly cleansed prior to application of SANTYL. Debilitated patients should be closely monitored for systemic bacterial infections because of the theoretical possibility that debriding enzymes may increase the risk of bacteremia. A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when SANTYL was not confined to the wound. SANTYL is not indicated for wound closure. Discontinue use of SANTYL after granulation tissue is well-established.

Adverse Reactions: No allergic sensitivity or toxic reactions have been noted in clinical use when used as directed. The risk information provided herein is not comprehensive. To see the complete Prescribing Information, please see the FDA-approved product labelling, here: https://www.santyl.com/pdf/SANTYL-PI.pdf

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

 

References:
1. Diegelmann RF, Evans MC. Wound healing: an overview of acute, fibrotic and delayed healing. Front Biosci. 2004;9:283-289.
2. Heldin CH, Westermark B. Mechanism of action and in vivo role of platelet-derived growth factor. Physiol Rev. 1999;79:1283-1316.
3. Edmonds M, Foster AV, Vowden P. Wound bed preparation for diabetic ulcers. In: Moffatt C, ed. European Wound Management Association (EWMA). Position Document: Wound Bed Preparation in Practice. London, England: MEP Ltd; 2004:6-11.
4. Enoch S, Harding K. Wound bed preparation: the science behind the removal of barriers to healing. Wounds. 2003;15:213-229.
5. REGRANEX gel Prescribing Information.

How to use REGRANEX

Simple, convenient application

Three-step application process – prepare, apply and cover1

Designed for a flexible, one-daily application schedule as part of effective wound care and assessment, to be applied by either the clinician, caregiver or patient.

Decide with the patient who will apply REGRANEX GEL, and use the simple application process below.

 Reminder Always remind patients to refrigerate REGRANEX gel.

 

 Wash hands and squeeze the calculated amount of REGRANEX gel onto a clean, firm, non-absorbent surface (such as wax paper). Do not let the tip of the REGRANEX gel tube touch the wound or any other surface.

 Use an application aid to spread REGRANEX gel over the entire wound surface in a thin, even layer of around 1/16 of an inch (roughly the thickness of a penny).

 Cover the area with saline-moistened gauze dressing. After approximately 12 hours, remove the dressing and rinse with saline or water to remove the remaining REGRANEX gel. Cover with a new saline-moistened dressing (without REGRANEX gel) for the remainder of the day.

For accurate dosage, please refer to the simple dosage calculation.

Talking to your patient and promoting self-care

Patients have been shown to engage with a treatment regimen if they believe:2

  • It makes sense and is effective
  • The benefits outweigh the costs
  • The environment supports regimen-related behaviours

To enhance compliance with REGRANEX gel:

 Refer patients to REGRANEX360 to answer questions about obtaining and applying REGRANEX gel.

 

 Use simple and clear language, providing written instructions in support. Ask patients to repeat instructions back to you and encourage them to take notes.

 Encourage patients to bring caregivers to their appointments. Utilize behavioural contracts to improve compliance, referring patients to a diabetes behavioural specialist where appropriate.

Your compliance checklist

health care professional

 In the office:

  • Note who is applying REGRANEX gel (patient or caregiver)
  • Set an alarm for daily application and dressing change reminders
  • Schedule weekly or bi-weekly physician appointments
  • Remind the patient/caregiver to review the accompanying medication guide

person

 At home:

  • Maintain off-loading and examine feet daily
  • Apply REGRANEX gel as directed
  • Remember to refrigerate REGRANEX gel
  • Contact a clinician with any concerns or side effects

For further guidance, please contact us.

Important safety information

Indications: REGRANEX (becaplermin) gel 0.01% ("REGRANEX") is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.

Contraindications: REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application.

Warnings and Precautions: Malignancies distant from the site of application have occurred in REGRANEX users in a clinical study and in postmarketing use. REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers. The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans. REGRANEX is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.

Adverse Reactions: In clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care). In a retrospective follow-up study, eight of 291 subjects (2.7%) from the REGRANEX group, and two of 200 subjects (1%) from the placebo group were diagnosed with cancers during the follow-up period. An increased rate of death from systemic malignancies in patients dispensed three or more tubes of REGRANEX, observed in one of three retrospective postmarketing studies. Other adverse reactions that have been reported include a burning sensation, and erythema at the site of application. The risk information provided herein is not comprehensive. To see the complete prescribing information, please see the FDA-approved product labeling, here

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

 


References:
1. Heldin CH, Westermark B. Mechanism of action and in vivo role of platelet-derived growth factor. Physiol Rev. 1999;79:1283-1316.
2. Delamater AM. Improving patient adherence. Clin Diabetes. 2006;24:71-77.

REGRANEX 360

REGRANEX 360

Comprehensive support for you and your patients - making prescribing REGRANEX gel easy

REGRANEX 360 is a comprehensive programme designed to support prescribers and their patients, helping to simplify prior authorization and product acquisition while offering live support to patients.

Patient benefits:

  • Verification of benefits
  • Coordination of prior authorization submission and appeal
  • Follow-up with patient around delivery, application and compliance with REGRANEX gel instructions
  • Patient care coordinators can answer questions about ordering and application
  • At-home delivery around the patient’s schedule

Steps to make prescribing REGRANEX gel easy

 Prescriber calls 1-888-REGRANEX (734-7263).

 

 In some cases a benefits investigation may be performed.

 

 Prior authorization is populated with data from the intake form (or it is submitted with appropriate benefits investigation if appropriate). 

 Prior authorization is routed directly to the payer.

 

 REGRANEX 360 obtains prior authorization approval and send the clean prescription to specialty/retail pharmacy. The pharmacy then dispenses the REGRANEX gel.

 The REGRANEX 360 patient care coordinator contacts the patient to schedule product delivery, continuing communication throughout.

To find out more about REGRANEX 360, please contact us.

Important safety information

Indications: REGRANEX (becaplermin) gel 0.01% ("REGRANEX") is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.

Contraindications: REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application.

Warnings and Precautions: Malignancies distant from the site of application have occurred in REGRANEX users in a clinical study and in postmarketing use. REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers. The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans. REGRANEX is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.

Adverse Reactions: In clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care). In a retrospective follow-up study, eight of 291 subjects (2.7%) from the REGRANEX group, and two of 200 subjects (1%) from the placebo group were diagnosed with cancers during the follow-up period. An increased rate of death from systemic malignancies in patients dispensed three or more tubes of REGRANEX, observed in one of three retrospective postmarketing studies. Other adverse reactions that have been reported include a burning sensation, and erythema at the site of application. The risk information provided herein is not comprehensive. To see the complete prescribing information, please see the FDA-approved product labeling, here

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

Clinical Resources

REGRANEX in daily clinical practice

How to calculate dosage

The correct dosage for REGRANEX Gel can be calculated using these simple formulae*:

Ulcer length (cm) x Ulcer width (cm) ÷ 4 = length of gel per application (cm)

Alternatively:

Ulcer length (in) X ulcer width (in) x .6 = length of gel per application (in)

Each wound should be assessed individually In the event of multiple wounds, each wound should be assessed individually. Recalculate dose weekly or bi-weekly, based on the rate of change in the ulcer area. 

How to estimate the required number of tubes

To estimate the number of tubes required, use this simple calculation:

Length of gel per application (cm) x Estimated length of therapy (days) ÷ (60cm/tube) = estimated number of tubes required

Example:

Based on a 2cm x 3cm ulcer.

(1.5cm) x (14 days) ÷ 60cm/tube = 0.35 tubes

Order 1 tube, rounding up to the nearest full tube.

  • The days of therapy per tube are calculated based on a constant ulcer size and may change based on decreasing wound size as ulcer heals.1
  • If the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment, or complete healing has not occurred in 20 weeks, continued treatment with REGRANEX gel should be reassessed.2

 

 A clinical study showed that diabetic foot ulcer patients treated with REGRANEX gel recevied an average 1.5 tubes.3

 

This information is not intended to supercede independent clinical judgment or institutional protocols. Although each 15g tube of REGRANEX gel is estimated to dispense 60cm of gel, actual dispensation may vary depending on user characteristics and application methods.

Download full prescribing information here

Promoting systematic, holistic and multidisciplinary wound care4,5

T.I.M.E. Our new T.I.M.E. clinical decision support tool (CDST) was developed with expert clinicians to promote consistency in wound care and assessment4,5, shown to give clinicians confidence in decision-making.6

Download T.I.M.E. CDST 

*Applying more than the calculated amount of REGRANEX Gel has not been shown to be beneficial.

Copay Assistance Program Terms and Conditions
Not valid for prescriptions eligible to be reimbursed under Medicare (including Medicare part D and Medicare Advantage), Medicaid, TRICARE, CHAMPUS, the Puerto Rico Governmental Health Insurance Plan, or other federal, state, or governmental healthcare programs. Valid in the U.S. only, void where taxed, restricted, or prohibited by law. Accepted by participating pharmacies only. The Copay Assistance Program is not insurance and may be changed or discontinued at any time without notice.

Important safety information

Indications: REGRANEX (becaplermin) gel 0.01% ("REGRANEX") is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.

Contraindications: REGRANEX is contraindicated in patients with known neoplasm(s) at the site(s) of application.

Warnings and Precautions: Malignancies distant from the site of application have occurred in REGRANEX users in a clinical study and in postmarketing use. REGRANEX contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. The efficacy of REGRANEX has not been established for the treatment of pressure ulcers and venous stasis ulcers and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue or ischemic diabetic ulcers. The effects of becaplermin on exposed joints, tendons, ligaments, and bone have not been established in humans. REGRANEX is a non-sterile, low bioburden preserved product. Therefore, it should not be used in wounds that close by primary intention.

Adverse Reactions: In clinical trials, erythematous rashes occurred in 2% of subjects treated with REGRANEX (and good ulcer care) or placebo (and good ulcer care). In a retrospective follow-up study, eight of 291 subjects (2.7%) from the REGRANEX group, and two of 200 subjects (1%) from the placebo group were diagnosed with cancers during the follow-up period. An increased rate of death from systemic malignancies in patients dispensed three or more tubes of REGRANEX, observed in one of three retrospective postmarketing studies. Other adverse reactions that have been reported include a burning sensation, and erythema at the site of application. The risk information provided herein is not comprehensive. To see the complete prescribing information, please see the FDA-approved product labeling, here

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

 

References:
1. Data on file. Smith & Nephew. October 2012.
2. Heldin CH, Westermark B. Mechanism of action and in vivo role of platelet-derived growth factor. Physiol Rev. 1999;79:1283-1316.
3. Lantis JC II, Boone D, Gendics C, Todd G. Analysis of patient cost for recombinant human platelet-derived growth factor therapy as the first-line treatment of the insured patient with a diabetic foot ulcer. Adv Skin Wound Care. 2009;22:167-171.
4. Ousey K, Gilchrist B, Jaimes H. Understanding clinical practice challenges: a survey performed with wound care clinicians to explore wound assessment frameworks. Wounds International. 2018;9(4):58-62.
5. Moore Z, Dowsett C, Smith G, et al. TIME CDST: an updated tool to address the current challenges in wound care. J Wound Care. 2019;28(3):154-161. Available at: Journal of Wound Care.
6. Swanson T, Duynhoven K, Johnstone D. Using the new T.I.M.E. Clinical Decision Support Tool to promote consistent holistic wound management and to eliminate variation in practice in Victoria, Australia: Part 1. Wounds International. 2019;10(2):38–47. Available at: https://www.woundsinternational.com/journals/latest-issue/wounds-international-journal 

Want to learn more about REGRANEX gel?             

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Patients prescribed REGRANEX gel may be eligible to save up to $200 with our Copay Assistance Program. 

Download and give to patients

For full prescribing information, please refer to this downloadable PDF:

Prescribing information