Becaplermin

Becaplermin
Names
Trade namesRegranex
Clinical data
Drug classplatelet-derived growth factor.[1]
Main usesDiabetic foot ulcer due to neuropathy[1]
Side effectsRed rash[1]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Pregnancy
category
  • US: C (Risk not ruled out)
    Routes of
    use    		Topical
    External links
    AHFS/Drugs.comMonograph
    MedlinePlusa699049
    Legal
    Legal status

    Becaplermin, sold under the brand name Regranex, is a medication used for diabetic foot ulcer of the leg due to neuropathy.[1] It is only used in cases that have sufficient blood supply.[1] It is applied to the skin.[1]

    Common side effects include a red rash.[1] Other side effects may include cancer.[1] Safety in pregnancy is unclear.[2] It is a platelet-derived growth factor.[1]

    Becaplermin was approved for medical use in the United States in 1997.[1] While it was approved for use in Europe in 1999, this approval was subsequently withdrawn.[3] It was refused approval for gum tissue loss in Europe in 2009.[4] In the United States it costs about 1,200 USD for a 15 gram tube as of 2022.[5]

    Medical uses

    The drug is used for the treatment of diabetic foot ulcers.[6] Studies of becaplermin showed that when used with good wound care, complete healing significantly increased and the ulcers healed on average 6 weeks faster.[7] Pharmacoeconomic studies reinforce the cost effectiveness of becaplermin as an adjunct to good wound care.[8]

    The amount of becaplermin to be applied will vary depending upon the size of the ulcer area. Becaplermin should be stored in the refrigerator.[9] Analysis of healing human wounds showed that PDGF-BB induces fibroblast proliferation and differentiation and was found to increase healing in patients with decreased healing capacity, such as people living with diabetes. [10]

    Contraindications

    Becaplermin must not be used at the site of a skin cancer.[11]

    Side effects

    The most common side effects in clinical studies were erythematous rashes.[11]

    A boxed warning has been added to the safety label to describe an increase rate of death from cancer when three or more tubes are used.[12] Regranex should be used with caution in patients with known malignancy.[9]

    See also

    References

    1. 1 2 3 4 5 6 7 8 9 10 "DailyMed - REGRANEX- becaplermin gel". dailymed.nlm.nih.gov. Archived from the original on 24 March 2021. Retrieved 8 January 2022.
    2. ↑ "Becaplermin Monograph for Professionals". Drugs.com. Retrieved 8 January 2022.
    3. ↑ "Regranex". Archived from the original on 11 January 2022. Retrieved 8 January 2022.
    4. ↑ "Gemesis". Archived from the original on 5 April 2021. Retrieved 8 January 2022.
    5. ↑ "Becaplermin Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 8 January 2022.
    6. ↑ Nagai MK, Embil JM (February 2002). "Becaplermin: recombinant platelet derived growth factor, a new treatment for healing diabetic foot ulcers". Expert Opinion on Biological Therapy. 2 (2): 211–8. doi:10.1517/14712598.2.2.211. PMID 11849120. S2CID 28408255.
    7. ↑ Wieman TJ, Smiell JM, Su Y (May 1998). "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. 21 (5): 822–7. doi:10.2337/diacare.21.5.822. PMID 9589248. S2CID 20595962.
    8. ↑ Persson U, Willis M, Odegaard K, Apelqvist J (2000). "The cost-effectiveness of treating diabetic lower extremity ulcers with becaplermin (Regranex): a core model with an application using Swedish cost data". Value in Health : The Journal of the International Society for Pharmacoeconomics and Outcomes Research. 3 Suppl 1: 39–46. doi:10.1046/j.1524-4733.2000.36027.x. PMID 16464208.
    9. 1 2 "REGRANEX Gel Highlights of Prescribing Information" (PDF). Smith & Nephew, Inc. Archived from the original (PDF) on 26 August 2016.
    10. ↑ Heldin CH, Westermark B. Mechanism of action and in vivo role of platelet-derived growth factor. Physiol Rev. 1999;79:1283-1316.
    11. 1 2 FDA Professional Drug Information for Regranex.
    12. ↑ Waknine Y (9 June 2008). "Diabetic Ulcer Gel Gets Black Box Warning". Medscape. Archived from the original on 24 June 2019. Retrieved 14 October 2021.
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