Becaplermin

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Becaplermin
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Trade names Regranex
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MedlinePlus a699049
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Topical
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Becaplermin (brand name Regranex) is a cicatrizant, available as a topical gel. Regranex is a human platelet-derived growth factor indicated along with good wound care for the treatment of lower extremity diabetic neuropathic ulcers. [1] It is also known as "platelet-derived growth factor BB". [1]

Contents

Medical uses

The drug is used for the treatment of diabetic foot ulcers. [2] Studies of becaplermin showed that when used with good wound care, complete healing significantly increased and the ulcers healed on average 6 weeks faster. [3] Pharmacoeconomic studies reinforce the cost effectiveness of becaplermin as an adjunct to good wound care. [4]

The amount of becaplermin to be applied will vary depending upon the size of the ulcer area. Becaplermin should be stored in the refrigerator. [1] 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. [5]

Contraindications

Becaplermin must not be used at the site of a skin cancer. [6]

Adverse effects

The most common side effects in clinical studies were erythematous rashes. [6]

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. [7] Regranex should be used with caution in patients with known malignancy. [1]

See also

Related Research Articles

<span class="mw-page-title-main">Ulcer (dermatology)</span> Type of cutaneous condition

An ulcer is a sore on the skin or a mucous membrane, accompanied by the disintegration of tissue. Ulcers can result in complete loss of the epidermis and often portions of the dermis and even subcutaneous fat. Ulcers are most common on the skin of the lower extremities and in the gastrointestinal tract. An ulcer that appears on the skin is often visible as an inflamed tissue with an area of reddened skin. A skin ulcer is often visible in the event of exposure to heat or cold, irritation, or a problem with blood circulation.

<span class="mw-page-title-main">Wound</span> Acute injury from laceration, puncture, blunt force, or compression

A wound is a rapid onset of injury that involves lacerated or punctured skin, or a contusion from blunt force trauma or compression. In pathology, a wound is an acute injury that damages the epidermis of the skin. To heal a wound, the body undertakes a series of actions collectively known as the wound healing process.

Diabetic neuropathy is various types of nerve damage associated with diabetes mellitus. Symptoms depend on the site of nerve damage and can include motor changes such as weakness; sensory symptoms such as numbness, tingling, or pain; or autonomic changes such as urinary symptoms. These changes are thought to result from a microvascular injury involving small blood vessels that supply nerves. Relatively common conditions which may be associated with diabetic neuropathy include distal symmetric polyneuropathy; third, fourth, or sixth cranial nerve palsy; mononeuropathy; mononeuropathy multiplex; diabetic amyotrophy; and autonomic neuropathy.

<span class="mw-page-title-main">Peripheral neuropathy</span> Nervous system disease affecting nerves beyond the brain and spinal cord

Peripheral neuropathy, often shortened to neuropathy, is a general term describing damage or disease affecting the nerves. Damage to nerves may impair sensation, movement, gland, or organ function depending on which nerves are affected; in other words, neuropathy affecting motor, sensory, or autonomic nerves result in different symptoms. More than one type of nerve may be affected simultaneously. Peripheral neuropathy may be acute or chronic, and may be reversible or permanent.

<span class="mw-page-title-main">Platelet-derived growth factor</span> Signaling glycoprotein regulating cell proliferation

Platelet-derived growth factor (PDGF) is one among numerous growth factors that regulate cell growth and division. In particular, PDGF plays a significant role in blood vessel formation, the growth of blood vessels from already-existing blood vessel tissue, mitogenesis, i.e. proliferation, of mesenchymal cells such as fibroblasts, osteoblasts, tenocytes, vascular smooth muscle cells and mesenchymal stem cells as well as chemotaxis, the directed migration, of mesenchymal cells. Platelet-derived growth factor is a dimeric glycoprotein that can be composed of two A subunits (PDGF-AA), two B subunits (PDGF-BB), or one of each (PDGF-AB).

<span class="mw-page-title-main">Epidermal growth factor</span> Protein that stimulates cell division and differentiation

Epidermal growth factor (EGF) is a protein that stimulates cell growth and differentiation by binding to its receptor, EGFR. Human EGF is 6-kDa and has 53 amino acid residues and three intramolecular disulfide bonds.

<span class="mw-page-title-main">Neuropathic arthropathy</span> Medical condition

Neuropathic arthropathy, also known as Charcot joint after the first to describe it, Jean-Martin Charcot, refers to progressive degeneration of a weight-bearing joint, a process marked by bony destruction, bone resorption, and eventual deformity due to loss of sensation. Onset is usually insidious.

<span class="mw-page-title-main">Maggot therapy</span> Wound care by maggot therapy

Maggot therapy is a type of biotherapy involving the introduction of live, disinfected maggots into non-healing skin and soft-tissue wounds of a human or other animal for the purpose of cleaning out the necrotic (dead) tissue within a wound (debridement), and disinfection.

<span class="mw-page-title-main">Venous ulcer</span> Medical condition

Venous ulcer is defined by the American Venous Forum as "a full-thickness defect of skin, most frequently in the ankle region, that fails to heal spontaneously and is sustained by chronic venous disease, based on venous duplex ultrasound testing." Venous ulcers are wounds that are thought to occur due to improper functioning of venous valves, usually of the legs. They are an important cause of chronic wounds, affecting 1% of the population. Venous ulcers develop mostly along the medial distal leg, and can be painful with negative effects on quality of life.

A chronic wound is a wound that does not heal in an orderly set of stages and in a predictable amount of time the way most wounds do; wounds that do not heal within three months are often considered chronic. Chronic wounds seem to be detained in one or more of the phases of wound healing. For example, chronic wounds often remain in the inflammatory stage for too long. To overcome that stage and jump-start the healing process, a number of factors need to be addressed such as bacterial burden, necrotic tissue, and moisture balance of the whole wound. In acute wounds, there is a precise balance between production and degradation of molecules such as collagen; in chronic wounds this balance is lost and degradation plays too large a role.

<span class="mw-page-title-main">Negative-pressure wound therapy</span> Therapeutic technique

Negative-pressure wound therapy (NPWT), also known as a vacuum assisted closure (VAC), is a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds and second- and third-degree burns. The therapy involves the controlled application of sub-atmospheric pressure to the local wound environment using a sealed wound dressing connected to a vacuum pump. The use of this technique in wound management started in the 1990s and this technique is often recommended for treatment of a range of wounds including dehisced surgical wounds, closed surgical wounds, open abdominal wounds, open fractures, pressure injuries or pressure ulcers, diabetic foot ulcers, venous insufficiency ulcers, some types of skin grafts, burns, sternal wounds. It may also be considered after a clean surgery in a person who is obese.

<span class="mw-page-title-main">Diabetic shoe</span> Shoes intended to reduce the risk of skin breakdown in diabetics

Diabetic shoes are specially designed shoes, or shoe inserts, intended to reduce the risk of skin breakdown in diabetics with existing foot disease and relieve pressure to prevent diabetic foot ulcers.

<span class="mw-page-title-main">Arterial insufficiency ulcer</span> Medical condition

Arterial insufficiency ulcers are mostly located on the lateral surface of the ankle or the distal digits. They are commonly caused by peripheral artery disease (PAD).

Transdermal Continuous Oxygen Therapy is a wound closure technique for chronic and acute wounds which blankets a wound in oxygen on a 24-hour basis until the wound heals. Unlike hyperbaric oxygen treatment for chronic wounds, oxygen treatment used in this therapy is not systemic in nature and treats only the wound area. This treatment differs from topical oxygen treatments, as topical oxygen typically involves sporadic treatments of 1–3 hours several times per week, while TCOT treatment is 24/7 by nature.

<span class="mw-page-title-main">Diabetic foot</span> Medical condition

A diabetic foot disease is any condition that results directly from peripheral artery disease (PAD) or sensory neuropathy affecting the feet of people living with diabetes. Diabetic foot conditions can be acute or chronic complications of diabetes. Presence of several characteristic diabetic foot pathologies such as infection, diabetic foot ulcer and neuropathic osteoarthropathy is called diabetic foot syndrome. The resulting bone deformity is known as Charcot foot.

Chronic wound pain is a condition described as unremitting, disabling, and recalcitrant pain experienced by individuals with various types of chronic wounds. Chronic wounds such as venous leg ulcers, arterial ulcers, diabetic foot ulcers, pressure ulcers, and malignant wounds can have an enormous impact on an individual’s quality of life with pain being one of the most distressing symptoms.

<span class="mw-page-title-main">Diabetic foot ulcer</span> Medical condition

Diabetic foot ulcer is a major complication of diabetes mellitus, and probably the major component of the diabetic foot.

Total contact casting (TCC) is a specially designed cast designed to take weight off of the foot (off-loading) in patients with diabetic foot ulcers (DFUs). Reducing pressure on the wound by taking weight off the foot has proven to be very effective in DFU treatment. DFUs are a major factor leading to lower leg amputations among the diabetic population in the US with 85% of amputations in diabetics being preceded by a DFU. Furthermore, the five-year post-amputation mortality rate among diabetics is estimated at 45% for those with neuropathic DFUs.

Nepidermin, also known as recombinant human epidermal growth factor (rhEGF), is a recombinant form of human epidermal growth factor (EGF) and a cicatrizant. As a recombinant form of EGF, nepidermin is an agonist of the epidermal growth factor receptor (EGFR), and is the first EGFR agonist to be marketed. It was developed by Cuban Center for Genetic Engineering and Biotechnology (CIBG), and has been marketed by Heber Biotech as an intralesional injection for diabetic foot ulcer under the trade name Heberprot‐P since 2006. As of 2016, Heberprot‐P had been marketed in 23 countries, but remains unavailable in the United States. In 2015, preparations were made to conduct the Phase III trials required for FDA approval, however as of 2023 developments in U.S.-Cuba relations have stymied importation of the drug from Cuba.

<span class="mw-page-title-main">Diabetic foot infection</span> Medical condition

Diabetic foot infection is any infection of the foot in a diabetic person. The most frequent cause of hospitalization for diabetic patients is due to foot infections. Symptoms may include pus from a wound, redness, swelling, pain, warmth, tachycardia, or tachypnea. Complications can include infection of the bone, tissue death, amputation, or sepsis. They are common and occur equally frequently in males and females. Older people are more commonly affected.

References

  1. 1 2 3 4 "REGRANEX Gel Highlights of Prescribing Information" (PDF). Smith & Nephew, Inc. Archived from the original (PDF) on 26 August 2016.
  2. 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.
  3. 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.
  4. 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. 3 Suppl 1: 39–46. doi: 10.1046/j.1524-4733.2000.36027.x . PMID   16464208.
  5. Heldin CH, Westermark B. Mechanism of action and in vivo role of platelet-derived growth factor. Physiol Rev. 1999;79:1283-1316.
  6. 1 2 FDA Professional Drug Information for Regranex.
  7. Waknine Y (9 June 2008). "Diabetic Ulcer Gel Gets Black Box Warning". Medscape.