Becaplermin

Used to treat ulcers in diabetes patients, Becaplermin is a topical gel which can be applied to the affected area.

Overview

Foot and leg ulcers are usually caused by poor circulation. This is particularly common in patients with diabetes, who often experience high blood pressure and therefore poor blood flow to parts of the body. These sores and ulcers care breaks in the skin and can be extremely painful, as well as difficult to heal. In severe cases, the ulcers do not heal and become a chronic condition. This can make even the most simple of tasks difficult and painful for the patient.

Becaplermin is a gel medication usually prescribed to patients with diabetes that have developed sores or ulcers in the feet or legs. The gel is applied directly to the wound to help it heal quickly and prevent it from becoming infected. Becaplermin is most effective when it is used as just one part of a holistic treatment plan, to include good all-round ulcer care. This may include using crutches to take the pressure off the affected area when walking, wearing special shoes, or using a wheelchair. Patients will also be prescribed a further mediation to help with the treatment of infections that may develop as a result of the sores.

Patients that have had their ulcers stapled or stitched will not be able to use becaplermin. Instead, another treatment will be prescribed to help heal and manage pain caused by the wound.

Becaplermin is a substance that is naturally produced by the human body, derived from platelet growth. Its function is to help the healing of wounds by repairing and replacing dead tissues. The substance helps the body to produce blood cells that are essential to healing and closing open wounds.

Becaplermin is usually applied once or twice per day and can be administered by the patient directly onto the affected area. It is most effective if its usage instructions are fully followed and patients adhere to the dosage set by their doctors. Becaplermin is also known by its brand name Regranex in the United States.

The drug has been issued with a serious health warning, since a clinical study carried out in 2011 found that it could be related to cancer risk in patients. Although the drug was not linked to the cause of the disease, it was found to increase the risk of death in patients that had contracted cancer. [ref 1]

Conditions treated

  • Foot and leg ulcers in patients with diabetes

Type of medicine

  • Topical, supplied as a gel

Side effects

Patients have reported a range of side effects when using this medication. Usually, symptoms are not severe, but they may be uncomfortable and persistent. Patients should contact a doctor for advice if they find their side effects do not go away, or if they are worried. Common side effects include:

  • Skin rashes
  • Burning sensation at the site of application
  • Peeling of the skin
  • Blistering
  • Skin irritation, such as itching

Rarer and more severe side effects include:

  • Serious allergic reactions, such as skin irritations on a much more significant level
  • Swelling of the throat, face or tongue
  • Difficulty breathing
  • Dizziness and faintness
  • Severe burning feeling at the site of the ulcer

Dosage

The dose of becaplermin recommended depends on the size of the affected area. Your doctor will use a chart to determine the size of your wound and the amount of becaplermin to be applied. [ref 2] The length of gel to be applied in centimeters is determined by the following formula:

  • Length x width / 4 for a 15g tube
  • Length x width / 2 for a 2g physician sample tube

Your doctor or physician will be able to help you to recalculate your dosage at weekly or biweekly intervals, depending on the healing progress of the wound. The gel is usually applied once to twice per day.

To apply each dose of becaplermin, you should first read all the accompanying leaflets carefully and consult your doctor for advice. Wash your hands thoroughly before and after use. Apply the gel with a cotton swap, NOT with the tip of the container. Squeeze the correct amount of becaplermin onto a strip of wax paper. Then, use a clean cotton swab to spread the gel over the affected area in an even and thin layer.

Once the gel is applied, cover the area with saline dressing, and leave for 12 hours. After this, rinse the area with water or a saline solution.

Major drug interactions

Drug interactions are reactions between two or more substances. These reactions may mean that either drug becomes less effective or creates unexpected side effects. Major drug interactions can be highly dangerous and therefore should be avoided.

There are no drugs that are known to interact with becaplermin. However, this does not mean that there are not interactions that exist. You should always tell your doctor the full details about any other medication you are taken and any other condition you have. This will help your doctor to diagnose the safest and most effective medication for your individual needs.

Warnings

Oral consumption

Do not take becaplermin via the mouth. It is not designed for oral administration and consuming it may result in serious side effects such as vomiting. Consult your doctor immediately if you have consumed becaplermin via the mouth.

Cancer risk

Currently there is no data to show that people who use becaplermin are more likely to develop cancer than those that don’t use the gel. There has, however, been a recent study that found that those that had taken the medication are more likely to die from a cancer if they develop it than those that did not use becaplermin. Therefore, you should take all necessary precautions before taking this medication by telling your doctor if you have suffered from any form of cancer in the past. You may be recommended a different course of treatment.

Allergies

As becaplermin is applied directly to the affected area of the skin, patients are more vulnerable to allergic reactions around the wound and to the skin. These include rashes, blistering, hives, swelling in the face, tongue, lips and throat. You should consult your doctor if you start to develop an allergic reaction; in these instances, you may need to stop applying becaplermin. An alternative topical gel may be prescribed.

Pregnancy and breast-feeding

Before taking becaplermin, you should consult your doctor if you are pregnant or breast-feeding. Your doctor will be able to judge whether the benefits to your health outweigh the risk to your baby. As becaplermin is usually used by elderly patients – as the condition is typically more common in older people – there is little data available on the impact of the drug on pregnant patients, fetuses or breast-feeding babies.

Other diseases

Always tell your doctor if you are suffering from any other medical conditions, as these may impact the effectiveness of becaplermin. It may also pose a risk to your health if you use this medication while you are suffering from certain other conditions. Of particular interest to your doctor will be a history of suffering from cancers or other skin conditions.

Overdose

If you or someone you know has taken more becaplermin than prescribed, seek medical advice, or call your local poison control center. Be prepared by establishing how much of the medication was used, and when it was applied.

Storage

You should always keep your becaplermin subscription in the container it was supplied with. When you are not using the medication, you should keep the tube or container tightly shut so that it cannot be tampered with by children or animals.

Becaplermin should be kept refrigerated at all times when not in use. This is ideally at a temperature of between 2-8 degrees centigrade. Do not freeze your medication. Keep it away from heat or light sources; do not leave exposed to sunlight and do not keep near radiators. You should also keep your becaplermin prescription away from water and damp areas; keep it in a dry corner of the refrigerator to avoid it becoming penetrated by water.

Once your becaplermin subscription expires, do not attempt to use it. Outdated medication can cause you harm and may lead to worsening of your ulcers, or even infection. Always wipe your becaplermin container or tube clean after each use to prevent bacteria from entering the gel.

If you have becaplermin gel that you no longer need, you must dispose of it carefully. You can read about the FDA’s recommendations for the safe disposal of medicines, as well as find out about any medication take-back schemes that are available in your area.

Always store your medication out of the reach of children. Around 60,000 children have to visit emergency rooms every year due to consuming drugs that were left within their reach [ref 3] – becaplermin gel is a serious hazard to children if consumed.

Summary

When used as part of a holistic treatment program, becaplermin can be effective in reducing the severity of leg and foot ulcers in diabetic patients, and can often heal the wounds completely. This can lead to a better quality of life for patients, easing movement and relieving pain. However, the patient must also take additional steps to help the ulcers to heal, including introducing a good ulcer care plan and refraining from putting unnecessary pressure on the affected area while it is healing.

It is also the responsibility of the patient to take extra care to follow all application instructions; becaplermin requires a careful, precise and clean application, and requires attention to care throughout the course of treatment. If patients – for example less mobile patients such as the elderly – are unable to fulfil this routine themselves, they will need access to a carer that can carry out the applications successfully.

There are certain unknown factors regarding becaplermin and risk of death from cancer. Patients should always tell their doctor if they have suffered from cancer previously, and alternative treatment may be issued to those with cancer or at increased risk of developing the condition. Studies have suggested that becaplermin can affect survival rates of those that contract cancer; healthcare professionals should proceed with caution and always make sure that patients aware of this possible risk.

Despite the risks involved, becaplermin remains a common treatment for leg and foot ulcers and is used without any severe side effects in the majority of cases. Although it may be several weeks before patients notice any improvements in their condition, the positive impact on their health can be long-lasting as a result of this medication.

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Last Reviewed:
December 25, 2017
Last Updated:
February 09, 2018
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