Becaplermin Topical

Becaplermin comes as a gel to apply to the skin. It is usually applied once a day to the ulcer. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use becaplermin gel exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. Using more gel than your doctor prescribed will not help your ulcer heal faster.

Your doctor will show you how to measure becaplermin gel and will tell you how much gel to apply. The amount of gel you will need depends on the size of your ulcer. Your doctor will examine your ulcer every 1-2 weeks, and may tell you to use less gel as your ulcer heals and grows smaller.

It may take up to 20 weeks for you to feel the full benefit of becaplermin gel. Continue to use becaplermin gel for as long as it is prescribed by your doctor, even if your ulcer appears to be healed. Your doctor will tell you when your ulcer is completely healed and no longer needs treatment with becaplermin gel.

Becaplermin gel is for use on the skin only. Do not swallow the medication. Do not apply the medication to any part of your body other than the ulcer that is being treated.

To apply becaplermin gel, follow these steps:

1. Wash your hands thoroughly.
2. Gently rinse the wound with water. Wash your hands again.
3. Squeeze the length of gel your doctor has told you to use onto a clean, non-absorbent surface such as wax paper. Do not touch the tip of the tube to the wax paper, the ulcer, or any other surface. Recap the tube tightly after use.
4. Use a clean cotton swab, tongue depressor, or other applicator to spread the gel over the ulcer surface in an even layer about 1/16th of an inch (0.2 centimeters) thick.
5. Moisten a piece of gauze dressing with saline and place it on the wound. The gauze should cover only the wound, not the skin around it.
6. Place a small, dry pad dressing over the wound. Wrap a soft, dry gauze bandage over the pad and hold it in place with adhesive tape. Be careful not to attach the adhesive tape to your skin.
7. After about 12 hours, remove the bandage and gauze dressing and rinse the ulcer gently with saline or water to remove whatever gel is left.
8. Bandage the ulcer following the instructions in steps 5 and 6. Do not reuse the gauze, dressing, or bandage that you removed before washing the ulcer. Use fresh supplies.

Before using becaplermin gel,

• tell your doctor and pharmacist if you are allergic to becaplermin, any other medications, or parabens.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional products and herbal supplements you are taking or plan to take. Be sure to mention other medications that are applied to the ulcer.
• tell your doctor if you have or have ever had the condition mentioned in the IMPORTANT WARNING section.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using becaplermin gel, call your doctor.

Becaplermin gel may cause side effects. Tell your doctor if this symptom is severe or does not go away:

• rash

Becaplermin gel may cause other side effects. Tell your doctor if you have any unusual problems while you are using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For becaplermin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to becaplermin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of becaplermin in children and teenagers younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of becaplermin in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of becaplermin. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer, any type—Use with caution. May make this condition worse.

• Skin cancer or tumors at the site of the skin ulcer—Should not be used in patients with this condition.

• Wounds that show exposed joints, tendons, ligaments, or bone—Use of becaplermin is not recommended because it is not known if it would work for these conditions.

• Wounds that are closed manually by your doctor—Use of becaplermin is not recommended because these wounds require a sterile product.

You should not use this medication if you are allergic to becaplermin or parabens, or if you have skin cancer affecting your feet. Do not apply becaplermin over any wound or surgical incision that has been closed with stitches, staples, or surgical tape.

A becaplermin dose is measured by the length of a ribbon of gel squeezed from the medicine tube. Ask your doctor, pharmacist, or wound care counselor if you have any questions about how to measure your becaplermin dose.

You will need to recalculate your dose about every week or two as the size of your ulcer changes. Follow your doctor's instructions.

Do not apply becaplermin gel more than once per day and never use more than your prescribed dose. Using more of the medication will not make it work faster and may cause unwanted side effects.

Use this medication for the full prescribed length of time. Call your doctor if your symptoms do not improve, or if they get worse while using becaplermin topical.

Becaplermin topical is only part of a complete ulcer care treatment program that may also include routine foot exams and avoiding weight on the affected foot. Follow your doctor's instructions very closely.

Some people who used 3 or more courses of treatment with becaplermin topical have developed cancer. However, it is not known whether this medication actually causes cancer. Talk with your doctor about your own specific cancer risk.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Using more of this medication will not make it work faster and may cause unwanted side effects.

A becaplermin dose is measured by the length of a ribbon of gel squeezed from the medicine tube. To calculate the proper dose, measure the length and width of your ulcer and use one of the following formulas:

• When using a 15-gram tube of becaplermin gel: multiply length x width x 0.6. For example, 2 inches x 1 inch x 0.6 = 1.25 inches of gel.

• When using a 2-gram tube of becaplermin gel: multiply length x width x 1.3. For example, 2 inches x 1 inch x 1.3 = 2.75 inches of gel.

• To measure the dose in centimeters: Multiply length x width and divide by 4 if using a 15-gram tube, or divide by 2 if using a 2-gram tube. For example, 4 centimeters x 2 centimeters / 4 = 2 centimeters of gel from the 15-gram tube; or 4 centimeters x 2 centimeters / 2 = 4 centimeters of gel from the 2-gram tube.

• Ask your doctor, pharmacist, or wound care counselor if you have any questions about how to measure your becaplermin dose.

Make sure you are aware of which tube size you are using when calculating your becaplermin topical dose. Always check your refills to make sure you have received the correct tube size prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

You will need to recalculate your dose about every week or two as the size of your ulcer changes. Follow your doctor's instructions.

Wash your hands before and after using this medication.

To apply becaplermin topical gel:

• Squeeze a ribbon of gel (in the correct length for your ulcer) onto a clean, firm surface that will not absorb the gel such as wax paper.

• To keep the tip of the medicine tube from getting contaminated, do not allow the tip to touch any surface, including your fingers, the firm surface, or the ulcer you are treating.

• Use a cotton swab, tongue depressor, or other disposable applicator to lift the gel from the firm surface

• Spread the gel evenly in a thin layer (about 1/16 of an inch thick) over the ulcerated skin area.

• Cover the treated skin area with a cotton gauze bandage that has been moistened with saline. Leave this gauze dressing on for the next 12 hours.

• After 12 hours have passed, remove the gauze and rinse the ulcer with saline or water to remove the gel. Moisten a new gauze bandage with saline and cover the ulcer without applying any becaplermin gel.

Do not apply becaplermin gel more than once per day and never use more than your prescribed dose.

Use this medication for the full prescribed length of time. Call your doctor if your symptoms do not improve, or if they get worse while using becaplermin topical.

Becaplermin topical is only part of a complete ulcer care treatment program that may also include routine foot exams and avoiding weight on the affected foot. Follow your doctor's instructions very closely.

Store in the refrigerator, do not freeze. Keep the medicine tube tightly capped when not in use. Do not use becaplermin gel past the expiration date on the tube.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using becaplermin topical and call your doctor at once if you have severe itching, redness, blistering, peeling, or other skin irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.