Regranex

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

Yes

Included as part of the PRECAUTIONS section.

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.

Serious side effects have been reported with Regranex. See the "Drug Precautions" section.

Common side effects of Regranex include skin rashes.

This is not a complete list of Regranex side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

General

Becaplermin is available in the following dosage form(s) and strength(s):

Gel: 0.01%1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

For topical use; not for oral, ophthalmic or intravaginal use.1

To calculate the length of becaplermin gel to apply, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters.1

Patient Counseling Information

Counsel patients to review and discuss any questions or concerns with their healthcare provider before starting becaplermin and at regular intervals while receiving becaplermin.1

Patients should be advised that they should read the medication guide. 1

Hands should be washed thoroughly before applying becaplermin gel.1

The tip of the tube should not come into contact with the ulcer or any other surface; the tube should be recapped tightly after each use. 1

A cotton swab, tongue depressor, or other application aid should be used to apply becaplermin gel.1

Becaplermin gel should only be applied once a day in a carefully measured quantity. The measured quantity of gel should be spread evenly over the ulcerated area to yield a thin continuous layer of approximately 1/16 of an inch thickness. The measured length of the gel to be squeezed from the tube should be adjusted according to the size of the ulcer. The amount of becaplermin gel to be applied daily should be recalculated at weekly or biweekly intervals by the physician or wound care giver.1

Step-by-Step Instructions for Application of Becaplermin Gel

Squeeze the calculated length of gel onto a clean, firm, nonabsorbable surface (e.g., wax paper).1

With a clean cotton swab, tongue depressor, or similar application aid, spread the measured becaplermin gel over the ulcer surface to obtain an even layer.1

Cover with a saline moistened gauze dressing. After approximately 12 hours, the ulcer should be gently rinsed with saline or water to remove residual gel and covered with a saline-moistened gauze dressing (without becaplermin gel). It is important to use becaplermin gel together with a good ulcer care program, including a strict non-weight-bearing program. Excess application of becaplermin gel has not been shown to be beneficial. Becaplermin gel should be stored in the refrigerator. Do not freeze becaplermin gel. Becaplermin gel should not be used after the expiration date on the bottom, crimped end of the tube.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

There are no data on the effects of becaplermin overdose.

Regranex Gel contains becaplermin, a recombinant human platelet-derived growth factor for topical administration. Becaplermin is produced by recombinant DNA technology by insertion of the gene for the B chain of platelet-derived growth factor (PDGF) into the yeast, Saccharomyces cerevisiae. Becaplermin has a molecular weight of approximately 25 KD and is a homodimer composed of two identical polypeptide chains that are bound together by disulfide bonds. Regranex Gel is a non-sterile, low bioburden, preserved, sodium carboxymethylcellulose-based (CMC) topical gel, containing the active ingredient becaplermin and the following inactive ingredients: carboxymethylcellulose sodium, glacial acetic acid, l-lysine hydrochloride, m-cresol, methylparaben, propylparaben, sodium acetate trihydrate, sodium chloride, and water for injection. Each gram of Regranex Gel contains 100 mcg of becaplermin.

Regranex Gel is available in multi-use tubes in the following size:

15 g tube NDC 50484-810-15

Regranex Gel is for external use only.

Store refrigerated at 2° – 8° C (36° – 46°F). Do not freeze. Do not use the gel after the expiration date shown at the bottom of the tube.