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REGRANEX
Overview
What is REGRANEX?
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, . 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.
What does REGRANEX look like?
What are the available doses of REGRANEX?
Gel: 0.01% ()
What should I talk to my health care provider before I take REGRANEX?
How should I use REGRANEX?
For topical use; not for oral, ophthalmic or intravaginal use.
The amount of REGRANEX Gel to be applied will vary depending upon the size of the ulcer area. To calculate the length of gel to apply to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters. To calculate the length of gel in inches, use the formula shown below in Table 1, and to calculate the length of gel in centimeters, use the formula shown below in Table 2.
Using the calculation, each square inch of ulcer surface will require approximately 2/3 inch length of gel squeezed from a 15g tube, or approximately 1 1/3 inch length of the gel from a 2g tube (physician sample). For example, if the ulcer measures 1 inch by 2 inches, then a 1 1/4 inch length of gel should be used for 15g tubes (1 × 2 × 0.6 = 1 1/4) and 2 3/4 inch gel length should be used for a 2g tube (1 × 2 × 1.3 = 2 3/4).
Using the calculations for ulcer size in centimeters, each square centimeter of ulcer surface will require approximately a 0.25 centimeter length of gel squeezed from a 15g tube, or approximately a 0.5 centimeter length of gel from a 2g tube. For example, if the ulcer measures 4 cm by 2 cm, then a 2 centimeter length of gel should be used for a 15g tube [(4 × 2) ÷ 4 = 2] and a 4 centimeter length of gel should be used for a 2g tube [(4 × 2) ÷ 2 = 4].
The amount of REGRANEX Gel to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals depending on the rate of change in ulcer area. The weight of REGRANEX Gel from 15g tubes is 0.65g per inch length and 0.25g per centimeter length.
To apply REGRANEX Gel, the calculated length of gel should be squeezed on to a clean measuring surface, e.g., wax paper. The measured REGRANEX Gel is transferred from the clean measuring surface using an application aid and then spread over the entire ulcer area to yield a thin continuous layer of approximately 1/16 of an inch thickness. The site(s) of application should then be covered by a saline moistened dressing and left in place for approximately 12 hours. The dressing should then be removed and the ulcer rinsed with saline or water to remove residual gel and covered again with a second moist dressing (without REGRANEX Gel) for the remainder of the day. REGRANEX Gel should be applied once daily to the ulcer until complete healing has occurred. If the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with REGRANEX Gel should be reassessed. The step-by-step instructions for applying REGRANEX Gel for home administration are described under "Patient Counseling Information". [
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What interacts with REGRANEX?
Sorry No Records found
What are the warnings of REGRANEX?
Sorry No Records found
What are the precautions of REGRANEX?
Sorry No Records found
What are the side effects of REGRANEX?
Sorry No records found
What should I look out for while using REGRANEX?
REGRANEX Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application.
An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX Gel in a postmarketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy. [
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What might happen if I take too much REGRANEX?
There are no data on the effects of becaplermin overdose.
How should I store and handle REGRANEX?
Keep out of reach of children.Fluvoxamine maleate tablets, USP should be protected from high humidity and stored at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container.Keep out of reach of children.Fluvoxamine maleate tablets, USP should be protected from high humidity and stored at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container.Keep out of reach of children.Fluvoxamine maleate tablets, USP should be protected from high humidity and stored at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container.REGRANEX Gel is available in multi-use tubes in the following size:15 g tube NDC 50484-810-15REGRANEX 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.REGRANEX Gel is available in multi-use tubes in the following size:15 g tube NDC 50484-810-15REGRANEX 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.REGRANEX Gel is available in multi-use tubes in the following size:15 g tube NDC 50484-810-15REGRANEX 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.REGRANEX Gel is available in multi-use tubes in the following size:15 g tube NDC 50484-810-15REGRANEX 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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
REGRANEX Gel has biological activity similar to that of endogenous platelet-derived growth factor, which includes promoting the chemotactic recruitment and proliferation of cells involved in wound repair and enhancing the formation of granulation tissue.
Non-Clinical Toxicology
REGRANEX Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application.An increased rate of mortality secondary to malignancy was observed in patients treated with 3 or more tubes of REGRANEX Gel in a postmarketing retrospective cohort study. REGRANEX Gel should only be used when the benefits can be expected to outweigh the risks. REGRANEX Gel should be used with caution in patients with known malignancy. [
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Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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