Rx Item-Regranex 0.01% Gel 15Gm By Healthpoint

REGRANEX- becaplermin gel
Ortho-McNeil-Janssen Pharmaceuticals, Inc.

WARNING: INCREASED RATE OF MORTALITY SECONDARY TO MALIGNANCY

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. [see Warnings and Precautions (5.1) ]

1 INDICATIONS AND USAGE

1.1 Indication


REGRANEX (becaplermin) Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply, when used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control.

DOSAGE AND ADMINISTRATION

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.
DOSAGE FORMS AND STRENGTHS

Gel: 0.01%; clear, colorless to straw-colored gel

4 CONTRAINDICATIONS

REGRANEX Gel is contraindicated in patients with known neoplasm(s) at the site(s) of application.

5 WARNINGS AND PRECAUTIONS

5.1 Cancer and Cancer Mortality
REGRANEX Gel contains becaplermin, a recombinant human platelet-derived growth factor, which promotes cellular proliferation and angiogenesis. [see Clinical Pharmacology (12.1) ] The benefits and risks of becaplermin treatment should be carefully evaluated before prescribing. Becaplermin should be used with caution in patients with a known malignancy.

RX ITEM-Regranex 0.01% Gel 15Gm By Healt
NDC 50484-0810-15 UPC/GTIN No.3-50484-81015-3 Mfg.Part No.81015

Regranex 0.01% Gel 15Gm By Healthpoint
BRAND: REGRANEX NDC: 50484-0810-15,50484081015 UPC: 3-50484-81015-3,350484810153 Healthpoint Ltd

BECAPLERMIN TOPICAL GEL (
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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