A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Regranex Warnings, Precautions, Pregnancy, Nursing, Abuse - Becaplermin
Regranex Warnings, Precautions, Pregnancy, Nursing, Abuse - Becaplermin
WARNINGS
REGRANEX (becaplermin) Gel is a non-sterile, low bioburden preserved
product. Therefore, it should not be used in wounds that close by primary
intention.
PRECAUTIONS
For external use only.
If application site reactions
occur, the possibility of sensitization
or irritation caused by
parabens or m-cresol should be considered.
The effects of becaplermin on exposed joints, tendons, ligaments, and
bone have not been established
in humans. In preclinical
studies, rats injected at
the metatarsals with 3 or 10 µg/site (approximately 60 or 200 µg/kg)
of becaplermin every other day for 13 days displayed histological changes
indicative of accelerated bone
remodeling consisting of periosteal
hyperplasia and subperiosteal
boneresorption and exostosis. The soft
tissue adjacent to the injection
site had fibroplasia with accompanying
mononuclear cell
infiltration reflective
of the ability of PDGF to stimulate
connective tissue
growth.
Information for Patients
Patients should be advised that:
- hands should be washed thoroughly before applying REGRANEX Gel;
- the tip of the t.b.
should not come into contact
with the ulcer or any other
surface; the t.b. should be recapped
tightly after each use; - a cotton swab, tongue
depressor, or other application aid
should be used to apply REGRANEX Gel;
- REGRANEX Gel should only be applied once a day in a carefully measured
quantity (see DOSAGE AND ADMINISTRATION
section). 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 REGRANEX Gel to be applied daily should be recalculated at weekly or
biweekly intervals by the physician
or wound care giver;
Step-by-step instructions for application of REGRANEX Gel are as follows:
- Squeeze the calculated length
of gel on to a clean, firm, non-absorbable surface,e.g., wax
paper.
- With a clean cotton swab,
tongue depressor, or similar
application and spread the measured REGRANEX Gel over the ulcer surface
to obtain an even layer.
- 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 REGRANEX
Gel);
- it is important to use REGRANEX Gel together with a good ulcer
care program, including a strict non-weight-bearing program;
- excess application of REGRANEX Gel has not been shown to be beneficial;
- REGRANEX Gel should be stored in the refrigerator. Do not freeze REGRANEX
Gel;
- REGRANEX Gel should not be used after the expiration
date on the bottom, crimped end
of the tube.
Drug Interactions
It is not known if REGRANEX Gel interacts with other topical
medications applied to the ulcer
site. The use of REGRANEX Gel with other topical
drugs has not been studied.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Becaplermin was not genotoxic
in a battery of in vitro
assays, (including those for bacterial and mammalian cell
point mutation, chromosomal
aberration, and DNA damage/repair).
Becaplermin was also not mutagenic in an in vivo assay
for the induction of micronuclei
in mouse bone
marrow cells.
Carcinogenesis and reproductive
toxicity studies have not
been conducted with REGRANEX Gel.
Pregnancy: Category C
Animal reproduction
studies have not been conducted with REGRANEX Gel. It is also not known
whether REGRANEX Gel can cause
fetal harm when administered
to a pregnant woman
or can affect reproductive
capacity. REGRANEX Gel should be given to pregnant
women only if clearly needed.
Nursing Mothers
It is not known whether becaplermin is excreted in human
milk. Because many drugs are secreted in human
milk, caution should be exercised when REGRANEX Gel is administered to
nursing women.
Pediatric Use
Safety and effectiveness
of REGRANEX Gel in pediatric
patients below the age of 16 years
have not been established.
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