Approved Drug Label (PDF)
5
Warnings and Precautions
5.3 Severe Cutaneous Adverse Reactions (SCARs)
Newly added
subsection:
SCARs,
including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN),
drug reaction with eosinophilia and systemic symptoms (DRESS), and acute
generalized exanthematous pustulosis (AGEP), which can be lifethreatening or
fatal, have been reported in association with gemcitabine treatment [see Adverse Reactions (6.2)]. Monitor
patients for signs and symptoms of severe cutaneous adverse reactions.
Permanently discontinue gemcitabine in patients who develop SCARs.
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
6.2 Postmarketing
Experience
Additions and/or
revisions underlined:
…
Skin: Cellulitis; pseudocellulitis; severe cutaneous adverse reactions (SCARs), including Stevens- Johnson syndrome (SJS), toxic epidermal necrolysis
(TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute
generalized exanthematous pustulosis (AGEP); desquamation and bullous skin
eruptions
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
…
Severe Cutaneous
Adverse Reactions (SCARs)
Advise
patients of the risks of SCARs, including Stevens-Johnson syndrome (SJS), toxic
epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms
(DRESS), and acute generalized exanthematous pustulosis (AGEP).
Instruct patients to immediately contact their healthcare provider should
any signs or symptoms of severe skin rash or skin peeling, blistering and/or
mouth sores occur [see Warnings and
Precautions (5.3)].
…
Approved Drug Label (PDF)
4
Contraindications
(addition
underlined)
Gemcitabine
Injection is contraindicated in patients with a known hypersensitivity to
gemcitabine. Reactions include anaphylaxis.
5
Warnings and Precautions
5.4 Hemolytic Uremic Syndrome
(addition
underlined)
Hemolytic
uremic syndrome (HUS), including fatalities from renal failure or the
requirement for dialysis, can occur with gemcitabine. In clinical trials, HUS
occurred in 0.25% of 2429 patients. Most fatal cases of renal failure were due
to HUS. Serious cases of
thrombotic microangiopathy (TMA) other than HUS have been reported with
gemcitabine.
…
5.6 Embryo-Fetal Toxicity
(addition
underlined)
Based
on animal data and its mechanism of action, Gemcitabine Injection can
cause fetal harm when administered to a pregnant woman. Gemcitabine was
teratogenic, embryotoxic, and fetotoxic in mice and rabbits.
…
6
Adverse Reactions
(addition underlined)
6.1 Clinical Trials Experience
(extensive
additions and revisions, please refer to
label for more information)
6.2 Postmarketing Experience
(additions
underlined)
…
Blood and
Lymphatic System: TMA
…
Pulmonary: Interstitial
pneumonitis, pulmonary fibrosis, pulmonary edema, adult respiratory distress
syndrome (ARDS), pulmonary eosinophilia
…
8
Use in Specific Populations
8.1 Pregnancy
(additions
underlined)
Risk
Summary
Based
on animal data and its mechanism of action, Gemcitabine Injection can cause
fetal harm when administered to a pregnant woman. There are no available data on the use of
gemcitabine in pregnant women. In animal reproduction studies,
gemcitabine was teratogenic, embryotoxic, and fetotoxic in mice and rabbits (see Data). Advise pregnant women of the
potential risk to a fetus.
…
Data
Animal Data
Gemcitabine
is embryotoxic in mice. Daily dosing of gemcitabine to pregnant mice
increased the incidence of fetal malformation (cleft palate, incomplete ossification)
at doses of 1.5 mg/kg/day [approximately 0.005 times the 1000 mg/m2 clinical
dose based on body surface area (BSA)]. Gemcitabine was embryotoxic and
fetotoxic in rabbits. Daily dosing of gemcitabine to pregnant rabbits
resulted in fetotoxicity (decreased fetal viability, reduced litter sizes, and
developmental delays) and increased the incidence of fetal malformations
(fused pulmonary artery, absence of gall bladder) at doses of 0.1 mg/kg/day
(approximately 0.002 times the 1000 mg/m2 clinical dose based on BSA).
8.2 Lactation
(addition
underlined)
There
is no information regarding the presence of gemcitabine or its metabolites
in human milk, or their effects on the breastfed infant or on milk production.
Due to the potential for serious adverse reactions in breastfed infants, advise
women not to breastfeed during treatment with Gemcitabine Injection and for at
least one week following the last dose.
8.3 Females and
Males of Reproductive Potential
(additions
underlined)
Pregnancy
Testing
Verify
pregnancy status in females of reproductive potential prior to initiating
Gemcitabine Injection.
Contraception
Gemcitabine
Injection can cause fetal harm when administered to a pregnant woman .
Females
Because
of the potential for genotoxicity, advise females of reproductive
potential to use effective contraception during treatment with Gemcitabine
Injection and for 6 months after the final dose.
Males
Because
of the potential for genotoxicity, advise males with female partners of
reproductive potential to use effective contraception during treatment with
Gemcitabine Injection and for 3 months after the final dose.
Infertility
Males
Based
on animal studies, gemcitabine may impair fertility in males of reproductive
potential. It is not known whether these effects on fertility are
reversible.
8.5 Geriatric Use
(addition
underlined)
…
Gemcitabine
clearance is affected by age; however, there are no recommended dose
adjustments based on patients’ age.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(addition
underlined)
…
Lactation
Advise
women not to breastfeed during treatment with Gemcitabine Injection and for at
least one week after the last dose.
…
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pediatric Use
Additions
and/or revisions underlined:
The safety and effectiveness of
Gemcitabine Injection have not been established in pediatric
patients. The safety and
pharmacokinetics of gemcitabine were evaluated in a trial in pediatric patients
with refractory leukemia. The maximum tolerated dose was 10 mg/m2/min for 360
minutes weekly for three weeks followed by a one-week rest period. The
safety and activity … administered over 360 minutes weekly for three weeks
followed by a one-week rest period. Patients with M1 or M2 bone marrow on
Day 28 who did not experience unacceptable toxicity were eligible to receive a
maximum of one additional four-week course. Toxicities observed included
myelosuppression …
Get Email Alerts |
Guide
