Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Hepatotoxicity
Additions
underlined
![]()
…
Monitor
liver function tests (alanine aminotransferase [ALT], aspartate
aminotransferase [AST], and bilirubin) at baseline, during each cycle, and as
clinically indicated. Interrupt SUTENT for Grade 3 hepatotoxicity until
resolution to Grade less than or equal to1 or baseline, then resume
SUTENT at a reduced dose.
Discontinue
SUTENT in patients with Grade 4 hepatotoxicity, in patients without
resolution of Grade 3 hepatotoxicity, in patients who subsequently experience
severe changes in liver function tests and in patients who have other signs and
symptoms of liver failure. Safety in patients with ALT or AST >2.5 x upper
limit of normal (ULN) or with >5 x ULN and liver metastases has not been
established.
5.10 Reversible Posterior Leukoencephalopathy Syndrome
Additions
and/or revisions underlined
![]()
Reversible
posterior leukoencephalopathy syndrome (RPLS) has been reported in <1% of
patients, some of which were fatal. Patients can present with hypertension,
headache, decreased alertness, altered mental functioning, and visual loss,
including cortical blindness. Magnetic resonance imaging is necessary to
confirm the diagnosis. Discontinue SUTENT in patients developing RPLS.
5.12 Hypoglycemia
![]()
Additions
underlined
SUTENT
can result in symptomatic hypoglycemia, which may lead to loss of
consciousness, or require hospitalization. In the pooled safety population,
hypoglycemia occurred in 2% of the patients treated with SUTENT. Hypoglycemia
has occurred in clinical trials in 2% of the patients treated with SUTENT for
advanced RCC (Study 3) and GIST (Study 1) (n=577) and in approximately
10% of the patients treated with SUTENT for pNET (Study 6) (n=83). For
patients being treated with SUTENT for pNET, pre-existing abnormalities in
glucose homeostasis were not present in all patients who experienced
hypoglycemia.
…
5.13 Osteonecrosis of the Jaw
Additions
underlined
…
The
safety of resumption of SUTENT after resolution of osteonecrosis of the jaw has
not been established.
5.4 Hypertension
Additions
underlined
In
the pooled safety population, 29% of patients experienced hypertension. Grade 3
hypertension was reported in 7% of patients, and Grade 4 hypertension was
reported in 0.2%.
![]()
Monitor blood
pressure at baseline and as clinically indicated. Initiate and/or adjust
antihypertensive therapy as appropriate. In cases of Grade 3 hypertension,
withhold SUTENT until resolution to Grade less than or equal to1 or
baseline, then resume SUTENT at a reduced dose. Discontinue SUTENT in patients
with who develop Grade 4 hypertension.
5.5 Hemorrhagic Events and Viscus Perforation
![]()
Additions
underlined
Hemorrhagic events, some of which were
fatal, have involved the gastrointestinal tract, respiratory tract, tumor,
urinary tract, and brain. In the pooled safety population, 30% of patients
experienced hemorrhagic events, including Grade 3 or 4 in 4.2% of patients.
Epistaxis was the most common hemorrhagic event and gastrointestinal hemorrhage
was the most common Grade greater than or equal to 3-5 event.
![]()
…
Include
serial complete blood counts (CBCs) and physical examinations with the clinical
assessment of hemorrhagic events. Interrupt SUTENT for Grade 3 or 4
hemorrhagic events until resolution to Grade less than or equal to1 or
baseline, then resume SUTENT at a reduced dose.
Discontinue
SUTENT in patients without resolution of Grade 3 or 4 hemorrhagic events.
6
Adverse Reactions
6.1 Clinical Trials Experience
Additions and/or
revisions to Tables 4, 5, and 6; Please refer to label for complete
information.
8
Use in Specific Populations
8.5 Geriatric Use
Additions and/or revisions underlined
Of the 7527 patients with GIST, RCC (advanced
and adjuvant), or pNET who received SUTENT, 32% were 65 years and
older, and 7% were 75 years and older. Patients aged 65 years of age and
older had a higher incidence of Grade 3 or 4 adverse reactions (67%) than
younger patients (60%).
In the GIST study, 73 (30%) of the patients who
received SUTENT were 65 years and older. In the mRCC study, 152 (41%) of
patients who received SUTENT were 65 years and older. No
overall differences in safety or effectiveness were observed between these
patients and younger patients.
In the pNET study, 22 (27%) of the patients who
received SUTENT were 65 years and older. Clinical studies of SUTENT did
not include sufficient numbers of patients with pNET to determine if patients
65 years of age and older respond differently than younger patients.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions underlined
…
Your healthcare provider should do blood tests to
check your liver function before you start taking and during treatment with
SUTENT. Your healthcare provider may temporarily stop, reduce your dose, or
permanently stop treatment with SUTENT if you develop liver problems.
…
What
are possible side effects of SUTENT?
SUTENT
may cause serious side effects, including:
…
Your healthcare
provider may temporarily stop, reduce your dose, or permanently stop treatment
with SUTENT if you develop serious side effects.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Hepatotoxicity
(Additions and/or revisions are underlined)
SUTENT can cause severe hepatotoxicity, resulting in liver
failure or death. Liver failure occurred at an incidence of <1% in clinical
trials... Monitor liver function tests (alanine aminotransferase [ALT], aspartate
aminotransferase [AST], and bilirubin) before initiation of treatment,
during each cycle of treatment, and as clinically indicated…
Safety in patients with ALT or AST >2.5 x upper limit of normal
(ULN) or, if due to liver metastases, >5.0 x ULN has not been established.
5.11 Hypoglycemia
(Additions and/or revisions are underlined)
SUTENT can result in symptomatic hypoglycemia, which may lead
to loss of consciousness, or require hospitalization. Hypoglycemia has
occurred in clinical trials in 2% of the patients treated with SUTENT for advanced
RCC and GIST and in approximately 10% of the patients treated with SUTENT for
pNET. In the adjuvant treatment of RCC study, no patients on SUTENT
experienced hypoglycemia.
5.12 Osteonecrosis of the Jaw (ONJ)
(Additions and/or revisions are underlined)
…Consider preventive dentistry prior to treatment with SUTENT. If
possible, avoid invasive dental procedures while on SUTENT treatment, particularly
in patients receiving intravenous bisphosphonate therapy.
5.14 Embryo-Fetal Toxicity
(Subsection title has been revised; Additions and/or revisions are
underlined)
Based on findings from animal studies and its mechanism of action, SUTENT
can cause fetal harm when administered to pregnant woman. Administration of
sunitinib to pregnant rats and rabbits during the period of organogenesis
resulted in teratogenicity at approximately 5.5 and 0.3 times the clinical
systemic exposure (AUC) at the recommended daily doses (RDD) of 50 mg/day,
respectively.
Advise pregnant women of the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception during
treatment with SUTENT and for 4 weeks following the final dose.
5.2 Cardiovascular Events
(Additions and/or revisions are underlined)
Discontinue SUTENT in the presence of clinical manifestations of
congestive heart failure (CHF). Interrupt SUTENT and/or reduce the
dose in patients without clinical evidence of CHF who have an ejection
fraction of >20% but <50% below baseline or below the
lower limit of normal if baseline ejection fraction is not obtained.
In patients without cardiac risk factors a baseline evaluation of
ejection fraction should be considered. Carefully monitor patients for clinical
signs and symptoms of CHF while receiving SUTENT. Baseline and periodic
evaluations of left ventricular ejection fraction (LVEF) should also be
considered while these patients are receiving SUTENT.
Cardiovascular events, including heart failure, cardiomyopathy, myocardial
ischemia, and myocardial infarction, some of which were fatal, have been
reported.
In patients treated with SUTENT (N=7527) for GIST, advanced
RCC, adjuvant treatment of RCC and pNET, 3% of patients experienced heart
failure; 71% of the patients with heart failure were reported as recovered.
Fatal cardiac failure was reported in <1% of patients.
In the adjuvant treatment of RCC study, 11 patients in each
arm experienced a decreased ejection fraction meeting Grade 2 CTCAE criteria
(LVEF 40-50% and a 10-19% decrease from baseline). No patients had a
Grade 3-4 decrease in ejection fraction. The ejection fractions of three
patients in the SUTENT arm and 2 patients in the placebo arm did not
return to greater than or equal to 50% or baseline by the time of last measurement. No patients who
received SUTENT were diagnosed with CHF.
5.3 QT Interval Prolongation and Torsade de Pointes
(Additions and/or revisions are underlined)
SUTENT can cause QT interval prolongation in a
dose-dependent manner, which may lead to an increased risk for ventricular
arrhythmias including Torsade de Pointes…
Monitor patients with a history of QT interval prolongation,
patients who are taking antiarrhythmics, or patients with relevant pre-existing
cardiac disease, bradycardia, or electrolyte disturbances…
5.4 Hypertension
(Additions and/or revisions are underlined)
In patients treated with SUTENT (N=7527) in GIST,
advanced RCC, adjuvant treatment of RCC and pNET, 29% of
patients experienced hypertension. Grade 3 hypertension was reported in 7%
of patients, and Grade 4 hypertension was reported in 0.2% of
patients.
5.5 Hemorrhagic Events and Viscus Perforation
(Subsection title has been revised; additions and/or revisions are
underlined)
Hemorrhagic events reported through postmarketing experience,
some of which were fatal, have included GI, respiratory, tumor, urinary tract, and
brain hemorrhages. In patients treated with SUTENT (N=7527) for GIST,
advanced RCC, adjuvant treatment of RCC and pNET, 30% of patients
experienced hemorrhagic events, and 4.2% of patients experienced
a Grade 3 or 4 event. Epistaxis was the most common hemorrhagic adverse reaction
and gastrointestinal hemorrhage was the most common Grade greater than or equal to 3
event.
…Cases of pulmonary hemorrhage, some with a fatal outcome, have been
observed in clinical trials and have been reported in postmarketing experience
in patients treated with SUTENT for metastatic RCC, GIST, and metastatic
lung cancer. SUTENT is not approved for use in patients with lung cancer.
Clinical assessment of hemorrhagic events should include serial complete
blood counts (CBCs) and physical examinations.
Serious, sometimes fatal, gastrointestinal complications including
gastrointestinal perforation, have been reported in patients with
intra-abdominal malignancies treated with SUTENT.
5.6 Tumor Lysis Syndrome (TLS)
(Additions and/or revisions are underlined)
Cases of TLS, some fatal, occurred in clinical trials and have
been reported in postmarketing experience, primarily in patients with RCC or
GIST treated with SUTENT…
5.7 Thrombotic Microangiopathy
(Additions and/or revisions are underlined)
Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic
purpura and hemolytic uremic syndrome, sometimes leading to renal failure or a
fatal outcome, occurred in clinical trials and in postmarketing
experience of SUTENT as monotherapy and administered in combination with
bevacizumab…
6
Adverse Reactions
(Additions and/or revisions are underlined)
The following serious adverse reactions are discussed in greater
detail in other sections of the labeling.
Hepatotoxicity
Cardiovascular Events
QT Interval Prolongation and Torsade de
Pointes
Hypertension
Hemorrhagic Events
Tumor Lysis Syndrome (TLS)
Thrombotic Microangiopathy
Proteinuria
Dermatologic Toxicities
Thyroid Dysfunction
Hypoglycemia
Osteonecrosis of the Jaw (ONJ)
Wound Healing
6.1 Clinical Trials Experience
(Additions and/or revisions are underlined)
…
The data described in the Warnings and Precautions reflect exposure
to SUTENT (N = 7527) in GIST, advanced RCC, adjuvant treatment of RCC, and
pNET. In this database, the most common adverse reactions (greater than or
equal to 25%) are fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea,
decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome,
hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and
thrombocytopenia.
The data below reflect exposure to SUTENT in 966 patients who
participated in the treatment phase of randomized trials of GIST (n=202),
advanced RCC (n=375), adjuvant treatment of RCC (n=306), and pNET (n=83).
Gastrointestinal Stromal Tumor (GIST)
The safety of SUTENT was evaluated in Study 1, a randomized,
double-blind, placebo-controlled trial in which previously treated patients
with GIST received SUTENT 50 mg daily on Schedule 4/2 (n=202) or placebo
(n=102).
Table 1. Adverse Reactions
Reported in Study 1 in Greater than or Equal to 10% of GIST
Patients Who Received SUTENT in the Double-Blind Treatment Phase and More
Commonly Than in Patients Given Placebo (Table has been revised; please refer to label)
Table 2. Laboratory Abnormalities Reported in Study 1 in Greater
than or Equal to 10% of GIST Patients Who Received SUTENT or Placebo in the
Double-Blind Treatment Phase (Table has been revised; please refer to label)
Advanced Renal Cell Carcinoma (RCC)
The safety of SUTENT was evaluated in Study 3, a
double-blind, active-controlled trial in which previously untreated patients
with locally advanced or metastatic RCC received SUTENT 50 mg daily on
Schedule 4/2 (n=375) or IFN-alpha 9 million International Units
(MIU) (n=360).
Table 3.Adverse Reactions Reported in Study 3 in Greater than or
Equal to 10% of Patients With RCC Who Received SUTENT or IFN-alpha (Table has been revised; please refer to label)
Table 4. Laboratory Abnormalities Reported in Study 3 in Greater
than or Equal to 10% of Treatment-Naïve RCC Patients Who Received SUTENT or
IFN-alpha (Table has been revised; please refer to label)
Long-Term Safety in RCC
The long-term safety of SUTENT in patients with metastatic RCC was
analyzed across 9 completed clinical studies conducted in the first-line,
bevacizumab-refractory, and cytokine-refractory treatment settings. The
analysis included 5739 patients, of whom 807 (14%) were treated for at least 2
years and 365 (6%) for at least 3 years. Prolonged treatment with SUTENT did
not appear to be associated with new types of adverse reactions. There appeared
to be no increase in the yearly incidence of adverse reactions at later time
points.
Hypothyroidism increased during the second year of treatment with
new cases reported up to year 4.
Adjuvant Treatment of RCC
The safety of SUTENT was evaluated in S-TRAC, a randomized,
double-blind, placebo-controlled trial in which patients who had undergone
nephrectomy for RCC received SUTENT 50 mg daily (n=306) on Schedule 4/2 or
placebo (n=304). The median duration of treatment was 12.4 months (range:
0.13-14.9) for SUTENT and 12.4 months (range: 0.03-13.7) for placebo. Permanent
discontinuation due to an adverse reaction occurred in 28% of patients on
SUTENT and 6% on placebo. Adverse reactions leading to permanent
discontinuation in >2% of patients include hand-foot syndrome and
fatigue/asthenia. Dosing interruptions or delays occurred in 166 (54%) and 84
(28%) patients on SUTENT and placebo, respectively. One hundred forty patients
(45.8%) out of 306 patients in the SUTENT arm and 15 patients (5%) out of 304
patients in the placebo arm had dose reductions.
Table 5 compares the incidence of common (greater than or equal to
10%) treatment-emergent adverse reactions for patients receiving SUTENT versus
placebo.
Table 5. Adverse
Reactions Reported in S-TRAC in Greater than or Equal to 10% of
Patients With RCC Who Received SUTENT and More Commonly Than in Patients Given
Placebo (Table has been added; please refer to label)
Grade 4 adverse reactions in patients on SUTENT included hand-foot
syndrome (1%), fatigue (<1%), abdominal pain (< 1%), stomatitis (<1%),
and pyrexia (< 1%). Grade 4 adverse reactions in patients on placebo
included asthenia (<1%) and hypertension (<1%).
Grade 3-4 laboratory abnormalities that occurred in greater than or
equal to 2% of patients receiving SUTENT include neutropenia (13%),
thrombocytopenia (5%), leukopenia (3%), lymphopenia (3%), elevated alanine
aminotransferase (2%), elevated aspartate aminotransferase (2%), hyperglycemia
(2%), and hyperkalemia (2%).
Advanced Pancreatic Neuroendocrine Tumors (pNET)
The safety of SUTENT was
evaluated in Study 6, a randomized, double-blind, placebo-controlled
trial in which patients with progressive pNET received SUTENT 37.5 mg daily
continuous dosing (n=83) or placebo (n=82)…
…Table 6 compares the incidence of common (?10%)
treatment-emergent adverse reactions for patients receiving SUTENT and reported
more commonly in patients receiving SUTENT than in patients receiving placebo.
Table 6. Adverse
Reactions Reported in the pNET Study 6 in Greater than or Equal to
10% of Patients Who Received SUTENT and More Commonly Than in Patients Given
Placebo (Table has been revised; please refer to label)
Table 7 provides common (greater than or equal to 10%)
treatment-emergent laboratory abnormalities.
Table 7. Laboratory Abnormalities Reported in the pNET Study 6
in Greater than or Equal to 10% of Patients Who Received SUTENT (Table has been revised; please refer to label)
Venous Thromboembolic Events
In patients treated with SUTENT (N=7527) for GIST,
advanced RCC, adjuvant treatment of RCC and pNET, 3.5% of patients
experienced a venous thromboembolic event; 2.2% Grade 3-4.
Pancreatic Function
Pancreatitis was observed in 5 patients (1%) receiving SUTENT for
treatment-naïve RCC compared to 1 patient (<1%) receiving IFN-alpha. In a
trial of patients receiving adjuvant treatment for RCC, 1 patient (<1%) on
SUTENT and none on placebo experienced pancreatitis. Pancreatitis was
observed in 1 patient (1%) receiving SUTENT for pNET and 1 patient (1%)
receiving placebo.
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)
Risk Summary
Based on animal reproduction studies and its mechanism of action,
SUTENT can cause fetal harm when administered to a pregnant woman. There are
no available data in pregnant women to inform a drug-associated risk. In animal
developmental and reproductive toxicology studies, oral administration
of sunitinib to pregnant rats and rabbits throughout organogenesis
resulted in teratogenicity (embryolethality, craniofacial and skeletal
malformations) at 5.5 and 0.3 times the AUC in patients administered the
recommended daily doses (RDD), respectively. Advise pregnant women or females of reproductive
potential of the potential hazard to a fetus.
The background risk of major birth defects and miscarriage for the
indicated populations are unknown. However, the estimated background risk in
the United States (U.S.) general population of major birth defects is 2%-4% and
of miscarriage is 15%-20% of clinically recognized pregnancies.
Data
Animal Data
In a female fertility and early embryonic development study, female
rats were administered oral sunitinib (0.5, 1.5, 5 mg/kg/day) for 21 days prior
to mating and for 7 days after mating. Embryolethality was observed at 5
mg/kg/day (approximately 5 times the AUC in patients administered the RDD of 50
mg/day).
In embryo-fetal developmental toxicity studies, oral sunitinib was
administered to pregnant rats (0.3, 1.5, 3, 5 mg/kg/day) and rabbits
(0.5, 1, 5, 20 mg/kg/day) during the period of organogenesis. In rats,
embryolethality and skeletal malformations of the ribs and vertebrae
were observed at the dose of 5 mg/kg/day (approximately 5.5 times the systemic
exposure [combined AUC of sunitinib + primary active metabolite] in patients
administered the RDD). No adverse fetal effects were observed in rats at
doses less than or equal to 3 mg/kg/day (approximately 2 times the AUC in
patients administered the RDD). In rabbits, embryolethality was observed at
5 mg/kg/day (approximately 3 times the AUC in patients administered the RDD), and
craniofacial malformations (cleft lip and cleft palate) were observed at
greater than or equal to 1 mg/kg/day (approximately 0.3 times the AUC in
patients administered the RDD of 50 mg/day).
Sunitinib (0.3, 1, 3 mg/kg/day) was evaluated in a pre- and postnatal
development study in pregnant rats. Maternal body weight gains were reduced
during gestation and lactation at doses ?1 mg/kg/day (approximately 0.5
times the AUC in patients administered the RDD). At 3 mg/kg/day (approximately
2 times the AUC in patients administered the RDD), reduced neonate body weights
were observed at birth and persisted in the offspring of both sexes during the
preweaning period and in males during postweaning period. No adverse
developmental effects were observed at doses less than or equal to 1 mg/kg/day.
8.2 Lactation
(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)
There is no information regarding the presence of sunitinib and its
metabolites in human milk. Sunitinib and its metabolites were
excreted in rat milk at concentrations up to 12-fold higher than in plasma.
Because of the potential for serious adverse reactions in breastfed infants
from SUTENT, advise a lactating woman not to breastfeed during treatment with
SUTENT and for at least 4 weeks after the last dose.
Data
Animal Data
In lactating female rats administered 15 mg/kg, sunitinib and its
metabolites were excreted in milk at concentrations up to 12-fold higher than
in plasma.
8.3 Females and Males of Reproductive Potential
(Pregnancy and Lactation Labeling Rule (PLLR) Conversion; additions and/or revisions are underlined)
Based on animal reproduction studies and its mechanism of action,
SUTENT can cause fetal harm when administered to a pregnant woman.
Pregnancy Testing
Females of reproductive potential should have a pregnancy test
before treatment with SUTENT is started.
Contraception
Females
Advise females of reproductive potential to use effective
contraception during treatment with SUTENT and for at least 4 weeks after the
last dose.
Males
Based on findings in animal reproduction studies, advise male
patients with female partners of reproductive potential to use effective
contraception during treatment with SUTENT and for 7 weeks after the last dose.
Infertility
Based on findings in animals, male and female fertility may be compromised
by treatment with SUTENT.
8.5 Geriatric Use
(Additions and/or revisions are underlined)
Of 825 patients with GIST or metastatic RCC who received SUTENT
on clinical studies, 277 (34%) were 65 and over…Among the 158 patients at
least age 65 receiving adjuvant SUTENT/placebo for RCC, the hazard ratio for
disease-free survival was 0.59 (95% CI: 0.36, 0.95). Among patients 65 years
and older receiving adjuvant SUTENT/placebo for RCC, 50 patients (16%) in the
SUTENT arm experienced a Grade 3-4 adverse reaction, compared to 15 patients
(5%) in the placebo arm.
8.7 Renal Impairment
(Additions and/or revisions are underlined)
No adjustment to the starting dose is required when administering
SUTENT to patients with mild (CLcr 50– 80 mL/min), moderate (CLcr
30–<50 mL/min), or severe (CLcr <30 mL/min) renal impairment who
are not on dialysis…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Hepatotoxicity
Inform patients of the signs and symptoms of hepatotoxicity. Advise
patients to contact their healthcare provider immediately for signs or symptoms
of hepatotoxicity.
Cardiovascular Events
Advise patients to contact their healthcare provider if they develop
symptoms of heart failure.
QT Prolongation and Torsade de Pointes
Inform patients of the signs and symptoms of QT prolongation. Advise
patients to contact their healthcare provider immediately in the event of
syncope, pre-syncopal symptoms, and cardiac palpitations.
Hypertension
Inform patients of the signs and symptoms of hypertension. Advise
patients to undergo routine blood pressure monitoring and to contact their
health care provider if blood pressure is elevated or if they experience signs
or symptoms of hypertension.
Hemorrhagic Events
Advise patients that SUTENT can cause severe bleeding. Advise
patients to immediately contact their healthcare provider for bleeding or
symptoms of bleeding.
Gastrointestinal Disorders
Advise patients that gastrointestinal disorders such as
diarrhea, nausea, vomiting, and constipation may develop during SUTENT
treatment and to seek immediate medical attention if they experience persistent
or severe abdominal pain because cases of gastrointestinal perforation
and fistula have been reported in patients taking SUTENT.
Dermatologic Effects and Toxicities
Advise patients that depigmentation of the hair or skin may
occur during treatment with SUTENT due to the drug color (yellow). Other
possible dermatologic effects may include dryness, thickness or cracking of
skin, blister or rash on the palms of the hands and soles of the feet. Severe
dermatologic toxicities including Stevens-Johnson syndrome, Toxic Epidermal
Necrolysis, erythema multiforme, and necrotizing fasciitis have been
reported. Advise patients to immediately inform their healthcare provider if
severe dermatologic reactions occur.
Thyroid Dysfunction
Advise patients that SUTENT can cause thyroid dysfunction. Advise
patient to contact their healthcare provider if symptoms of abnormal thyroid
function occur.
Hypoglycemia
Advise patients that SUTENT can cause severe hypoglycemia and may
be more severe in patients with diabetes taking antidiabetic medications. Inform
patients of the signs, symptoms, and risks associated with hypoglycemia.
Advise patients to immediately inform their healthcare provider if severe
signs or symptoms of hypoglycemia occur.
Osteonecrosis of the Jaw
Advise patients to consider preventive dentistry prior
to treatment with SUTENT. Inform patients being treated with SUTENT, particularly
who are receiving bisphosphonates, to avoid invasive dental procedures if
possible.
If possible, avoid invasive dental procedures while on SUTENT
treatment, particularly in patients receiving intravenous bisphosphonate
therapy.
…
Embryo-Fetal Toxicity
Advise females to inform their healthcare provider if they are
pregnant or become pregnant. Inform female patients of the risk to a fetus and
potential loss of the pregnancy.
Advise females of reproductive potential to use effective
contraception during treatment and for 4 weeks after receiving the last dose of
SUTENT.
Advise males with female partners of reproductive potential to use
effective contraception during treatment and for 7 weeks after receiving the
last dose of SUTENT.
Lactation
Advise lactating women not to breastfeed during treatment with
SUTENT and for at least 4 weeks after the last dose.
Infertility
Advise patients that male and female fertility may be compromised by
treatment with SUTENT.
Missed Dose
Advise patients that miss a dose of SUTENT by less than 12 hours to
take the missed dose right away. Advise patients that miss a dose of SUTENT by
more than 12 hours to take the next scheduled dose at its regular time.
MEDICATION GUIDE
(Additions and/or revisions are underlined)
What is the most important information I should know about SUTENT?
SUTENT can cause serious side effects including:
- Severe liver problems, that can lead
to death.
…Your healthcare provider may tell you to temporarily or permanently
stop taking SUTENT if you develop liver problems.
See “What are the possible side effects of SUTENT?” for more
information about side effects.
What is SUTENT?
SUTENT is a prescription medicine used to treat:
- adults with kidney cancer that has not
spread (localized), and who are at high risk of RCC coming back again
after having kidney surgery.
Before taking SUTENT tell your
healthcare provider about all of your medical conditions, including if you:
- plan to have any surgery or dental
procedures
- are pregnant or plan to become pregnant.
SUTENT can harm your unborn baby.
Females who are able to become pregnant:
Your healthcare provider should do a
pregnancy test before you start treatment with SUTENT.
You should use effective birth control
(contraception) during treatment and for at least 4 weeks after your last dose
of SUTENT.
Tell your healthcare provider right away if
you become pregnant or think you are pregnant during treatment with SUTENT.
Males with female partners who are able to become
pregnant should use effective birth control (contraception) during treatment
and for 7 weeks after your last dose of SUTENT.
SUTENT may cause fertility problems in males and females. Tell your
healthcare provider if this is a concern for you.
- are breastfeeding or plan to breastfeed. Do
not breastfeed during treatment with SUTENT and for at least 4 weeks (1
month) after the last dose.
…Especially tell your healthcare provider if you are taking or have
taken an osteoporosis medicine.
How should I take SUTENT?
- Your healthcare provider may do blood
tests before each cycle of treatment to check you for side effects.
- If you miss a dose of Sutent by less
than 12 hours, take the missed dose right away. If you miss a dose
of SUTENT by more than 12 hours, just take your next dose at your
regular time. Do not make up the missed dose. Tell your healthcare
provider about any missed dose.
What are possible side effects
of SUTENT?
SUTENT may cause serious side
effects, including:
- Heart problems…Your healthcare provider may stop your
treatment with SUTENT if you have signs and symptoms of heart failure.
- Abnormal
heart rhythm changes. Changes in the electrical activity of your heart
called QT prolongation can cause irregular heart beats that can be life
threatening…Tell your healthcare provider immediately if you feel
dizzy, faint, or have abnormal heartbeats during your treatment with
SUTENT
- you feel faint or
lightheaded, or you pass out
- feel your heart beat is
irregular or fast
- dizziness
- High blood pressure. High blood
pressure is common with SUTENT, and may sometimes be severe. Follow your
healthcare provider’s instructions about having your blood pressure
checked regularly. Call your healthcare provider if your blood pressure is
high, or if you have any of the following signs or symptoms of high blood
pressure:
- severe headache
- dizziness
- lightheadedness
- change in vision
Your healthcare provider may temporarily stop your treatment with
SUTENT until your high blood pressure is controlled.
- Bleeding problems. Bleeding
is common with SUTENT, but SUTENT can also cause severe bleeding problems
that can lead to death. Call your healthcare provider right away if
you have any of these symptoms or a serious bleeding problem during
treatment with SUTENT, including:
Your healthcare provider:
- may do blood tests if needed and
monitor you for bleeding
- Serious stomach and intestinal
problems, that can sometimes lead to death. Some people have
had tears in their stomach or intestine (perforation), or have developed
an abnormal opening between the stomach and intestine (fistula). Get
medical help right away if you get stomach-area (abdominal) pain that does
not go away or is severe during treatment with SUTENT.
- Tumor
lysis syndrome (TLS)… TLS can cause kidney failure and the need for
dialysis treatment, abnormal heart rhythm, seizure, and sometimes death…
- Thrombotic
microangiopathy (TMA) including thrombotic thrombocytopenia purpura (TTP) and
hemolytic uremic syndrome (HUS). TMA is a condition that
involves injury to the smallest
blood vessels, and blood clots that can happen while
taking SUTENT. TMA is accompanied by a
decrease in red cells and cells that are involved with clotting. TMA
may harm your body’s organs such
as the brain and kidneys, and can sometimes lead to death. Your
healthcare provider may tell you
to stop taking SUTENT if you develop TMA.
- Protein
in your urine. Some people who have taken SUTENT have developed protein
in their urine, and in some
cases, kidney problems that can lead to death…
- Serious skin and mouth reactions. Treatment
with SUTENT has caused severe skin reactions that can lead to death, including:
- severe rash with
blisters or peeling of the skin.
- painful sores or ulcers on
the skin, lips or inside the mouth.
- tissue damage (necrotizing
fasciitis).
If you have any signs or symptoms of severe skin reactions, stop
taking SUTENT and call your healthcare provider or get medical help right away.
- Thyroid problems…Tell your healthcare provider if you
have any of the following signs and symptoms during your treatment with
SUTENT:
- Low blood sugar (hypoglycemia)…
Call your healthcare provider right away if you have any signs or
symptoms of severe low blood sugar during your treatment with SUTENT.
- Jaw-bone problems (osteonecrosis). Severe
jaw bone problems have happened in some people who take SUTENT. Certain
risk factors such as taking a bisphosphonate medicine or having dental
disease may increase your risk of getting osteonecrosis…Your
healthcare provider may tell you to avoid dental procedures, if possible,
during your treatment with SUTENT, especially if you are receiving a bisphosphonate
medicine into a vein (intravenous).
- Wound
healing problems. Wounds may not heal properly during SUTENT
treatment. Tell your healthcare provider if you have or plan to have any
surgery before starting or during treatment with SUTENT.
- Your healthcare provider
may tell you to temporarily stop taking SUTENT if you are planning to
have certain types of surgery.
- Your healthcare provider
should tell you when you may start taking SUTENT again after surgery.
Common side effects of SUTENT include:
- pain, swelling or sores inside of your
mouth
- indigestion
- stomach-area (abdominal) pain
- high blood pressure
- low platelet counts
SUTENT may also cause other skin problems including: dryness,
thickness or cracking of the skin.
How do I store SUTENT?
- Store SUTENT at room temperature, between
68°F to 77°F (20°C to 25°C).
What are the ingredients in SUTENT?
Yellow gelatin capsule shells: titanium dioxide and
yellow iron oxide.
Black printing ink: shellac, propylene glycol,
potassium hydroxide and black iron oxide.
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