Pronunciation
(tra ME ti nib)
Index Terms
GSK1120212Trametinib
Dimethyl Sulfoxide
Dosage Forms
Excipient
information presented when available (limited, particularly for generics);
consult specific product labeling.
Tablet, Oral:
Mekinist: 0.5
mg, 2 mg
Brand Names:
U.S.
Mekinist
Pharmacologic
Category
Antineoplastic
Agent, MEK Inhibitor
Pharmacology
Trametinib
reversibly and selectively inhibits mitogen-activated extracellular kinase
(MEK) 1 and 2 activation and kinase activity. MEK is a downstream effector of
the protein kinase B-raf (BRAF); BRAF V600 mutations result in constitutive
activation of the BRAF pathway (including MEK1 and MEK2). Through inhibition of
MEK 1 and 2 kinase activity, trametinib causes decreased cellular
proliferation, cell cycle arrest, and increased apoptosis (Kim 2013). The
combination of trametinib and dabrafenib allows for greater inhibition of the
MAPK pathway, resulting in BRAF V600 melanoma cell death (Flaherty 2012).
Trametinib plus dabrafenib has been reported to synergistically inhibit cell
growth in lung cancer cell lines which are BRAF V600E-mutant (Planchard 2016).
Absorption
Rapid; decreased
with a high-fat, high-calorie meal
Distribution
214 L
Metabolism
Predominantly
deacetylation (via hydrolytic enzymes) alone or with mono-oxygenation or in
combination with glucuronidation
Excretion
Feces (>80%);
urine (<20% with <0.1% as unchanged drug)
Time to Peak
1.5 hours;
delayed with a high-fat, high-calorie meal
Half-Life
Elimination
4 to 5 days
Protein Binding
~97% to plasma
proteins
Use: Labeled
Indications
Melanoma
(metastatic or unresectable): Treatment of unresectable or metastatic
melanoma in patients with a BRAF V600E or BRAF V600K mutation (as detected by
an approved test), either as a single-agent or in combination with dabrafenib.
Limitations of
use: Trametinib is not indicated for use in melanoma patients who have received
prior BRAF-inhibitor therapy.
Non-small cell
lung cancer (metastatic): Treatment of metastatic non-small cell lung cancer
(NSCLC) in patients with BRAF V600E mutation as detected by an approved test
(in combination with dabrafenib).
Contraindications
There are no
contraindications listed in the manufacturer's US labeling.
Canadian
labeling: Hypersensitivity
to trametinib or any component of the formulation.
Dosing: Adult
Note: Confirm
BRAF V600 mutation status prior to treatment initiation.
Melanoma
(metastatic or unresectable) (with BRAF V600E or BRAF V600K mutations): Oral: 2 mg
once daily (either as a single-agent or in combination with dabrafenib),
continue until disease progression or unacceptable toxicity.
Non-small cell
lung cancer (metastatic) (with BRAF V600E mutation): Oral: 2 mg once
daily (in combination with dabrafenib); continue until disease progression or
unacceptable toxicity (Planchard 2016).
Missed doses: Do not
take a missed dose within 12 hours of the next dose.
Dosing: Renal
Impairment
Mild to moderate
impairment (GFR ≥30 mL/minute/1.73 m2): No dosage adjustment
necessary.
Severe
impairment (GFR <30 mL/minute/1.73 m2): There are no dosage
adjustments provided in the manufacturer's labeling (has not been studied);
however, renal excretion is low and is unlikely to affect drug exposure.
Dosing: Hepatic
Impairment
Mild impairment
(total bilirubin ≤ ULN and AST > ULN or total bilirubin
>1 to 1.5 times ULN with any AST): No dosage adjustment necessary.
Moderate to
severe impairment: There are no dosage adjustments provided in the
manufacturer's labeling (has not been studied).
Dosing:
Adjustment for Toxicity
Recommended
trametinib dose reductions for toxicity:
First dose
reduction: 1.5 mg once daily
Second dose
reduction: 1 mg once daily
Subsequent
modification (if unable to tolerate 1 mg once daily): Permanently discontinue
Note: If using
combination therapy, refer to dabrafenib monograph for recommended dabrafenib
dose reductions
Cardiac:
Asymptomatic,
10% or greater absolute decrease in LVEF from baseline and LVEF is below
institutional lower limits of normal (LLN) from pretreatment value: Interrupt
trametinib therapy for up to 4 weeks. If LVEF improves to normal within 4 weeks
following therapy interruption, resume at a lower dose level. If LVEF does not
improve to normal within 4 weeks following therapy interruption, permanently
discontinue trametinib.
>20% absolute
decrease in LVEF from baseline and LVEF is below institutional LLN: Permanently
discontinue trametinib.
Symptomatic
heart failure: Permanently discontinue trametinib.
Dermatologic:
Intolerable
Grade 2 skin toxicity or Grade 3 or 4 skin toxicity: Interrupt trametinib
therapy for up to 3 weeks. If toxicity improves within 3 weeks, resume at a
lower dose level. If toxicity does not improve within 3 weeks following therapy
interruption, permanently discontinue trametinib.
New primary
cutaneous malignancies: No trametinib dosage modification is necessary.
Fever: Fever
>40°C (104°F) or fever (any severity) complicated by rigors, hypotension,
dehydration, or renal failure: Interrupt trametinib therapy until fever
resolves, then resume at the same or a lower dose level. May require
prophylactic antipyretics (secondary prophylaxis) upon resumption. Administer
corticosteroids (eg, prednisone 10 mg daily or equivalent) for at least 5 days
for second or subsequent pyrexia if temperature does not return to baseline
within 3 days of onset of fever, or for fever associated with complications
(eg, dehydration, hypotension, severe chills/rigors with no evidence of active
infection).
Hemorrhage:
Grade 3
hemorrhage: Interrupt trametinib therapy. If hemorrhage improves, resume at a
lower dose level. If hemorrhage does not improve following therapy
interruption, permanently discontinue trametinib.
Grade 4
hemorrhage: Permanently discontinue trametinib.
Ocular:
Uveitis and
iritis: No trametinib dosage modification necessary.
Retinal pigment epithelial
detachments (RPED): Interrupt trametinib therapy for up to 3 weeks. If improves
within 3 weeks following therapy interruption, resume at the same or lower dose
level. If RPED does not improve within 3 weeks following therapy interruption,
reduce dose or permanently discontinue trametinib.
Retinal vein
occlusion: Permanently discontinue trametinib.
Pulmonary: Interstitial
lung disease or pneumonitis: Permanently discontinue trametinib.
Venous
thromboembolism:
Uncomplicated
DVT or PE: Interrupt trametinib therapy for up to 3 weeks. If improves to ≤
grade 1 within 3 weeks following therapy interruption, resume at a lower dose
level. If toxicity does not improve within 3 weeks following therapy
interruption, permanently discontinue trametinib.
Life-threatening
PE: Permanently discontinue trametinib.
Other toxicity:
Intolerable
Grade 2 adverse reaction or any Grade 3 adverse reaction: Interrupt therapy. If
toxicity improves to ≤ grade 1 following therapy interruption, resume at a
lower dose level. If toxicity does not improve following therapy interruption,
permanently discontinue trametinib.
Grade 4 adverse
reaction:
First
occurrence: Interrupt trametinib therapy until improves to ≤grade 1, then
resume at a lower dose level or permanently discontinue trametinib.
Recurrence:
Permanently discontinue trametinib.
New primary
noncutaneous malignancy: No trametinib dosage modification is necessary.
Administration
Oral: Administer
at least 1 hour before or 2 hours after a meal. Administer dose at the same
time each day, whether administered as a single agent or in combination with
dabrafenib (when administered in combination with dabrafenib, take the once
daily trametinib dose either with the morning or with the evening dabrafenib
dose).
Storage
Store refrigerated
at 2°C to 8°C (36°F to 46°F); do not freeze. Dispense in original bottle; do
not remove desiccant. Protect from light and moisture. Do not transfer to pill
boxes.
Drug
Interactions
Amodiaquine:
CYP2C8 Inhibitors may increase the serum concentration of Amodiaquine. Avoid
combination
Dabrafenib:
Trametinib may enhance the adverse/toxic effect of Dabrafenib. Monitor
therapy
Adverse
Reactions
Adverse
reactions reported with monotherapy:
>10%:
Cardiovascular:
Hypertension (15%), cardiomyopathy (7% to 11%; defined as cardiac failure,
decreased left ventricular ejection fraction, or left ventricular dysfunction)
Dermatologic:
Skin toxicity (87%, most commonly dermatitis acneiform rash, palmar-plantar
erythrodysesthesia, erythema, skin rash; severe: 12%; severe toxicity and
secondary skin infection requiring hospitalization: 6%), skin rash (57%; grades
3/4: 8%), acneiform eruption (19%; grades 3/4: <1%), xeroderma (11%)
Endocrine &
metabolic: Hypoalbuminemia (42%)
Gastrointestinal:
Diarrhea (43%), stomatitis (15%), abdominal pain (13%)
Hematologic
& oncologic: Anemia (38%; grades 3/4: 2%), lymphedema (32%; includes edema,
peripheral edema; grades 3/4: 1%), hemorrhage (13%; includes epistaxis,
gingival bleeding, hematochezia, rectal hemorrhage, melena, vaginal hemorrhage,
hemorrhoidal hemorrhage, hematuria, conjunctival hemorrhage; grades 3/4:
<1%)
Hepatic:
Increased serum AST (60%), increased serum ALT (39%), increased serum alkaline
phosphatase (24%)
1% to 10%:
Cardiovascular:
Decreased left ventricular ejection fraction (5%, ≥20% below baseline),
bradycardia
Central nervous
system: Dizziness
Dermatologic:
Paronychia (10%), pruritus (10%; grades 3/4: 2%), cellulitis, folliculitis,
pustular rash
Gastrointestinal:
Dysgeusia, xerostomia
Neuromuscular
& skeletal: Rhabdomyolysis
Ophthalmic:
Blurred vision, dry eye syndrome
Respiratory:
Interstitial pulmonary disease (≤2%), pneumonitis (≤2%)
<1% (Limited
to important or life-threatening): Retinal detachment, retinal vein occlusion
Adverse
reactions reported with dual therapy (trametinib plus dabrafenib):
>10%
Cardiovascular:
Hypertension (25% to 26%), peripheral edema (21% to 25%; includes edema and
lymphedema; grades 3/4: ≤1% ), prolonged Q-T Interval on ECG (4% QTcF increased
>60 msec; <1% QTcF prolongation to >500 msec)
Central nervous
system: Headache (30% to 33%), chills (31%; grades 3/4: <1%), dizziness (11%
to 14%)
Dermatologic:
Skin toxicity (55% any skin toxicity; severe toxicity: <1%), skin rash (32%
to 42%; includes generalized rash, pruritic rash, erythematous rash, papular
rash, vesicular rash, macular rash, maculopapular rash, folliculitis rash;
grades 3/4: ≤1%), xeroderma (10% to 12%)
Endocrine &
metabolic: Hyperglycemia (60% to 65%; grades 3/4: 5% to 6%), hypoalbuminemia
(48% to 53%), hypophosphatemia (38%), exacerbation of diabetes mellitus (27%),
hyponatremia (24% to 25%)
Gastrointestinal:
Nausea (34% to 35%), diarrhea (30% to 31%), vomiting (25% to 27%), abdominal
pain (18% to 26%), constipation (13%)
Hematologic
& oncologic : Neutropenia (46% to 50%; grades 3/4: 6% to 7%), anemia (43%;
grades 3/4: 2%), lymphocytopenia (32% to 38%; grades 3/4: 8% to 9%),
thrombocytopenia (19% to 21%; grades 3/4: <1%), hemorrhage (18% to 19%;
includes epistaxis, hematochezia, decreased hemoglobin, purpura, rectal
hemorrhage; grades 3/4: 2%; includes hepatic hematoma, duodenal ulcer
hemorrhage)
Hepatic:
Increased serum AST (59% to 60%), increased serum alkaline phosphatase (49% to
50%), increased serum ALT (44% to 48%)
Neuromuscular
& skeletal: Arthralgia (25% to 26%), myalgia (13% to 15%)
Respiratory:
Cough (20% to 21%)
Miscellaneous:
Fever (54% to 57%; grades 3/4: 5% to 7%), febrile reaction (complicated with
dehydration: 2%, complicated with severe chills/rigors: <1%, complicated
with renal failure: <1%, complicated with syncope: <1%)
1% to 10%
Cardiovascular:
Bradycardia (<10%), cardiomyopathy (6%), venous thromboembolism (3%; deep
vein thrombosis, pulmonary embolism), hypertension
Central nervous
system: Intracranial hemorrhage (1%)
Gastrointestinal:
Gastrointestinal hemorrhage (6%), pancreatitis
Hematologic
& oncologic: Basal cell carcinoma (3%), squamous cell carcinoma of skin
(3%; including keratoacanthoma)
Neuromuscular
& skeletal: Rhabdomyolysis (<10%)
Respiratory:
Pneumonitis (1%)
<1% (Limited
to important or life-threatening): Malignant melanoma
Warnings/Precautions
Concerns related
to adverse effects:
• Bone marrow
suppression: Neutropenia (including grade 3 and 4 events) has been observed
when used in combination with dabrafenib. Monitor complete blood counts at
baseline and as clinically needed during therapy.
• Cardiac
events: Cardiac events such as heart failure, left ventricular dysfunction, or
decreased left ventricular ejection fraction (LVEF) were observed in clinical
trials (for single-agent trametinib and when used in combination with
dabrafenib). The median time to onset of cardiomyopathy in melanoma patients
for single-agent trametinib was ~2 months (range: 16 to 156 days) and ~8 months
(range: ~1 to 25 months) when used in combination with dabrafenib. The median
time of onset of cardiomyopathy in patients with NSCLC was 6.7 months (range:
1.4 to 14.1 months). In some patients, cardiomyopathy developed within the
first month of treatment. Assess LVEF (by echocardiogram or MUGA scan) prior to
therapy initiation, at one month, and then at 2- to 3-month intervals while on
therapy. Cardiac dysfunction may require treatment interruption, dosage
reduction, or discontinuation; such measures resulted in resolution of
cardiomyopathy in some patients.
• Dermatologic
toxicity: Dermatologic toxicity (eg, rash, dermatitis, acneiform rash,
palmar-plantar erythrodysesthesia syndrome, and erythema) was commonly observed
in trametinib-treated patients (either as a single-agent or when used in
combination with dabrafenib); some patients required hospitalization for severe
toxicity or for secondary skin infections. In melanoma studies, the median time
to onset and resolution of skin toxicity for single-agent trametinib was 15
days (range: 1 to 221 days) and 48 days (range: 1 to 282 days), respectively.
The median time to onset and resolution of skin toxicity for combination
therapy was 2 months (range: 1 day to 22 months) and 1.2 months (range: 1 day
to ~24 months), respectively in melanoma studies. Monitor for dermatologic
toxicity and signs/symptoms of secondary infections. Treatment interruption,
dose reduction, and/or therapy discontinuation may be necessary.
• Febrile
reactions: Serious febrile reactions and fever (any severity) accompanied by
hypotension, rigors/chills, dehydration, or renal failure may occur when
trametinib is used in combination with dabrafenib. The incidence and severity
were higher with combination therapy than with single-agent dabrafenib; the
median time to onset of fever was 1.2 months (range: 1 to 23 days) and duration
was 3 days (range: 1 day to 1.7 months) for patients receiving combination
therapy for the treatment of melanoma. Withhold trametinib for fever >104°F
(if using in combination, withhold dabrafenib for fever ≥101.3°F) or for any
fever with rigors/chills, hypotension, dehydration, or renal failure (evaluate
for infection); may require prophylactic antipyretics as secondary prophylaxis
upon therapy resumption. Administer corticosteroids (eg, prednisone 10 mg daily
or equivalent) for at least 5 days for second or subsequent episodes of pyrexia
if temperature does not return to baseline within 3 days of fever onset, or for
pyrexia associated with complications (eg, dehydration, hypotension, severe
chills/rigors with no evidence of active infection).
•
Gastrointestinal events: Colitis and GI perforation, including fatal cases,
have been reported with monotherapy and when administered concomitantly with dabrafenib;
monitor closely for development of colitis and GI perforations.
• Hemorrhage:
Hemorrhage, including symptomatic bleeding in a critical area/organ, may occur
with trametinib, either as a single agent or in combination with dabrafenib.
Major bleeding events (some fatal) included intracranial or gastrointestinal
hemorrhage. May require treatment interruption and dosage reduction;
permanently discontinue trametinib (and dabrafenib) for all grade 4 hemorrhagic
events and any grade 3 event that does not improve with therapy interruption.
•
Hepatotoxicity: Elevated liver function tests have been reported with
trametinib, including grade 3 and 4 events. Monitor hepatic function as
clinically necessary.
• Hyperglycemia:
While not reported with single-agent trametinib, hyperglycemia may occur while
on combination therapy with dabrafenib; may require initiation of insulin or
oral hypoglycemic agent therapy (or an increased dose if already taking).
Monitor serum glucose at baseline and as clinically necessary in patients with
preexisting diabetes or hyperglycemia. Instruct patients to report symptoms of
severe hyperglycemia (eg, polydipsia, polyuria).
• Hypertension:
May cause hypertension; monitor blood pressure.
• Malignancy:
New primary cutaneous malignancies (which are associated with dabrafenib as
single-agent therapy) may occur when trametinib is given in combination with
dabrafenib. The incidence of basal cell carcinoma (BCC) in melanoma patients is
~3% for combination therapy versus 6% for single-agent dabrafenib. The median
time to BCC diagnosis ranged from ~3 to 24 months for patients receiving
combination therapy for the treatment of melanoma. Cutaneous squamous cell
carcinomas (cuSCC), including keratoacanthoma, occurred at a lower rate for
combination therapy in melanoma patients compared to single-agent dabrafenib
(3% vs 10%, respectively), with a median time to diagnosis ranging from ~2 to
17 months for combination therapy. Cases of cuSCC also occurred in patients
with NSCLC, with a first occurrence onset ranging from 25 days to ~12 months.
New primary melanoma occurred rarely in patients receiving trametinib.
Dermatologic exams should be performed prior to initiation of combination
therapy, every 2 months while receiving combination treatment, and for up to 6
months following discontinuation. There are case reports of noncutaneous
malignancies, including pancreatic cancer (KRAS mutation-positive), colorectal
cancer (recurrent NRAS mutation-positive), hand and neck cancer, and
glioblastoma, with combination therapy; monitor for signs/symptoms of
noncutaneous malignancies. No trametinib dosage modification is necessary for
new primary cutaneous and noncutaneous malignancies; dabrafenib should be
permanently discontinued if RAS mutation-positive noncutaneous malignancies
develop.
• Ocular
toxicity: Retinal pigment epithelial detachments (RPED) and retinal vein
occlusion were seen in clinical trials (rare). Detachments were typically
bilateral and multifocal and occurred in the central macular area of the retina.
Retinal vein occlusion may lead to macular edema, decreased visual function,
neovascularization, and glaucoma. Promptly (within 24 hours) refer patients for
ophthalmological evaluations if loss of vision or other visual disturbances
occur. Ophthalmic exams (including retinal evaluation) should be performed
periodically during treatment and with visual disturbances. Interrupt
trametinib therapy for RPED; may resume if resolves within 3 weeks; reduce the
dose or discontinue if not resolved within 3 weeks. Permanently discontinue if
retinal vein occlusion develops. Uveitis and iritis have been reported when
trametinib is used in combination with dabrafenib and are managed
symptomatically with ophthalmic steroid and mydriatic drops (does not require
alteration in trametinib therapy).
• Pulmonary
toxicity: Interstitial lung disease (ILD) and pneumonitis were observed in
clinical trials. The median time to initial presentation in melanoma patients
was ~5 months (range: 2 to ~6 months). Monitor for new or progressive pulmonary
symptoms (eg, cough, dyspnea, hypoxia, pleural effusion, infiltrates); withhold
treatment if symptoms occur; permanently discontinue with diagnosis of ILD or
pneumonitis.
• Venous
thromboembolism: Venous thromboembolic events (some fatal) may occur (was
observed when used in combination with dabrafenib). DVT and PE occurred at an
increased incidence with combination therapy. Patients should seek immediate
medical attention with symptoms of DVT or PE (shortness of breath, chest pain,
arm/leg swelling). Withhold trametinib for uncomplicated DVT or PE; may resume
at a lower dose if improves within 3 weeks; permanently discontinue trametinib
for life-threatening PE.
Concurrent drug
therapy issues:
• Combination
therapy with dabrafenib: Serious adverse reactions (tumor promotion, hemolytic
anemia), which occur with single-agent dabrafenib, may also occur when
trametinib is administered in combination with dabrafenib.
• Drug-drug
interactions: Potentially significant interactions may exist, requiring dose or
frequency adjustment, additional monitoring, and/or selection of alternative
therapy. Consult drug interactions database for more detailed information.
Other
warnings/precautions:
• Appropriate
use: Trametinib is not indicated for treatment of patients with melanoma who
have progressed on prior BRAF-inhibitor therapy. Prior to initiating therapy,
confirm BRAF mutation status with an approved test; approved for use in
melanoma patients with BRAF V600K and BRAF V600E mutations and NSCLC patients with
BRAF V600E mutation. Data regarding use in melanoma patients with BRAF V600K
mutation is limited; compared to BRAF V600E mutation, lower response rates have
been observed with BRAF V600K mutation. Data regarding other less common BRAF
V600 mutations in melanoma is lacking.
Monitoring
Parameters
BRAF V600K or
V600E mutation status (prior to treatment); CBC and liver function tests at
baseline and periodically; assess LVEF (by echocardiogram or MUGA scan) at
baseline, 1 month after therapy initiation, and then at 2- to 3-month
intervals; ophthalmological evaluation periodically during treatment and with
visual disturbances; monitor for signs/symptoms of pulmonary toxicity (eg,
cough dyspnea, hypoxia, pleural effusion, or infiltrates); monitor for dermatologic
toxicity and secondary skin infections; blood pressure; diarrhea;
signs/symptoms of bleeding, colitis, and GI perforations.
For patients
receiving combination therapy with dabrafenib: Blood glucose (baseline and
periodically in patients with preexisting diabetes or hyperglycemia);
dermatologic exams should be performed prior to treatment initiation, every 2
months while receiving combination treatment, and for up to 6 months following
therapy discontinuation. Monitor for signs/symptoms of cutaneous and
noncutaneous malignancies and uveitis/iritis.
Monitor
adherence.
Pregnancy
Considerations
Adverse effects
were observed in animal reproduction studies. Based on its mechanism of action,
trametinib would be expected to cause fetal harm if administered to a pregnant
woman. Females of reproductive potential should use a highly effective
contraceptive during therapy and for 4 months after treatment is complete. When
trametinib is used in combination with dabrafenib, a highly effective
nonhormonal contraceptive method should be used (dabrafenib may diminish
efficacy of hormonal contraceptives). Fertility may also be impaired in
females. Due to a risk for impaired spermatogenesis, males who may want to
father a child should seek fertility/family planning counseling prior to
initiating combination therapy with dabrafenib.
Patient
Education
• Discuss
specific use of drug and side effects with patient as it relates to treatment.
(HCAHPS: During this hospital stay, were you given any medicine that you had
not taken before? Before giving you any new medicine, how often did hospital
staff tell you what the medicine was for? How often did hospital staff describe
possible side effects in a way you could understand?)
• Patient may
experience dry skin, nail changes, mouth sores, mouth irritation, lack of
appetite, or vomiting. Have patient report immediately to prescriber signs of
blood clots (numbness or weakness on one side of the body; pain, redness,
tenderness, warmth, or swelling in the arms or legs; change in color of an arm
or leg; angina; shortness of breath; tachycardia; or coughing up blood), signs
of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing
up blood; hematuria; black, red, or tarry stools; bleeding from the gums;
abnormal vaginal bleeding; bruises without a reason or that get bigger; or any
severe or persistent bleeding), signs of fluid and electrolyte problems (mood
changes, confusion, muscle pain or weakness, abnormal heartbeat, severe
dizziness, passing out, tachycardia, increased thirst, seizures, loss of
strength and energy, lack of appetite, urinary retention or change in amount of
urine passed, dry mouth, dry eyes, or nausea or vomiting), signs of kidney
problems (urinary retention, hematuria, change in amount of urine passed, or
weight gain), signs of heart problems (cough or shortness of breath that is new
or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of
more than five pounds in 24 hours, dizziness, or passing out), acne, severe
skin redness, persistent skin rash, redness or irritation of palms of hands or
soles of feet, signs of a severe pulmonary disorder (lung or breathing problems
like difficulty breathing, shortness of breath, or a cough that is new or
worse), severe loss of strength and energy, chills, severe dizziness, passing
out, severe headache, severe nausea, severe diarrhea, severe abdominal pain,
severe abdominal cramps, blurred vision, blindness, vision changes, or visual
halos or bright colors around lights (HCAHPS).
• Educate
patient about signs of a significant reaction (eg, wheezing; chest tightness;
fever; itching; bad cough; blue skin color; seizures; or swelling of face,
lips, tongue, or throat). Note: This is not a comprehensive
list of all side effects. Patient should consult prescriber for additional
questions.
Intended Use and
Disclaimer: Should not be printed and given to patients. This information is
intended to serve as a concise initial reference for health care professionals
to use when discussing medications with a patient. You must ultimately rely on
your own discretion, experience, and judgment in diagnosing, treating, and
advising patients.
