Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Central Nervous System Effects
Additions
and/or revisions underlined:
Central
nervous system (CNS) adverse reactions occurred in patients receiving VITRAKVI,
including dizziness, cognitive impairment, mood disorders, and sleep
disturbances.
In
patients who received VITRAKVI (n=444), all grades CNS effects including
cognitive impairment, mood disorders, dizziness and sleep disorders were observed
in 40.3% with Grades 3-4 in 3.8% of patients.
Cognitive
impairment occurred in 11% of patients. The median time to onset of cognitive
impairment was 6 months (range: 2 days to 56 months). Cognitive impairment
occurring in greater than or equal to 1%
of patients included memory impairment (4.1%), disturbance in attention
(3.6%), confusional state (2.3%), cognitive disorder (1.6%), delirium (1.4%),
and hallucination (1.1%). Grade 3 cognitive adverse reactions occurred in
1.8% of patients and Grade 4 cognitive adverse reactions in 0.2% of
patients. Among the 49 patients with cognitive impairment, 6%
required a dose modification, and 18% required dose interruption.
Mood
disorders occurred in 14% of patients. The median time to onset of mood disorders
was
3.3
months (range: 1 day to 65 months). Mood disorders occurring in greater
than or equal to 1% of patients included anxiety (5%), agitation (3.2%),
depression (3.2%), irritability (2.3%), and restlessness (1.1%).
Grade 3 mood disorders occurred in 0.9% of patients. Among the 63
patients who experienced mood disorders, no patient required a dose
modification, and 1.6% required dose interruption.
Dizziness
occurred in 22% of patients, and Grade 3 dizziness occurred in 0.9%
of patients. Among the 96 patients who experienced dizziness, 6% of
patients required a dose modification, and 5% required dose interruption.
Sleep
disturbances occurred in 12% of patients. Sleep disturbances included
insomnia (9%), somnolence (3.4%), and sleep disorder (0.5%).
Grade 3 sleep disturbances occurred in 0.2% of patients. Among the 54 patients
who experienced sleep disturbances, no patient required a dose
modification, and 3.7% required dose interruption.
![]()
…
5.2 Skeletal Fractures
Additions
and/or revisions underlined:
Skeletal
fractures can occur in patients taking VITRAKVI.
Among
444 patients who received VITRAKVI across clinical trials, fractures occurred
in 7% of patients; 6% of 290 adult patients and 10% of 154 pediatric
patients. Median time to first fracture was 13 months (range 27
days to 73 months) in patients followed per fracture. The most common
fractures were of the rib (1.4%), fibula, foot, or wrist (0.7%
each). Most fractures were associated with minimal or moderate trauma. Some
fractures were associated with radiologic abnormalities suggestive of local
tumor involvement.
5.3 Hepatotoxicity
Additions
and/or revisions underlined:
In
patients who received VITRAKVI (n=444), increased AST of any grade
occurred in 62% of patients and increased ALT of any grade occurred in 61%.
Grade 3-4 increased AST or ALT occurred in 7% and 8% of patients,
respectively [see Adverse Reactions (6.1)].
The median time to onset of increased AST was 1.9 months (range: 4 days
to 3.8 years). The median time to onset of increased ALT was 1.9
months (range: 1 day to 4.9 years). Increased AST and ALT leading to dose
modifications occurred in 1.6% and 3.2% of patients,
respectively. Increased AST or ALT led to permanent discontinuation in 4
(0.9%) patients.
…
6
Adverse Reactions
6.1 Clinical Trials Experience
Extensive additions and/or revisions, please refer to label for complete
information.
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
…
The efficacy of VITRAKVI was evaluated in 131
pediatric patients and is described in the Clinical Studies section [see Clinical Studies (14)]. The safety
of VITRAKVI was evaluated in 154 pediatric patients who received VITRAKVI.
Of these 154 patients, 31% were <1 month to < 2 years (n = 47),
49% were 2 years to < 12 years (n = 75), and 21% were 12 years to
< 18 years (n = 32); 25% had metastatic disease, 44% had
locally advanced disease, and 31% had primary CNS; and 82% had
received prior treatment for their cancer, including surgery, radiotherapy, or
systemic therapy, including radioactive iodine therapy (RAI). The most
common cancers were infantile fibrosarcoma (32%), primary CNS tumors (31%),
soft tissue sarcoma (27%), and thyroid cancer (4%). The median duration
of exposure was 14.8 months (range: 0.4 months to 87.4 months).
… Adverse reactions occurring more frequently (at least a 10% increase in per-patient
incidence) in pediatric patients compared to adult patients were vomiting (51%
versus 18%), pyrexia (47% versus 15%), cough (36% versus 23%), diarrhea
(34% versus 21%), upper respiratory tract infection (33% versus
10%), headache (25% versus 13%), nasopharyngitis (20% versus 7%), nasal congestion
(18% versus 7%), gastroenteritis (13% versus 2%), and rhinitis (12% versus 0%).
Laboratory abnormalities occurring more frequently
(at least a 10% increase in per-patient incidence) in pediatric patients compared
to adult patients were AST increased (75% versus 55% in adults), ALT
increased (69% versus 57% in adults), neutrophil count decrease (59%
versus 20% in adults), leukocyte count decrease (46% versus 32% in
adults), hyperkalemia (39% versus 16%), glucose decrease (29%
versus 13% in adults), and lymphocyte increase (25% versus 1%).
Three of the 154 pediatric patients discontinued VITRAKVI due to an
adverse reaction associated with a laboratory abnormality (1 patient with Grade
3 increased ALT and 2 patients with Grade 3 decreased neutrophil count).
…
8.5 Geriatric Use
Additions and/or revisions underlined:
Of 444 patients in the overall safety population
who received VITRAKVI, 20% of patients were
Greater than or equal to 65 years of age and 6% of
patients were greater than or equal to 75 years of age. No overall differences
in safety or effectiveness of VITRAKVI were observed between patients 65
years and older and younger adult patients.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Extensive
additions and/or revisions, please refer to label for complete information.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.3 Hepatotoxicity
Additions
and/or revisions underlined:
Hepatotoxicity
including drug-induced liver injury (DILI) has been reported in patients taking
VITRAKVI.
In
patients who received VITRAKVI, increased AST of any grade occurred in 52% of
patients and increased ALT of any grade occurred in 45%. Grade 3-4 increased
AST or ALT occurred in 3.1% and 2.5% of patients, respectively [see Adverse Reactions (6.1)]. The
median time to onset of increased AST was 2.1 months (range: 1 day to 4.3
years). The median time to onset of increased ALT was 2.3 months (range: 1 day
to 4.2 years). Increased AST and ALT leading to dose modifications occurred in
1.4% and 2.2% of patients, respectively. Increased AST or ALT led to permanent
discontinuation in 3 (1.1%) of patients.
There
have been reports in adult patients from clinical studies and postmarketing
cases of Grade greater
than or equal to 2 increases in ALT and/or AST with increases in bilirubin greater
than or equal to 2 x ULN.
Obtain liver function
tests (ALT, AST, ALP and bilirubin) before initiation of VITRAKVI and
monitor every 2 weeks during the first 2 months of treatment, then
monthly thereafter, or more frequently following the occurrence of Grade 2
or greater AST or ALT elevation. Temporarily withhold, reduce the dose,
or permanently discontinue VITRAKVI based on severity [see Dosage and
Administration (2.4)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
Additions and/or revisions underlined:
Before
taking VITRAKVI, tell your healthcare provider about all of your medical
conditions, including if you:
…
- Tell your healthcare provider right away if you
become pregnant during treatment with VITRAKVI or think you may be pregnant.
…
How should I take
VITRAKVI?
…
- Your healthcare provider will provide you with the VITRAKVI oral
solution, oral syringes and bottle adaptors or send you to a pharmacy
that can provide you with VITRAKVI oral solution, oral syringes and bottle
adaptors.
…
What are the
possible side effects of VITRAKVI?
VITRAKVI may cause
serious side effects, including:
…
Your healthcare provider may decrease your dose, temporarily stop or permanently stop your treatment
with VITRAKVI if you develop serious side effects.
The
most common side effects of VITRAKVI include:
…
How should
I store VITRAKVI?
Store VITRAKVI capsules
at room temperature between 68?F to 77?F (20?C to 25?C).
Store VITRAKVI oral solution in the refrigerator between 36° F to 46° F (2° C to 8° C). Do not freeze.
Throw away (dispose
of) any unused VITRAKVI oral solution:
- Bottle of 50 mL: remaining
31 days after
first opening the bottle
What are the ingredients in VITRAKVI?
Active ingredient: larotrectinib
Inactive ingredients:
Capsule: gelatin, titanium
dioxide and edible ink
Oral Solution Packaged in One Bottle Containing
100 mL: purified water, hydroxypropyl betadex, sucrose, glycerin, sorbitol,
citric acid, sodium phosphate, sodium
citrate dihydrate, propylene
glycol and flavoring. Preserved with methylparaben and potassium sorbate.
Oral Solution Packaged in Two Bottles Each
Containing 50 mL: purified water, hydroxypropyl betadex, sucralose, sodium
citrate, strawberry flavor, and citric acid. Preserved with sodium benzoate.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Central Nervous System Effects
Subsection title
revised; Additions and/or revisions underlined:
Central nervous system (CNS) adverse reactions occurred
in patients receiving VITRAKVI, including dizziness, cognitive impairment, mood
disorders, and sleep disturbances.
In patients who
received VITRAKVI, all grades CNS effects including cognitive impairment,
mood disorders, dizziness and sleep disorders were observed in 42% with Grades 3-4
in 3.9% of patients.
Cognitive impairment occurred in 11% of patients. The median time to onset of cognitive impairment was 5.6
months (range: 2 days to 41 months). Cognitive impairment occurring in greater than or equal to 1% of
patients included memory impairment (3.6%), confusional state (2.9%),
disturbance in attention (2.9%), delirium (2.2%), cognitive disorders (1.4%),
and Grade 3 cognitive adverse reactions occurred in 2.5%
of patients. Among the 30 patients with cognitive impairment, 7% required a
dose modification, and 20% required dose interruption.
Mood disorders occurred in 14% of patients. The median time to onset of mood disorders was 3.9 months (range:
1 day to 40.5 months). Mood disorders occurring in greater than or equal to 1% of patients included
anxiety (5%), depression (3.9%), agitation (2.9%), and irritability (2.9%).
Grade 3 mood disorders occurred in 0.4% of patients. Dizziness occurred in 27%
of patients, and Grade 3 dizziness occurred in 1.1% of patients. Among
the 74 patients who experienced dizziness, 5% of patients required a dose
modification, and 5% required dose interruption.
Sleep disturbances occurred in 10% of patients. Sleep
disturbances included insomnia (7%), somnolence (2.5%), and sleep disorder
(0.4%). There were no Grade 3-4 sleep disturbances. Among the 28 patients who experienced
sleep disturbances, 1 patient each (3.6%) required a dose modification or dose
interruption.
Advise patients and caretakers of these risks with
VITRAKVI. Advise patients not to drive or operate hazardous machinery if they are
experiencing neurologic adverse reactions. Withhold or permanently discontinue VITRAKVI
based on the severity. If withheld, modify the VITRAKVI dosage when resumed [see
Dosage and Administration (2.3)].
5.2 Skeletal Fractures
Newly added
subsection:
Among
187 adult patients who received VITRAKVI across clinical trials, fractures were
reported in 7% and among 92 pediatric patients, fractures were reported in 9% (N=279;
8%). Median time to fracture was 11.6 months (range 0.9 to 45.8 months) in patients
followed per fracture. Fractures of the femur, hip or acetabulum were reported
in 4 patients (3 adult, 1 pediatric). Most fractures were associated with
minimal or moderate trauma. Some fractures were associated with radiologic
abnormalities suggestive of local tumor involvement.
VITRAKVI
treatment was interrupted due to fracture in 1.4% patients.
Promptly
evaluate patients with signs or symptoms of potential fracture (e.g., pain, changes
in mobility, deformity). There are no data on the effects of VITRAKVI on
healing of known fractures or risk of future fractures.
5.3 Hepatotoxicity
Additions and/or
revisions underlined:
In patients who
received VITRAKVI, increased AST of any grade occurred in 52% of patients
and increased ALT of any grade occurred in 45%. Grade 3-4 increased
AST or ALT occurred in 3.1% and 2.5% of patients, respectively
[see Adverse Reactions (6.1)]. The median
time to onset of increased AST was 2.1 months (range: 1 day to 4.3
years). The median time to onset of increased ALT was 2.3 months (range:
1 day to 4.2 years). Increased AST and ALT leading to dose
modifications occurred in 1.4% and 2.2% of patients,
respectively. Increased AST or ALT led to permanent discontinuation in 3
(1.1%) of patients.
Monitor
liver tests, including ALT and AST, every 2 weeks during the first month of treatment,
then monthly thereafter, and as clinically indicated. Withhold or permanently
discontinue VITRAKVI based on the severity. If withheld, modify the VITRAKVI
dosage when resumed [see Dosage and
Administration (2.3)].
6
Adverse Reactions
Additions and/or
revisions underlined:
The following clinically significant adverse reactions
are described elsewhere in the labeling:
Central Nervous System Effects [see Warnings and Precautions (5.1)]
Skeletal Fractures [see Warnings and Precautions (5.2)]
Hepatotoxicity [see
Warnings and Precautions (5.3)]
6.1 Clinical Trials Experience
Extensive changes;
please refer to label
7
Drug Interactions
7.1 Effects of Other Drugs on VITRAKVI
Additions and/or
revisions underlined:
Strong
and Moderate CYP3A4 Inhibitors
Coadministration
of VITRAKVI with a strong or moderate CYP3A4 inhibitor may increase
larotrectinib plasma concentrations, which may result in a higher incidence of adverse
reactions [see Clinical Pharmacology
(12.3)]. Avoid coadministration of VITRAKVI with strong CYP3A4 inhibitors,
including grapefruit or grapefruit juice. If coadministration of strong CYP3A4
inhibitors cannot be avoided, modify VITRAKVI dose as recommended [see Dosage and Administration (2.4)]. In patients coadministered a
moderate CYP3A4 inhibitor with VITRAKVI, monitor for adverse reactions more
frequently and reduce the VITRAKVI dosage based on the severity of emergent
adverse reactions [see Dosage and
Administration (2.3)].
Strong
and Moderate CYP3A4 Inducers
Coadministration
of VITRAKVI with a strong or moderate CYP3A4 inducer may decrease
larotrectinib plasma concentrations, which may decrease the efficacy of
VITRAKVI [see Clinical Pharmacology
(12.3)]. Avoid coadministration of VITRAKVI with strong CYP3A4 inducers,
including St. John’s wort. If coadministration of strong CYP3A4 inducers cannot
be avoided, modify VITRAKVI dose as recommended. For coadministration with
moderate CYP3A4 inducers, modify VITRAKVI dose as recommended [see Dosage and Administration (2.5)].
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or
revisions underlined:
The
safety and effectiveness of VITRAKVI in pediatric patients was established based
upon data from three multicenter, open-label, single-arm clinical trials in adult
or pediatric patients 28 days and older [see
Adverse Reactions (6.1), Clinical Studies (14)].
The
efficacy of VITRAKVI was evaluated in 12 pediatric patients and is described in
the Clinical Studies section [see
Clinical Studies (14)]. The safety of VITRAKVI was evaluated in 92 pediatric
patients who received VITRAKVI. Of these 92 patients, 36% were <1
month to < 2 years (n = 33), 41% were 2 years to < 12 years
(n = 38), and 23% were 12 years to < 18 years (n = 21);
29% had metastatic disease, 42% had locally advanced disease, and
27% had primary CNS; and 86% had received prior treatment for their
cancer, including surgery, radiotherapy, or systemic therapy. The most common
cancers were infantile fibrosarcoma (37%), primary CNS tumors (27%),
soft tissue sarcoma (24%), and thyroid cancer (7%). The median
duration of exposure was 7.4 months (range: 0.4 months to 39
months).
Due
to the small number of pediatric and adult patients, the single arm design of
clinical studies of VITRAKVI, and confounding factors such as differences in
susceptibility to infections between pediatric and adult patients, it is not
possible to determine whether differences in the incidence of adverse reactions
to VITRAKVI are related to patient age or other factors. Adverse reactions occurring
more frequently (at least a 10% increase in per-patient incidence) in pediatric
patients compared to adult patients were pyrexia (45% versus 13%), vomiting
(42% versus 17% in adults), diarrhea (35% versus 23% in adults), rash (28%
versus 15% in adults), upper respiratory tract infection (23% versus 8% in adults),
nasopharyngitis (16% versus 6% in adults), and otitis media and rhinitis (each
14% versus 0.5% in adults).
Laboratory
abnormalities occurring more frequently (at least a 10% increase in
per-patient incidence) in pediatric patients compared to adult patients were AST
increased (63% versus 49% in adults), neutrophil count decrease (60% versus
16% in adults), leukocyte count decrease (39% versus 27% in adults),
hyperkalemia (36% versus 15%), and lymphocyte increase (24% versus
0.5%). Two of the 92 pediatric patients discontinued VITRAKVI due to
an adverse reaction (Grade 3 increased ALT and Grade 3 decreased neutrophil
count).
The
pharmacokinetics of VITRAKVI in the pediatric population were similar to those seen
in adults [see Clinical Pharmacology
(12.3)].
…
8.5 Geriatric Use
Additions and/or
revisions underlined:
Of
279 patients in the overall safety population who received VITRAKVI, 19%
of patients were greater than or equal to 65 years of age and 5% of patients were greater than or equal to 75 years of age. Clinical studies of VITRAKVI
did not include sufficient numbers of subjects aged 65 and over to determine
whether they respond differently from younger subjects.
8.6 Hepatic Impairment
Additions and/or
revisions underlined:
No
dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh
A).
Larotrectinib
clearance was reduced in subjects with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic
impairment [see Clinical Pharmacology (12.3)]. Reduce VITRAKVI dose as recommended [see Dosage and Administration (2.6)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or
revisions underlined:
Advise
the patient to read the FDA-approved patient labeling (Patient Information and
Instructions for Use).
Central
Nervous System Effects
Advise
patients to notify their healthcare provider if they experience new or worsening
neurotoxicity. Advise patients not to drive or operate hazardous machinery if
they are experiencing neurologic adverse reactions [see Warnings and Precautions (5.1)].
Skeletal
Fractures
Inform
patients that bone fractures have been reported in patients taking VITRAKVI.
Advise patients to report symptoms such as pain, changes in mobility, or deformity
to their healthcare provider [see
Warnings and Precautions (5.2)].
…
PATIENT INFORMATION
Extensive changes;
please refer to label
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Central Nervous System Effects
(Newly
added section. See label for complete information)
5.2 Skeletal Fractures
(Newly
added section. See label for complete information)
5.3 Hepatotoxicity
(Additions and/or revisions underlined)
In patients who received VITRAKVI, increased AST of any grade occurred
in 52% of patients and increased ALT of any grade occurred in 45%. Grade 3-4 increased AST or ALT occurred in 3.1% and 2.5%
of patients, respectively [see Adverse Reactions
(6.1)]. The median time
to onset of increased AST
was 2.1 months (range:
1 day to 4.3 years). The
median time to onset of increased
ALT was 2.3 months (range: 1 day to 4.2 years). Increased AST and ALT
leading to dose modifications occurred in 1.4% and 2.2% of patients, respectively. Increased
AST or ALT led to permanent discontinuation in 3 (1.1%)
of patients.
6
Adverse Reactions
(Additions and/or revisions underlined)
The following
clinically significant adverse reactions are described elsewhere
in the labeling:
6.1 Clinical Trial Experience
(Extensive
changes; please refer to label)
8
Use in Specific Populations
8.4 Pediatric Use
(Additions and/or revisions underlined)
The safety of VITRAKVI was
evaluated in
92 pediatric patients who received VITRAKVI.
Of these 92 patients, 36% were <1 month to < 2 years
(n = 33), 41% were 2
years to < 12 years (n = 38),
and 23% were 12
years to < 18 years (n = 21);
29% had metastatic disease, 42% had locally advanced
disease, and 27% had primary CNS; and 86% had received prior
treatment for their cancer,
including surgery, radiotherapy,
or systemic
therapy. The most common cancers
were infantile fibrosarcoma (37%),
primary CNS tumors (27%),
soft tissue sarcoma (24%), and thyroid cancer (7%). The median duration of exposure
was 7.4 months (range: 0.4 months to 39 months).
Due to the small number of pediatric and adult patients,
the single arm design of clinical studies of VITRAKVI,
and confounding factors such as differences in susceptibility to infections between
pediatric and adult patients,
it is not possible to determine whether differences in the incidence of adverse
reactions to VITRAKVI are related
to patient age or other factors. Adverse reactions occurring more frequently (at
least a 10% increase in per-patient incidence) in pediatric patients
compared to adult patients were
pyrexia (45% versus 13%), vomiting
(42% versus 17% in adults),
diarrhea (35% versus 23% in adults),
rash (28% versus 15% in adults), upper respiratory
tract infection (23% versus 8% in adults), nasopharyngitis
(16% versus 6% in adults),
and otitis media and rhinitis
(each 14% versus 0.5% in adults).
Laboratory abnormalities occurring more frequently (at least a 10%
increase in per-patient incidence) in pediatric patients compared to adult patients were AST increased (63% versus 49% in adults),
neutrophil count decrease (60% versus 16% in adults), leukocyte count decrease (39% versus
27% in adults), hyperkalemia (36%
versus 15%), and lymphocyte
increase (24% versus 0.5%). Two
of the 92 pediatric patients discontinued
VITRAKVI due to an adverse reaction (Grade
3 increased ALT and Grade
3 decreased
neutrophil count).
8.5 Geriatric Use
(Additions and/or revisions underlined)
Of 279 patients in the overall safety population who received VITRAKVI,
19% of patients were
? 65 years of age
and 5% of patients were ? 75 years of
age. Clinical studies of VITRAKVI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(Additions and/or revisions underlined)
Advise the patient to read
the FDA-approved patient labeling (Patient
Information and Instructions
for Use).
Central Nervous System Effects
Advise patients to notify their healthcare
provider if they experience new or
worsening neurotoxicity. Advise patients not to drive
or operate hazardous machinery
if they are experiencing neurologic adverse reactions [see Warnings and Precautions (5.1)].
Skeletal Fractures
Inform patients that bone
fractures have been reported
in patients taking VITRAKVI. Advise patients
to report
symptoms such as pain, changes
in mobility, or deformity to their healthcare provider [see Warnings and Precautions
(5.2)].
Patient Information
(Additions and/or revisions underlined)
It is not known if VITRAKVI is safe and effective in
children younger than 28 days of age. . .
Do not breastfeed during treatment and for 1 week after the final
dose of VITRAKVI.
Certain other medicines may affect how VITRAKVI works and
VITRAKVI may affect
how other medicines work. Know the medicines you take.
. .
• Swallow VITRAKVI capsules whole with water. Do not
chew or crush the capsules.
• If you miss a dose of VITRAKVI, take it as soon as you
remember. If your next scheduled dose is due within 6 hours, skip
the missed dose and take your next dose at your regular time.
• If you
take too much VITRAKVI, call your healthcare provider or go to the nearest
hospital emergency room right away.
VITRAKVI may cause serious side effects, including:
• Central nervous system (CNS) problems. VITRAKVI may cause
dizziness, confusion, problems with
concentration, attention, and memory, changes in your mood,
and sleep problems. Tell your healthcare provider if
you develop any of these symptoms or they get worse. Your
healthcare provider may temporarily stop treatment,
decrease your dose, or permanently stop VITRAKVI if you
develop central nervous system symptoms with
VITRAKVI.
• Bone fractures. Bone fractures can happen with VITRAKVI.
Tell your healthcare provider if you develop pain,
changes in your ability to move around, or bone
abnormalities.
• Liver problems. Increased liver enzymes in blood tests are
common in people who take VITRAKVI. Increased liver
enzymes can sometimes lead to liver problems which can
become serious. Your healthcare provider will do blood
tests to check your liver function every 2 weeks during the
first month of treatment with VITRAKVI, then monthly, as
needed. Tell your healthcare provider right away if you
develop symptoms of liver problems including: loss of
appetite, nausea or vomiting, or pain on the upper right
side of your stomach area. Your healthcare provider may
temporarily stop treatment, decrease your dose, or
permanently stop VITRAKVI if you develop liver problems with
VITRAKVI.
The most common side effects of VITRAKVI include:
• low red blood cell and white blood cell counts
• muscle and bone pain
• tiredness
• low levels of protein called albumin in the blood
• increased levels of enzyme called alkaline
phosphatase in the blood (test for liver or bone problems)
• cough
• constipation
• diarrhea
• dizziness
• low levels of calcium in the blood
• nausea
• vomiting
• fever
• stomach (abdomen) pain
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