Approved Drug Label (PDF)
4
Contraindications
Additions and/or
revisions underlined:
TOUJEO is contraindicated:
5
Warnings and Precautions
Additions and/or
revisions underlined:
5.2 Hyperglycemia or
Hypoglycemia with Changes in Insulin Regimen
Changing to TOUJEO
from other Insulin Therapies
5.3 Hypoglycemia
‘the patient’
replaces ‘an individual’ throughout subsection.
Newly added
information to end of subsection:
The long-acting effect
of TOUJEO may delay recovery from hypoglycemia compared to shorter- acting
insulins.
Risk Factors for Hypoglycemia
‘insulins’
replaces ‘insulin preparations’
‘patients’
replaces ‘individuals’
‘concomitant drugs’
replaces ‘coadministered medication’
5.4 Hypersensitivity
Reactions
‘insulins’
replaces ‘insulin products’
Additions and/or
revisions underlined:
TOUJEO is contraindicated
in patients who have had hypersensitivity reactions to insulin glargine or any
of the excipients in TOUJEO.
5.6 Hypokalemia
insulins’ replaces
‘insulin products’
6
Adverse Reactions
Additions and/or
revisions underlined:
6.1 Clinical
Trials Experience
Table 1: Adverse Reactions
Occurring greater than or equal to 5% in Two Pooled Clinical Trials of 26
Weeks and 16 Weeks Duration in Adults with Type 1 Diabetes
Table 2: Adverse Reactions
Occurring greater than or equal to 5% in Three Pooled Clinical Trials of
26 Weeks Duration in Adults with Type 2 Diabetes
8
Use in Specific Populations
8.1 Pregnancy
Clinical Considerations
Additions and/or
revisions underlined:
Disease-Associated
Maternal and/or Embryo/fetal Risk
Hypoglycemia and hyperglycemia
occur more frequently during pregnancy in patients with pre- gestational
diabetes.
Poorly controlled diabetes in pregnancy increases the maternal risk for
diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery,
and delivery complications …
8.5 Geriatric Use
Additions and/or
revisions underlined:
… No overall differences
in safety or effectiveness of TOUJEO have been observed between
patients 65 years of age and older and younger adult patients.
Nevertheless, caution
should be exercised when TOUJEO is administered to geriatric patients. In geriatric
patients with diabetes, the initial dosing, dose increments, and maintenance
dosage should be conservative to avoid hypoglycemia …
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). There are separate Instructions for Use for TOUJEO SoloStar and
TOUJEO Max SoloStar.
Hypoglycemia
Due to
Medication Errors
Newly added information:
Hypersensitivity Reactions
Advise patients that
hypersensitivity reactions have occurred with TOUJEO. Inform patients on the
symptoms of hypersensitivity reactions [see
Warnings and Precautions (5.5)].
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Never Share a TOUJEO Solostar or TOUJEO Max Solostar Pen Between Patients
(Additions and/or
revisions underlined)
TOUJEO
SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pens must never
be shared between patients, even if the needle is changed. Pen sharing poses a risk
for transmission of blood-borne pathogens.
6
Adverse Reactions
6.1 Clinical Trials Experience
(Additions and/or
revisions underlined)
…
The
data in Table 2 reflect the exposure of 1242 patients with type 2 diabetes to TOUJEO
with mean exposure duration of 25 weeks. The type 2 diabetes population had the
following characteristics: Mean age was 59 years and mean duration of diabetes was
13 years. Fifty-three percent were male, 88% were Caucasian, 7% were Black or African
American, and 17% were Hispanic. At baseline, mean eGFR was 79 mL/min/1.73 m^2 and
27% of patients had an eGFR greater than or equal to 90 mL/min/1.73 m^2. The mean BMI was 35 kg/m^2. HbA1c
at baseline was greater or equal to 8% in 66% of patients.
TOUJEO
was studied in 233 pediatric patients (6-17 years of age) with type 1 diabetes for
a mean duration of 26 weeks.
Common
adverse reactions (occurring greater than or equal to 5%) in TOUJEO-treated subjects during clinical
trials in adult patients with type 1 diabetes mellitus and type 2 diabetes
mellitus are listed in Table 1 and Table 2, respectively. Common adverse reactions
for TOUJEO-treated pediatric subjects with type 1 diabetes mellitus were similar
to the adverse reactions listed in Table 1. Hypoglycemia is discussed in a dedicated
subsection below.
…
Hypoglycemia
Hypoglycemia
is the most commonly observed adverse reaction in patients using insulin, including
TOUJEO.
The rates of reported hypoglycemia depend on the definition of hypoglycemia used,
diabetes type, insulin dose, intensity of glucose control, background therapies,
and other intrinsic and extrinsic patient factors. For these reasons, comparing
rates of hypoglycemia in clinical trials for TOUJEO with the incidence of hypoglycemia
for other products may be misleading and also may not be representative of hypoglycemia
rates that will occur in clinical practice.
In
the TOUJEO adult program, severe hypoglycemia was defined as an event requiring
assistance of another person to administer a resuscitative action. In the pediatric
program, severe hypoglycemia was defined as an event with semiconsciousness,
unconsciousness, coma and/or convulsions in a patient who had altered mental
status and could not assist in his own care and who may have required glucagon or
intravenous glucose.
The
incidence of severe hypoglycemia in adult patients with type 1 diabetes receiving
TOUJEO as part of a multiple daily injection regimen was 6.6% at 26 weeks. The incidence
of hypoglycemia with a glucose level less than 54 mg/dL with or without symptoms
was 77.7% at 26 weeks.
The
incidence of severe hypoglycemia in pediatric patients with type 1 diabetes receiving
TOUJEO as part of a multiple daily injection regimen was 6% at 26 weeks and the
incidence of hypoglycemia accompanied by a self-monitored or plasma glucose value
less than 54 mg/dL regardless of symptoms was 80.3%.
The
incidence of severe hypoglycemia in adult patients with type 2 diabetes was 5%
at 26 weeks in patients receiving TOUJEO as part of a multiple daily injection regimen,
and 1.0% and 0.9% respectively at 26 weeks in the two studies where patients received
TOUJEO as part of a basal- insulin only regimen. The incidence of hypoglycemia accompanied
by a self-monitored or plasma glucose value less than 54 mg/dL regardless of symptoms
in patients with type 2 diabetes receiving TOUJEO ranged from 9% to 44.6%
at 26 weeks and the highest risk was again seen in patients receiving TOUJEO as
part of a multiple daily injection regimen.
…
8
Use in Specific Populations
8.4 Pediatric Use
(Additions and/or
revisions underlined)
The
safety and effectiveness of TOUJEO to improve glycemic control in type 1 and type
2 diabetes mellitus have been established in pediatric patients 6 years of age and
older.
The
use of TOUJEO for this indication is supported by evidence from an adequate and
well- controlled study in 463 pediatric patients 6 to 17 years of age with type
1 diabetes mellitus and from studies in adults with diabetes mellitus.
The
safety and effectiveness of TOUJEO have not been established in pediatric patients
less than 6 years of age.
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).
Never
Share a TOUJEO SoloStar or TOUJEO Max SoloStar Pen Between Patients
Advise
patients that they must never share TOUJEO SoloStar or TOUJEO Max SoloStar pen with
another person even if the needle is changed. Pen sharing poses a risk for transmission
of blood-borne pathogens.
Hyperglycemia
or Hypoglycemia
Inform
patients that hypoglycemia is the most common adverse reaction with insulin.
Inform patients of the symptoms of hypoglycemia. Inform patients that the ability
to concentrate and react may be impaired as a result of hypoglycemia. This may present
a risk in situations where these abilities are especially important, such as driving
or operating other machinery. Advise patients who have frequent hypoglycemia or
reduced or absent warning signs of hypoglycemia to use caution when driving or operating
machinery.
Advise
patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia
and that changes in insulin regimen should be made under close medical supervision.
Inform
patients that if they change to TOUJEO from other basal insulins they may experience
higher average fasting plasma glucose levels in the first weeks of therapy. Advise
patients to monitor glucose daily when initiating TOUJEO.
Medication
Errors
Instruct
patients to always check the insulin label before each injection. The “300 units/mL
(U-300)” is highlighted in honey gold on the labels of TOUJEO and TOUJEO Max SoloStar
single-patient-use prefilled pens.
Inform
patients that TOUJEO (insulin glargine injection) 300 units/mL contains 3 times
as much insulin in 1 mL as standard insulin (100 units/mL). To avoid dosing errors
and potential overdose, instruct patients to never use a syringe to remove TOUJEO
from the TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen.
Inform
patients that the dose counter of TOUJEO SoloStar or TOUJEO Max SoloStar single-
patient-use prefilled pen shows the number of units of TOUJEO to be injected
and no dose recalculation is required.
Administration
TOUJEO
must only be used if the solution is clear and colorless with no particles visible. Patients must be advised that TOUJEO must
NOT be diluted or mixed with any other insulin or solution.
PATIENT INFORMATION
(Additions and/or
revisions underlined)
…
What is TOUJEO?
TOUJEO
is a long-acting man-made insulin used to control high blood sugar in adults and
children who are 6 years of age and older with diabetes mellitus.
TOUJEO
is not for use to treat diabetic ketoacidosis.
- It
is not known if TOUJEO is safe and effective in children under 6 years of age.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen
Additions and/or
revisions underlined:
Changes
in an insulin regimen (e.g., insulin strength, manufacturer, type, injection
site or method of administration) may affect glycemic control and
predispose to hypoglycemia or hyperglycemia. Repeated insulin injections
into areas of lipodystrophy or localized cutaneous amyloidosis have been
reported to result in hyperglycemia; and a sudden change in the injection site
(to unaffected area) has been reported to result in hypoglycemia.
Make
any
changes to a patient’s insulin regimen under close medical supervision with
increased frequency of blood glucose monitoring. Advise patients who have
repeatedly injected into areas of lipodystrophy or localized cutaneous
amyloidosis to change the injection site to unaffected areas and closely monitor
for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of
concomitant oral antidiabetic products may be needed.
Changing
to TOUJEO from other Insulins
On
a unit-to-unit basis, TOUJEO has a lower glucose lowering effect than LANTUS.
In clinical trials, patients who changed to TOUJEO from other basal insulins
experienced higher average fasting plasma glucose levels in the first weeks of
therapy compared to patients who were changed to LANTUS. Higher doses of
TOUJEO were required to achieve similar levels of glucose control
compared to LANTUS in clinical trials.
The onset of
action of TOUJEO
develops over 6 hours following an injection. In type 1 diabetes
patients treated with IV insulin, consider the longer onset of action
of TOUJEO before stopping
IV insulin. The full glucose
lowering effect may not be apparent for at least 5
days.
To
minimize the risk of hyperglycemia when initiating TOUJEO monitor glucose
daily, titrate TOUJEO as described in this prescribing information, and adjust coadministered
glucose- lowering therapies per standard of care.
6
Adverse Reactions
Newly added
subsection:
6.3 Postmarketing
Experience
The
following additional adverse reactions have been identified during postapproval
use of TOUJEO. Because these reactions are reported voluntarily from a
population of uncertain size, it is not always possible to reliably estimate
their frequency or establish a causal relationship to drug exposure.
Localized
cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has
been reported with repeated insulin injections into areas of localized
cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to
an unaffected injection site.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Medication Errors
Additions and/or
revisions underlined:
…
To avoid dosing errors and potential overdose, instruct patients to never use a
syringe to remove TOUJEO from the TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use
prefilled pen.
PATIENT INFORMATION
How
should I use TOUJEO?
In all instances,
‘disposable’ is replace with ‘single-patient-use’
Additions and/or
revisions underlined:
TOUJEO
is injected under the skin (subcutaneously) of your upper legs (thighs),
upper arms, or stomach area (abdomen).
Change (rotate) your injection sites within the
area you choose with each dose to reduce your risk
of getting lipodystrophy (pits in skin or thickened skin) and localized
cutaneous amyloidosis (skin with lumps) at the injection sites.
Do not use the exact same spot for each injection.
Do not inject where the skin has pits, is
thickened, or has lumps.
Do not inject where the skin is tender, bruised,
scaly or hard, or into scars or damaged skin.
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