TRESIBA FlexTouch, Руководство пользователя

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TRESIBA ® (insulin degludec injection) 9
The time to first occurrence of MACE with TRESIBA ® as compared to insulin glargine U-100 was
non-inferior (HR: 0.91; 95% CI [0.78;1.06]; see Figure 3). The results of the primary composite
MACE endpoint and a summary of its individual components are shown in Table 15.
Table 15: Analysis of the Composite 3-point MACE and Individual Cardiovascular
Endpoints in DEVOTE
TRESIBA ® Insulin glargine U-100
N 3818 3819
Number of
Patients (%)
Rate per
100 PYO*
Number of
Patients (%)
Rate per
100 PYO*
Hazard Ratio
(95% CI)
Composite of first event
of CV death, non-fatal
MI, or non-fatal stroke
(3-Point MACE)
325 (8.5) 4.41 356 (9.3) 4.86
0.91
[0.78; 1.06]
CV death 136 (3.6) 1.85 142 (3.7) 1.94
Non-fatal MI 144 (3.8) 1.95 169 (4.4) 2.31
Non-fatal stroke 71(1.9) 0.96 79(2.1) 1.08
*PYO = patient-years of observation until first MACE, death, or trial discontinuation
Figure 3: Cumulative Event Probability for Time to First MACE in DEVOTE
Number of subjects at risk
Time to first event (Months)
Hazard Ratio (95% CI)
0.91[0.78; 1.06]
10
8
6
4
2
0
Sub
jec
ts
with
an
e
ven
t (%
)
0
IGlar
IDeg IDeg
IGlar IDeg IDeg
3819
3818 3818
3758
3765 3765
3703
3721 3721
3655
3669 3669
3595
3611 3611
3530
3563 3563
3472
3504 3504
2832
2851 2851
1742
1767 1767
811
811 811
205
217 217
3 6 9 12 15 18 21 24 27 30
Hypoglycemia Outcomes - Patients with T2DM and Atherosclerotic CVD
The pre-specified secondary endpoints of event and incidence rates of severe hypoglycemia
were sequentially tested.
Severe hypoglycemia was defined as an episode requiring assistance of another person to
actively administer carbohydrate, glucagon, or other resuscitative actions and during which
plasma glucose concentration may not have been available, but where neurological recovery
following the return of plasma glucose to normal was considered sufficient evidence that the
event was induced by a low plasma glucose concentration.
The incidence of severe hypoglycemia was lower in the TRESIBA
®
group as compared to the
insulin glargine U-100 group (Table 16). Glycemic control between the two groups was similar
at baseline and throughout the trial.
Table 16: Severe Hypoglycemic Episodes in Patients Treated with TRESIBA ® or
Insulin Glargine U-100 in DEVOTE
TRESIBA ® Insulin glargine U-100
N 3818 3819
Severe Hypoglycemia
Percent of patients with events 4.9% 6.6%
Estimated odds ratio [95%CI]
TRESIBA
®
/Insulin glargine U-100
0.73 [0.60; 0.89]*
Events per 100 Patient Years of
Observation
3.70 6.25
Estimated rate ratio [95%CI]
TRESIBA
®
/Insulin glargine U-100
0.60 [0.48; 0.76]*
* Test for superiority evaluated at 5% level for significance, (2-sided p<0.001)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
TRESIBA ® injection is available as a clear and colorless solution in the following package sizes
(see Table 17).
Table 17: Presentations of TRESIBA
®
TRESIBA
®
Presentation
Total
volume Concentration
Total units
available in
presentation
NDC
number
Max
dose per
injection
Dose
increment
Package
Size
U-100 single-
patient-use
FlexTouch ® Pen
3 mL 100 units/mL 300 Units 0169-2660-15 80 Units 1 Unit
5 pens/
pack
U-100 multiple-
dose Vial
10 mL 100 units/mL 1,000 Units 0169-2662-11
– –
1 vial/
pack
U-200 single-
patient-use
FlexTouch ® Pen
3 mL 200 units/mL 600 Units 0169-2550-13 160 Units 2 Unit
3 pens/
pack
TRESIBA ® U-100 FlexTouch ® dials in 1 unit increments.
TRESIBA
®
U-200 FlexTouch
®
dials in 2 unit increments.
16.2 Recommended Storage
Store TRESIBA ® vials in the original carton to protect from light. Unused TRESIBA ® should be
stored in a refrigerator (36ºF to 46ºF [2ºC to 8ºC]). Do not store in the freezer or directly adjacent
to the refrigerator cooling element. Do not freeze. Do not use TRESIBA
®
if it has been frozen.
The storage conditions are summarized in Table 18:
Table 18: Storage Conditions for TRESIBA
®
Not in-use (unopened) In-use (opened)
Refrigerated
(36°F to 46°F
[2°C to 8°C])
Room
Temperature
(below 86°F
[30°C])
Room
Temperature
(below 86°F
[30°C])
Refrigerated
(36°F to 46°F
[2°C to 8°C])
3 mL TRESIBA
®
U-100 FlexTouch ®
Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks)
10 mL TRESIBA
®
U-100 Vial
Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks)
3 mL TRESIBA
®
U-200 FlexTouch ®
Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks)
17 PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient
Information and Instructions for Use).
Never Share a TRESIBA
®
FlexTouch
®
Pen, Needle, or Syringe Between Patients
Advise patients that they should never share a TRESIBA
®
FlexTouch
®
pen device with another
person, even if the needle is changed. Advise patients using TRESIBA
®
vials not to share needles
or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens
[see Warnings and Precautions (5.1)] .
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 hyper- or hypoglycemia.
Advise patients that changes in insulin regimen should be made under close medical supervision
[see Warnings and Precautions (5.2)] .
Medication Errors
Inform patients to always check the insulin label before each injection [see Warnings and
Precautions (5.4)] . Inform patients that the dose counter of TRESIBA
®
FlexTouch
®
pen shows
the number of units of TRESIBA ® to be injected. NO dose re-calculation is required [see Dosage
and Administration (2.2)] . Instruct patients to never use a syringe to remove TRESIBA
®
from the
FlexTouch
®
disposable insulin prefilled pen.
Rx Only
Date of Issue: 11/2018
Version: 7
Novo Nordisk ® , TRESIBA ® , FlexTouch ® , LEVEMIR ® , NOVOLOG ® , NovoFine ® and NovoTwist ® are
registered trademarks of Novo Nordisk A/S.
PATENT Information: http://novonordisk-us.com/patients/products/product-patents.html
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark
For information about TRESIBA
® contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-800-727-6500
www.novonordisk-us.com
© 2015-2018 Novo Nordisk
US18TSM00504 December 2018