LANTUS XR Label Information

BPOM Approval 2017

 

Note : TOUJEO brand name = LANTUS XR

LANTUS XR ®  SoloSTAR ®  pen device

2
NOT FOR PROMOTIONAL USE
SAGLB.TJO.16.02.0087
 

Redesigned LANTUS XR SoloSTAR ®  pen device:

1,3
Accurate, precise and easy to use
• Design based on SoloSTAR ®  technology1
• 1:1 dose conversion1-3
• 450 U of insulin per cartridge1
• 80 U max dose per injection2
• 1 U/click dose dialing2
• Reduced injection force
vs. Lantus SoloSTAR ® 3
• Ergonomic design
improvements1

1. Adapted from Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P; 2. Toujeo SmPC. Available at http://www.ema.europa.eu/docs/e
http://www.ema.europa.eu/docs/en_GB/docum
n_GB/document_library/EPAR
ent_library/EPAR_-
_-
 _Product_Information/human/000309/WC5
 _Product_Information/human/0 00309/WC500047935.p
00047935.pdf
df (Accessed February 2016); 3. Klonoff D et al. J Diabetes
Diabetes Sci Technol. 2015;10:125-30
2015;10:125-30
3
NOT FOR PROMOTIONAL USE
SAGLB.TJO.16.02.0087
 

Gla-300 Solo
SoloSTAR
STAR in
insulin-naïve T2DM
Improved ease of use and ease of
o f learning
• Ease of use and ease of learning scores generally improved
improved (decreased)
(decreased) during the study
• At Week 4, 95.0% of participants assessed
assessed Gla-300 SoloSTAR
SoloSTAR as excellent or good overall,
overall,
compared with 89.7% at baseline
• No participants assessed
assessed Gla-300 SoloSTAR
SoloSTAR as poor or very poor overall
overall at any visit
• At Week 4, 97.5% of participants said that they would recommend Gla-300 SoloSTAR

Percentage
Percentage of excelle
excellent/good
nt/good response after 4 weeks of treatment

Ease of use Ease of selecting the dose

Ease of correcting a misdialed dose
Ease of reading the insulin dose
Ease of feeling/hearing dialing clicks
Force/effort needed to inject insulin
Smoothness/gentleness of injection
Ease of knowing if injection is complete
Ease of reading remaining insulin

Ease of learning
Ease of learning
General ease of use
Overall assessment
Would you recommend the Gla-300 pen injector?
//
500 10 60 20 70 80 80 90 90100 100
Percentage assessing Gla-300 SoloSTAR
SoloSTAR as ‘excellent/good’ assessment, or responding Yes to ‘Would you
recommend the Gla-300 pen injector?’ after 4 weeks

Adapted from Pohlmeier H et al. Poster presentation at ADA 2015; Abstract 1052-P

4
 

Accuracy and injection force of

Gla-300 Solo
SoloSTAR
STAR vs
other devices
Dose accuracy
• All tested pens met the International Organization for Standardization (ISO) requirements for
dosing accurac
accuracy
y

• Between-dose variation was similar for

for all tested pens, but Gla-300 SoloSTAR
SoloSTAR showed the
lowest between-dose variation (greatest reproducibility) at all dose levels

Half-maximal dose Maximal dose

(30/40 U) (60/80 U)

Klonoff D et al.
al. J Diabet
Diabetes
es Sci Technol. 2015 Aug
Aug 26. pii: 1932296815601441. [Epub ahead of print]

5
 

Accuracy and injection force of

Gla-300 Solo
SoloSTAR
STAR vs
other devices
Injection force
• Both the mean plateau injection force
force and the mean maximum injection forc
force
e was significantly
lower for Gla-300 SoloSTAR
SoloSTAR than for the other
other 2 pens at
half maximal and at maximal doses (P<0.0271)

Half-maximal dose (30/40 U) Maximal dose (60/80 U)

*P<0.0271 vs individual pens at both dose levels

le vels
Klonoff D et al.
al. J Diabet
Diabetes
es Sci Technol. 2015 Aug
Aug 26. pii: 1932296815601441. [Epub ahead of print]

6
 

LANTUS XR ®
Insulin glargine

Indication:
Treatment of diabetes mellitus in adults.

LANTUS XR Product Information approved by BPOM 2017

FOR TOUJEO
TOUJEO EXPERT’S BUREAU - ASIA discussion only SAAS.TJO.16.09.0027e
 

LANTUS XR posology and flexibility in dosing

LANTUS XR is a basal insulin for once-daily administration at any time

time
.
of the day
day,, preferably at the same
s ame time every
ever y day.
day.

• If needed patients can administer

LANTUS XR up to 3 hours before or
after their usual time of administration.
• Patients who forget a dose, should be
advised to check their blood sugar and
then resume their usual once-daily dosing
schedule.
 –  Patients should be informed not to
inject a double dose to make up for a
forgotten dose.

TOUJEO EXPERT’S BUREAU - ASIA discussion only

FOR TOUJEO SAAS.TJO.16.09.0027e
 

Initiating LANTUS XR

SAAS.TJO.16.09.0027e
 

Initi
Initiat
atin
ing
g LA
LANT
NTUS
US XR

• Patients with type 1 diabetes mellitus 

 –  LANTUS XR is to be used once-daily with meal-time insulin and
requires individual dose adjustments.

•  – 
Patients with type 2 diabetes mellitus 
The recommended daily starting dose is 0.2 units/kg followed by
individual dose adjustments.

TOUJEO EXPERT’S BUREAU - ASIA discussion only

FOR TOUJEO SAAS.TJO.16.09.0027e
 

Initi
Initiat
atin
ing
g LA
LANT
NTUS
US XR

• Patients with type 1 diabetes mellitus (T1DM)

 –  LANTUS XR must be combined with short-/rapid-acting insulin to cover
meal-time insulin requirements.
 –  LANTUS XR is to be used once-daily with meal-time insulin and requires
individual dose adjustments.
 –  Approximately one-third to one-half of the total daily insulin dose (the
rest of the total daily insulin dose should be given as a short-acting
insulin and divided between each daily meal).
 –  As a general rule, 0.2–0.4 units/kg can be used to calculate the initial
total daily insulin dose.

TOUJEO EXPERT’S BUREAU - ASIA discussion only

FOR TOUJEO SAAS.TJO.16.09.0027e
 

1. Switch between Lantus ®  and LANTUS XR

Lantus® and LANTUS XR are not bioequivalent and are

not directly interchangeable1
1,2
Unit-to-unit based XR
higher LANTUS but
 ®  a

dose
Switch from
LANTUS XR (by ~10-18%) may be
Lantus ®  needed to achieve target
ranges for plasma
1
glucose levels

Reduce the dose

Switch from (by ~20%) to reduce the
LANTUS
LANTUS XR risk of hypoglycem
hypoglycemia
ia1

FOR TOUJEO
TOUJEO EXPERT’S BUREAU - ASIA discussion only SAAS.TJO.16.09.0027e
 

2. Switch from other basal insulins to LANTUS XR

When switching from an intermediate or long-acting insulin to LANTUS XR, a
change of the dose of the basal insulin may be required and the
concomitant
concom itant anti-hyperglycemi
anti-hyperglycemicc treatment may need to be adjusted.

Switch from Unit-to-unit based on the

To once-daily
once-daily previous basal
LANTUS XR insulin dose
basal insulins

Recommended initial
Recommended i nitial
Switch from To LANTUS XR dose is 80%
twice-daily once-daily of the total daily dose of
basal insulins LANTUS XR basal insulin that is
being discontinued

FOR TOUJEO
TOUJEO EXPERT’S BUREAU - ASIA discussion only SAAS.TJO.16.09.0027e
 

3. Switch from LANTUS XR to other basal insulins

Please refer to the

Switch from prescribing information of
To other basal
once-daily the medicinal product to
insulins
LANTUS XR which the patient is
switching

FOR TOUJEO
TOUJEO EXPERT’S BUREAU - ASIA discussion only SAAS.TJO.16.09.0027e
 

Special patient populations

 – elderly
 – elderly
 – hepatic
 – hepatic impairment
 – renal
 – renal impairment

Note :
in elderly,
elderly, progressive deterioration of renal function may lead
to steady decrease insulin requirement 
In patient with renal impairment, insulin requirement
r equirement maybe
diminished due to reduced insulin metabolism 

TOUJEO EXPERT’S BUREAU - ASIA discussion only

FOR TOUJEO SAAS.TJO.16.09.0027e
 

Flexibility of dosing injection time with Gla-300

• Morning vs evening injection in T1DM
 –  In EDITION 4, there were no clinically relevant differences
differences in HbA1C improvement or hypoglycemia with
morning or evening Gla-300 injections (further confirmed by findings from the T1DM CGM trial). 2
1

• In EDITION 1 and 2 sub-studies in T2DM (Months 6–9) administration of Gla-300 with a flexible
hypoglycemia.3
dosing* time had no effect on glycemic control and incidence of hypoglycemia.

Pooled data of EDITION 1 and 2 sub-studies Pooled data of EDITION 1 and 2 sub-studies
(mITT population) (safety population)
60
Flexibl
Flexible
e dosi
dosing
ng Fixed
Fixed dos
dosin
ing
g   g
  n   t
   i
  c
  n   n
  e 50 Flexible dosing
n = 99 n = 95   e   v
   i
  r   e Fixed dosing
  e   c 40
HbA1C,%   p   i
  x   m
  e   e
  s   c 30
   t
Month 6, mean (SD) 7.30 (0.93) 7.30 (0.96)   y
  n   l
  a   g
   i   o
  p
  c   p
   i   y 20
Month 6–9, LS mean 0.05 (0.06) 0.00 (0.07)    t
  r   h
  a   1
chang
change
e (S
(SE)
E)   p
         ≥
   % 10
LS mean difference 0.05
0
(95% CI) (–0.13
(–0.13 to 0.2
0.23)
3) Any time of day (24 h) Nocturnal (00:00 to 05:59 h)
Confirmed (≤70 mg/dL [≤3.9 mmol/L])
or severe hypoglycemia
*Flexible dosing
dosing time: Once-daily injection intervals
intervals of 24 ± 3 h
CGM, continuous glucose monitoring; CI, confidence interval; HbA1C, glycated
glycated hemoglobin
hemoglobin A1C; LS, least squares; mITT, modified intention-to-treat;
intention-to-treat; SD, standard deviation; SE, standard error;
T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus

1. Home PD, et al. Diabetes Care 2015;

Care 2015; 38:2217–25;
38:2217–25; 2. Bergenstal
Bergenstal RM, et al. Diabetes
Diabetes Technol
Technol Ther 2015;17:A16–A17; 3. Adapted from Riddle M et al. Diabetes
Ther 2015;17:A16–A17; Diabetes Technol Ther 
2016; 18:252–7.

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Summary

• When switching from Gla-100 (Lantus®) to LANTUS XR , this can be done

on a unit-to-unit basis
• Switching from OD basal insulins to OD LANTUS XR can be done unit-to-
unit based on the previous basal insulin dose.
• Switching from BID basal insulins to OD LANTUS XR, the recommended
initial LANTUS XR dose is 80% of the total daily dose of basal
basa l insulin that
is being discontinued.
• If needed patients can administer LANTUS XR up to 3 hours before or
after their usual time of administration.
• Doses should be individualized based on the type of diabetes, metabolic
needs, blood
blood glucose monitoring
monitoring results
results and glycemic
glycemic control goal
goal of the
patient
• Dose adjustments should be considered for special populations

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