Lantus SoloSTAR Quick Reference Manual - page 17
Table 11: LANTUS Timing of Daily Dosing in Type 1 (Study H) and Type 2 (Study I)
Diabetes Mellitus
Study H
Study I
Treatment duration
24 weeks
24 weeks
Treatment in
combination with:
Insulin lispro
Glimepiride
LANTUS
Breakfast
LANTUS
Dinner
LANTUS
Bedtime
LANTUS
Breakfast
LANTUS
Bedtime
NPH
Bedtime
Number of subjects
treated
*
112
124
128
234
226
227
HbA1c
Baseline mean
7.6
7.5
7.6
9.1
9.1
9.1
Mean change from
baseline
-0.2
-0.1
0.0
-1.3
-1.0
-0.8
Basal insulin dose
(U)
Baseline mean
22
23
21
19
20
19
Mean change from
baseline
5
2
2
11
18
18
Total insulin dose (U)
NA
†
NA
NA
Baseline mean
52
52
49
Mean change from
baseline
2
3
2
Body weight (kg)
Baseline mean
77.1
77.8
74.5
80.7
82
81
Mean change from
baseline
0.7
0.1
0.4
3.9
3.7
2.9
**total number of patients evaluable for safety
*Intent to treat
†Not applicable
16.
HOW SUPPLIED/STORAGE AND HANDLING
16.1 How supplied
LANTUS solution for injection 100 units per mL (U-100) is available as:
Dosage Unit/Strength
Package size
NDC #
0088
10 mL vials
100 Units/mL
Pack of 1
2220-33
3 mL cartridge system
*
100 Units/mL
package of 5
2220-52
3 mL SoloStar
®
disposable
insulin device
100 Units/mL
package of 5
2219-05
*Cartridge systems are for use only in OptiClik
®
(Insulin Delivery Device)
Needles are not included in the packs.
BD Ultra-Fine™ needles
1
to be used in conjunction with SoloStar and OptiClik are sold separately and
are manufactured by BD.
1
The brands listed are the registered trademarks of their respective owners and are not trademarks
of sanofi-aventis U.S. LLC
16.2 Storage
LANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS
if it has been frozen.
Unopened Vial/Cartridge system/SoloStar disposable insulin device:
Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator,
36°F – 46°F (2°C – 8°C). Discard after the expiration date.
Open (In-Use) Vial:
Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can
be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature
is not greater than 86°F (30°C).
Open (In-Use) Cartridge system:
The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room
temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system
in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without
cartridge system, in a refrigerator at any time.
Open (In-Use) SoloStar disposable insulin device:
The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature
(below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be
discarded 28 days after being opened.
These storage conditions are summarized in the following table:
Not in-use
(unopened)
Refrigerated
Not in-use
(unopened)
Room Temperature
In-use
(opened)
(See Temperature
Below)
10 mL Vial
Until expiration date
28 days
28 days
Refrigerated or room
temperature
3 mL Cartridge
system
Until expiration date
28 days
28 days
Refrigerated or room
temperature
3 mL Cartridge
system inserted into
OptiClik
®
28 days
Room temperature
only (Do not
refrigerate)
3 mL SoloStar
®
disposable insulin
device
Until expiration date
28 days
28 days
Room temperature
only
(Do not refrigerate)
16.3 Preparation and handling
Parenteral drug products should be inspected visually prior to administration whenever the solution and
the container permit. LANTUS must only be used if the solution is clear and colorless with no particles
visible.
Mixing and diluting: LANTUS must NOT be diluted or mixed with any other insulin or solution [See
Warnings and Precautions (5.2)].
Vial: The syringes must not contain any other medicinal product or residue.
Cartridge system/SoloStar: If OptiClik, the Insulin Delivery Device used with the LANTUS cartridge
system, or SoloStar disposable insulin device, malfunctions, LANTUS may be drawn from the cartridge
system or from SoloStar into a U-100 syringe and injected.
17.
PATIENT COUNSELING INFORMATION
17.1 Instructions for patients
Patients should be informed that changes to insulin regimens must be made cautiously and only under
medical supervision.
Patients should be informed about the potential side effects of insulin therapy, including lipodystrophy
(and the need to rotate injection sites within the same body region), weight gain, allergic reactions, and
hypoglycemia. Patients should be informed 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. Patients who have frequent hypoglycemia or
reduced or absent warning signs of hypoglycemia should be advised to use caution when driving or
operating machinery.
Accidental mix-ups between LANTUS and other insulins, particularly short-acting insulins, have been
reported. To avoid medication errors between LANTUS and other insulins, patients should be instructed
to always check the insulin label before each injection.
LANTUS must only be used if the solution is clear and colorless with no particles visible. Patients must
be advised that LANTUS must NOT be diluted or mixed with any other insulin or solution.
Patients should be advised not to share disposable or reusable insulin devices or needles with other
patients, because doing so carries a risk for transmission of blood-borne pathogens.
Patients should be instructed on self-management procedures including glucose monitoring, proper
injection technique, and management of hypoglycemia and hyperglycemia. Patients must be instructed
on handling of special situations such as intercurrent conditions (illness, stress, or emotional
disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin
dose, inadequate food intake, and skipped meals.
Patients with diabetes should be advised to inform their health care professional if they are pregnant
or are contemplating pregnancy.
Refer patients to the LANTUS
″Patient Information″ for additional information.
17.2 FDA approved patient labeling
See attached document at end of Full Prescribing Information.
Rev. April 2010
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
©2010 sanofi-aventis U.S. LLC
Patient Information
LANTUS
®
10 mL vial (1000 units per vial) 100 units per mL (U-100)
(insulin glargine [recombinant DNA origin] injection)
• What is the most important information I should know about LANTUS?
• What is LANTUS?
• Who should NOT take LANTUS?
• How should I use LANTUS?
• What kind of syringe should I use?
• Mixing with LANTUS
• Instructions for Use
Á How do I draw the insulin into the syringe?
Á How do I inject LANTUS?
• What can affect how much insulin I need?
• What are the possible side effects of LANTUS and other insulins?
• How should I store LANTUS?
• General Information about LANTUS
Read this
″Patient Information″ that comes with LANTUS (LAN-tus) before you start using it and each
time you get a refill because there may be new information. This leaflet does not take the place of
talking with your healthcare provider about your condition or treatment. If you have questions about
LANTUS or about diabetes, talk with your healthcare provider.
6
Lantus PI.April.2010