Product Storage & Stability Information

1. What should I do if the product is left out at room temperature?

Expiration dates for refrigerated (before first use) product and in-use times for room temperature (after first use) product are based on proprietary data generated by Novo Nordisk and approved by regulatory authorities, such as the Food and Drug Administration (FDA), to ensure that potency of properly handled product is maintained while the product is in use. The FDA allows manufacturers to issue timelines that ensure the longest in-use time without sacrificing potency.

Please refer to the individual Novo Nordisk products regarding recommended storage times and temperatures.







2. What should I do if the product is exposed to frozen temperatures?

To prevent loss of potency, clumping, frosting, or precipitation, Novo Nordisk products should not be frozen (below 36ºF or 2ºC). Do not use products exposed to frozen temperatures.

3. What should I do if the product is exposed to high temperatures?

Storage at high temperatures above 86°F or above 30°C should be avoided for all Novo Nordisk products. Do not use if products are exposed to temperatures above 86°F (30°C). The product should be inspected for changes such as clumping, precipitation, or change in color or clarity that may indicate a loss in potency.

GLP-1 RAs

Ozempic®1

Ozempic® can be used as long as the product has not been exposed to temperatures below 36°F or above 86°F. If Ozempic® was exposed to non-refrigerated temperatures (any temperature above 46ºF), the product must be used or discarded within 56 days. Ozempic® should be inspected for changes such as precipitation, or change in color or clarity that may indicate a loss in potency.

Recommended Storage Conditions for the Ozempic® Pen1

BEFORE FIRST USE

Refrigerated (36°F-46°F)

Until expiration date


AFTER FIRST USE

Room Temperature (59ºF-86ºF)

56 days

Refrigerated (36°F-46°F)

56 days

Recommendations for Ozempic® Pen

Victoza®2

Victoza® can be used as long as the product has not been exposed to temperatures below 36°F or above 86°F. If unopened Victoza® was exposed to non-refrigerated temperatures (any temperature above 46ºF), the product must be used or discarded within 30 days. Victoza® should be inspected for changes such as precipitation, or change in color or clarity that may indicate a loss in potency.

Recommended Storage Conditions for the Victoza® Pen2

BEFORE FIRST USE

Refrigerated (36°F-46°F)

Until expiration date


AFTER FIRST USE

Room Temperature (59ºF-86ºF)

30 days

Refrigerated (36°F-46°F)

30 days

Recommendations for Victoza® Pen

Saxenda®3

Saxenda® can be used as long as the product has not been exposed to temperatures below 36°F or above 86°F. If Saxenda® was exposed to non-refrigerated temperatures (any temperature above 46ºF), the product must be used or discarded within 30 days. Saxenda® should be inspected for changes such as precipitation, or change in color or clarity that may indicate a loss in potency.

Recommended Storage Conditions for the Saxenda® Pen3

BEFORE FIRST USE

Refrigerated (36°F-46°F)

Until expiration date


AFTER FIRST USE

Room Temperature (59ºF-86ºF)

30 days

Refrigerated (36°F-46°F)

30 days

Recommendations for Saxenda® Pen

GlucaGen® and Insulins

GlucaGen®4

Before Reconstitution:
The GlucaGen® package may be stored up to 24 months at controlled room temperature (68ºF-77°F/20°C-25°C) prior to reconstitution. Avoid freezing GlucaGen® and protect it from light by keeping it in the original package. GlucaGen® should not be used after the expiration date on the vials.

After Reconstitution:
Reconstituted GlucaGen® should be used immediately. Discard any unused portion. If the solution shows any sign of gel formation or particles, it should be discarded.

After the product is manufactured, Novo Nordisk Inc. stores and transports GlucaGen® HypoKit® under refrigerated conditions (36°-46°F/2°-8°C) since maintaining controlled room temperature conditions may be difficult during shipping. Refrigerating the product will not damage it; however, freezing of the product should be avoided.

Insulins5-9

Unused (unopened) insulin vials, devices, or cartridges inadvertently left at room temperature can be returned to refrigeration but must be used within designated days of initially being stored at room temperature (see Tables 1 and 2). Products not used within the listed time periods should be discarded.

Table 1. Recommended Storage Conditions for Insulin Analogs5-9

NovoLog® vial

BEFORE FIRST USE

Room Temperature (below 86ºF)a,b

28 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 86ºF)a

28 days

Refrigerated (36ºF-46ºF)

28 days


NovoLog® FlexPen®

BEFORE FIRST USE

Room Temperature (below 86ºF)a,b

28 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 86ºF)a

28 days

Refrigerated (36ºF-46ºF)

N/Ac


NovoLog® FlexTouch®d

BEFORE FIRST USE

Room Temperature (below 86ºF)a,b

28 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 86ºF)a

28 days

Refrigerated (36ºF-46ºF)

N/Ac


NovoLog® PenFill®

BEFORE FIRST USE

Room Temperature (below 86ºF)a,b

28 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 86ºF)a

28 days

Refrigerated (36ºF-46ºF)

N/Ac


NovoLog® Mix 70/30 vial

BEFORE FIRST USE

Room Temperature (below 86ºF)a,b

28 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 86ºF)a

28 days

Refrigerated (36ºF-46ºF)

28 days


NovoLog® Mix 70/30 FlexPen®

BEFORE FIRST USE

Room Temperature (below 86ºF)a,b

14 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 86ºF)a

14 days

Refrigerated (36ºF-46ºF)

N/Ac


Fiasp® vial

BEFORE FIRST USE

Room Temperature (below 86ºF)a,b

28 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 86ºF)a

28 days

Refrigerated (36ºF-46ºF)

28 days


Fiasp® FlexTouch®

BEFORE FIRST USE

Room Temperature (below 86ºF)a,b

28 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 86ºF)a

28 days

Refrigerated (36ºF-46ºF)

28 days


Levemir® vial

BEFORE FIRST USE

Room Temperature (below 86ºF)a,b

42 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 86ºF)a

42 days

Refrigerated (36ºF-46ºF)

42 days


Levemir® FlexTouch®

BEFORE FIRST USE

Room Temperature (below 86ºF)a,b

42 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 86ºF)a

42 days

Refrigerated (36ºF-46ºF)

N/Ac


Tresiba® U-100 and U-200 FlexTouch®

BEFORE FIRST USE

Room Temperature (below 86ºF)a,b

56 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 86ºF)a

56 days

Refrigerated (36ºF-46ºF)

56 days

Recommendations for Insulin Analogs

aUnrefrigerated products should be discarded if not used within the time periods listed, whether or not they have been punctured or are in-use.
bUnused (unopened) FlexTouch®, FlexPen® and NovoLog® PenFill® inadvertently left at room temperature can be returned to refrigeration but must be used within designated days of initially being stored at room temperature.
cOnce in use, should be stored at room temperatures below 86ºF.
dNovoLog® FlexTouch® is not currently available in the United States.

Table 2. Recommended Storage Conditions for Human Insulin11-12

Novolin® R vial

(including ReliOn® brand)f  

BEFORE FIRST USE

Room Temperature (below 77ºF)a,e

42 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 77ºF)a

42 days

Refrigerated (36ºF-46ºF)

N/Ag


Novolin® N vial

(including ReliOn® brand)f  

BEFORE FIRST USE

Room Temperature (below 77ºF)a,e

42 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 77ºF)a

42 days

Refrigerated (36ºF-46ºF)

N/Ag


Novolin® 70/30 vial

(including ReliOn® brand)f  

BEFORE FIRST USE

Room Temperature (below 77ºF)a,e

42 days

Refrigerated (36ºF-46ºF)

Until expiration date

AFTER FIRST USE

Room Temperature (below 77ºF)a

42 days

Refrigerated (36ºF-46ºF)

N/Ag

Recommendations for Human Insulin

eUnused (unopened) product inadvertently left at room temperature can be returned to refrigeration but must be used within designated days of initially being stored at room temperature.
fReliOn® brand - manufactured by Novo Nordisk and sold exclusively at WalMart and Sam's Club Pharmacies
gOnce in use, Novolin® vials and Novolin®/ReliOn® vials should not be refrigerated.

Combination Product

Xultophy® 100/3.613

There are no studies that show the safety and efficacy of Xultophy® 100/3.6 used after expiration or when stored outside of the recommended conditions. As such, Novo Nordisk cannot guarantee the potency of Xultophy® 100/3.6 when stored outside of the recommended storage conditions.

Recommended Storage Conditions for Xultophy® 100/3.613

BEFORE FIRST USE

Refrigerated (36°F-46°F)

Until expiration date


AFTER FIRST USE

Room Temperature (59ºF-86ºF)h

21 days

Refrigerated (36°F-46°F)

21 days

Recommendations for Xultophy® 100/3.6

hUnrefrigerated products should be discarded if not used within the time periods listed, whether or not they have been punctured or are in use.

Growth Hormone Disorders

Norditropin®14

After initial use, all Norditropin® FlexPro® prefilled pens can EITHER be stored at room temperature up to 77ºF/25ºC for use within 3 weeks, OR in the refrigerator (36ºF-46ºF/2ºC-8ºC) for use within 4 weeks. It is preferable to choose one storage option and any unused portion must be discarded.

Recommended Storage Conditions for Norditropin® FlexPro®14

BEFORE FIRST USE

Refrigerated (36°F-46°F)

Until expiration date


AFTER FIRST USE

Room Temperature (up to 77ºF)

3 weeks

Refrigerated (36°F-46°F)

4 weeks

Recommendations for Norditropin®

Hemophilia and Rare Bleeding Disorders

NovoSeven® RT15

Novo Nordisk does not recommend use of NovoSeven® RT when stored outside of refrigerated or controlled room temperature conditions (36ºF-77°F/2ºC-25°C) prior to reconstitution.

Prior to reconstitution, store NovoSeven® RT and histidine diluent between 36ºF-77°F (2ºC-25°C). Unreconstituted NovoSeven® RT stored between 36ºF-77°F (2ºC-25°C) will retain biologic activity until the expiration date specified on the package label. NovoSeven® RT should not be used after the expiration date. Exposure to direct sunlight should be avoided. Do not freeze NovoSeven® RT or histidine diluent.

Reconstituted NovoSeven® RT may be stored either at room temperature (up to 77°F) or refrigerated for up to 3 hours. Administration should take place immediately or within 3 hours after dissolution and any unused solution should be discarded. As indicated in the prescribing information, Novo Nordisk recommends that reconstituted NovoSeven® RT be discarded after 3 hours.

Novoeight®16

Prior to reconstitution, Novoeight® and diluent (0.9% sodium chloride solution) can be stored between 36ºF-46°F (2ºC-8°C) for up to 30 months from the date of manufacture until the expiration date stated on the label. Within the 30-month period, Novoeight® may also be stored at room temperature not to exceed 86°F (30°C) for up to 12 months or up to 104°F (40°C) for no longer than 3 months.

If Novoeight® is stored at room temperature, record the date the product was removed from the refrigerator in the space provided on the outer carton. At the end of the 12-month period, immediately use the product or discard it. Do not return Novoeight® to the refrigerator.

Novoeight® should not be used after the expiration date stated on the vial or after the end of the 12-month period at room temperature storage. The product should be stored protected from light and should not be frozen.

After Reconstitution
Reconstituted Novoeight® may be stored at room temperature for up to 4 hours (up to 86°F/30°C), or for up to 2 hours (86°F-104°F/30°C-40°C). Store the reconstituted product in the vial. If administration does not take place immediately or within the specified 4 or 2-hour time-frame post-reconstitution, any unused reconstituted solution should not be used and should be discarded.

Tretten®17

Novo Nordisk does not recommend use of Tretten® when stored outside of refrigerated conditions (36ºF-46°F/2ºC-8°C) prior to reconstitution.

Prior to reconstitution, Tretten® and diluent (Sterile Water for Injection) should be stored between 36ºF-46°F (2ºC-8°C). Unreconstituted Tretten® stored between 36ºF-46°F (2ºC-8°C) will retain biologic activity until the expiration date specified on the package label. Tretten® should not be used after the expiration date. The product should be stored protected from light and should not be frozen.

Reconstituted Tretten® may be stored either at room temperature (up to 77°F/25°C) or refrigerated for up to 3 hours. Administration should take place immediately or within 3 hours after dissolution and any unused solution should be discarded. Reconstituted Tretten® should not be frozen or stored in syringes.

Rebinyn®18

Prior to reconstitution, Rebinyn® and diluent (10mM histidine solution) can be stored between 36ºF-46°F (2ºC-8°C) for up to 24 months from the date of manufacture until the expiration date stated on the label. Within the 24-month period, Rebinyn® may also be stored at room temperature not to exceed 86°F (30°C) for up to 6 months

If Rebinyn® is stored at room temperature, record the date the product was removed from the refrigerator in the space provided on the outer carton. At the end of the 6-month period, immediately use the product or discard it. Do not return Rebinyn® to the refrigerator.

Rebinyn® should not be used after the expiration date stated on the vial or after the end of the 6-month period at room temperature storage. The product should be stored protected from light and should not be frozen.

Reconstituted Rebinyn® may be stored at room temperature (up to 86°F/30°C) for up to 4 hours. Store the reconstituted product in the vial. Administration should take place immediately or within 4 hours after reconstitution and any unused solution should be discarded.

References:

  1. Ozempic® Prescribing Information. Plainsboro, NJ: Novo Nordisk.
  2. Victoza® Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
  3. Saxenda® Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
  4. GlucaGen® HypoKit® Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
  5. NovoLog® Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
  6. NovoLog® Mix 70/30 Prescribing Information. Plainsboro, NJ. Novo Nordisk Inc.
  7. Fiasp® Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
  8. Levemir® Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
  9. Tresiba® Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
  10. Novolin® R Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
  11. Novolin® N Patient Package Insert. Plainsboro, NJ: Novo Nordisk Inc.
  12. Novolin® 70/30 Patient Package Insert. Plainsboro, NJ: Novo Nordisk Inc.
  13. Xultophy® 100/3.6 Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
  14. Norditropin® Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
  15. NovoSeven® RT Prescribing Information. Plainsboro, NJ; Novo Nordisk Inc.
  16. Novoeight® Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.
  17. Tretten® Prescribing Information. Plainsboro, NJ; Novo Nordisk Inc.
  18. Rebinyn® Prescribing Information. Plainsboro, NJ; Novo Nordisk Inc