Table 1.
Storage Recommendations for Different Insulin Products in the United States and European Union With the Shelf Life In-Use and the Maximum Temperature In-Use.
Type | Active substance | Manufacturer | Brand name | Region | Year first approval | Packaging | Shelf life in-use | Max. temperature in-use |
---|---|---|---|---|---|---|---|---|
Intermediate acting (NPH) | Isophane insulin | Eli Lilly | Humulin N | United States | 1982 | Prefilled pen | 14 days | 30°C |
Vial | 31 days | 30°C | ||||||
Novo Nordisk | Novolin N | United States | 1991 | Prefilled pen | 28 days | 30°C | ||
Vial | 42 days | 25°C | ||||||
Sanofi | Insuman Basal | EU | 1997 | Pen cartridge | 4 weeks | 25°C | ||
Prefilled pen | 4 weeks | 25°C | ||||||
Vial | 4 weeks | 25°C | ||||||
Long acting | Insulin degludec | Novo Nordisk | Tresiba | EU | 2013 | Pen cartridge | 8 weeks | 30°C |
Prefilled pen | 8 weeks | 30°C | ||||||
United States | 2015 | Prefilled pen | 8 weeks | 30°C | ||||
Vial | 8 weeks | 30°C | ||||||
Insulin detemir | Novo Nordisk | Levemir | EU | 2004 | Pen cartridge | 6 weeks | 30°C | |
Prefilled pen | 6 weeks | 30°C | ||||||
United States | 2005 | Prefilled pen | 42 days | 30°C | ||||
Vial | 42 days | 30°C | ||||||
Insulin glargine | Eli Lilly | Abasaglar | EU | 2015 | Pen cartridge | 28 days | 30°C | |
Prefilled pen | 28 days | 30°C | ||||||
Basaglar | United States | 2015 | Prefilled pen | 28 days | 30°C | |||
Mylan | Semglee | EU | 2018 | Prefilled pen | 4 weeks | 30°C | ||
Sanofi | Lantus | EU | 2000 | Prefilled pen | 28 days | 30°C | ||
Vial 10 mL | 28 days | 30°C | ||||||
United States | 2000 | Prefilled pen | 28 days | 30°C | ||||
Vial 10 mL | 28 days | 30°C | ||||||
Toujeo | EU | 2015 | Prefilled pen | 6 weeks | 30°C | |||
United States | 2015 | Prefilled pen | 56 days | 30°C | ||||
Long acting + glp-1 agonist | Insulin degludec + liraglutide | Novo Nordisk | Xultophy | EU | 2014 | Prefilled pen | 21 days | 30°C |
United States | 2016 | Prefilled pen | 21 days | 30°C | ||||
Insulin glargine + lixisenatide | Sanofi | Soliqua | United States | 2016 | Prefilled pen | 28 days | 25°C | |
Suliqua | EU | 2017 | Prefilled pen | 28 days | 25°C | |||
Premixed | Human insulin + human insulin isophane | Eli Lilly | Humulin 70/30 | United States | 1989 | Prefilled pen | 10 days | 30°C |
Vial | 31 days | 30°C | ||||||
Novo Nordisk | Actraphane | EU | 2002 | Pen cartridge | 6 weeks | 30°C | ||
Prefilled pen | 6 weeks | 30°C | ||||||
Vial | 6 weeks | 25°C | ||||||
Insulatard | EU | 2002 | Pen cartridge | 6 weeks | 30°C | |||
Prefilled pen | 6 weeks | 30°C | ||||||
Vial | 4 weeks | 25°C | ||||||
Mixtard | EU | 2002 | Pen cartridge | 6 weeks | 30°C | |||
Prefilled pen | 6 weeks | 30°C | ||||||
Vial | 6 weeks | 25°C | ||||||
Novolin 70/30 | United States | 1991 | Prefilled pen | 28 days | 30°C | |||
Vial | 42 days | 25°C | ||||||
Protaphane | EU | 2002 | Pen cartridge | 6 weeks | 30°C | |||
Prefilled pen | 6 weeks | 30°C | ||||||
Vial | 4 weeks | 25°C | ||||||
Sanofi | Insuman Comb | EU | 1997 | Pen cartridge | 4 weeks | 25°C | ||
Prefilled pen | 4 weeks | 25°C | ||||||
Vial | 4 weeks | 25°C | ||||||
Insulin aspart + protamine-crystallized insulin aspart | Novo Nordisk | NovoLog Mix 70/30 | United States | 2001 | Prefilled pen | 14 days | 30°C | |
Vial | 28 days | 30°C | ||||||
NovoMix | EU | 2000 | Pen cartridge | 4 weeks | 30°C | |||
Prefilled pen | 4 weeks | 30°C | ||||||
Insulin degludec/insulin aspart | Novo Nordisk | Ryzodeg | EU | 2013 | Pen cartridge | 4 weeks | 30°C | |
Prefilled pen | 4 weeks | 30°C | ||||||
Ryzodeg 70/30 | United States | 2015 | Prefilled pen | 28 days | 30°C | |||
Insulin lispro + insulin lispro protamine | Eli Lilly | Humalog Mix | United States | 1999 | Prefilled pen | 10 days | 30°C | |
Vial | 28 days | 30°C | ||||||
Rapid acting | Human insulin | MannKind | Afrezza | United States | 2014 | Inhaler cartridge | 10 days | 30°C |
Insulin aspart | Novo Nordisk | Fiasp | EU | 2017 | Pen cartridge | 4 weeks | 30°C | |
Prefilled pen | 4 weeks | 30°C | ||||||
Vial | 4 weeks | 30°C | ||||||
United States | 2017 | Prefilled pen | 28 days | 30°C | ||||
Vial | 28 days | 30°C | ||||||
NovoLog | United States | 2000 | Pen cartridge | 28 days | 30°C | |||
Prefilled pen | 28 days | 30°C | ||||||
Vial | 28 days | 30°C | ||||||
NovoRapid | EU | 1999 | Pen cartridge | 4 weeks | 30°C | |||
Prefilled pen | 4 weeks | 30°C | ||||||
Pump cartridge | in use: 7 days | 30°C | ||||||
Vial | 4 weeks | 30°C | ||||||
Insulin glulisine | Sanofi | Apidra | EU | 2004 | Pen cartridge | 4 weeks | 25°C | |
Prefilled pen | 4 weeks | 25°C | ||||||
Vial | 4 weeks | 25°C | ||||||
United States | 2004 | Prefilled pen | 28 days | 25°C | ||||
Vial | 28 days | 25°C | ||||||
Vial (use in pump) | 2 days | 37°C | ||||||
Insulin lispro | Eli Lilly | Humalog | EU | 1996 | Pen cartridge | 28 days | 30°C | |
Prefilled pen | 28 days | 30°C | ||||||
Vial | 28 days | 30°C | ||||||
United States | 1996 | Pen cartridge | 28 days | 30°C | ||||
Prefilled pen | 28 days | 30°C | ||||||
Vial | 28 days | 30°C | ||||||
Liprolog | EU | 2001 | Pen cartridge | 28 days | 30°C | |||
Prefilled pen | 28 days | 30°C | ||||||
Vial | 28 days | 30°C | ||||||
Sanofi | Admelog | United States | 2017 | Prefilled pen | 28 days | 30°C | ||
Vial | 28 days | 30°C | ||||||
Insulin lispro Sanofi | EU | 2017 | Pen cartridge | 4 weeks | 30°C | |||
Prefilled pen | 4 weeks | 30°C | ||||||
Vial | 4 weeks | 30°C | ||||||
Short acting/regular | Human insulin | Eli Lilly | Humulin R | United States | 1982 | Vial | 31 days | 30°C |
Humulin R U-500 | United States | 1994 | Prefilled pen | 28 days | 30°C | |||
Vial | 40 days | 30°C | ||||||
Novo Nordisk | Actrapid | EU | 2002 | Pen cartridge | 6 weeks | 30°C | ||
Prefilled pen | 6 weeks | 30°C | ||||||
Vial (40 U/mL) | 4 weeks | 25°C | ||||||
Vial (100 U/mL) | 6 weeks | 25°C | ||||||
Novolin R | United States | 1991 | Prefilled pen | 28 days | 30°C | |||
Vial | 42 days | 25°C | ||||||
Sanofi | Insuman Implantable | EU | 1997 | Vial | 45 days | 37°C | ||
Insuman Infusat | EU | 1997 | Pump cartridge | 2 weeks | na | |||
Vial | 2 weeks | 25°C | ||||||
Insuman Rapid | EU | 1997 | Prefilled pen | 4 weeks | 25°C | |||
Vial | 4 weeks | 25°C |
Abbreviation: NPH, neutral protein Hagedorn.
Source: Information taken from the Summary of Product Characteristics (SmPC) from FDA and European Assessment Reports (EPAR) from EMA.19