Drug Shortage Detail: Insulin Glargine Injection (Recombinant)

syringes with needles

Products Affected – Description

  • Basaglar Tempo Pen subcutaneous injection, Lilly USA, LLC, 100 units/mL, 3 mL pen injector, 5 count, NDC 00002-8214-05
  • Lantus Solostar Pen subcutaneous injection, Sanofi-Aventis, 100 units/mL, 3 mL pen injector, 5 count, NDC 00088-2219-05
  • Semglee subcutaneous injection, Biocon, 100 units/mL, 10 mL vial, NDC 83257-0011-11 – discontinued
  • Semglee Pen subcutaneous injection, Biocon, 100 units/mL, 3 mL pen injector, 5 count, NDC 83257-0012-33 – discontinued

Reason for the Shortage

  • Biocon discontinued Semglee vials and pens on December 31, 2025. The generic vials and pens are available.
  • Lilly has Basaglar and Rezvoglar Kwikpens available. Lilly is discontinuing Basaglar Tempo pens by the end of 2026 due to a business decision.
  • Tempo pens are available through July 27, 2026. After that date, patients can use their Tempo Pens until the expiration date. However, the Tempo Platform will stop recording patient diabetes-related data on July 28, 2026. On December 31, 2026, the TempoSmart App and Tempo Insights portal will be discontinued. Additional information can be found at lillytempo.com.
  • Sanofi has Lantus Solostar pens on shortage due to increased demand. Lantus vials, U-300 Solostar pens, and Toujeo pens remain available.
  • Winthrop has insulin glargine injection available.

Available Products

  • Basaglar Kwikpen subcutaneous injection, Lilly USA, LLC, 100 units/mL, 3 mL pen injector, 5 count, NDC 00002-7715-59
  • Insulin Glargine U-300 Max Solostar subcutaneous injection, Winthrop, 300 units/mL, 3 mL pen injector, 2 count, NDC 00955-2900-02
  • Insulin Glargine U-300 Solostar subcutaneous injection, Winthrop, 300 units/mL, 1.5 mL pen injector, 3 count, NDC 00955-3900-03
  • Lantus subcutaneous injection, Sanofi-Aventis, 100 units/mL, 10 mL vial, NDC 00088-2220-33
  • Rezvoglar Kwikpen subcutaneous injection, Lilly USA, LLC, 100 units/mL, 3 mL pen injector, 5 count, NDC 00002-8980-05
  • Toujeo 1.5 mL Prefilled Pen subcutaneous injection, Sanofi-Aventis, 300 units/mL, 1.5 mL pen injector, 3 count, NDC 00024-5869-03
  • Toujeo Max 3 mL Prefilled Pen subcutaneous injection, Sanofi-Aventis, 300 units/mL, 3 mL pen injector, 2 count, NDC 00024-5871-02
  • Insulin glargine-yfgn, recombinant subcutaneous injection, Biocon, 100 units/mL, 10 mL vial, NDC 83257-0014-11
  • Insulin glargine-yfgn, recombinant subcutaneous injection, Biocon, 100 units/mL, 3 mL pen injector, 5 count, NDC 83257-0015-32

Estimated Resupply Dates

  • Lilly is discontinuing Basaglar Tempo pens by the end of 2026. Tempo pens are available through July 27, 2026.
  • Sanofi has Lantus Solostar 3 mL pens on intermittent back order and the company is releasing supplies as they become available.

Implications for Patient Care

  • Sanofi advises patients on Lantus Solostar pens to consult with their healthcare provider to ensure continued access to insulin glargine during this temporary period of limited supply of Lantus Solostar pens.
  • Patients on Basaglar Tempo pens should work with their healthcare provider to transition to Lilly insulin KwikPens or other insulin pens as soon as possible.
  • This drug is used to improve glycemic control in adult and pediatric patients with diabetes mellitus.[1-2]
  • Off-label indications include the treatment of hyperglycemia in gestational diabetes mellitus and in persistent hyperglycemia in hospitalized patients with or without a history of diabetes.[2]

Safety

Though doses can often be converted unit for unit when converting individuals from one basal insulin to another, an initial dose reduction of 10-20% can be used in individuals at a high risk for hypoglycemia or in very tight management. A dose reduction is typically needed when switching from U-300 glargine to another insulin. Extra caution should be taken when switching between insulin concentrations or when transitioning from pen devices to vials, as these changes may increase the risk of dosing confusion and may result in significant under- or overdosing.[3-4]

Alternative Agents & Management

  • Other long-acting insulin options include insulin degludec or insulin NPH. 1. When converting between long-acting insulins, consider a 10-20% dose reduction in individuals in very tight management or at risk for hypoglycemia.[3] 2. Long-acting insulin analogs may be interchanged with NPH with a 20% reduction in dose and divided based on predicted meal frequency.[5]
  • There is now a once-weekly basal insulin formulation, Awiqli, which may offer an alternative basal insulin option for select individuals with type 2 diabetes mellitus.[6] 1. If converting from daily basal insulin to once-weekly basal insulin, administer the first dose on the day after the last day of basal insulin. 2. Week 1 dosage: initiate Awiqli at 10.5 times the daily basal insulin dose, rounded to the nearest 10 units 3. Week 2 and beyond: The recommended dosage is the previous total daily basal insulin dose multiplied by 7, then rounded to the nearest 10 units. The recommended dosage can be titrated from the previous dosage based on the patients blood glucose monitoring results and glycemic control needs.

References

  1. Lantus SoloStar (insulin glargine) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; 2023.
  2. Lexicomp Online. Insulin glargine: Drug information. Lexi-Drugs. Hudson, OH: UpToDate, Inc. https://online.lexi.com
  3. American Diabetes Association Professional Practice Committee. 9. Pharmacologic approaches to glycemic treatment: Standards of Care in Diabetes—2026. Diabetes Care. 2026;49(Suppl 1):S183-S215. doi:10.2337/dc26-S009
  4. Institute for Safe Medication Practices. ISMP Guidelines for Optimizing Safe Subcutaneous Insulin Use in Adults. Horsham, PA: Institute for Safe Medication Practices; May 2017.
  5. American Diabetes Association. Switching between insulin products in humanitarian response situations. Updated March 18, 2022. https://diabetes.org/sites/default/files/2023-10/Switching-Between-Insulin-Products-in-Humanitarian-Response-2022-Easter-Europe-3-18-2022-DDRC-English-v3.pdf
  6. Awiqli (insulin icodec-abae) injection [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761326Orig2s000lbl.pdf

Source: Drug Shortage Detail: Insulin Glargine Injection (Recombinant)

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