Glyxambi Advantage vs other FDC

Document ID: PC-PH-101925

25/02/2021

Author: Boehringer Ingelheim

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PC-PH-101925
Production date: February 2021

IMPORTANT SAFETY INFORMATION

What important information I should know about Empagliflozin + Linagliptin (Glyxambi®)?

Special warnings and precautions that should be taken into consideration when prescribing Empagliflozin + Linagliptin (Glyxambi®) include:

  • Pancreatitis

  • Risk of volume depletion

  • Genital mycotic infections

  • Diabetic Ketoacidosis

  • Complicated urinary tract infections

  • Hypoglycemia

  • Necrotizing fasciitis

  • Allergic (hypersensitivity) reactions

  • Hypercholesterolemia

  • Arthritis

  • Bullous pemphigoid

What are the contraindications to Empagliflozin + Linagliptin (Glyxambi®)?

Empagliflozin + Linagliptin (Glyxambi®) should not be used in patients with type 1 diabetes, patients with severe renal impairment and end stage renal disease, those who have hypersensitivity to Empagliflozin or Linagliptin or any of the excipients.

What should I ask my patients before prescribing Empagliflozin + Linagliptin (Glyxambi®)?

Ask your patients if they are currently taking other medications like the following:

  • Insulin and sulphonylureas. These may increase the risk of hypoglycaemia. Therefore, a lower dose of insulin or sulphonylureas may be required to reduce the risk of hypoglycaemia when used in combination with Empagliflozin + Linagliptin (Glyxambi®).

  • Diuretics. Empagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension.

  • UGT inhibitors and inducers. Co-medication with known inducers of UGT enzymes should be avoided because of a risk of decreased efficacy of empagliflozin.

  • Rifampin. Co-administration of rifampicin decreased linagliptin exposure by 40%, suggesting that the efficacy of linagliptin may be reduced when administered in combination with a strong P-glycoprotein (P-gp) or cytochrome P450 (CYP) isozyme CYP3A4 inducer, particularly if these are administed long-term.

Ask your patients if they are pregnant or planning to be pregnant or are breastfeeding or planning to breastfeed. There are limited data on the use of Empagliflozin + Linagliptin (Glyxambi®) in pregnant women. It is also not known whether the drug is excreted in human milk. As a precautionary measure, it is preferable to avoid the use of Empagliflozin + Linagliptin (Glyxambi®) during pregnancy and breastfeeding.