Glyxambi® Abridged Prescribing Information
For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.
GLYXAMBI®: Abridged Prescribing Information GLYXAMBI® FDC of empagliflozin and linagliptin film-coated Tablets – 10 mg/5 mg, 25 mg/5 mg.
Composition: 1 film-coated tablet contains linagliptin 5 mg and Empagliflozin 10 mg or 25 mg.
Indications: GLYXAMBI® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. GLYXAMBI® is not recommended in patients with type 1 diabetes. It may increase the risk of diabetic ketoacidosis in these patients. GLYXAMBI® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using GLYXAMBI®.
Dosage and administration: The recommended dose of GLYXAMBI® is 10 mg empagliflozin/5 mg linagliptin once daily in the morning, taken with or without food. In patients tolerating GLYXAMBI®, the dose may be increased to 25 mg empagliflozin/5 mg linagliptin once daily. In patients with volume depletion, correcting this condition prior to initiation of GLYXAMBI® is recommended.
Contraindications: GLYXAMBI® is contraindicated in patients with severe renal impairment, end-stage renal disease, or dialysis, or a history of serious hypersensitivity reaction to empagliflozin, linagliptin, or any of the excipients in GLYXAMBI® such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyper-reactivity.
Side-effects, Special warnings, and Precautions: Pancreatitis: There have been post-marketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking linagliptin. If pancreatitis is suspected, promptly discontinue GLYXAMBI® and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using GLYXAMBI®. Heart Failure: An association between DPP-4 inhibitor treatment and heart failure has been observed in cardiovascular outcomes trials for two other members of the DPP-4 inhibitor class. Consider the risks and benefits of GLYXAMBI® prior to initiating treatment in patients at risk for heart failure. If heart failure develops, evaluate, and manage according to current standards of care and consider discontinuation of GLYXAMBI®. Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Patients treated with GLYXAMBI® presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise, should be assessed for necrotizing fasciitis. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue GLYXAMBI®, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control. Volume Depletion: Empagliflozin causes intravascular volume contraction. Before initiating GLYXAMBI®, assess for volume contraction and correct volume status if indicated. Ketoacidosis: Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization have been identified in post-marketing surveillance in patients with type 1 and type 2 diabetes mellitus receiving sodium glucose co-transporter-2 (SGLT2) inhibitors, including empagliflozin. If ketoacidosis is suspected, GLYXAMBI® should be discontinued, patient should be evaluated, and prompt treatment should be instituted. In patients treated with GLYXAMBI® consider monitoring for ketoacidosis and temporarily discontinuing GLYXAMBI® in clinical situations known to predispose to ketoacidosis. For patients who undergo scheduled surgery, consider temporarily discontinuing GLYXAMBI® for at least 3 days prior to surgery. Acute Kidney Injury and Impairment in Renal Function: Before initiating GLYXAMBI®, consider factors that may predispose patients to acute kidney injury. If acute kidney injury occurs, discontinue GLYXAMBI® promptly and institute treatment. Use of GLYXAMBI® is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2. GLYXAMBI is likely to be ineffective in this setting based upon its mechanism of action. Precaution should be taken for other adverse events like urosepsis and pyelonephritis, hypoglycemia with concomitant use with Insulin and Insulin secretagogues, genital mycotic infections, hypersensitivity reactions, severe and disabling arthralgia, bullous pemphigoid, which have been observed with the individual components of GLYXAMBI®. Use of GLYXAMBI® is not recommended in pregnancy and lactation. Rhabdomyolysis has been reported in post-marketing experience with linagliptin. Adverse reactions noted in >5% patients treated with Empagliflozin and linagliptin are urinary tract infections, nasopharyngitis and upper respiratory tract infections.
Shelf Life: 36 Months.
Storage: Store in a safe place out of the reach of children. Do not store above 30 °C.
[Source: GLYXAMBI® PI Version dated 31-May-2023].
This is abridged prescribing information for GLYXAMBI®. It is recommended to refer to the full prescribing information before prescribing.