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Saxagliptin / metformin ER

Class
Hypoglycemic agents
Subclass
Dipeptidyl peptidase-4 inhibitor / biguanide combination
Generic name
sAXagliptin / metFORMIN ER
Brand names
Kombiglyze XR®
Contains
Metformin
Saxagliptin
Common formulations
Film-coated tablet
See also
Metformin (Riomet®)
Dosage and administration
Adults patients
Treatment of diabetes mellitus type 2
•
Start at: 2.5-5/500-1,000 mg PO daily
•
Maximum: 5/2,000 mg per day
Taken with the evening meal. Titrate based on response and tolerability.
Indications for use
Labeled indications
Adults
•
Treatment of diabetes mellitus type 2
Safety risks
Boxed warnings
Lactic acidosis
•
Use extreme caution in patients with renal impairment, concomitant use of certain drugs (carbonic anhydrase inhibitors, such as topiramate), age ≥ 65 years, undergoing a radiological evaluation with contrast, surgery, and other procedures, hypoxic states (such as acute congestive HF), excessive alcohol intake, and hepatic impairment. Assess eGFR before initiating metformin and monitor annually or more frequent in patients at risk of renal impairment.
Contraindications
Hypersensitivity to saxagliptin/metformin or its components
Metabolic acidosis
•
Do not use saxagliptin/metformin in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
Use of iodine-containing contrast medium
•
Discontinue saxagliptin/metformin before iodinated contrast imaging in patients with an eGFR 30-60 mL/min/1.73 m², history of liver disease, alcohol use disorder, or HF, or in patients who will be administered intra-arterial iodinated contrast. Reassess eGFR 48 hours after the imaging and restart metformin if renal function is stable.
Warnings and precautions
Acute pancreatitis
•
Maintain a high level of suspicion, as saxagliptin has been associated with an increased risk of acute pancreatitis.
Angioedema
•
Use caution in patients with a history of angioedema related to other DPP4 inhibitors.
Arthralgia
•
Maintain a high level of suspicion, as DPP4 inhibitors have been associated with an increased risk of severe and disabling arthralgia.
Bullous pemphigoid
•
Maintain a high level of suspicion, as DPP4 inhibitors have been associated with an increased risk of bullous pemphigoid.
Decreased blood glucose
•
Use caution in patients taking insulin or insulin secretagogues. Consider reducing the insulin or insulin secretagogue dose.
HF
•
Use caution in patients with a history of HF or renal impairment. Assess renal function before initiating saxagliptin/metformin.
Increased serum saxagliptin levels
•
Use caution in patients with strong CYP3A4/5 inhibitors, such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin. Maximum dose of 2.5/1,000 mg once daily.
Vitamin B12 deficiency
•
Maintain a high level of suspicion, as metformin has been associated with an increased risk of vitamin B12 deficiency. Assess hematologic parameters annually and vitamin B12 every 2-3 years.
Specific populations
Renal impairment
eGFR ≥ 45 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Monitor renal function. Monitor for lactic acidosis. Discontinue before iodinated contrast imaging in patients with an eGFR 45-60 mL/min/1.73 m².
eGFR 30-45 mL/min/1.73 m²
•
Do not initiate. Maximal dose of 2.5 mg PO daily for saxagliptin component. Monitor renal function. Monitor for lactic acidosis. Assess the benefit/risk of continuing therapy in patients initiated on saxagliptin/metformin at higher eGFR rates. Discontinue before iodinated contrast imaging.
eGFR < 30 mL/min/1.73 m²
•
Do not use.
Renal replacement therapy
Any modality
•
Do not use.
Hepatic impairment
Any severity
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Consider safer alternatives. Insulin is the preferred first-line treatment for diabetes in pregnancy.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
↓ blood glucose, diarrhea, vomiting
Common 1-10%
•
Acute kidney injury, allergic reactions, ↓ blood lymphocyte count, peripheral edema, abdominal pain, abdominal distension, constipation, dyspepsia, heartburn, flatulence, dizziness, change in taste, headache, nausea, urinary tract infections, upper respiratory tract infections, vitamin B12 deficiency
Uncommon < 1%
•
Bone fracture, lactic acidosis, metabolic acidosis, renal failure, tuberculosis
Unknown frequency
•
Acute pancreatitis, anaphylaxis, rhabdomyolysis, idiopathic thrombocytopenic purpura, bullous pemphigoid, heart failure, drug-induced liver injury, ↑ liver enzymes, megaloblastic anemia, arthralgia, angioedema, chest discomfort, palpitations, myalgia, chills, skin flushing, skin rash, hyperhidrosis, weight loss, lightheadedness, encephalopathy
Interactions
Drug(s)
Check Interactions
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