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Onglyza 5mg Tablet
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Indications & Clinical Uses
- Onglyza (saxagliptin) 5 mg tablets contain a dipeptidyl peptidase-4 (DPP-4) inhibitor used alongside diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
- It works by increasing levels of incretin hormones, which help the body release insulin and reduce sugar production after meals, in a glucose-dependent way that carries a low risk of hypoglycaemia on its own.
- Onglyza can be used alone or combined with other diabetes medicines, such as metformin, sulfonylureas, thiazolidinediones or insulin, when these alone do not give adequate control.
- It is not approved for type 1 diabetes or for treating diabetic ketoacidosis, and it is not a substitute for insulin in people who require it.
- Onglyza is taken by mouth once daily, with or without food, and the same 5 mg once-daily dose and indication apply in both the United States and the European Union.
Side Effects
- Common side effects of Onglyza (saxagliptin) include upper respiratory tract infection, urinary tract infection, and headache.
- Peripheral swelling (oedema) can occur, particularly when Onglyza is combined with a thiazolidinedione.
- Onglyza does not carry a boxed warning, but large cardiovascular safety trials found a higher rate of hospitalisation for heart failure in people taking it compared with placebo, particularly those with existing heart or kidney disease, so new or worsening shortness of breath, swelling of the legs, or sudden weight gain should be reported promptly.
- Rare but serious risks include acute pancreatitis (severe, persistent abdominal pain that may spread to the back, with or without vomiting), severe and sometimes disabling joint pain, and bullous pemphigoid, a blistering skin condition that can require hospital treatment.
- Seek urgent medical attention for symptoms of a severe allergic reaction, such as facial or throat swelling, difficulty breathing, or a widespread skin rash.
Precautions & Warnings
- Onglyza (saxagliptin) is not recommended in people with a history of heart failure, as clinical trials showed an increased risk of hospitalisation for heart failure, particularly in those with pre-existing heart or kidney impairment; report new breathlessness, ankle swelling or rapid weight gain promptly.
- Onglyza should be stopped immediately if pancreatitis is suspected, and it should not be restarted if pancreatitis is confirmed.
- The dose is reduced in people with moderate to severe kidney impairment, and kidney function should be assessed before starting and periodically during treatment.
- It is contraindicated in anyone with a history of a serious hypersensitivity reaction, such as anaphylaxis or angioedema, to saxagliptin.
- If severe joint pain develops, Onglyza may need to be discontinued.
- Onglyza has not been studied in pregnancy or breastfeeding and is generally avoided in favour of other treatments in these situations; it is not for use in children, and hypoglycaemia risk increases when combined with insulin or a sulfonylurea.
Avoid Interactions
- Strong CYP3A4/5 inhibitors — including ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin — significantly raise saxagliptin levels, so the Onglyza dose is limited to 2.5 mg once daily when any of these are used together.
- Combining Onglyza with insulin or a sulfonylurea increases the risk of hypoglycaemia (low blood sugar), so a lower dose of the other medicine may be needed.
- There is no clinically significant interaction with metformin.
- Tell your healthcare provider about all prescription and over-the-counter medicines, herbal products and supplements you take, including any new antifungal or antibiotic treatment, since these are common sources of interaction.
- There is no specific interaction with food, though excess alcohol can affect blood sugar control and increase the chance of low blood sugar, especially when combined with insulin or a sulfonylurea.
References
Frequently Asked Questions
Onglyza (saxagliptin) is a tablet used with diet and exercise to control blood sugar in adults with type 2 diabetes. It boosts natural incretin hormones that help release insulin after meals. It's not for type 1 diabetes and is often combined with metformin or other diabetes medicines.
Take one Onglyza 5 mg tablet by mouth once daily, with or without food, at roughly the same time each day. It can be taken alone or alongside other diabetes medicines your healthcare provider prescribes, such as metformin or insulin.
Common effects of Onglyza (saxagliptin) include urinary and respiratory infections and headache. It has no boxed warning, but trials linked it to more heart failure hospitalisations, so report new breathlessness or leg swelling. Severe abdominal pain or joint pain also needs prompt medical review.
Avoid strong CYP3A4 inhibitors such as ketoconazole, clarithromycin and ritonavir, which raise Onglyza (saxagliptin) levels and require a lower dose. Combining it with insulin or a sulfonylurea raises hypoglycaemia risk. Tell your healthcare provider about every medicine you start.
If you miss a dose of Onglyza, take it as soon as you remember that same day, then continue your normal schedule — never take two doses together. Store the tablets at room temperature, 20°C to 25°C, away from moisture.
Onglyza (saxagliptin) has no boxed warning, but cardiovascular trials found more heart failure hospitalisations with it than placebo, especially in people with existing heart or kidney disease. Tell your healthcare provider about any history of heart failure before starting, and report new swelling or breathlessness.
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