saxagliptin / metformin ER
Kombiglyze XR is a combination diabetes medication for adults with Type 2 diabetes. It contains two active ingredients: saxagliptin and metformin. Kombiglyze XR works best to improve blood sugar levels when it's used along with a balanced diet and exercise routine. The extended-release tablet is taken by mouth once each day in the evening with a meal. The dosage depends on the other diabetes medications you might be taking. Side effects include diarrhea, nausea, and headache.
What is Kombiglyze XR?
What is Kombiglyze XR used for?
How Kombiglyze XR works
Kombiglyze XR is a combination of two diabetes medications that help lower blood sugar.
Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It stops the protein DPP-4 from working. This allows insulin to stick around in the body longer. It also stops your body from making glucagon, a hormone that raises blood sugar. This helps control your blood sugar levels.
Metformin is a biguanide that works in a few ways. It stops your liver from making sugar. And it lowers the amount of sugar your body absorbs from food and drinks. Metformin also helps your body use its natural insulin better.
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What are the side effects of Kombiglyze XR?
Common Side Effects
- Headache (8%)
- Nose and throat irritation (7%)
Other Side Effects
- Diarrhea
- Nausea or vomiting
- Upper respiratory tract infection
- Urinary tract infection (UTI)
- Low blood sugar
Serious Side Effects
- High lactic acid levels in the blood (lactic acidosis): more tiredness and weakness, stomach pain, muscle pain, more sleepiness, breathing problems
- Inflammation of the pancreas (pancreatitis): severe stomach pain that spreads to your back, nausea, vomiting
- Heart failure: feeling out of breath; swelling of your feet, ankles or legs, rapid weight gain
- Severe allergic reaction: rash; hives; peeling skin; swelling of the face, tongue, or throat; trouble breathing
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
- High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue
- Low vitamin B12 level—pain, tingling, or numbness in the hands or feet, muscle weakness, dizziness, confusion, trouble concentrating
- Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
- Redness, blistering, peeling, or loosening of the skin, including inside the mouth
- Severe joint pain
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Headache
- Nausea
- Runny or stuffy nose
- Sore throat
- Vomiting
Pros and cons of Kombiglyze XR
Pros
Combines two diabetes medications into a single pill for convenience
Taken by mouth once per day
Low risk of low blood sugar (hypoglycemia) when taken by itself
Cons
Harder to customize the dose of each active ingredient because it's a combination medication
Risk of lactic acidosis
Not a good option for people with severe kidney problems
Not for people with Type 1 diabetes or diabetic ketoacidosis
Pharmacist tips for Kombiglyze XR
Take Kombiglyze XR in the evening with a meal. This medication can sometimes cause stomach upset, so food can help ease this side effect.
Swallow the Kombiglyze XR tablets whole. Never cut, crush, or chew the tablet. This can damage the outer coating of the tablet, which can make the medication work less well and raise your risk of side effects. Talk to your prescriber if you're having trouble swallowing the tablets whole.
Ask your prescriber how often you should check your blood sugar levels while you're taking Kombiglyze XR. Keep track of your readings and share them with your care team. Your prescriber can adjust your treatment plan based on the pattern of your blood sugar levels.
Be sure to get any blood work done as recommended while you're taking Kombiglyze XR. Your prescriber will check your A1C (your average blood sugar level over 3 months). This helps check how well the medication is working. Your prescriber might change your dose based on your lab results.
Avoid alcohol while you're taking Kombiglyze XR. Alcohol can put you at risk of having low blood sugar (hypoglycemia). It can also make you more likely to have stomach upset. And drinking too much alcohol can raise your risk for a serious condition called lactic acidosis.
Your prescriber might want to check your vitamin B12 levels. It's possible for Kombiglyze XR to make you have low vitamin B12 levels, which can lead to anemia. Your prescriber might recommend vitamin B12 supplements to help if needed.
Tell your healthcare team if you're going to have surgery or test that'll use contrast dye. Kombiglyze XR can interact with the dye and affect your kidneys for a short time. This can raise your risk of lactic acidosis. Your care team will tell you if you need to stop taking the medication before your procedure and when to start it again.
To get the most out of your treatment, talk to your care team about a plan for prepping nutritious meals and exercising regularly. They can suggest a wide range of options that you can choose from.
Frequently asked questions about Kombiglyze XR
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What are the risks and warnings for Kombiglyze XR?
Kombiglyze XR can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Lactic acidosis
Risk factors: Kidney problems | Liver problems | Heart problems | Age 65 or older | Drinking a lot of alcohol | People with food or fluid restrictions | Using contrast dye for surgery or other procedures
Kombiglyze XR has metformin in it. Although rare, metformin can cause a serious condition called lactic acidosis (too much lactic acid in the blood). This condition can be serious and life-threatening. Tell your prescriber about your health problems and any other medications you take before starting Kombiglyze XR. They can check if you're at risk for lactic acidosis.
Call your care team right away if you have fast breathing, shortness of breath, a heartbeat that feels strange, a very upset stomach, or muscle pain. Also call if you feel very sleepy, tired, weak, dizzy, or cold. These can be signs of too much lactic acid in your blood.
Inflammation of pancreas (pancreatitis)
Although rare, some people who took saxagliptin, an ingredient in Kombiglyze XR, have had swelling in their pancreas (pancreatitis). It's not clear if people who've had pancreatitis are more likely to get it again during treatment. To be safe, tell your prescriber if you've had pancreatitis in the past.
Stop taking Kombiglyze XR and get medical help right away if you have severe stomach pain that spreads to your back and doesn't go away. This can happen with or without nausea or vomiting and could be signs of pancreatitis.
Risk of heart failure
Risk factors: History of heart failure | History of kidney problems
In a study, some people developed heart failure while taking saxagliptin, one of the ingredients in Kombiglyze XR. These people had or were at risk of heart disease. Let your diabetes care team know about your medical history, especially if you've had heart failure, other heart problems, or kidney problems. They can talk to you about the risks and benefits of treatment.
Get medical help right away if you have signs of heart failure. These include trouble breathing, fast or uneven heartbeat, swelling in the ankles or feet, rapid weight gain, and chest pain.
Low vitamin B12 levels
Risk factors: Long-term use of Kombiglyze XR | Lower than average calcium absorption | Lower than average vitamin B12 absorption
The metformin in Kombiglyze XR can cause low vitamin B12 levels. This can lead to anemia (low red blood cell count). Your prescriber might check your vitamin B12 levels levels throughout treatment.
Contact your care team if you feel tired, short of breath, dizzy, or a "pins-and-needles" sensation or numbness in your hands or feet. These might be signs of vitamin B12 deficiency. If your levels are low, they might recommend a supplement to get your levels back up.
Low blood sugar levels (hypoglycemia) when taken with other diabetes medications
Risk factors: Changes in diet and exercise | Drinking alcohol | Age 65 or older | Liver or kidney problems | Taking other medications for diabetes
You have a higher chance of low blood sugar (hypoglycemia) if you take Kombiglyze XR with certain other diabetes medications. Particular examples include insulin and sulfonylureas like glipizide. Very low blood sugar can be life-threatening.
Symptoms of low blood sugar include feeling shaky, very hungry, confused, or weak. You also might be nervous or anxious, have a fast heartbeat, or sweat. Be sure you know how to spot and treat low blood sugar. Talk to your care team if you're worried about having low blood sugar levels while taking Kombiglyze XR.
Joint pain
Some people who've taken DPP-4 inhibitors like the saxagliptin in Kombiglyze XR have had severe joint pain. This can happen anytime from a day to many years after starting the medication. For most people, the pain goes away after they stop the medication. Speak to your prescriber right away if you have any discomfort in your joints.
Serious allergic reactions
Risk factor: History of allergy to DPP-4 inhibitors (also called "gliptins") or metformin
Kombiglyze XR can cause serious allergic reactions. This can include a life-threatening reaction called anaphylaxis. Allergic reactions most often happen within the first 3 months of treatment. But they can also happen at any time. Stop taking Kombiglyze XR and get medical care right away if you have an allergic reaction. Watch for a widespread rash, skin peeling, swelling in the face, or trouble breathing.
Tell your prescriber if you've had an allergic reaction to other DPP-4 inhibitors or "gliptins". These include Januvia (sitagliptin) or alogliptin (Nesina). It's not clear, but you might have another allergic reaction if you take Kombiglyze XR.
Severe skin reaction
Some people have had an itchy, blistering rash while taking DPP-4 inhibitors, like the saxagliptin in Kombiglyze XR. This rash is called bullous pemphigoid. The blisters or sores usually go away after you stop the medication and get treated. Talk to a healthcare professional if you have itchy skin, a rash with blisters, or sores while taking Kombiglyze XR. You might need to stop the medication and see a dermatologist.
Kombiglyze XR dosage forms
Typical dosing for Kombiglyze XR
Your diabetes care team will find the starting dose of Kombiglyze XR that's right for you. It'll depend on the other medications you're taking.
Kombiglyze XR is taken by mouth once every evening with food. You'll usually start at a low dose. Then, your prescriber will slowly raise the dose based on how well it manages your blood sugar and if you have any side effects.
The maximum dose is 5 mg/2,000 mg (saxagliptin/metformin extended release) by mouth once daily with dinner.
How much does Kombiglyze XR cost?
Kombiglyze XR contraindications
Poor kidney function
Metabolic acidosis (including diabetic ketoacidosis)
Allergic reaction to saxagliptin or metformin
What are alternatives to Kombiglyze XR?
Type 2 diabetes in adults
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References
Best studies we foundAmblee, A., et al. (2016). Combination of saxagliptin and metformin is effective as initial therapy in new-onset type 2 diabetes mellitus with severe hyperglycemia. The Journal of Clinical Endocrinology & Metabolism.
AstraZeneca Pharmaceuticals LP. (2024). Kombiglyze XR- saxagliptin and metformin hydrochloride tablet, film coated, extended release [package insert]. DailyMed.
Kasina, S. V. S. K., et al. (2023). Dipeptidyl peptidase IV (DPP IV) inhibitors. StatPearls.
MedlinePlus. (2022). Lactic acidosis.
Scirica, B. M., et al. (2013). Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. The New England Journal of Medicine.
U.S. Food and Drug Administration. (2016). FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain.
You and Your Hormones. (2021). Glucagon.
You and Your Hormones. (2021). Insulin.
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