Symptoms include malaise, muscle aches and pains, respiratory distress, increasing sleepiness, and nonspecific abdominal or stomach discomfort. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.
Lowering your blood sugar requires insulin, which is produced by your pancreas. Saxagliptin, a dipeptidyl peptidase-4 inhibitor (DPP4 inhibitor), helps the pancreas release insulin into your blood after eating a meal, which helps lower blood sugar. Metformin is a biguanide drug; it prevents the liver from releasing too much sugar.
Keeping your blood sugar (blood glucose) within a normal range helps control type 2 diabetes and prevents possible complications such as kidney disease or nerve damage.
Kombiglyze XR is a prescription product, so you can’t purchase it over the counter (OTC). You’ll receive a prescription from your healthcare provider and get the medication from your pharmacy.
What Is Kombiglyze XR Used For?
The Food and Drug Administration (FDA) approved Kombiglyze XR to treat type 2 diabetes as an add-on treatment with diet and exercise. Type 2 diabetes is the most common form of diabetes. In 2021, diabetes was estimated to affect 537 million adults globally.
Brand Name: Kombiglyze XR
Administration Route: Oral
Drug Availability: Prescription
Therapeutic Classification: Antidiabetic (DPP-4 inhibitor/biguanide)
Available Generically: No
Controlled Substance: N/A
Active Ingredient: Saxagliptin/extended-release metformin
Dosage Form: Extended-release tablet
Early symptoms of type 2 diabetes may include:
Excessive hunger or thirstThe need to urinate frequentlyFatigueTingling in the nervesBlurry vision
Many people don’t notice any of these symptoms and are diagnosed due to lab tests during visits to their healthcare providers.
Often, more than one medicine is necessary to lower blood sugar levels in people with type 2 diabetes. Kombiglyze is available as a combination pill so that you can take just one pill instead of two separate ones. You and your healthcare provider should establish that you are a good candidate for both saxagliptin and metformin before starting Kombiglyze.
How to Take Kombiglyze XR
The XR in Kombiglyze XR stands for extended-release. This means that the tablet is designed to release the drug more slowly into your system. Because of this, it should be taken just once daily, with your evening meal.
Always swallow the pill whole; never crush, cut, or chew it.
Storage
Store Kombiglyze at room temperature (between 68 and 77 degrees Fahrenheit) in the original container with the lid on. Keep it out of the reach of children and pets. Avoid storing your pill bottle in an area with heat and moisture, like the bathroom or kitchen.
If you’re traveling by plane, keep Kombiglyze in your carry-on luggage so that you aren’t separated from it if your checked luggage goes missing. If you’re traveling by car, take care not to leave your pill bottle in hot or cold temperatures for long periods, like overnight in the car.
What Are the Side Effects of Kombiglyze XR?
This is not a complete list of side effects and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.
An important value that healthcare providers use to monitor type 2 diabetes is called an A1C. It’s also called an HbA1C, hemoglobin A1C, glycated hemoglobin, or glycosylated hemoglobin test. Your A1C is a measure of your average blood sugar levels over time. It will likely take a month or two to see a decrease in your A1C reading after you begin taking Kombiglyze.
Common Side Effects
The most common side effects associated with Kombiglyze XR include the following. Note that common in this case means they were experienced by greater than or equal to 5% of patients in clinical trials. None of these was experienced by more than 10% of people in trials:
Diarrhea Nausea or vomiting Headache Upper respiratory infection or nasopharyngitis (cold-like symptoms)
Severe Side Effects
Potentially serious side effects of Kombiglyze include:
Hypoglycemia, or blood sugar levels below 70 milligrams per deciliter (mg/dL), primarily in trials in which Kombiglyze was added to other antidiabetic medicines like insulin or sulfonylurea drugs such as Diabeta (glyburide) or Glucotrol (glipizide) Hypersensitivity reactions such as urticaria (redness, rash, or itching) and skin swelling Urinary tract infection Lymphopenia (low count of a certain type of white blood cell) which would need to be determined by lab tests run by your healthcare provider
Call your healthcare provider immediately if you feel that you’re experiencing serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.
Long-Term Side Effects
Overall, both saxagliptin and metformin are considered safe and effective for long-term use. One potential long-term effect of metformin is that it can cause vitamin B12 deficiency over time, which can lead to nerve damage or blood problems. It’s a good idea to have levels checked annually if you’re taking metformin or a product that contains it like Kombiglyze XR.
Dosage: How Much Kombiglyze XR Should I Take?
Modifications
Due to the possible effects of this medication, there may be changes to how it is used.
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (extended-release tablets): For type 2 diabetes: For patients taking metformin alone: Adults—The metformin dose is the same as the dose you are already taking. Your doctor may adjust your dose until your blood sugar is controlled. However, the dose is usually not more than 5 milligrams (mg) of saxagliptin and 2000 mg of metformin once a day. Children—Use and dose must be determined by your doctor. For patients taking saxagliptin alone: Adults—At first, one tablet containing 5 milligrams (mg) of saxagliptin and 500 mg of metformin once a day. Your doctor may adjust your dose until your blood sugar is controlled. However, the dose is usually not more than 5 mg of saxagliptin and 2000 mg of metformin once a day. Children—Use and dose must be determined by your doctor. For patients using 2. 5 milligrams (mg) of saxagliptin and extended-release metformin together: Adults—One tablet containing 2. 5 mg of saxagliptin and 1000 mg of metformin once a day. Children—Use and dose must be determined by your doctor.
Pregnancy
It is unknown whether taking Kombiglyze XR while pregnant increases the risk of birth defects or miscarriage. Metformin is often used in pregnancy, but solid data on its use is limited. It does cross the placenta, so some unknowns exist about the drug’s effect on the fetus in utero (in the uterus).
There are fewer anecdotal cases and less information about using saxagliptin in pregnancy. Talk with your healthcare provider about how to control your diabetes while pregnant.
Breastfeeding
It is not known whether metformin and saxagliptin are present in human breast milk, so no definite recommendations can be made. Since many drugs do get secreted into human milk, use caution when breastfeeding and discuss with your healthcare provider whether you should continue taking Kombiglyze XR while breastfeeding.
Children
The safety and efficacy of Kombiglyze XR have not been established in children.
Adults 65 and Older
Adults aged 65 and older are more likely to have lower renal (kidney) function. Metformin, and therefore Kombiglyze XR, should not be used in individuals with significantly decreased kidney function. This is something that should be considered before starting this medication and monitored regularly in people taking it.
Missed Dose
If you forget to take a dose of Kombiglyze, skip it and take your next regularly scheduled dose on the next day with your evening meal. Do not double up doses to make up for missed ones.
Overdose: What Happens If I Take Too Much Kombiglyze XR?
As long as you are taking Kombiglyze XR as prescribed, you don’t need to be worried about overdosing. In the event of taking too many pills, it’s possible you will need to have some of the medicine removed from your system by a process called hemodialysis. If you think this may be the case, contact your healthcare provider immediately or go to the nearest emergency department.
Precautions
What Are Reasons I Shouldn’t Take Kombiglyze XR?
Kombiglyze is not or may not be the best choice if you have:
If someone collapses or isn’t breathing after taking Kombiglyze XR, call 911 immediately.
Let your doctor or dentist know you are taking this medicine. Your doctor may advise you to temporarily stop taking this medicine before you have major surgery or diagnostic tests, including procedures that use contrast dye.
Under certain conditions, too much metformin can cause a condition called lactic acidosis. The symptoms of lactic acidosis are severe, appear quickly, and usually occur when other health problems are present, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If symptoms of lactic acidosis occur, you should get immediate emergency medical help.
Pancreatitis (swelling and inflammation of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
If you are rapidly gaining weight, having shortness of breath, chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of a heart problem.
This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema. These conditions may be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or chest tightness.
This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.
This medicine may cause severe joint pain. Call your doctor right away if you have severe joint pain with this medicine.
This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Kidney disease: Do not use Kombiglyze XR if a lab value that measures kidney function called serum creatinine comes back high (greater than or equal to 1. 5 mg/dL for males and greater than or equal to 1. 4 mg/dL for females) or if you have low creatinine clearance (another measure of kidney function). Acid-base disorders such as acute or chronic metabolic acidosis, including diabetic ketoacidosis: Diabetic ketoacidosis should be treated with insulin. A history of a serious hypersensitivity reaction to Kombiglyze XR or saxagliptin, such as anaphylaxis, angioedema, or exfoliative skin conditions.
What Other Medications Interact With Kombiglyze XR?
Some drugs can interact with Kombiglyze XR and should be monitored by your healthcare provider.
CYP3A4 inhibitors can interrupt how the body processes Kombiglyze XR and make it stay in your system for longer. These include:
Norvir (ritonavir) Reyataz (atazanavir) Biaxin XL (clarithromycin) Sporanox (itraconazole) Serzone (nefazodone) Viracept (nelfinavir) Keteck (telithromycin)
When taken with Kombiglyze XR, certain medications can increase exposure to metformin, thereby increasing the risk of lactic acidosis. These include:
Ranexa (ranolazine) Caprelsa (vandetanib) Tivicay (dolutegravir) Tagamet HB (cimetidine)
Carbonic anhydrase inhibitors, such as Topamax (topiramate), can also raise the risk of lactic acidosis.
Some drugs can raise blood sugar levels. Make sure your healthcare provider knows what medications you take. Your provider may decide to increase your Kombiglyze XR dose or change your other medications.
Common drugs that can increase blood sugar levels include:
Thiazides and other diuretics such as Microzide (hydrochlorothiazide), Thalitone (chlorthalidone), Lasix (furosemide) Corticosteroids such as Medrol (methylprednisolone) or Rayos (prednisone) Thyroid products such as Synthroid (levothyroxine) Estrogens and oral contraceptives (birth control) Calcium channel blocking drugs such as Cardizem (diltiazem), Verelan (verapamil), or Norvasc (amlodipine)
What Medications Are Similar to Kombiglyze XR?
Other drugs similar to Kombiglyze XR include those that share classes with saxagliptin and metformin.
Other DPP4 inhibitor drugs similar to saxagliptin:
Onglyza (saxagliptin), the same drug that makes up part of Kombiglyze XR, but in a single-drug product Januvia (sitagliptin) Tradjenta (linagliptin) Nesina (alogliptin)
Other available brand names of metformin products include:
Glucophage: The main brand name product and is immediate release, as opposed to extended releaseGlucophage XR, Fortamet, and Glumetza are extended-release metformin productsRiomet is an oral solution of metformin
The above is not a list of drugs recommended to take with Kombiglyze XR. You should not take these drugs together. Discuss any questions with a pharmacist or healthcare provider.
How Can I Stay Healthy While Taking Kombiglyze XR?
Although type 2 diabetes is a common condition, learning how to manage it can be overwhelming, especially when you’re starting on new medications. In addition to your drug regimen, lifestyle changes can affect your blood sugar control.
Try to maintain a balanced, modified diet and incorporate physical activity into your routine. If needed, talk with a healthcare provider about the best ways to do this. You may also benefit from consulting a registered dietitian/nutritionist (RDN) about dietary options.
Learning more about the condition, communicating with diabetes educators and other individuals living with the condition, and adapting to lifestyle changes can empower you to take control of your diabetes.
