Saxagliptin & Metformin

Saxagliptin/metformin is a prescription medication used to treat type 2 diabetes in adults. Saxagliptin/metformin is a single tablet containing two prescription drugs. Saxagliptin belongs to a group of drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors, which help lower blood sugar levels. Metformin belongs to a group of drugs called biguanides, which decrease the amount of sugar made by the liver and help the body respond to insulin.

This medication comes as extended release tablets and is usually taken once a day, with meals. Swallow the saxagliptin/metformin extended release tablets whole. Do not  crush, cut, or chew saxagliptin/metformin extended release tablets.

Common side effects of saxagliptin/metformin include upper respiratory infections, stuffy nose, sore throat, diarrhea, nausea and vomiting.

Saxagliptin/metformin is a prescription medicine, containing saxagliptin and metformin, that is used with diet and exercise to help control high blood sugar in adults with type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose of saxagliptin/metformin will be individualized.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The maximum daily dose of saxagliptin/metformin is 5 mg for saxagliptin and 2000 mg for metformin extended-release.

WARNING: LACTIC ACIDOSIS

Lactic acidosis is a rare, but serious, complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.

The onset of lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress.

Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.

If acidosis is suspected, saxagliptin/metformin should be discontinued and the patient hospitalized immediately.

Serious side effects can happen in people taking saxagliptin/metformin, including:

1. Lactic Acidosis. Metformin, one of the medicines in saxagliptin/metformin, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking saxagliptin/metformin and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis:

• feel very weak and tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have unusual sleepiness or sleep longer than usual
• have unexplained stomach or intestinal problems with nausea and vomiting, or diarrhea
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a slow or irregular heartbeat

• have kidney problems. People whose kidneys are not working properly should not take saxagliptin/metformin.
• have liver problems.
• have congestive heart failure that requires treatment with medicines.
• drink a lot of alcohol (very often or short-term “binge” drinking).
• get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
• have certain x-ray tests with injectable dyes or contrast agents.
• have surgery.
• have a heart attack, severe infection, or stroke.
• are 80 years of age or older and have not had your kidney function tested.

2. Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start taking saxagliptin/metformin:

• inflammation of your pancreas (pancreatitis)
• stones in your gallbladder (gallstones)
• a history of alcoholism
• high blood triglyceride levels
• a history of a serious hypersensitivity reaction to saxagliptin/metformin, such as anaphylaxis, angioedema, or exfoliative skin conditions

It is not known if having these medical problems will make you more likely to get pancreatitis with saxagliptin/metformin.

Stop taking saxagliptin/metformin and contact your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

3. Low blood sugar (hypoglycemia) may become worse in people who also take another medication to treat diabetes, such as sulfonylureas or insulin. Tell your healthcare provider if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your healthcare provider. Symptoms of low blood sugar include:

• shaking
• sweating
• rapid heartbeat
• change in vision
• hunger
• headache
• change in mood

4. Severe and persistent joint pain. If you experience severe and persistent joint pain, contact your doctor right away. Do not stop taking your medication. Your doctor will decide if your medication is the possible cause of severe  joint pain and will discontinue the drug if appropriate.

5. Allergic (hypersensitivity) reactions, such as:

• swelling of your face, lips, throat, and other areas on your skin
• difficulty with swallowing or breathing
• raised, red areas on your skin (hives)
• skin rash, itching, flaking, or peeling

• have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine)
• have kidney problems
• have a history of a serious hypersensitivity reaction to saxagliptin/metformin, such as anaphylaxis, angioedema, or exfoliative skin conditions

Saxagliptin/metformin can cause serious side effects. See "Drug Precautions."

Common side effects of saxagliptin/metformin include:

• upper respiratory tract infection
• stuffy or runny nose and sore throat
• urinary tract infection
• headache
• diarrhea
• nausea and vomiting

Taking saxagliptin/metformin with meals can help lessen the common stomach side effects of metformin. If you have unexplained stomach problems, tell your healthcare provider. Stomach problems that start later during treatment may be a sign of something more serious.

Low blood sugar (hypoglycemia) may become worse in people who also take another medication to treat diabetes, such as sulfonylureas or insulin. Tell your healthcare provider if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your healthcare provider. Symptoms of low blood sugar include:

• shaking
• sweating
• rapid heartbeat
• change in vision
• hunger
• headache
• change in mood

Tell your healthcare provider if you have any side effects that bother you or that do not go away.

These are not all of the possible side effects of saxagliptin/metformin. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone.

Tell your healthcare provider if you will be starting or stopping certain other types of medicines, such as antibiotics, or medicines that treat fungus or HIV/AIDS, because your dose of saxagliptin/metformin might need to be changed.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. It is not known if saxagliptin/metformin will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if saxagliptin/metformin passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you take saxagliptin/metformin.

Saxagliptin/metformin can cause low blood sugar (hypoglycemia) especially if you take another medication to treat diabetes. kNow the signs and symptoms of low blood sugar.

Saxagliptin/metformin should be taken with meals to help lessen an upset stomach side effect.

Swallow saxagliptin/metformin whole. Do not crush, cut, or chew saxagliptin/metformin.

You may sometimes pass a soft mass in your stools (bowel movement) that looks like saxagliptin/metformin tablets.