FDA approves Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) for type 2 diabetes

The US Food and Drug Administration (FDA) has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D).

This medicine is used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

Qternmet XR is NOT for:

people with type 1 diabetes.

people with diabetic ketoacidosis (increased ketones in your blood or urine).

Qternmet XR is only for people currently taking metformin.

It is not known if this medicine is safe and effective in children younger than 18 years of age.

Do not take Qternmet XR if you:

are allergic to dapagliflozin, saxagliptin, metformin, or any of the ingredients.

Symptoms of a serious allergic reaction may include: swelling of the face, lips, throat and other areas of your skin, difficulty with swallowing or breathing, skin rash, itching, flaking or peeling, raised red areas on your skin (hives).

If you have any of these symptoms, stop taking Qternmet XR and contact your healthcare provider or go to the nearest hospital emergency room right away.

have moderate to severe kidney problems or are on dialysis.

have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine).

Before taking Qternmet XR, tell your healthcare provider about all of your medical conditions, including if you:

have type 1 diabetes or have had diabetic ketoacidosis (increased ketones in your blood or urine).

are going to have surgery.

are eating less due to illness, surgery or a change in your diet.

drink alcohol very often or drink a lot of alcohol in the short term (“binge” drinking).

have kidney problems.

have liver problems.

have a history of urinary tract infections or problems urinating.

have heart problems, including heart failure.

have had swelling of the face, lips, tongue and throat (angioedema) when you used a medicine called a dipeptidyl peptidase-4 (DPP-4) inhibitor like saxagliptin, one of the medicines in Qternmet XR.

have or have had bladder cancer.

have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas.

are going to get injection of dye or contrast agents for an x-ray procedure. Qternmet XR may need to be stopped for a short time.

are pregnant or plan to become pregnant. Qternmet XR may harm your unborn baby. If you are pregnant or plan to become pregnant, call your healthcare provider right away to talk about the best way to control your blood sugar.

are a woman who has not gone through menopause (premenopausal) who does not have periods regularly or at all. Qternmet XR can cause the release of an egg from an ovary in a woman (ovulation). This can increase your chance of getting pregnant.

are breastfeeding or plan to breastfeed. It is not known if Qternmet XR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment. Breastfeeding is not recommended while taking Qternmet XR.

Qternmet XR side effects

Qternmet XR may cause serious side effects, including:

Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with dapagliflozin, one of the medicines in Qternmet XR. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with dapagliflozin even if your blood sugar is less than 250 mg/dL.

Stop taking Qternmet XR and call your healthcare provider right away if you get any of the following symptoms: nausea, tiredness, vomiting, trouble breathing, stomach area (abdominal) pain.

If you get any of these symptoms during your treatment, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.

Kidney problems. Sudden kidney injury has happened to people taking dapagliflozin. Talk to your healthcare provider right away if you: reduce the amount of food or liquid you drink, for example if you are sick and cannot eat, or you start to lose liquids from your body with vomiting, diarrhea, or being in the sun too long.

Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.

Low blood sugar (hypoglycemia). If you take Qternmet XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, this can increase your risk of getting low blood sugar. Signs and symptoms of low blood sugar may include: shaking or feeling jittery, hunger, change in mood, sweating, headache, confusion, rapid heartbeat, drowsiness, irritability, change in vision, weakness.

A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take dapagliflozin, one of the medicines in Qternmet XR. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals: pain or tenderness, swelling, redness of skin (erythema)

Serious allergic reaction. Qternmet XR may cause serious allergic reactions. Stop taking Qternmet XR and get medical help right away if you develop any of the following symptoms of a serious allergic reaction including: swelling of the face, lips, tongue, throat and other areas of your skin, difficulty with swallowing or breathing, skin rash, itching, flaking, or peeling, raised red patches on your skin (hives).

Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 levels before. Your healthcare provider may do blood tests to check your vitamin B12 levels.

Vaginal yeast infection. Women who take Qternmet XR may get vaginal yeast infections. Symptoms of a vaginal yeast infection include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), vaginal itching

Yeast infection of the penis (balanitis). Men who take Qternmet XR may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of a yeast infection of the penis include: redness, itching, or swelling of the penis, rash of the penis, foul smelling discharge from the penis, pain in the skin around the penis.

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis.  

Bladder cancer. In studies of dapagliflozin in people with diabetes, bladder cancer occurred in a few more people who were taking dapagliflozin than in people who were taking other diabetes medicines. There were too few cases to know if bladder cancer was related to dapagliflozin. You should not take Qternmet XR if you have bladder cancer. Tell your healthcare provider right away if you have any of the following symptoms: blood or a red color in your urine, pain while you urinate

Joint pain. Some people who take DPP-4 inhibitors like saxagliptin, may develop joint pain that can be severe. Call your healthcare provider right away if you have severe joint pain.

Skin reaction. Some people who take DPP-4 inhibitors, one of the medicines in Qternmet XR, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking Qternmet XR.

 

FDA approves Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) for type 2 diabetes

The US Food and Drug Administration (FDA) has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type-2 diabetes (T2D). This medicine is used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. Qternmet XR is NOT for: people with type 1 diabetes. people with diabetic ketoacidosis (increased ketones in your blood or urine). Qternmet XR is only for people currently taking metformin. It is not known if this medicine is safe and effective in children younger than 18 years of age. Do not take Qternmet XR if you: are allergic to dapagliflozin, saxagliptin, metformin, or any of the ingredients. Symptoms of a serious allergic reaction may include: swelling of the face, lips, throat and other areas of your skin, difficulty with swallowing or breathing, skin rash, itching, flaking or peeling, raised red areas on your skin (hives). If you have any of these symptoms, stop taking Qternmet XR and contact your healthcare provider or go to the nearest hospital emergency room right away. have moderate to severe kidney problems or are on dialysis. have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine). Before taking Qternmet XR, tell your healthcare provider about all of your medical conditions, including if you: have type 1 diabetes or have had diabetic ketoacidosis (increased ketones in your blood or urine). are going to have surgery. are eating less due to illness, surgery or a change in your diet. drink alcohol very often or drink a lot of alcohol in the short term (binge drinking). have kidney problems. have liver problems. have a history of urinary tract infections or problems urinating. have heart problems, including heart failure. have had swelling of the face, lips, tongue and throat (angioedema) when you used a medicine called a dipeptidyl peptidase-4 (DPP-4) inhibitor like saxagliptin, one of the medicines in Qternmet XR. have or have had bladder cancer. have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas. are going to get injection of dye or contrast agents for an x-ray procedure. Qternmet XR may need to be stopped for a short time. are pregnant or plan to become pregnant. Qternmet XR may harm your unborn baby. If you are pregnant or plan to become pregnant, call your healthcare provider right away to talk about the best way to control your blood sugar. are a woman who has not gone through menopause (premenopausal) who does not have periods regularly or at all. Qternmet XR can cause the release of an egg from an ovary in a woman (ovulation). This can increase your chance of getting pregnant. are breastfeeding or plan to breastfeed. It is not known if Qternmet XR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment. Breastfeeding is not recommended while taking Qternmet XR. Qternmet XR side effects Qternmet XR may cause serious side effects, including: Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with dapagliflozin, one of the medicines in Qternmet XR. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with dapagliflozin even if your blood sugar is less than 250 mg/dL. Stop taking Qternmet XR and call your healthcare provider right away if you get any of the following symptoms: nausea, tiredness, vomiting, trouble breathing, stomach area (abdominal) pain. If you get any of these symptoms during your treatment, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL. Kidney problems. Sudden kidney injury has happened to people taking dapagliflozin. Talk to your healthcare provider right away if you: reduce the amount of food or liquid you drink, for example if you are sick and cannot eat, or you start to lose liquids from your body with vomiting, diarrhea, or being in the sun too long. Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting. Low blood sugar (hypoglycemia). If you take Qternmet XR with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, this can increase your risk of getting low blood sugar. Signs and symptoms of low blood sugar may include: shaking or feeling jittery, hunger, change in mood, sweating, headache, confusion, rapid heartbeat, drowsiness, irritability, change in vision, weakness. A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take dapagliflozin, one of the medicines in Qternmet XR. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals: pain or tenderness, swelling, redness of skin (erythema) Serious allergic reaction. Qternmet XR may cause serious allergic reactions. Stop taking Qternmet XR and get medical help right away if you develop any of the following symptoms of a serious allergic reaction including: swelling of the face, lips, tongue, throat and other areas of your skin, difficulty with swallowing or breathing, skin rash, itching, flaking, or peeling, raised red patches on your skin (hives). Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have had low vitamin B12 levels before. Your healthcare provider may do blood tests to check your vitamin B12 levels. Vaginal yeast infection. Women who take Qternmet XR may get vaginal yeast infections. Symptoms of a vaginal yeast infection include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), vaginal itching Yeast infection of the penis (balanitis). Men who take Qternmet XR may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of a yeast infection of the penis include: redness, itching, or swelling of the penis, rash of the penis, foul smelling discharge from the penis, pain in the skin around the penis. Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Bladder cancer. In studies of dapagliflozin in people with diabetes, bladder cancer occurred in a few more people who were taking dapagliflozin than in people who were taking other diabetes medicines. There were too few cases to know if bladder cancer was related to dapagliflozin. You should not take Qternmet XR if you have bladder cancer. Tell your healthcare provider right away if you have any of the following symptoms: blood or a red color in your urine, pain while you urinate Joint pain. Some people who take DPP-4 inhibitors like saxagliptin, may develop joint pain that can be severe. Call your healthcare provider right away if you have severe joint pain. Skin reaction. Some people who take DPP-4 inhibitors, one of the medicines in Qternmet XR, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking Qternmet XR.