FDA approves Synjardy (empagliflozin/ metformin hydrochloride) for Type 2 diabetes
Eli Lilly and Company; Boehringer Ingelheim
The U.S. Food and Drug Administration (FDA) has approved Synjardy (empagliflozin and metformin hydrochloride) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY), for the treatment of adults with type 2 diabetes (T2D).
Synjardy is a combination of empagliflozin and metformin two medicines with complementary mechanisms of action to help control blood glucose in people with T2D. Empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Metformin, a commonly prescribed initial treatment for T2D, lowers glucose production by the liver and its absorption in the intestine.
Synjardy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with empagliflozin and metformin. Synjardy is not for the treatment of type 1 diabetes or diabetic ketoacidosis.
The Synjardy label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with Synjardy.
The FDA approval of Synjardy is based on results from multiple clinical trials examining the co-administration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with T2D.
Synjardy was also recently approved by the European Medicines Agency in May 2015.
Synjardy is a prescription medicine that contains 2 diabetes medicines, empagliflozin and metformin. Synjardy can be used along with diet and exercise to improve blood sugar in adults with type 2 diabetes who have already been treated with either empagliflozin or metformin and their blood sugar is not controlled well enough, or who are currently taking both empagliflozin and metformin as separate medicines.
Synjardy is not for people with type 1 diabetes, or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
Possible side effects of Synjardy
Synjardy may cause serious side effects including:
Dehydration. Synjardy can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up. You may be at higher risk of dehydration if you have low blood pressure, kidney problems, are 65 years of age or older, are on a low salt diet, or take medicines to lower your blood pressure, including water pills (diuretics).
Low blood sugar (hypoglycemia). If you take Synjardy with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered. Symptoms of low blood sugar may include headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion, shaking or feeling jittery, dizziness, or sweating.
Kidney problems. Synjardy can cause kidney problems, especially in people 75 years of age or older and people who already have kidney problems. Vaginal yeast infection. Women who take Synjardy may get vaginal yeast infections. Talk to your doctor if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
Yeast infection of the penis. Men who take Synjardy may get a yeast infection of the skin around the penis, especially uncircumcised males and those with chronic infections. Talk to your doctor if you experience redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around penis.
Urinary tract infection. Tell your doctor if you have any signs and symptoms of a urinary tract infection that may include a burning feeling when passing urine, urine that looks cloudy, pain in the pelvis, or back pain. 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 blood levels before. Your doctor may do blood tests to check your vitamin B12 levels.
Increased fats in your blood (cholesterol). The most common side effects of Synjardy include stuffy or runny nose and sore throat, urinary tract infections, female genital infections, diarrhea, headache, nausea, and vomiting.
These are not all the possible side effects of Synjardy. For more information, ask your doctor or pharmacist.
Source: Eli Lilly and Company; Boehringer Ingelheim
