A type 2 diabetes treatment developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY) and Boehringer Ingelheim Corp. is now available by prescription. The U.S. Food and Drug Administration approved Jardiance earlier this month for use in improving blood glucose levels.
August 26, 2014
Ridgefield, Conn. and Indianapolis, Ind. — Jardiance (empagliflozin) tablets are now available by prescription in pharmacies across the United States, including Walgreens, Rite Aid, Kroger and many other leading chain and independent retailers, according to Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY). The U.S. Food and Drug Administration (FDA) approved JARDIANCE on August 1, 2014 as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D). JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
“As a testament to the joint commitment by Boehringer Ingelheim and Lilly to improve care for people with diabetes, our alliance is proud to make JARDIANCE available so quickly following its approval by the FDA,” said Kathleen Dowd, senior vice president, marketing, Boehringer Ingelheim Pharmaceuticals, Inc. “We believe JARDIANCE is an exciting new treatment option with the potential to help many of the millions of adults with type 2 diabetes who have difficulty controlling their blood sugar levels.”
JARDIANCE, a once-daily, 10 mg or 25 mg tablet, is a sodium glucose co-transporter-2 (SGLT2) inhibitor. JARDIANCE works by blocking the reabsorption of glucose in the kidney, increasing glucose excretion and lowering blood glucose levels in adults with type 2 diabetes who have elevated blood glucose levels.
Patients should not take JARDIANCE if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in JARDIANCE. JARDIANCE can cause some people to have dehydration (the loss of body water and salt), which may lead to a drop in blood pressure, and may cause patients to feel dizzy or faint.
The JARDIANCE Simple Savings co-pay support program is available online and in many doctors' offices for patients who qualify. For terms and conditions and any questions regarding eligibility or benefits, visit JARDIANCEsavings.com or call 1-866-279-8990.
The FDA approval of JARDIANCE was based on results from a large clinical program comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. Phase III studies showed JARDIANCE significantly reduced hemoglobin A1C (a measure of average blood glucose over the past two to three months) after 24 weeks as a stand-alone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone. Although JARDIANCE is not approved for lowering weight or blood pressure, modest reductions in both weight and systolic blood pressure were observed in clinical trials.
The most common adverse reactions associated with JARDIANCE were urinary tract infections and vaginal yeast infections. Hypoglycemia was more commonly reported in patients treated with the combination of JARDIANCE and sulfonylurea or insulin.
To learn more about JARDIANCE and for full prescribing information visit: www.JARDIANCE.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.
Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.
Approximately 29 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. T2D is the most common type, accounting for an estimated 85 to 95 percent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
What is JARDIANCE?
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about JARDIANCE?
JARDIANCE can cause serious side effects, including:
Dehydration. JARDIANCEcan 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 a higher risk of dehydration if you:
have low blood pressure
take medicines to lower your blood pressure, including water pills (diuretics)
are on a low salt diet
have kidney problems
are 65 years of age or older.
Vaginal yeast infection. Women who take JARDIANCE 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 JARDIANCE 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.
Who should not take JARDIANCE?
Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.
Symptoms of serious allergic reactions to JARDIANCE may include:
skin rash raised red patches on your skin (hives) swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing.
If you have any of these symptoms, stop taking JARDIANCE and contact your doctor or go to the nearest emergency room right away.
Do not take JARDIANCE if you have severe kidney problems or are on dialysis.
What should I tell my doctor before using JARDIANCE?
Tell your doctor if you:
have kidney problems. Your doctor may do blood tests to check your kidneys before and during your treatment with JARDIANCE
have liver problems have a history of urinary tract infections or problems with urination have any other medical conditions are pregnant or planning to become pregnant. It is unknown if JARDIANCE will harm your unborn baby are breastfeeding, or plan to breastfeed. It is unknown if JARDIANCE passes into your breast milk.
Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar such as insulin.
What are other possible side effects of JARDIANCE?
Low blood sugar (hypoglycemia): if you take JARDIANCE with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include:
Fast heart beat
Shaking or feeling jittery
Kidney Problems, especially in people 75 years of age or older and people who already have kidney problems
Urinary Tract Infection: symptoms may include burning feeling when passing urine, pain in the pelvis or back, or urine that looks cloudy
Increased fats in your blood (cholesterol).
The most common side effects of JARDIANCE include urinary tract infections, and yeast infections in females.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see full Prescribing Information, including Patient Information.