Xigduo xr fda prescribing information, side effects and uses. Xigduo xr dapagliflozin and metformin hcl extendedrelease tablets, for oral use. Official label printer friendly view all sections close all sections. Xigduo xr can cause serious side effects, including. Dapagliflozin removes excess sugar from the body through the urine. The fda has approved fixeddose combinations of metformin with either canagliflozin invokamet or dapagliflozin xigduo xr table for. Xigduo xr is indicated as an adjunct to diet and exercise to improve. On this page about xigduo xr 10 you will find information relating to side effects, age restrictions, food interactions, whether the medicine is available at a. Xigduo xr is a drug marketed by astrazeneca ab and is included in one nda. Goodrx has partnered with insiderx and astrazeneca to reduce the price for this prescription. Conditions that can precipitate dka while taking xigduo include a very low carbohydrate.
Xigduo xr tablets are available in the following dosage forms and strengths. There are currently no generic alternatives to xigduo xr. Ketoacidosis is a serious condition, which may need to be treated in. Patients on xigduo xr may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. Most medicare plans restrict the amount of this prescription that can be purchased at one time. Taking your tablets at the same time each day will have the best effect. Xigduo xr contains 2 prescription medicines called dapagliflozin and metformin. Feb 03, 2020 xigduo xr is available for oral administration as tablets containing the equivalent of 2. Xigduo xrdapagliflozin and metformin hcl extendedrelease. Invokamet and xigduo xr two new combinations for type 2. Xigduo xr can cause serious side effects, including lactic acidosis.
There are eight patents protecting this drug and two paragraph iv challenges. Data sources include ibm watson micromedex updated 28 feb 2020, cerner multum updated 2 mar 2020, wolters kluwer updated. Xigduo xr is a combination of dapagliflozin, a sodiumglucose cotransporter 2 sglt2 inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Find information about common, infrequent and rare side effects of xigduo xr oral. Savings and support get the xigduo xr savings cardand get connected to other support services. Webmd provides information about interactions between xigduo xr oral and dapagliflozinertugliflozinaceinhibitorsarbs. Interactions between xigduo xr oral and dapagliflozin. Xigduo xr is a combination of dapagliflozin and metformin hcl extendedrelease. Recommended dosage take xigduo xr once daily in the morning with food. Xigduo increases the chance of getting a yeast infection of the penis or vagina. For eligible patients who have been prescribed xigduo xr savings your eligible patients may appreciate.
Audio under revision, check back soon dapagliflozinmetformin hydrochloride consumer medicine information what is in this leaflet. Avoid getting up too fast from a sitting or lying position, or you may feel. It will also help you remember when to take the tablets. Xigduo xr is available for oral administration as tablets containing the equivalent of 2.
If you need to purchase a greater amount at one time, it. Xigduo xr is not covered by most medicare and insurance plans. Fda approves oncedaily xigduo xr tablets for adults. This leaflet answers some common questions about xigduo xr. If you need to have any type of xray or ct scan using a dye that is injected into your veins, you may need to temporarily stop taking xigduo xr. We offer a variety of services that surround you with support, including. Xigduo xr dapagliflozin and metformin hydrochloride. Xigduo xr should be taken at approximately the same time each day. Get an rx savings coupon for xigduo xr dapagliflozinmetformin hcl. Needymeds has free information on medication and healthcare costs savings programs including prescription assistance programs and medical and dental clinics. Ketoacidosis is a serious condition, which may need to be treated in a hospital.
Xigduoxr coupon 2020 new manufacturer xigduoxr coupon. Drugs az pill identifier supplements symptom checker diseases dictionary media. Lactic acidosis is a medical emergency and must be treated in a hospital. Xigduo xr dapagliflozin and metformin hcl is a combination of two oral antihyperglycemic medications used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate. For patients not already taking dapagliflozin, the recommended starting dose for dapagliflozin is 5 mg once daily. Whether youve already gotten a card from your doctor, or you need to download a card to get started, weve made it easy for you to begin saving now. Xigduo xr dapagliflozinmetformin hydrochloride drug. Pdf bioequivalence of dapagliflozinmetformin extendedrelease. Call your healthcare provider right away if you have any of the following symptoms.
Download and print this card, and present it with your prescription to the pharmacist at your retail pharmacy. The situation regarding covid19 is changing rapidly, and to minimize any potential impact on you, we may send additional doses of product in our shipments over the coming weeks. Medicare coverage and pricing details for xigduo xr. Includes high cholesterol hyperlipoproteinemia, hypertriglyceridemia, sitosterolemia. Treatment for type 2 diabetes mellitus in adults xigduo xr. Xigduo xr side effects, dosage, interactions drugs. Apr 11, 2020 when do xigduo xr patents expire, and when can generic versions of xigduo xr launch. Xigduo xr dapagliflozin and metformin hcl extendedrelease. Xigduo contains less than 1mmol sodium 23mg per dose, i. This is more likely in people who have had yeast infections in the past.
Oct 29, 2014 xigduo xrdapagliflozin and metformin hcl extendedrelease tablets. At astrazeneca, we view the safety and wellbeing of our patients as the highest priority. Interuption of treatment with xigduo should be considered in t2dm patients who are hospitalized for major surgical procedures, serious infections or acute serious medical illness. Food and drug administration has approved oncedaily xigduo xr dapagliflozin and metformin hydrochloride extendedrelease for the treatment of adults with type 2 diabetes. Some medicare plans have restrictions on coverage of xigduo xr that may include. Occasionally, the inactive ingredients of xigduo xr will be eliminated in the feces as a soft, hydrated mass that may resemble the original tablet.
Before initiating xigduo xr, consider risk factors for ketoacidosis. Product name xigduo xr 5mgmg, modified release tablet xigduo xr 10mg500mg, modified release tablet xigduo xr 10mgmg, modified release tablet 2. Side effects of xigduo xr and similar diabetes drugs have been linked to a potential risk of diabetic ketoacidosis, kidney failure, heart attacks, strokes and other injuries. Uses, side effects, interactions, dosage pillintrip. Xigduo xr should be taken once daily in the morning with food with gradual dose escalation to reduce the gastrointestinal gi side effects due to metformin.
Xigduo xr dapagliflozin metformin extended release. In approximately half of the cases, acute kidney injury occurred within 1 month of starting the drug, and most patients improved after discontinuing the drug. Learn more about medicare prescription drug plans and savings with goodrx. Side effects of xigduo xr dapagliflozin and metformin hcl. Dapagliflozin is indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors. Food and drug administration 10903 new hampshire avenue silver spring, md 20993 1888infofda 18884636332 contact fda. It lowers blood sugar and may increase your risk of lactic acidosis.
This page is maintained for informational purposes only. Xigduo contains dapagliflozin and metformin hydrochloride. Give one of our xigduo xr care partners a call for help with the support you need. Print download pdf send by name of the medicinal product. Metformin, one of the medicines in xigduo xr, can cause a rare, but serious, side effect called lactic acidosis a buildup of lactic acid in the blood that can cause death. Xigduo xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Xigduo xr medicare coverage and copay details goodrx.
The test product in this study xigduo xr 10 mg is the highest dose formulation for both components. Get an rx savings coupon for xigduo xr dapagliflozinmetformin hcl extendedrelease tablets. Savings for xigduo xr dapagliflozin and metformin hcl. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with xigduo xr. This drug has two hundred and fiftyfive patent family members in fortyfive countries. Pdf bioequivalence of dapagliflozinmetformin extended. Xigduo xr dapagliflozin and metformin hcl extended. Dapagliflozin is indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease cvd or multiple cardiovascular cv risk factors. It does not take the place of talking to your doctor or pharmacist. Your doctor will do blood tests to monitor how well your kidneys are working while you are taking xigduo. Xigduo xr dapagliflozin metformin extended release basics. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
Decisions regarding your health and treatment of your condition should be made with your own healthcare provider. Xigduo xr tablets must be swallowed whole and never crushed, cut, or chewed. Dapagliflozin and metformin xr in the fcdp were bioequivalent to the individual component tablets marketed in the. Swallow xigduo xr tablets whole and never crush, cut, or chew. Feb 01, 2020 xigduo xr is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Xigduo xr provides an effective treatment option for patients when both dapagliflozin and metformin are appropriate in addition to diet and exercise. When do xigduo xr patents expire, and when can generic versions of xigduo xr launch. Multi ingredient medications may also be listed when applicable. Xigduo xr dapagliflozin metformin extended release should be stopped 48 hours before andor after surgery or any imaging procedure needing contrast dye. Xigduo xr should be taken with or immediately after food in the evening. Metformin, one of the medicines in xigduo xr, can cause a rare but serious condition called lactic acidosis a buildup of an acid in the blood that can cause death. Xigduo xr is a prescription medicine used with diet, exercise and sometimes other medicines such as insulin, a sulfonylurea, or a dipeptidyl peptidase dpp4 inhibitor, or a glucagon like peptide. Lactic acidosis is a medical emergency and must be treated in the hospital.
Multiple pictures are displayed for those medicines available in different strengths, marketed under different brand names and for medicines manufactured by different pharmaceutical companies. Find patient medical information for xigduo xr oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Read the clinical trial results, including primary endpoints for mean a1c levels for xigduo xr dapagliflozin and metformin hcl extendedrelease tablets vs combination glipizide plus metformin. Dapagliflozinmetformin hydrochloride modified release tablets. Persons with disabilities having problems accessing the pdf files below may call 301 796. Check our savings tips for copay cards, assistance programs, and other ways to reduce your cost. Download cmi pdf download large text cmi pdf what is in this leaflet. Your doctor will have to do blood work to test your kidneys and liver before you start taking xigduo xr dapagliflozin metformin extended release. Oct 01, 2019 xigduo xr is not for treating type 1 diabetes. Dosing and administration xigduo xr dapagliflozin and. Webmd provides information about interactions between xigduo xr oral and dapagliflozinertugliflozinpotassiumsparingdiuretics. Please see full prescribing information, including boxed warnings for brilinta, bydureon, bydureon bcise, kombiglyze xr, lumoxiti, symlin and xigduo xr you may report side effects related to astrazeneca products by clicking here this information is intended for us consumers and health care professionals only. You should not use xigduo xr if you have severe kidney disease or diabetic ketoacidosis call your doctor for treatment. Xigduo xr care partners cannot provide medical advice and can only provide information about astrazeneca medications.