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Insulin Degludec And Liraglutide

Xultophy 100/3.6 New Fda Drug Approval | Centerwatch

Xultophy 100/3.6 New Fda Drug Approval | Centerwatch

Xultophy 100/3.6 is a combination of insulin degludec, a long-acting human insulin analog, and liraglutide, a glucagon-like peptide 1 (GLP-1) receptor agonist. Xultophy 100/3.6 is specificallyindicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily). Xultophy 100/3.6 is supplied as an injection for subcutaneous administration in thigh, upper arm or abdomen. Prior to administration with Xultophy 100/3.6, the use of liraglutide or basal insulin should be discontinued. The recommended starting dosage is 16 units (16 units of insulin degludec and 0.58 mg of liraglutide) given subcutaneously once daily. Xultophy 100/3.6 should be administered once daily at same time each day with or without food. The maximum daily dosage is 50 units (50 units of insulin degludec and 1.8 mg of liraglutide). Xultophy 100/3.6 pen delivers doses from 10 to 50 units with each injection; each Xultophy 100/3.6 dosage unit contains 1 unit of insulin degludec and 0.036 mg of liraglutide. Alternative antidiabetic products should be used if patients require a Xultophy 100/3.6 daily dosage: persistently below 16 units, or over 50 units. Please see full prescribing information for titration recommendations. The FDA approval of Xultophy100/3.6 was based on efficacy and safety data from the DUAL (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) clinical development program. In three DUAL trials involving 1,393 adults with type 2 diabetes, patients who were inadequately controlled on liraglutide or basal insulin therapy and switched to Xultophy 100/3.6 achieved reductions in A1C. For adults uncontrolled on basal ins Continue reading >>

Cost Effectiveness Of Insulin Degludec Plus Liraglutide (ideglira) In A Fixed Combination For Uncontrolled Type 2 Diabetes Mellitus In Sweden

Cost Effectiveness Of Insulin Degludec Plus Liraglutide (ideglira) In A Fixed Combination For Uncontrolled Type 2 Diabetes Mellitus In Sweden

Cost Effectiveness of Insulin Degludec Plus Liraglutide (IDegLira) in a Fixed Combination for Uncontrolled Type 2 Diabetes Mellitus in Sweden 1Novo Nordisk Scandinavia AB, Box 505, 202 15 Malm, Sweden 2IHE, The Swedish Institute for Health Economics, Lund, Sweden sa Ericsson, Phone: +46 706 388385, Email: [email protected] . Author information Copyright and License information Disclaimer Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. This article has been cited by other articles in PMC. Patients with uncontrolled type 2 diabetes mellitus (T2DM) are a priority group for intensified therapy without weight gain and with low risk of hypoglycaemia. This study evaluates the cost effectiveness of insulin degludec plus liraglutide (IDegLira, Xultophy) compared with six potential intensification treatment options for patients with T2DM that is uncontrolled with basal insulin. The Swedish Institute for Health Economics (IHE) Cohort Model of Type 2 Diabetes was used with Swedish input data, a 40-year time frame and a societal perspective. The comparators for treatment intensification included insulin glargine, neutral protamine Hagedorn (NPH) insulin, insulin aspart plus either glargine or NPH, and liraglutide plus either glargine or NPH. Clinical data for all comparators (except NPH insulin) were based on an indirect treatment comparison of several studies. Prices were obtained from the 2014 Swedish Dental and Pharmaceutical Benefits Agency (Tandvrds- Continue reading >>

Insulin Degludec-liraglutide Pen

Insulin Degludec-liraglutide Pen

Nausea , vomiting , stomach upset, decreased appetite, diarrhea , constipation , stuffy/ runny nose , or pain/redness/irritation at the injection site may occur. Nausea usually lessens as you continue to use this medication . If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Vomiting / diarrhea that doesn't stop may result in a serious loss of body water ( dehydration ). Contact your doctor promptly if you notice any symptoms of dehydration , such as unusual dry mouth /thirst, fast heartbeat, or dizziness / lightheadedness . Tell your doctor right away if you have any serious side effects, including: signs of low potassium level in the blood (such as muscle cramps , weakness , irregular heartbeat), signs of kidney problems (such as change in the amount of urine). Get medical help right away if you have any very serious side effects, including: signs of pancreatitis or gallbladder disease (such as persistent nausea/vomiting, severe stomach / abdominal pain ). This medication can cause low blood sugar ( hypoglycemia ). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise . Symptoms of low blood sugar include sudden sweating , shaking, fast heartbeat, hunger , blurred vision , dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar . If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda Continue reading >>

Insulin Degludec-liraglutide

Insulin Degludec-liraglutide

Insulin Degludec-Liraglutide Interactions Do not drink alcohol. Check your other medicine labels to be sure these products do not contain alcohol. Insulin degludec and liraglutide may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin degludec and liraglutide. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Insulin degludec and liraglutide is injected under the skin once daily. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes. Use only the injection pen supplied with this medicine. Do not dilute or mix other medicines in the injection with insulin degludec and liraglutide. Your care provider will show you the best places on your body to inject this medicine. Use a different place each time you give an injection. Do not inject into the same place two times in a row. You may use this medicine with or without food, but use it the same time each day. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. Call your doctor if you have ongoing vomiting or diarrhea. You can easily become dehydrated while using Continue reading >>

A Trial To Investigate The Single Dose Pharmacokinetics Of Insulin Degludec/liraglutide Compared With Insulin Degludec And Liraglutide In Healthy Chinese Subjects

A Trial To Investigate The Single Dose Pharmacokinetics Of Insulin Degludec/liraglutide Compared With Insulin Degludec And Liraglutide In Healthy Chinese Subjects

You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT03292185 Information provided by (Responsible Party): Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information The main purpose of the trial is to compare the bioavailability (extent of drug absorption into the circulation) of insulin degludec and liraglutide as part of a combination product insulin degludec/liraglutide compared to the corresponding doses of single, separate injections of insulin degludec and liraglutide. Participants will receive all three test substances. The order of trial administration will be allocated by chance. During the trial period, serials of blood samples will be collected from the participants at three dosing periods, in order to determine the concentration of insulin degludec and liraglutide. The total volume of blood taken throughout the whole trial period will be less than 400 mL. Participants will be asked to stay on daytime and overnight in the trial sites on some predefined days. For other outpatient days, participants need to attend the trial site as required for drug administration or required assessments. Drug: insulin degludec/liraglutide Drug: insulin degludec Drug: liraglutide Three-period complete cross-over, six treatment Continue reading >>

Selected Important Safety Information

Selected Important Safety Information

Selected Important Safety Information WARNING: RISK OF THYROID C-CELL TUMORS Liraglutide, one of the components of Xultophy® 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Xultophy® 100/3.6 causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Xultophy® 100/3.6 is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Xultophy® 100/3.6 and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Xultophy® 100/3.6. Indications and Limitations of Use Xultophy® 100/3.6 (insulin degludec and liraglutide injection) 100 units/mL and 3.6 mg/mL is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily). Xultophy® 100/3.6 is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Xultophy® 100/3.6 has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Xultophy® 100/3.6 is not recommended for us Continue reading >>

Type 2 Diabetes: Insulin Degludec/liraglutide (xultophy)

Type 2 Diabetes: Insulin Degludec/liraglutide (xultophy)

Type 2 diabetes: insulin degludec/liraglutide (Xultophy) The content of this evidence summary was up-to-date in July 2015 . See summaries of product characteristics (SPCs), British national formulary (BNF) or the MHRA or NICE websites for up-to-date information. In people who are insulin-nave, insulin degludec/liraglutide (Xultophy) was noninferior to insulin degludec alone and superior to liraglutide alone for reductions in HbA1c (with a difference of 0.64% compared with liraglutide). In people previously treated with basal insulin, insulin degludec/liraglutide was superior to insulin degludec alone for reducing HbA1c with a difference of 1.1%. The safety profile and longterm safety concerns of insulin degludec/liraglutide are broadly in line with those of the 2included components. Regulatory status: Insulin degludec/liraglutide ( Xultophy ) was launched in the UK in November 2014. It is the first fixedratio combination basal insulin and glucagonlike peptide1 [GLP1] receptor agonist preparation to be licensed in the UK. Insulin degludec (Tresiba: 100units per ml and 200units per ml ) and liraglutide ( Victoza ) are available in the UK as the individual component preparations. Insulin degludec/liraglutide was noninferior to insulin degludec alone (treatment difference 0.47%points) and superior to liraglutide alone (treatment difference 0.64%points) for change in HbA1c from baseline (1RCT; n=1663; 26weeks). Insulin degludec/liraglutide was superior to insulin degludec alone (treatment difference 1.1%points) for change in HbA1c from baseline (1RCT; n=413; 26weeks). The European public assessment (EPAR) report concluded that the safety profile is in general similar to that of the 2included components. Longterm safety concerns are the same as for the other GLP1 receptor ag Continue reading >>

Novo Nordisk Launches Xultophy 100/3.6 (insulin Degludec And Liraglutide Injection) In The United States

Novo Nordisk Launches Xultophy 100/3.6 (insulin Degludec And Liraglutide Injection) In The United States

Novo Nordisk Launches Xultophy 100/3.6 (insulin degludec and liraglutide injection) in the United States - New combination treatment option for adults with type 2 diabetes now available in pharmacies - Eligible patients pay as little as $1 per day with the Xultophy 100/3.6 Savings Card, some restrictions apply PLAINSBORO, N.J., May 3, 2017 /PRNewswire/ --Novo Nordisk, a world leader in diabetes care, today announced the availability of its new combination therapy Xultophy 100/3.6 (insulin degludec and liraglutide injection, 100 units/mL and 3.6 mg/mL) at pharmacies nationwide. Xultophy 100/3.6 combines long-acting basal insulin Tresiba (insulin degludec U-100) with the #1 prescribed glucagon-like peptide-1 receptor agonist (GLP1-RA) therapy Victoza (liraglutide)1 in a single, once-daily injection. Xultophy 100/3.6 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).2 For more information about Xultophy 100/3.6, visit www.Xultophy10036.com . In clinical studies, Xultophy 100/3.6 reduced A1C and lowered blood sugar for 24 hours, including before and after meals.2 Xultophy 100/3.6 can be taken any time of day with or without food.2 "Continuing research and development to find safe and effective medications for people living with diabetes is important, particularly for those who require additional A1C-lowering options," said Dr. Steve Edelman, Founder and Director, Taking Control of Your Diabetes. "Now that Xultophy 100/3.6 is available, patients with type 2 diabetes who are uncontrolled on basal insulin have a new combination that can help achieve their individualized treatment goals." Novo Continue reading >>

Liraglutide/insulin Degludec (rx)

Liraglutide/insulin Degludec (rx)

Dosing & Uses Type 2 Diabetes Mellitus Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are inadequately controlled on basal insulin (<50 units/day) or liraglutide (≤1.8 mg/day) Recommended starting dose: 16 units (ie, 16 units insulin degludec and 0.58 mg liraglutide) SC qDay Maximum daily dose: 50 units (50 units of insulin degludec and 1.8 mg of liraglutide) The pen delivers doses from 10-50 units with each injection Each dosage unit contains 1 unit of insulin degludec and 0.036 mg of liraglutide Use alternative antidiabetic products if patients require a daily dosage persistently below 16 units or over 50 units May titrate dose upwards or downwards by 2 units every 3-4 days based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal until the desired fasting plasma glucose is achieved May be temporarily down-titrated to <16 units (ie, 10-15 units); however, if persistent dosages <16 units required, discontinue and use alternative therapy To minimize the risk of hypoglycemia or hyperglycemia, additional titration may be needed Changes in physical activity, meal patterns (ie, macronutrient content or timing of food intake), or renal or hepatic function During acute illness When used with other medications Dosage Modifications Severe (liraglutide/insulin degludec): Not studied Liraglutide: Postmarketing reports in patients with severe renal impairment of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis Dosing Considerations Limitations of use Not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of the rodent C-cell tum Continue reading >>

Insulin Degludec And Liraglutide (subcutaneous Route)

Insulin Degludec And Liraglutide (subcutaneous Route)

A nurse or other trained health professional may give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin. Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time. Each package of Xultophy contains a patient information sheet. Read this sheet carefully and make sure you understand: How to dispose of syringes, needles, and injection devices. It is best to use a different place on the body for each injection (eg, under the skin of your abdomen or stomach, thigh, or upper arm). If you have questions about this, contact a member of your health care team. Since this medicine lowers the blood glucose over 24 hours, it is best to use it at about the same time every day. The insulin solution should look clear and colorless. Do not use this medicine if it is cloudy or thickened. Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take Continue reading >>

The Efficacy Of Ideglira (insulin Degludec/liraglutide Combination) In Adults With Type 2 Diabetes Inadequately Controlled With A Glp-1 Receptor Agonist And Oral Therapy: Dual Iii Randomized Clinical Trial

The Efficacy Of Ideglira (insulin Degludec/liraglutide Combination) In Adults With Type 2 Diabetes Inadequately Controlled With A Glp-1 Receptor Agonist And Oral Therapy: Dual Iii Randomized Clinical Trial

The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial 1Coffs Endocrine & Diabetes Services, Coffs Harbour, NSW Australia 2Atlanta Diabetes Associates, Atlanta, GA USA 4Diabetology and Vascular Disease Unit, General Hospital, Narbonne, France 5Metabolic Institute of America, Tarzana, CA USA 8Monash University and Eastern Health, Box Hill, VIC Australia Sultan Linjawi, Email: [email protected] . This article has been cited by other articles in PMC. The progressive nature of type 2 diabetes necessitates treatment intensification. This often involves intensification with oral antidiabetic drugs (OADs) initially, followed by other agents, such as glucagon-like peptide-1 receptor agonists (GLP-1RAs), with the majority of patients eventually requiring insulin therapy. Therefore, this trial aimed to investigate the efficacy of IDegLira (combination of insulin degludec and liraglutide) in controlling glycemia in adults with type 2 diabetes who were inadequately controlled on a GLP-1RA and OADs. In this 26-week open-label phase 3b trial, patients on maximum-dose GLP-1RA therapy (liraglutide once daily or exenatide twice daily) with metformin alone or with pioglitazone and/or sulfonylurea were randomized 2:1 to IDegLira once daily (n=292) or to unchanged GLP-1RA therapy (n=146), continuing OADs at the pre-trial dose. After 26 weeks, HbA1c reductions were superior with IDegLira versus unchanged GLP-1RA; estimated treatment difference 0.94% (10.3mmol/mol), p<0.001. Mean HbA1c reduced from 7.8% to 6.4% (61.5 to 46.9mmol/mol) with IDegLira and from 7.7 to 7.4% (60.8 to 57.1mmol/mol) with unchanged GLP-1RA. With IDegLira, 75% and 63% Continue reading >>

European Medicines Agency - Find Medicine - Xultophy

European Medicines Agency - Find Medicine - Xultophy

What is Xultophy and what is it used for? Xultophy is a medicine that is used for the treatment of type-2 diabetes. It is used together with diabetes medicines taken by mouth in adults whose blood glucose (sugar) levels are not satisfactorily controlled by these medicines alone or combined with either a diabetes medicine called GLP-1 agonist or insulin. The active substances in Xultophy are insulin degludec and liraglutide. Xultophy is available as pre-filled disposable pens and can only be obtained with a prescription. It is given as an injection under the skin of the thigh, the upper arm or the abdomen (belly). The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the medicine work less well than expected. Patients can inject themselves with Xultophy if they have been trained appropriately. Xultophy is given once a day, preferably at the same time each day. The dose is adjusted individually for each patient, and the patients blood glucose should be regularly tested to find the lowest effective dose. For further information, see the package leaflet. Type-2 diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose, or the body is unable to use insulin effectively. One of the active substances in Xultophy, insulin degludec, is a replacement insulin that acts in the same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced. Insulin degludec is slightly different from human insulin as it is absorbed more slowly and regularly by the body after an injection and it has a long duration of action. The other active substance in Xultoph Continue reading >>

Novo Nordisk Receives Fda Approval For Xultophy® 100/3.6 (insulin Degludec And Liraglutide Injection)

Novo Nordisk Receives Fda Approval For Xultophy® 100/3.6 (insulin Degludec And Liraglutide Injection)

New combination therapy offers reductions in A1C for adults with Type 2 diabetes who are inadequately controlled on basal insulin (less than 50 units) daily or liraglutide (less than or equal to 1.8 mg) daily ® 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Xultophy® 100/3.6 is a once-daily, combination of Tresiba® (insulin degludec injection) and Victoza® (liraglutide) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily.1 Xultophy® 100/3.6 enters into a new class of diabetes treatments that combine a basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in a single, once-daily injection. "Novo Nordisk is committed to discovering and developing new medicines, like Xultophy® 100/3.6, that may make a difference in the way some adults with type 2 diabetes manage their diabetes and achieve their treatment goals," said Jakob Riis, executive vice president and head of North America Operations, Novo Nordisk A/S. "Combining Tresiba® and Victoza® into a single injection will offer patients a new option that may help control their blood sugar. We look forward to making Xultophy® 100/3.6 available to adults with type 2 diabetes in the first half of 2017." The approval of Xultophy® 100/3.6 is based on efficacy and safety data from the DUAL™ (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) clinical development program. In three DUAL™ trials involving 1,393 adults with type 2 diabetes, patients who were inadequately controlled on liraglutide or basal insulin therapy and switched to Xultophy® 100/3.6 achieved reductions in Continue reading >>

Insulin Degludec And Liraglutide

Insulin Degludec And Liraglutide

What is insulin degludec and liraglutide? Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin degludec is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours. Liraglutide is similar to a hormone that occurs naturally in the body and helps control blood sugar, insulin levels, and digestion. Insulin degludec and liraglutide is a combination medicine used to lower blood sugar in adults with type 2 diabetes mellitus . This medicine should be used together with diet and exercise. Insulin degludec and liraglutide is usually given when your blood sugar levels have not been well controlled by using other medications. Insulin degludec and liraglutide is not for people with type 1 diabetes . Insulin degludec and liraglutide may also be used for purposes not listed in this medication guide. Aging Issues: 12 of the Most Common Health Concerns Affecting Seniors You should not use this medicine if you have multiple endocrine neoplasia type 2 (tumors in your glands), a personal or family history of medullary thyroid cancer , insulin-dependent diabetes, or if you are having an episode of low blood sugar or diabetic ketoacidosis . In animal studies, liraglutide caused thyroid tumors or thyroid cancer . It is not known whether these effects would occur in people. Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath. You should not use this medicine if you are allergic to insulin or liraglutide. Do not use this medicine during an episode of low blood sugar, or if you have: multiple endocrine neoplasia type 2 (tumors in your glands); a personal or family history of medullary thyroid c Continue reading >>

What Is Xultophy® 100/3.6 (insulin Degludec And Liraglutide Injection) 100 Units/ml And 3.6 Mg/ml?

What Is Xultophy® 100/3.6 (insulin Degludec And Liraglutide Injection) 100 Units/ml And 3.6 Mg/ml?

What is the most important information I should know about Xultophy® 100/3.6? Xultophy® 100/3.6 may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, liraglutide, one of the components of Xultophy® 100/3.6, and medicines that work like liraglutide caused thyroid tumors, including thyroid cancer. It is not known if Xultophy® 100/3.6 will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Who should not use Xultophy® 100/3.6? Do not use Xultophy® 100/3.6 if: you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). you are allergic to insulin degludec, liraglutide, or any of the ingredients in Xultophy® 100/3.6. you are having an episode of low blood sugar. Xultophy® 100/3.6 is an injectable prescription medicine that contains 2 diabetes medicines, insulin degludec, 100 units/mL, and liraglutide, 3.6 mg/mL. Xultophy® 100/3.6 should be used along with diet and exercise to lower blood sugar (glucose) in adults with type 2 diabetes mellitus when blood sugar levels are not well controlled on: 1) basal insulin (less than 50 units daily) or 2) liraglutide (less than or equal to 1.8 mg daily). Xultophy® 100/3.6 is not recommended as the first choice of medicine for treating diabetes. It is not known if Xultophy® 100/3.6 can be used in people who have had pancreatitis. Xultophy® 100/3.6 is not recommended for use in combination with any other product containing liraglutide or another GLP-1 receptor Continue reading >>

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