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Starting treatment and titrating Xultophy® 100/3.6

Writing a prescription for Xultophy® 100/3.6 could be a step toward glycemic control for your adult patients with type 2 diabetes. Before prescribing, know the starting dose and see how to titrate Xultophy® 100/3.6.

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Xultophy® 100/3.6 Titration Start Icon

 

START


One starting dose for all patients1

Start patients converting from basal insulin or liraglutide at

16 UNITS


Xultophy® 100/3.6 Pen

16 units=16 units of insulin degludec and 0.58 mg liraglutide1    

  • Therapy with basal insulin and liraglutide should be discontinued prior to initiation of Xultophy® 100/3.61

Dial the dose like a basal insulin

The Xultophy® 100/3.6 Pen delivers a fixed-ratio combination in increments of 1 unit

(1 unit=1 unit of insulin degludec and 0.036 mg liraglutide)1


Dose once daily at the same time each day with or without food1


No waiting to inject when removed from the refrigerator1

primary_msg

Glycemic control when starting Xultophy® 100/3.6

A post-hoc analysis of DUAL™ V revealed that patients did not lose FPG control when converting from insulin glargine U-100 to Xultophy® 100/3.6.1,2 In the trial, patients on 20-50 units of insulin glargine U-100 at baseline were started on 16 units of Xultophy® 100/3.6 per day.2

Post-hoc analysis: change in FPG over time1,2

Weeks 4, 8, and 12 were exploratory prespecified endpoints in the trial. By 4 weeks, Xultophy® 100/3.6 significantly reduced FPG vs insulin glargine U-100.

See study design below.

Change in mean FPG for insulin degludec/liraglutide was –50.9 mg/dL; for insulin glargine, –49.9 mg/dL.
NS=not significant.
ETD=estimated treatment difference.
aP=0.0003.3
bP=0.0022.3
cP=0.0106.3

Weeks 4, 8, and 12 were exploratory prespecified endpoints in the trial. By 4 weeks, Xultophy® 100/3.6 significantly reduced FPG vs insulin glargine U-100.

See study design below.

“I know there are concerns within the medical community about taking somebody from a higher basal insulin dose like 30 or 40 units and starting them on a Xultophy® 100/3.6 dose of 16 units. However, the data has already demonstrated that there is no loss of glucose control in those first several weeks while patients are titrating to their goal.”

Jodi Strong, DNP, FNPBC, APNP, CDE, BCARM

“I know there are concerns within the medical community about taking somebody from a higher basal insulin dose like 30 or 40 units and starting them on a Xultophy® 100/3.6 dose of 16 units. However, the data has already demonstrated that there is no loss of glucose control in those first several weeks while patients are titrating to their goal.”

Jodi Strong, DNP, FNPBC, APNP, CDE, BCARM

secondary_msg

TITRATE

Every 3-4 days based on FPG1

After starting with 16 units of Xultophy® 100/3.6 (16 units of insulin degludec and 0.58 mg of liraglutide), instruct patients to titrate their dose up or down by 2 units every 3 to 4 days until the desired FPG is achieved.


Below FPG target

-2 units

Within FPG target

0 units

Above FPG target

+2 units

  • Maximum dose: 50 units=50 units of insulin degludec and 1.8 mg liraglutide1
  • In clinical trials, patients adjusted their dose on Monday and Thursday of each week2


Teaching titration to your patients

In a brief video, Dr Jodi Strong explains how she teaches patients to titrate Xultophy® 100/3.6, and what she does to support patients starting therapy.

Starting Adult Patients with Type 2 Diabetes on Xultophy® 100/3.6

Full Prescribing Information Important Safety Information

USA17XUM03207

Dosing and titration resources

Dosing card

Download the dosing card for all dosing and titration information in 1 place.

Dosing worksheet

Give each patient starting Xultophy® 100/3.6 take-home titration instructions by filling out this dosing worksheet. 

Titration video for patients

Share this video with your patients to help them learn how to titrate their Xultophy® 100/3.6 dose.

“My patients appreciate that they can take a combo product of a basal insulin with a GLP-1 receptor agonist in a once-daily injection with or without food. And they like the fact that they can adjust the dose based on their needs.”

Jodi Strong, DNP, FNPBC, APNP, CDE, BCARM

“My patients appreciate that they can take a combo product of a basal insulin with a GLP-1 receptor agonist in a once-daily injection with or without food. And they like the fact that they can adjust the dose based on their needs.”

Jodi Strong, DNP, FNPBC, APNP, CDE, BCARM


tertiary_msg

PRESCRIBE

Ready to prescribe Xultophy® 100/3.6?

How to prescribe

Dispense 1 box of 5 pens1

NDC 0169-2911-151

NDC 0169-2911-151

Provide a second prescription for pen needles

Provide titration instructions with FPG target range    

NDC 0169-2911-151

Provide a second prescription for pen needles

Provide titration instructions with FPG target range    

Starting dose of 16 units1

Provide a second prescription for NovoFine® Plus 32G pen needles

Provide titration instructions with FPG target range

Add Xultophy® 100/3.6 to your ePrescribing system

NDC: 0169-2911-15

Drug name: Xultophy® 100/3.6

Form / Strength: 100 units insulin degludec and 3.6 mg liraglutide per mL, 3 mL

Quantity: 15 mL (5 x 3 mL); 1500 units total

Dosage Form: Solution

The Xultophy® 100/3.6 Pen delivers doses from 10 to 50 units in a single injection with dose increments of 1 unit (1 unit = 1 unit of insulin degludec and 0.036 mg liraglutide).


EOP_callouts_viewed
Xultophy® 100/3.6 Pen

Using the Xultophy® 100/3.6 Pen

Patients can dial their dose just like a basal insulin and learn how to inject with this instructional video.

Get the details


Xultophy® 100/3.6 samples

Xultophy® 100/3.6 samples

Get your adult patients started toward glycemic control with complimentary samples of Xultophy® 100/3.6.

Request samples




Study design

DUAL™ V (Study C): A 26-week, randomized, parallel, open-label, treat-to-target trial in adult patients with type 2 diabetes inadequately controlled (A1C 7%-10%) on insulin glargine U-100 (20-50 units) + metformin, comparing the efficacy and safety of Xultophy® 100/3.6 (n=278) with continued up-titration of insulin glargine U-100 (n=279), both + metformin. The primary endpoint was change in A1C after 26 weeks of treatment. Secondary endpoints included change in laboratory-measured FPG, dose, change in body weight, percent of patients achieving A1C <7%, and episodes of hypoglycemia.1,2

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 use in combination with any other product containing liraglutide or another GLP-1 receptor agonist.
  • Xultophy® 100/3.6 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
  • Xultophy® 100/3.6 has not been studied in combination with prandial insulin.

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.

Contraindications

  • Xultophy® 100/3.6 is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Xultophy® 100/3.6, either of the active substances, or any of its excipients.

Warnings and Precautions

  • Risk of Thyroid C-cell Tumors: If serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging, the patient should be further evaluated.
  • Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide postmarketing. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Xultophy® 100/3.6 promptly and if pancreatitis is confirmed, do not restart. Consider other antidiabetic therapies in patients with a history of pancreatitis.
  • Never Share a Xultophy® 100/3.6 Pen Between Patients, even if the needle is changed. Sharing of the pen poses a risk for transmission of blood-borne pathogens.
  • Hyper- or Hypoglycemia with Changes in Xultophy® 100/3.6 Regimen: Monitor blood glucose in all patients. Changes in Xultophy® 100/3.6 regimen may affect glycemic control. Changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed.
  • Overdose Due to Medication Errors: Instruct patients to check the label before each injection since accidental mix-ups with insulin containing products can occur. Do not administer more than 50 units of Xultophy® 100/3.6 daily. Do not exceed the 1.8 mg maximum recommended dose of liraglutide or use with other GLP-1 receptor agonists.
  • Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin containing products, including Xultophy® 100/3.6, and may be life-threatening. Increase monitoring with changes to: dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment.
  • Acute Kidney Injury: Acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis, have been reported postmarketing for liraglutide, usually in association with nausea, vomiting, diarrhea, or dehydration. Advise patients of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
  • Hypersensitivity and Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, angioedema, bronchospasm, hypotension, and shock can occur. If a hypersensitivity reaction occurs, discontinue and treat per standard of care.
  • Hypokalemia: All insulin containing products, including Xultophy® 100/3.6 can lead to life-threatening hypokalemia, which may then cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
  • Fluid Retention and Congestive Heart Failure: Patients using insulin containing products, including Xultophy® 100/3.6, with thiazolidinediones (TZDs), which are PPAR-gamma agonists, should be observed for signs and symptoms of heart failure. If heart failure develops, dosage reduction or discontinuation of the TZD must be considered.
  • Macrovascular Outcomes: There have been no studies establishing conclusive evidence of macrovascular risk reduction with Xultophy® 100/3.6.

Adverse Reactions

  • The most common adverse reactions, reported in ≥5% of patients treated with Xultophy® 100/3.6 are nasopharyngitis, headache, nausea, diarrhea, increased lipase and upper respiratory tract infection.

Drug Interactions

  • Certain drugs may affect glucose metabolism, requiring dose adjustment and close monitoring of blood glucose. The signs and symptoms of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).  
  • Liraglutide-containing products, including Xultophy® 100/3.6, cause a delay of gastric emptying, and thereby have the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with liraglutide-containing products.

Use in Specific Populations

  • Xultophy® 100/3.6 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Please click here for Prescribing Information.

 

References:

  1. Xultophy 100/3.6 [package insert]. Plainsboro, NJ: Novo Nordisk Inc; November 2016.
  2. Lingvay I, Pérez Manghi F, García-Hernández P, et al; DUAL V Investigators. Effect of insulin glargine up-titration vs insulin degludec/liraglutide on glycated hemoglobin levels in patients with uncontrolled type 2 diabetes: the DUAL V randomized clinical trial. JAMA. 2016;315(9):898-907.
  3. Lingvay I, Norwood PC, Begtrup K, et al. Patients with T2D treated with insulin degludec/liraglutide (IDegLira) have a greater chance of reaching glycemic targets without hypoglycemia and weight gain than with insulin glargine (IG). Presented at: American Diabetes Association 76th Scientific Sessions; June 10-14, 2016; New Orleans, Louisiana.