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(insulin degludec and liraglutide)

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Overview

What is Xultophy 100/3.6?

XULTOPHY 100/3.6 (insulin degludec and liraglutide injection), for subcutaneous use,is a combination of a long-acting basal human insulin analog, insulin degludec, and a GLP-1 receptor agonist, liraglutide.

Insulin degludec

Insulin degludec is a long-acting basal human insulin analog. Insulin degludec is produced by a process that includes expression of recombinant DNA in followed by chemical modification.

Insulin degludec differs from human insulin in that the amino acid threonine in position B30 has been omitted and a side-chain consisting of glutamic acid and a C16 fatty acid has been attached (chemical name: LysB29(Nε-hexadecandioyl-γ-Glu) des(B30) human insulin). Insulin degludec has a molecular formula of CHNOS and a molecular weight of 6103.97. It has the following structure:

Figure 1: Structural Formula of Insulin degludec

Liraglutide

Liraglutide is an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in , has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. The molecular formula of liraglutide is CHNO and the molecular weight is 3751.2 Daltons. The structural formula (Figure 2) is:

Figure 2: Structural Formula of Liraglutide

XULTOPHY 100/3.6 is a sterile, aqueous, clear, and colorless solution. Each pre-filled pen contains 3 mL equivalent to 300 units insulin degludec and 10.8 mg liraglutide. Each mL contains 100 units insulin degludec and 3.6 mg liraglutide.

XULTOPHY 100/3.6 contains the following inactive ingredients per mL: glycerol 19.7 mg, phenol 5.70 mg, zinc 55 mcg, and water for injection. XULTOPHY 100/3.6 has a pH of approximately 8.15. Hydrochloric acid or sodium hydroxide may be added to adjust pH.



What does Xultophy 100/3.6 look like?



What are the available doses of Xultophy 100/3.6?

Injection: 100 units of insulin degludec per mL and 3.6 mg of liraglutide per mL in a 3 mL single-patient-use pen ().

What should I talk to my health care provider before I take Xultophy 100/3.6?

Pregnancy: XULTOPHY 100/3.6 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus ().

How should I use Xultophy 100/3.6?

XULTOPHY 100/3.6 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).

Limitations of Use:

The following are important dosing information for XULTOPHY 100/3.6, a combination of insulin degludec and liraglutide:

Table 1 presents the units of insulin degludec and the milligrams of liraglutide in each dosage of XULTOPHY 100/3.6.

Table 1: Units of Insulin Degludec and Milligrams of Liraglutide in Each Dosage of XULTOPHY 100/3.6

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What interacts with Xultophy 100/3.6?

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What are the warnings of Xultophy 100/3.6?

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What are the precautions of Xultophy 100/3.6?

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What are the side effects of Xultophy 100/3.6?

Sorry No records found


What should I look out for while using Xultophy 100/3.6?

XULTOPHY 100/3.6 is contraindicated:


What might happen if I take too much Xultophy 100/3.6?

Hypoglycemia (from insulin and liraglutide) and gastrointestinal adverse reactions (from liraglutide) may develop if a patient is dosed with more XULTOPHY 100/3.6 than required.

An excess of insulin-containing products like XULTOPHY 100/3.6 relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia . Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia. Hypokalemia must be corrected appropriately.

Overdoses have been reported in clinical trials and post-marketing use of liraglutide, one of the components of XULTOPHY 100/3.6. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.


How should I store and handle Xultophy 100/3.6?

Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13Potassium chloride extended-release capsules, USP, containing 600 mg of microencapsulated potassium chloride (equivalent to 8 mEq K), are pale orange capsules, imprinted "002" on the cap and body, packaged as follows:NDCNDCPotassium chloride extended-release capsules, USP, containing 750 mg of microencapsulated potassium chloride (equivalent to 10 mEq K), are pale orange and opaque white capsules, imprinted "001" on the cap and body, packaged as follows:NDCNDCNDCStore at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature.]Dispense in tight container as defined in the USP.  Nesher Pharmaceuticals USA LLC.St. Louis, MO 63044Distributed By:Zydus Pharmaceuticals USA Inc.Pennington, NJ 08534P10107  11/13


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

XULTOPHY 100/3.6

XULTOPHY 100/3.6 is a combination product consisting of insulin degludec and liraglutide.

Insulin degludec

The primary activity of insulin degludec is the regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis.

Liraglutide

Liraglutide is a Glucagon-Like Peptide-1 (GLP-1) receptor agonist that increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying.

Non-Clinical Toxicology
XULTOPHY 100/3.6 is contraindicated:

Potassium-sparing diuretics, angiotensin converting enzyme inhibitors (see ).

Liraglutide, one of the components of XULTOPHY 100/3.6, causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. It is unknown whether XULTOPHY 100/3.6 will cause 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.

Cases of MTC in patients treated with liraglutide have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and liraglutide use in humans.

XULTOPHY 100/3.6 is contraindicated in patients with a personal or family history of MTC or in patients with 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. Such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

The following serious adverse reactions are described below or elsewhere in the prescribing information:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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