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XULTOPHY 100/3.6
Diabetes
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Drug Name:

XULTOPHY 100/3.6 Rx

Generic Name and Formulations:
Insulin degludec 100 Units/mL, liraglutide 3.6mg/mL; soln for SC inj.

Company:
Novo Nordisk

Therapeutic Use:

Indications for XULTOPHY 100/3.6:

As adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (<50 Units daily) or liraglutide (≤1.8mg daily).

Limitations Of use:

Not recommended as first-line treatment for patients inadequately controlled on diet and exercise. Not studied in patients with history of pancreatitis; consider other antidiabetics. Not for use with other liraglutide- or GLP-1 receptor agonist-containing products. Not for treating type 1 diabetes mellitus or diabetic ketoacidosis. Not studied in combination with prandial insulin.

Adult:

Discontinue liraglutide or basal insulin prior to initiation. Give by SC inj once daily at the same time each day into thigh, upper arm or abdomen; rotate inj sites. Individualize; monitor and adjust as needed. Initially 16 Units once daily. Titrate dose by 2 Units every 3–4 days until desired FPG achieved; max 50 Units. If persistently <16 Units or >50 Units daily required: use alternative antidiabetic products. Switching from basal insulin or liraglutide: see full labeling.

Children:

Not established.

Contraindications:

History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2. During episodes of hypoglycemia.

Warnings/Precautions:

Risk of thyroid C-cell tumors; inform patients of potential risk and symptoms. Monitor for signs/symptoms of pancreatitis; discontinue if suspected; do not restart if confirmed. Instruct patients on diet, exercise, blood testing, proper administration of insulin, and management of hypoglycemia. Do not reuse or share pens or needles between patients. Increased risk of hypo- or hyperglycemia if changes in physical activity, meal patterns, renal or hepatic function, insulin regimen, and if acute illness occurs: monitor glucose more frequently and may need to adjust dose. Monitor potassium levels in patients at risk for hypokalemia (eg, concomitant K+-lowering or K+-sensitive drugs). Discontinue if hypersensitivity reactions occur. Pre-existing gastroparesis. Renal impairment or GI adverse reactions: monitor and avoid fluid depletion. Elderly. Pregnancy. Nursing mothers.

Interactions:

Do not mix or dilute with other insulins or solutions. Concomitant peroxisome proliferator-activated receptor (PPAR)-gamma agonists may cause fluid retention and heart failure; consider dose reduction or discontinue PPAR-gamma agonists. Increased risk of hypoglycemia with concomitant antidiabetics, ACE inhibitors, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs, sulfonamide antibiotics. Reduced efficacy with concomitant atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens, protease inhibitors, somatropin, sympathomimetics, thyroid hormones. Variable effects with β-blockers, clonidine, lithium salts, alcohol, pentamidine. Concomitant β-blockers, clonidine, guanethidine, reserpine may blunt hypoglycemia. May affect absorption of other drugs (delayed gastric emptying).

Pharmacological Class:

Human insulin analog + glucagon-like peptide-1 (GLP-1) receptor agonist.

Adverse Reactions:

Nasopharyngitis, headache, nausea, diarrhea, increased lipase, upper respiratory tract infection; hypoglycemia, hypokalemia, lipodystrophy, acute kidney injury; rare: pancreatitis, papillary thyroid carcinoma, anaphylactic reactions and angioedema.

REMS:

YES

Generic Availability:

NO

How Supplied:

Prefilled pen (3mL)—5

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