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SOLIQUA 100/33
Diabetes
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Drug Name:

SOLIQUA 100/33 Rx

Generic Name and Formulations:
Insulin glargine 100 Units/mL, lixisenatide 33mcg/mL; for SC inj; contains m-cresol.

Company:
Sanofi Aventis

Therapeutic Use:

Indications for SOLIQUA 100/33:

As adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (<60 Units daily) or lixisenatide.

Limitations Of use:

Not studied in patients with history of unexplained pancreatitis; consider other antidiabetics. Not for use with other lixisenatide- or GLP-1 receptor agonist-containing products. Not for treating type 1 diabetes mellitus or diabetic ketoacidosis. Not recommended in gastroparesis. Not studied in combination with prandial insulin.

Adult:

Discontinue lixisenatide or basal insulin prior to initiation. Give by SC inj once daily within the hour prior to first meal into thigh, upper arm or abdomen; rotate inj sites. ≥18yrs: individualize; monitor and adjust as needed. Inadequately controlled on <30 Units of basal insulin or on lixisenatide: initially 15 Units once daily. Inadequately controlled on 30–60 Units of basal insulin: initially 30 Units once daily. Titrate dose by 2–4 Units weekly until desired FPG achieved; max 60 Units. If <15 Units or >60 Units daily required: use alternative antidiabetic products. Switching from basal insulin or lixisenatide: see full labeling.

Children:

<18yrs: not established.

Contraindications:

During episodes of hypoglycemia.

Warnings/Precautions:

Instruct patients on diet, exercise, blood testing, proper administration of insulin, and management of hypoglycemia. Do not reuse or share pens, needles, or syringes between patients. Discontinue if hypersensitivity reactions occur. Monitor for signs/symptoms of pancreatitis; discontinue if suspected; do not restart if confirmed. History of pancreatitis: consider alternative antidiabetics. 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). Renal impairment or severe GI reactions: monitor and avoid fluid depletion. ESRD: not recommended. Elderly. Pregnancy. Nursing mothers.

Interactions:

Do not mix or dilute with other insulins or solutions. Concomitant thiazolidinediones (TZDs) may cause fluid retention and heart failure; consider dose reduction or discontinue TZDs. 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. Concomitant antibiotics, APAP, other drugs dependent on threshold concentration: administer ≥1hr before Soliqua; for oral contraceptives, take ≥1hr before or 11hrs after Soliqua.

Pharmacological Class:

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

Adverse Reactions:

Hypoglycemia, allergic reactions, inj site reactions, nausea, nasopharyngitis, diarrhea, upper RTI, headache, lipodystrophy, weight gain; hypokalemia.

Generic Availability:

NO

How Supplied:

SoloStar prefilled pen (3mL)—5

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