SOLIQUA 100/33 Dosage & Rx Info | Uses, Side Effects

Soliqua 100/33 Generic Name & Formulations

Legal Class

General Description

Insulin glargine 100 Units/mL, lixisenatide 33mcg/mL; for SC inj; contains m-cresol.

Pharmacological Class

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

How Supplied

SoloStar prefilled pen (3mL)—5

Manufacturer

Sanofi U.S.

Generic Availability

Mechanism of Action

The primary activity of insulin, including insulin glargine, is 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 inhibits lipolysis and proteolysis and enhances protein synthesis. Lixisenatide increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying.

Soliqua 100/33 Indications

Indications

As adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use

Not studied in patients with history of pancreatitis. Not for use with any 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.

Soliqua 100/33 Dosage and Administration

Adult

Discontinue basal insulin or GLP-1 agonist 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. Individualize; monitor and adjust as needed. Naive to basal insulin or GLP-1 agonist, currently on GLP-1 agonist, or on <30 Units/day of basal insulin: initially 15 Units once daily. Currently on 30–60 Units/day of basal insulin (with or without a GLP-1 receptor agonist): initially 30 Units once daily. All: titrate dose by 2–4 Units weekly until desired FPG achieved; max 60 Units daily.

Children

Not established.

Soliqua 100/33 Contraindications

Contraindications

During episodes of hypoglycemia.

Soliqua 100/33 Boxed Warnings

Not Applicable

Soliqua 100/33 Warnings/Precautions

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, even if the needle is changed. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis. History of anaphylaxis or angioedema with another GLP-1 receptor agonist. Discontinue if hypersensitivity reactions occur. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. History of pancreatitis: consider alternative antidiabetics. Increased risk of hyperglycemia or hypoglycemia if changes in physical activity, meal patterns, renal or hepatic function, insulin regimen, administration site, 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). Acute gallbladder disease (eg, cholelithiasis, cholecystitis). Perform gallbladder studies and appropriate clinical follow-up if cholelithiasis is suspected. Patients with visual impairment. Hepatic impairment: monitor; may need to adjust dose. Renal impairment or severe GI reactions: monitor and avoid fluid depletion. ESRD: not recommended. Elderly. Pregnancy. Nursing mothers.

Soliqua 100/33 Pharmacokinetics

Absorption

Median t_max: range 2.5–3.0 hours (lixisenatide).

Distribution

Plasma protein bound: 55% (lixisenatide).

Elimination

Half-life: ~3 hours.

Soliqua 100/33 Interactions

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, 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.

Soliqua 100/33 Adverse Reactions

Adverse Reactions

Hypoglycemia, nausea, nasopharyngitis, diarrhea, upper RTI, headache, lipodystrophy, weight gain; inj site reactions, hypokalemia, anaphylaxis, renal failure, possibly antibody formation.

Soliqua 100/33 Clinical Trials

See Literature

Soliqua 100/33 Note