• Type 2 diabetes mellitus (as adjunct to diet and exercise).

Contraindicated in:

• Hypersensitivity to either component
• Hypoglycemia
• History of pancreatitis
• End-stage renal disease
• Severe gastroparesis.

Use Cautiously in:

• Renal/hepatic impairment (↑ risk of hypoglycemia)
• Concomitant use with pioglitazone (↑ risk of fluid retention and worsening HF)
• Patients with visual impairment who may rely on audible clicks to dial their dose
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children
• Geri: Older adults may be more sensitive to hypoglycemic effects.

CV: peripheral edema.

Derm: erythema, pruritus.

Endo: hypoglycemia.

F and E: hypokalemia.

GI: nausea, vomiting, ↓ appetite, abdominal distention, abdominal pain, cholecystitis, cholelithiasis, constipation, diarrhea, dyspepsia, flatulence, PANCREATITIS.

GU: renal impairment (in association with nausea, vomiting, diarrhea, or dehydration).

Local: cutaneous amyloidosis, injection site reactions, lipodystrophy.

Metab: weight gain.

Neuro: headache.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).

Drug-Drug:

• Beta blockers and clonidine may mask some of the signs and symptoms of hypoglycemia.
• Albuterol, atypical antipsychotics, corticosteroids, danazol, diuretics, epinephrine, estrogens, isoniazid, niacin, oral contraceptives, phenothiazines, protease inhibitors, and thyroid supplements may require ↑ dose of insulin glargine/lixisenatide.
• ACE inhibitors, angiotensin II receptor blockers, antidiabetic agents, disopyramide, fibrates, fluoxetine, MAO inhibitors, octreotide, pentoxifylline, salicylates, and trimethoprim/sulfamethoxazole may require ↓ dose of insulin glargine/lixisenatide.
• Alcohol, beta-blockers, clonidine, lithium, and pentamidine may require ↑ or ↓ dose of insulin glargine/lixisenatide.
• Concurrent use with pioglitazone may ↑ risk of fluid retention and worsening HF.
• May alter the absorption of concurrently administered oral medications (take antibiotics andacetaminophen ≥1 hr before insulin glargine/lixisenatide; take oral contraceptives ≥1 hr before or ≥11 hr after insulin glargine/lixisenatide).

• Solution for injection (prefilled pens): insulin glargine 100 units/lixisenatide 33 mcg/mL;

• SC (Adults): Nave to basal insulin or to a GLP-1 receptor agonist, currently on GLP-1 receptor agonist, or currently receiving <30 units/day of basal insulin: 15 units (15 units insulin glargine/5 mcg lixisenatide) once daily (discontinue basal insulin or GLP-1 receptor agonist); may ↑ dose by 2–4 units every week until achieve adequate glycemic control (max dose = 60 units/day [60 units insulin glargine/20 mcg lixisenatide); Currently receiving 30–60 units/day of basal insulin (with or without a GLP–1 receptor agonist): 30 units (30 units insulin glargine/10 mcg lixisenatide) once daily (discontinue basal insulin or GLP-1 receptor agonist); may ↑ dose by 2–4 units every week until achieve adequate glycemic control (max dose = 60 units/day [60 units insulin glargine/20 mcg lixisenatide).

Soliqua

• Insulin glargine: Lowers blood glucose by stimulating glucose update in skeletal muscle and fat and by inhibiting hepatic glucose production.
• Lixisenatide: Acts as an agonist at the glucagon-like peptide-1 (GLP-1) receptor resulting in augmented glucose-dependent insulin secretion and slowing of gastric emptying.

• Improved glycemic control.

Therapeutic Classification: hormones, antidiabetics

Pharmacologic Classification: pancreatics

Insulin Glargine

Absorption: Provides slower prolonged absorption and a relatively constant concentrations over 24 hr.

Distribution: Identical to endogenous insulin.

Metabolism/Excretion: Partially metabolized at the site of injection to active insulin metabolites. Metabolized by liver, spleen, kidney, muscle.

Half-life: 5–6 min (prolonged in diabetic patients; biological half-life is longer).

Lixisenatide

Absorption: Bioavailability following SUBQ injection unknown.

Distribution: Extensively distributed to tissues.

Metabolism/Excretion: Degraded by proteolytic enzymes and excreted primarily through urine.

Half-life: 3 hr.

(blood levels)

• Instruct patient on correct technique for administration, timing of dose and concurrent oral medications, storage of medication, and disposal of used needles. Training should include a practice injection. If a dose is missed, omit and take next day dose at scheduled time; do not double doses in same day. Advise patient to read Medication Guide and Instructions for Use before starting therapy and with each Rx refill in case of changes.
• Inform patient that pen needles are not included with pen and must be purchased separately. Use new pen with each dose. Advise patient which needle length and gauge should be used.
• Caution patient not to share pen and needles, even if needle is changed. May cause transmission of blood-borne pathogens.
• Advise patient to stop taking lixisenatide and notify health care professional immediately if signs and symptoms of hypersensitivity or pancreatitis occur.
• Explain to patient that insulin glargine/lixisenatide helps control hyperglycemia but does not cure diabetes. Therapy is usually long term.
• Inform patient that insulin glargine/lixisenatide may cause lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in injected areas.
• Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hyperglycemic or hypoglycemic episodes.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications or alcohol.
• Advise patient to notify health care professional if nausea, vomiting, or fever develops, if unable to eat regular diet, or if blood sugar levels are not controlled.
• Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water, and notify health care professional. Risk of hypoglycemia is ↑ if sulfonylureas or basal infusion are taken concurrently with insulin glargine/lixisenatide.
• Caution patient to maintain adequate hydration (2 L liquid/day) to minimize risk or renal failure.
• Patients with diabetes mellitus should carry a source of sugar (candy, glucose gel) and identification describing their disease and treatment regimen at all times.
• Emphasize the importance of regular follow-up, especially during first few wk of therapy.
• Rep: Advise female patient taking oral contraceptives to take them at ≥1 hr before or 11 hr after insulin glargine/lixisenatide dose. Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

IN-soo-lin GLAR-jeen/lix-i-SEN-a-tide

NDC Code^*

• 0024- Sanofi-Aventis U.S. LLC
  • 0024-5761- Soliqua 100/33
    • 0024-5761-01- 1 SYRINGE in 1 CARTON (0024-5761-01) > 3 mL in 1 SYRINGE

• 0024- Sanofi-Aventis U.S. LLC
  • 0024-5761- Soliqua 100/33
    • 0024-5761-05- 5 SYRINGE in 1 CARTON (0024-5761-05) > 3 mL in 1 SYRINGE