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Adlyxin

Generic Name: Lixisenatide
Class: Incretin Mimetics
Chemical Name: l-Histidylglycyl-l-glutamylglycyl-l-threonyl-l-phenylalanyl-l-threonyl-l-seryl-l-α-aspartyl-l-leucyl-l-seryl-l-lysyl-l-glutaminyl-l-methionyl-l-α-glutamyl-l-α-glutamyl-l-α-glutamyl-l-alanyl-l-valyl-l-arginyl-l-leucyl-l-phenylalanyl-l-isoleucyl-l-α-glutamyl-l-tryptophyl-l-leucyl-l-lysyl-l-asparaginylglycylglycyl-l-prolyl-l-seryl-l-serylglycyl-l-alanyl-l-prolyl-l-prolyl-l-seryl-l-lysyl-l-lysyl-l-lysyl-l-lysyl-l-lysyl-l-lysinamide
Molecular Formula: C215H347N61O65S
CAS Number: 320367-13-3

Medically reviewed on July 30, 2018

Introduction

See also: Basaglar

Antidiabetic agent; synthetic, glucagon-like peptide-1 (GLP-1) receptor agonist (incretin mimetic).1 17 21 23 30

Uses for Adlyxin

Diabetes Mellitus

Used as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.1 4 5 6 7 8 9 10 11 12 13 14

Has been used as monotherapy or in combination with other antidiabetic agents, including metformin with or without a sulfonylurea; a sulfonylurea or thiazolidinedione with or without metformin; basal insulin (insulin glargine, insulin detemir, or isophane [NPH] insulin) with or without metformin or a sulfonylurea; or insulin glargine with or without metformin with or without a thiazolidinedione.1 4 5 6 7 8 9 10 11 12 13 17

Commercially available in fixed combination with insulin glargine (insulin glargine/lixisenatide; Soliqua 100/33) for use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus inadequately controlled on lixisenatide or on <60 units daily of basal insulin.15 16 18

Safety and efficacy of lixisenatide or insulin glargine/lixisenatide not established in patients with chronic pancreatitis or a history of unexplained pancreatitis; consider other antidiabetic agents in patients with a history of pancreatitis.1 15 (See Pancreatitis under Cautions.)

Safety and efficacy of lixisenatide or insulin glargine/lixisenatide in conjunction with short-acting (e.g., prandial) insulin not established; concomitant use not recommended.1 15

Lixisenatide alone or in combination with insulin glargine not indicated for use in patients with type 1 diabetes mellitus or diabetic ketoacidosis.1 15

Lixisenatide alone or in combination with insulin glargine not recommended for use in patients with gastroparesis.1 15 (See Patients with Gastroparesis under Cautions.)

Adlyxin Dosage and Administration

Administration

Administer lixisenatide or insulin glargine/lixisenatide by sub-Q injection using a prefilled injection pen;1 15 do not administer IV, IM, or via an insulin pump.12 15

Sub-Q Administration

Administer sub-Q into abdomen, thigh, or upper arm; rotate sites within an area.1 15

Lixisenatide: Administer within 1 hour before the first meal of the day, preferably the same meal each day (and at the same time each day).1 2 If a dose is missed, administer the dose within 1 hour before the next meal.1

Insulin glargine/lixisenatide: Administer within 1 hour before the first meal of the day.15 If a dose is missed, resume the once-daily regimen with the next scheduled dose.15

Consult drug labeling for additional details about administration.1 3 15 39

Dosage

Dosage of fixed combination (insulin glargine/lixisenatide) has been expressed in terms of the insulin glargine component; however, each mL of insulin glargine/lixisenatide contains 100 units of insulin glargine and 33 mcg of lixisenatide.15

If lixisenatide is used in combination with a sulfonylurea or basal insulin, reduction of sulfonylurea or basal insulin dosage may be required.1 (See Use with Drugs Known to Cause Hypoglycemia under Cautions.)

Safety and efficacy of lixisenatide or insulin glargine/lixisenatide and short-acting (e.g., prandial) insulin not established; such concomitant use not recommended by manufacturer.1 15

Adults

Diabetes Mellitus
Lixisenatide
Sub-Q

Initially, 10 mcg once daily for 14 days.1 On day 15, increase to 20 mcg once daily.1

Insulin Glargine/Lixisenatide
Sub-Q

Patients inadequately controlled on <30 units of basal insulin daily or on lixisenatide: Initially, 15 units (15 units insulin glargine/5 mcg lixisenatide) once daily.15

Patients inadequately controlled on 30–60 units of basal insulin daily: Initially, 30 units (30 units insulin glargine/10 mcg lixisenatide) once daily.15

Titrate dosage by 2–4 units every week based on the patient's metabolic needs, blood glucose concentrations, and glycemic control goal until desired fasting plasma glucose concentration is obtained.15 Recommended dosage of insulin glargine/lixisenatide is 15–60 units (15–60 units insulin glargine/5–20 mcg lixisenatide) once daily.15 Use alternative antidiabetic therapy if the patient requires a dosage of insulin glargine/lixisenatide <15 units (15 units insulin glargine/5 mcg lixisenatide) or >60 units (60 units insulin glargine/20 mcg lixisenatide) daily.15

Special Populations

Hepatic Impairment

Dosage adjustments not likely required.1 Frequent glucose monitoring and dosage adjustments may be required for patients with hepatic impairment receiving insulin glargine/lixisenatide.15

Renal Impairment

Mild or moderate renal impairment (eGFR 30–89 mL/minute per 1.73 m2): Dosage adjustment of lixisenatide not required.1 Monitor for changes in renal function and for adverse effects (e.g., hypoglycemia, nausea, vomiting) when initiating or escalating dosage.1 May require frequent glucose monitoring and dosage adjustments for patients receiving insulin glargine/lixisenatide.15

Severe renal impairment (eGFR 15 to <30 mL/minute per 1.73 m2): Limited experience with use of lixisenatide in patients with severe renal impairment; closely monitor for the occurrence of adverse GI effects and changes in renal function.1 May require frequent glucose monitoring and dosage adjustments for patients receiving insulin glargine/lixisenatide.15

End-stage renal disease (ESRD; eGFR <15 mL/minute per 1.73 m2): Data and experience lacking on use of lixisenatide or insulin glargine/lixisenatide in patients with ESRD; not recommended in such patients.1 15 (See Renal Effects under Cautions.)

Cautions for Adlyxin

Contraindications

Known hypersensitivity to lixisenatide or any ingredient in the formulation.1 15

Insulin glargine/lixisenatide also contraindicated during episodes of hypoglycemia.15

Warnings/Precautions

Pancreatitis

Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, reported during postmarketing experience in patients treated with GLP-1 receptor agonists.1 36 FDA evaluating unpublished findings suggesting an increased risk of pancreatitis and precancerous pancreatic cell changes in patients with type 2 diabetes mellitus receiving incretin mimetics.36 37

In clinical trials, incidence of pancreatitis in lixisenatide-treated patients versus patients who received other antidiabetic therapy was 21 versus 17 per 10,000 patient-years; some patients in these trials had risk factors for pancreatitis (e.g., history of cholelithiasis or alcohol abuse).1

FDA has recommended that clinicians continue to follow the recommendations in the prescribing information for incretin mimetics.36 Observe patients carefully for manifestations of pancreatitis after drug initiation.1 12 15 38 Contact clinician promptly if symptoms of pancreatitis occur, including persistent severe abdominal pain that sometimes radiates to the back and that may or may not be accompanied by vomiting.1 15 38 Manufacturer states that if pancreatitis is suspected, promptly discontinue lixisenatide or insulin glargine/lixisenatide and initiate appropriate management.1 15 38 If pancreatitis is confirmed, do not restart therapy with lixisenatide or insulin glargine/lixisenatide.1 15

Safety and efficacy of lixisenatide not established in patients with chronic pancreatitis or a history of unexplained pancreatitis; consider other antidiabetic therapies in patients with a history of pancreatitis.1 15

Sharing of Injection Pens

Do not share injection pens of lixisenatide or insulin glargine/lixisenatide among patients, even if the needle has been changed; sharing poses risk for transmission of blood-borne pathogens.1 2 3 15 38 39

Use with Drugs Known to Cause Hypoglycemia

Risk of hypoglycemia increased when lixisenatide used in combination with a sulfonylurea or basal insulin; may require reduction in sulfonylurea or insulin dosage.1

Safety and efficacy of lixisenatide in combination with short-acting (e.g., prandial) insulin not established; concomitant use not recommended by the manufacturer.1

Medication Errors

Administration of insulin glargine/lixisenatide in dose >60 units (of insulin glargine component) may result in overdose of lixisenatide component.15 Do not exceed maximum lixisenatide dosage of 20 mcg daily; do not use insulin glargine/lixisenatide in combination with another GLP-1 receptor agonist.15

Renal Effects

Deterioration of renal function (e.g., acute kidney injury and worsening of chronic renal failure, sometimes requiring hemodialysis) reported with GLP-1 receptor agonists during postmarketing experience.1 15 Some patients did not have known underlying renal disease.1 15 Other factors (nausea, vomiting, diarrhea, or dehydration) were present in most patients.1 15

Monitor renal function closely during initiation or escalation of lixisenatide or insulin glargine/lixisenatide dosage in patients with renal impairment and in those with severe GI adverse effects.1 15

Immunogenicity

Development of antibodies to lixisenatide reported.1 Development of antibodies to lixisenatide and insulin glargine also reported with insulin glargine/lixisenatide therapy.15 Attenuated glycemic response reported in some patients with high (>100 nmol/L) antibody concentrations.1

If worsening glycemic control, failure to achieve targeted glycemic control, or clinically important injection-site or allergic reactions occur, consider alternative antidiabetic therapy.1 15

Macrovascular Outcomes

Evidence of macrovascular risk reduction with lixisenatide or insulin glargine/lixisenatide not conclusively demonstrated in controlled clinical trials.1 15

Use of Fixed Combinations

When lixisenatide is used in fixed combination with insulin glargine or other drugs, consider the cautions, precautions, contraindications, and interactions associated with the concomitant agent(s) in addition to those associated with lixisenatide.1 15

Sensitivity Reactions

Serious hypersensitivity reactions (anaphylaxis, angioedema) reported.1 Discontinue lixisenatide or insulin glargine/lixisenatide and promptly seek medical attention if hypersensitivity reaction occurs.1 15 Use with caution in patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist.1

Specific Populations

Pregnancy

Data are lacking on the use of lixisenatide or insulin glargine/lixisenatide in pregnant women.1 15 Lixisenatide has been associated with visceral and skeletal defects in rats and rabbits receiving the drug during organogenesis at dosages producing systemic exposures equal to or sixfold greater than, respectively, those achieved in humans at the highest recommended dosage (20 mcg/day).1 Lixisenatide or insulin glargine/lixisenatide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.1 15

Lactation

Lixisenatide is distributed into milk in rats; not known whether distributed into milk in humans.1 Consider the benefits of breast-feeding and the importance of lixisenatide to the woman along with any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.1

Pediatric Use

Safety and efficacy of lixisenatide or insulin glargine/lixisenatide not established in patients <18 years of age.1 15

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1 15 27 Use caution when administering insulin glargine/lixisenatide to geriatric patients since hypoglycemia may be difficult to recognize; initial dosing, dose increments, and maintenance dosage should be conservative to prevent hypoglycemia.15

Hepatic Impairment

Data lacking on use of lixisenatide in patients with acute or chronic hepatic impairment.1 Because lixisenatide is presumed to be cleared principally by the kidney, hepatic dysfunction not expected to affect pharmacokinetics; manufacturer makes no specific dosage recommendations for patients with hepatic impairment.1

Renal Impairment

Lixisenatide not recommended in patients with ESRD.1

In patients with mild, moderate, or severe renal impairment, lixisenatide plasma concentrations and systemic exposure were increased by 60, 42, or 83% and 34, 69, or 124%, respectively.1 No dosage adjustments recommended for patients with mild, moderate, or severe renal impairment receiving lixisenatide; however, closely monitor renal function of such patients and observe for adverse effects when initiating or escalating lixisenatide dosage.1 (See Renal Impairment under Dosage and Administration.)

Patients with Gastroparesis

Lixisenatide slows gastric emptying and may affect absorption of concomitantly administered oral drugs.1 (See GI Absorption of Other Drugs under Interactions.) Data lacking on use of lixisenatide or insulin glargine/lixisenatide in patients with preexisting gastroparesis.1 15

Common Adverse Effects

Lixisenatide: Nausea,1 4 vomiting,1 4 headache,1 4 diarrhea,1 dizziness,1 4 hypoglycemia.1 4

Insulin glargine/lixisenatide: Hypoglycemia,15 16 18 nausea,15 16 18 nasopharyngitis,15 diarrhea,15 upper respiratory tract infection,15 headache.15

Interactions for Adlyxin

In vitro, lixisenatide is neither an inducer nor an inhibitor of CYP isoenzymes; lixisenatide is not metabolized by CYP isoenzymes.30

GI Absorption of Other Drugs

Possible decreased rate and extent of absorption of concomitantly administered oral drugs; use caution with oral drugs that have a narrow therapeutic index or require careful clinical monitoring.1

With oral drugs for which efficacy depends on threshold concentrations or for which delay in effect would be undesirable, administer ≥1 hour before lixisenatide or insulin glargine/lixisenatide.1 15 If such drugs need to be administered with food, administer them with a meal or snack at a time when lixisenatide is not administered.1

Specific Drugs

Drug

Interaction

Comments

Acetaminophen

No change in overall AUC; decreased peak plasma concentration and increased time to peak plasma concentration of acetaminophen when administered 1 or 4 hours after lixisenatide1 30

No dosage adjustment necessary; administer acetaminophen ≥1 hour before lixisenatide31 33

Anti-infective agents, oral

Possible decreased rate and extent of anti-infective absorption with concomitant lixisenatide1

Administer oral anti-infective ≥1 hour before lixisenatide1

Atorvastatin

Decreased peak plasma concentration and increased time to peak plasma concentration with concurrent lixisenatide; increased AUC and peak plasma concentration when lixisenatide administered in morning and atorvastatin administered in evening1 30

Administer atorvastatin ≥1 hour before lixisenatide31 33

Digoxin

Decreased peak plasma digoxin concentration and delayed time to peak concentration when lixisenatide administered 30 minutes before digoxin; no change in digoxin steady-state AUC1 31

No change in digoxin dosage or timing of administration necessary; monitor appropriately31 33

Insulin

Increased risk of hypoglycemia with basal insulin; safety and efficacy of concurrent short-acting (e.g., prandial) insulin not established1

Consider reduced concomitant basal insulin dosage; concurrent use of short-acting (e.g., prandial) insulin not recommended1

Oral contraceptives (ethinyl estradiol/levonorgestrel)

Oral contraceptive given 1 or 4 hours after lixisenatide: Decreased peak plasma concentration and delayed time to peak plasma concentration of oral contraceptive components; overall AUC and mean terminal half-life not altered1

Oral contraceptive given 1 hour before or 11 hours after lixisenatide: No effect on peak plasma concentration, time to peak plasma concentration, AUC, or half-life of oral contraceptive components1

Administer oral contraceptive ≥1 hour before or 11 hours after lixisenatide1 31

Ramipril

Concomitant administration of lixisenatide and ramipril increased AUC and decreased the peak plasma concentration of ramipril and delayed time to peak plasma concentration of ramipril and ramiprilat (active metabolite) by 2.5 hours; no effect on AUC or peak plasma concentration of ramiprilat 1 30

No change in ramipril dosage or timing of administration necessary31 33

Sulfonylureas

Increased risk of hypoglycemia1

Consider reduced concomitant sulfonylurea dosage1

Warfarin

Decreased peak plasma concentration and delayed time to peak plasma concentration of warfarin during repeated lixisenatide dosing; no clinically important change in warfarin AUC or in INR1 31

No change in warfarin dosage or timing of administration necessary; monitor INR frequently31 33

Adlyxin Pharmacokinetics

Absorption

Bioavailability

Following sub-Q administration of lixisenatide, peak plasma concentration usually attained in 1–3.5 hours.1

Absorption of lixisenatide is similar when injected into abdomen, thigh, or arm.1

Special Populations

Peak plasma concentrations increased 60, 42, or 83% and AUC increased approximately 34, 69, or 124% in patients with mild, moderate, or severe renal impairment, respectively.1

Distribution

Extent

Distributed into milk in rats; not known whether distributed into human milk.1

Elimination

Metabolism

Principally glomerular filtration and proteolytic degradation.1 27

Half-life

Approximately 3 hours.1

Special Populations

Manufacturer states pharmacokinetics are independent of age, body weight, gender, and race.1

Stability

Storage

Parenteral

Injection

Lixisenatide: Before use, 2–8°C in original carton.1 3 After first use, <30ºC.1 3 Do not freeze; protect from light.1 2 Discard pen 14 days after first use.1

Insulin glargine/lixisenatide: Before use, 2–8°C in original carton.15 38 39 After first use, <25ºC.15 38 39 Do not freeze; protect from light.15 38 39 Discard pen 28 days after first use.15 38 39

Actions

  • Lixisenatide, a synthetic analog of a naturally occurring peptide (exendin-4) isolated from the saliva of Heloderma suspectum (Gila monster), is a GLP-1 receptor agonist (incretin mimetic).1 21 26 27 29

  • Stimulates insulin release in the presence of elevated glucose concentrations, suppresses glucose-dependent glucagon release, and slows gastric emptying, resulting in lower fasting and postprandial blood glucose concentrations and, potentially, weight loss in patients with type 2 diabetes mellitus.1 17 23 26

  • Long-acting GLP-1 agonists induce marked reductions in fasting plasma glucose (by stimulating insulin secretion) and modest reductions in postprandial glucose, while short-acting GLP-1 agonists (e.g., lixisenatide), have less of an effect on fasting plasma glucose concentrations and more of an effect on reducing postprandial glucose concentrations (by slowing gastric emptying and inhibiting glucagon secretion).23 26 29

  • Does not appear to be associated with clinically important prolongation of the corrected QT interval (QTc, Bazett's formula).1

Advice to Patients

  • Importance of patient reading medication guide and the injection pen instructions for use before initiating therapy and each time drug is dispensed.1 2 3 15 39

  • Importance of instructing patient and caregivers on preparation and use of injection pen prior to first use;1 15 39 training should include a practice injection.1

  • Importance of not mixing or diluting insulin glargine/lixisenatide with any other insulin or solution.15

  • Importance of informing patients of possibility of serious hypersensitivity reactions; instruct patients to discontinue lixisenatide or insulin glargine/lixisenatide and promptly seek medical advice if hypersensitivity symptoms occur.1 15

  • Importance of informing patient of the potential risk of acute pancreatitis.1 15 Importance of patient informing clinicians about a history of pancreatitis, gallstones, or alcoholism.2 Importance of informing patients about signs and symptoms of pancreatitis, including persistent severe abdominal pain sometimes radiating to the back that may or may not be accompanied by vomiting; importance of patient discontinuing lixisenatide or insulin glargine/lixisenatide and promptly notifying clinician if such signs or symptoms occur.1 15

  • Importance of informing patients that injection pens should not be shared with another person, even if the needle has been changed.1 2 3 15 38 Such sharing may pose a risk of transmitting or acquiring infection.1 2 3 15 38

  • Importance of informing patients of the risk of hypoglycemia, particularly if concomitant therapy with an insulin secretagogue (e.g., sulfonylurea) or insulin is used.1 2 15

  • Importance of informing patients of the potential risk of dehydration due to adverse GI effects; importance of advising patients to take precautions to avoid fluid depletion.1 2 15 Importance of informing patients of the potential risk for worsening renal function which in some cases may require dialysis.1 2 15

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 15 38

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 15 38

  • Importance of informing patients of other important precautionary information.1 15 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Lixisenatide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Kit, injection, for subcutaneous use

2 injection pens, 100 mcg/mL

Adlyxin Pen Maintenance Pack (available as prefilled injection pens)

Sanofi-Aventis

Kit, injection, for subcutaneous use

1 injection pen, 50 mcg/mL

1 injection pen, 100 mcg/mL

Adlyxin Pen Starter Pack (available as prefilled injection pens)

Sanofi-Aventis

Lixisenatide Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use

33 mcg/mL with Insulin Glargine 100 units/mL

Soliqua 100/33 (available as prefilled injection pens)

Sanofi-Aventis

AHFS DI Essentials™. © Copyright 2018, Selected Revisions July 30, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

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2. Sanofi-Aventis. Adlyxin (lixisenatide) injection), for subcutaneous use medication guide. Bridgewater, NJ; 2016 Jul.

3. Sanofi-Aventis. Adlyxin (lixisenatide) injection), for subcutaneous use instructions for use. Bridgewater, NJ; 2016 Jul.

4. Fonseca VA, Alvarado-Ruiz R, Raccah D et al. Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care. 2012; 35:1225-31. http://www.ncbi.nlm.nih.gov/pubmed/22432104?dopt=AbstractPlus

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6. Yu Pan C, Han P, Liu X et al. Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia). Diabetes Metab Res Rev. 2014; 30:726-35. http://www.ncbi.nlm.nih.gov/pubmed/24639432?dopt=AbstractPlus

7. Rosenstock J, Raccah D, Korányi L et al. Efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled on metformin: a 24-week, randomized, open-label, active-controlled study (GetGoal-X). Diabetes Care. 2013; 36:2945-51. http://www.ncbi.nlm.nih.gov/pubmed/23698396?dopt=AbstractPlus

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14. Pfeffer MA, Claggett B, Diaz R et al. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015; 373:2247-57. http://www.ncbi.nlm.nih.gov/pubmed/26630143?dopt=AbstractPlus

15. Sanofi-Aventis. Soliqua 100/33 (insulin glargine and lixisenatide injection), for subcutaneous use prescribing information. Bridgewater, NJ; 2017 Oct.

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17. . Lixisenatide for type 2 diabetes. Med Lett Drugs Ther. 2017; 59:19-21. http://www.ncbi.nlm.nih.gov/pubmed/28118649?dopt=AbstractPlus

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24. Christensen M, Miossec P, Larsen BD et al. The design and discovery of lixisenatide for the treatment of type 2 diabetes mellitus. Expert Opin Drug Discov. 2014; 9:1223-51. http://www.ncbi.nlm.nih.gov/pubmed/25119443?dopt=AbstractPlus

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33. Sanofi-Aventis. Bridgewater, NJ: Personal communication.

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38. Sanofi-Aventis. Soliqua 100/33 (insulin glargine and lixisenatide injection), for subcutaneous use medication guide. Bridgewater, NJ; 2017 Oct.

39. Sanofi-Aventis. Soliqua 100/33 (insulin glargine and lixisenatide injection), for subcutaneous use instructions for use. Bridgewater, NJ; 2017 Oct.

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