Lixisenatide

Aka: Lixisenatide, Adlyxin, Soliqua

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II. Background

  1. Lixisenatide was discontinued in the U.S. in 2023
    1. Soliqua (Lixisenatide combined with Insulin Glargine) is still available

III. Indications

  1. See GLP-1 Agonist
  2. Type II Diabetes Mellitus
    1. Very effective for weight loss in comorbid Obesity
    2. May be used in combination with Basal insulin (e.g. Lantus)
  3. Insulin deficiency and Insulin Resistance
    1. Adjunct to Glucophage, Sulfonylureas, Glitazones
  4. Weight Loss
    1. At least 50% of weight regained on stopping GLP-1 agents

IV. Contraindications

  1. See GLP-1 Agonist
  2. Type I Diabetes Mellitus
  3. Medullary Thyroid Carcinoma (personal or Family History)
  4. Multiple Endocrine Neoplasia syndrome type 2 (active)
  5. Concurrent prandial Insulin (Bolus Insulin)
    1. Basal insulin (e.g. Lantus) may be used
  6. Severe Gastrointestinal Diseases or Gastroparesis
    1. Relative contraindication due to the high Incidence of gastrointestinal side effects with GLP-1 Agonists
  7. Severe Chronic Kidney Disease Stage 5 (eGFR <15 ml/min)

V. Mechanism

  1. See GLP-1 Agonist
  2. Glucagon-Like Peptide 1 (GLP-1) Agonist, an Incretin Mimetic, derived from Gila monster Saliva
    1. Increases Glucose dependent Insulin secretion
    2. Inhibits Glucagon secretion
    3. Delays gastric emptying
    4. Decreases food intake (improves satiety and decreases appetite)
      1. Direct effects at the Hypothalamus, Nucleus Accumbens, ventral tegmental areas and Vagus Nerve

VI. Medications

  1. Precautions
    1. All GLP-1 Agonists are expensive ($600 to $1300 per month in 2024)
    2. GLP-1 shortages (esp. Semaglutide and Tirzepatide) have resulted in many online resellers
      1. Buy from only licensed pharmacies (U.S.), and appropriately accredited (e.g. compounding pharmacy)
      2. Certificates of analysis confirm active ingredient
  2. Lixisenatide (Adlyxin)
    1. Newer agent of the class (released in 2017)
    2. Once daily injection dosing
    3. Available in multidose 3 ml pens: 10 mcg dose (50 mcg/ml) or 20 mcg dose (100 mcg/ml)
  3. Combination: Insulin Glargine with Lixisenatide (Soliqua)
    1. Addition of Lixisenatide, may spare basal Insulin Dosing
    2. However, limits titration of basal Insulin Dosing (fixed dose combinations)
    3. Very expensive ($760 to 950 per month in 2024)

VII. Dosing

  1. Give subcutaneous doses in the upper arm, Abdomen or thigh (and rotate injection sites)
  2. Administer injection within 1 hour of first meal of day
  3. Start 10 mg SQ daily
  4. May increase to 20 mg SQ daily after 14 days

VIII. Adverse Effects

  1. See GLP-1 Agonist
  2. Nausea or Vomiting
    1. Eat smaller meals and more slowly, stopping before fullness (satiety)
    2. Consider short-term Ondansetron
    3. Consider dose reduction until tolerated
  3. Diarrhea
  4. Dizziness
  5. Headache
  6. Hypoglycemia
    1. Alone, GLP-1 Agonists do not significantly increase risk of Hypoglycemia
    2. Avoid combination with Bolus Insulin (Mealtime Insulin) or Insulin Secretagogues (e.g. Sulfonylureas)
    3. With Sulfonylurea: 14.4% at 5 mcg, 35.7% at 10 mcg
    4. With Metformin: 4.5% at 5 mcg, 5.3% at 10 mcg
  7. Pancreatitis (occurs with all GLP-1 Agonists)
    1. Singh (2013) JAMA Intern Med 173(7):534-9 [PubMed]
  8. Gallbladder disease (Cholelithiasis, Cholecystitis, Choledocholithiasis)
    1. Increased by one in 357 patients over 3 years of medication use
    2. Increased with longer use, higher dose and when GLP-1 Agonist is used for weight loss
    3. Faillie (2016) JAMA Intern Med 176(10): 1474-81 +PMID: 27478902 [PubMed]
  9. Subcutaneous Fat Loss
    1. Desired weight loss (esp. Semaglutide) may result in loose, sagging skin ("Ozempic face")
  10. Other serious but uncommon effects (<1%)
    1. Acute Kidney Injury
    2. Angioedema
    3. Suicidality (case reports, FDA is investigating as of 2024)

IX. Safety

  1. Unknown safety in Lactation
  2. Most GLP-1 Agonists have unknown safety in pregnancy (avoid)
    1. High dose weight loss GLP-1 Agonists (e.g. Saxena, Wegovy) are considered Pregnancy Category X

X. Drug Interactions

  1. Avoid using 2 Incretins (e.g. Byetta with Januvia) in combination
    1. Raises cost, risk of Pancreatitis without significant benefit
    2. (2012) Presc Lett 19(8): 45
  2. Concurrent prandial Insulin (Bolus Insulin)
    1. Basal insulin (e.g. Lantus) may be used
  3. Medications that require rapid gastrointestinal absorption
    1. Take at least one hour before Immediate release Lixisenatide (Adlyxin)

XI. Resources

  1. Lixisenatide (DailyMed)
    1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471orig1s000lbl.pdf
  2. Insulin Glargine with Lixisenatide: Soliqua (DailyMed)
    1. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4bba538b-cf7c-4310-ae8f-cb711ed21bcc

XII. References

  1. (2024) Presc Lett 31(7): 38
  2. (2024) Presc Lett 31(2): 8-9
  3. (2022) Presc Lett 30(2): 7
  4. (2019) Presc Lett 26(11):62-3
  5. (2019) Presc Lett 26(8):46
  6. (2018) Presc Lett 25(2)
  7. (2014) Presc Lett 21(12): 69
  8. (2012) Presc Lett 19(3): 15
  9. Nordt and Kaucher (2023) EM:Rap 23(9)
  10. Dungan (2005) Clin Diabetes 23: 56-62 [PubMed]
  11. Ezzo (2006) Am Fam Physician 73 [PubMed]
  12. Fineman (2003) Diabetes Care 26:2370-7 [PubMed]
  13. Jones (2007) Am Fam Physician 75:1831-5 [PubMed]
  14. Joy (2005) Ann Pharmacol 39:110-8 [PubMed]
  15. Vaughan (2024) Am Fam Physician 109(4): 333-42 [PubMed]

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Related Studies

Cost: Medications

soliqua (on 1/3/2022 at Medicaid.Gov Survey of pharmacy drug pricing)
SOLIQUA 100 UNIT-33 MCG/ML PEN $51.69 per ml
FPNotebook does not benefit financially from showing this medication data or their pharmacy links. This information is provided only to help medical providers and their patients see relative costs. Insurance plans negotiate lower medication prices with suppliers. Prices shown here are out of pocket, non-negotiated rates. See Needy Meds for financial assistance information. GoodRx is another tool for finding lower drug prices.

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