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Liraglutide

Class: Incretin Mimetics
Molecular Formula: C172H265N43O51
CAS Number: 204656-20-2
Brands: Saxenda, Victoza, Xultophy (combination)

Medically reviewed by Drugs.com on Jun 21, 2021. Written by ASHP.

Warning

    Risk of Thyroid C-Cell Tumors
  • Liraglutide causes dose-dependent and treatment duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice.

  • Unknown whether liraglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as relevance to humans of such tumors in rodents has not been determined.

  • Contraindicated in patients with a personal or family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2).

    Counsel patients regarding potential risk of MTC and inform them about symptoms of thyroid tumors. (See Advice to Patients.)

    Routine monitoring of serum calcitonin or use of thyroid ultrasound of uncertain value for early detection of MTC in patients receiving liraglutide. (See Risk of Thyroid C-Cell Tumors under Cautions.)

Introduction

Antidiabetic and antiobesity agent; acylated glucagon-like peptide-1 (GLP-1) agonist (incretin mimetic).

Uses for Liraglutide

Type 2 Diabetes Mellitus

Glycemic Control

Used as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Has been used in combination with metformin, a sulfonylurea, or the combination of metformin and a sulfonylurea as an adjunct to diet and exercise for the management of type 2 diabetes mellitus.

Used in fixed combination with insulin degludec (Xultophy) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Current guidelines for the treatment of type 2 diabetes mellitus generally recommend metformin as first-line therapy in addition to lifestyle modifications in patients with recent-onset type 2 diabetes mellitus or mild hyperglycemia because of its well-established safety and efficacy (i.e., beneficial effects on glycosylated hemoglobin [hemoglobin A1c; HbA1c], weight, and cardiovascular mortality).

In patients with metformin contraindications or intolerance (e.g., risk of lactic acidosis, GI intolerance) or in selected other patients, some experts suggest that initial therapy with a drug from another class of antidiabetic agents (e.g., a GLP-1 receptor agonist, sodium-glucose cotransporter 2 [SGLT2] inhibitor, dipeptidyl peptidase-4 [DPP-4] inhibitor, sulfonylurea, thiazolidinedione, basal insulin) may be acceptable based on patient factors.

May need to initiate therapy with 2 agents (e.g., metformin plus another drug) in patients with high initial HbA1c (>7.5% or ≥1.5% above target). In such patients with metformin intolerance, some experts suggest initiation of therapy with 2 drugs from other antidiabetic drug classes with complementary mechanisms of action.

Consider early initiation of combination therapy for the treatment of type 2 diabetes mellitus to extend the time to treatment failure and more rapidly attain glycemic goals.

For patients with inadequate glycemic control on metformin monotherapy, consider patient comorbidities (e.g., atherosclerotic cardiovascular disease [ASCVD], established kidney disease, heart failure), hypoglycemia risk, impact on weight, cost, risk of adverse effects, and patient preferences when selecting additional antidiabetic agents for combination therapy.

Consider early introduction of insulin for severe hyperglycemia (e.g., blood glucose of ≥300 mg/dL or HbA1c >9–10%), especially if accompanied by catabolic manifestations (e.g., weight loss, hypertriglyceridemia, ketosis) or symptoms of hyperglycemia.

Experts recommend that patients with type 2 diabetes mellitus who have established (or are at a high risk for) ASCVD, established kidney disease, or heart failure receive a GLP-1 receptor agonist or SGLT2 inhibitor with demonstrated cardiovascular disease benefit. In patients with these comorbidities, consider GLP-1 receptor agonist or SGLT2 inhibitor therapy independently of patient's HbA1c.

In patients with type 2 diabetes mellitus and CKD, consider a GLP-1 receptor agonist or SGLT2 inhibitor shown to reduce the risk of CKD progression, cardiovascular events, or both, in addition to metformin therapy or in those in whom metformin cannot be used.

In patients on metformin monotherapy without established ASCVD or indicators of high ASCVD risk, heart failure, or CKD, base decision regarding addition of other antidiabetic agents on avoidance of adverse effects, cost, and individual patient factors.

Safety and efficacy in combination with prandial insulin not demonstrated.

Liraglutide or fixed combination of insulin degludec and liraglutide (Xultophy) not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Victoza and Saxenda both contain liraglutide; do not use concomitantly.

Reduction in Risk of Major Adverse Cardiovascular Events

Used to reduce the risk of major adverse cardiovascular events (i.e., cardiovascular death, nonfatal MI, nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

Manufacturer states that effects on cardiovascular morbidity and mortality not established in patients receiving liraglutide for management of obesity.

Beneficial Effects on Renal Function

Some experts suggest that use of a GLP-1 receptor agonist may reduce risk of progression of albuminuria, cardiovascular events, or both in patients with type 2 diabetes mellitus and CKD who are at increased risk for cardiovascular events. Reduced risk of new or worsening nephropathy demonstrated with liraglutide in a clinical study.

Obesity

Used (as Saxenda) as an adjunct to a reduced-calorie diet and increased physical activity for the long-term management of body weight.

Used in patients who are obese (pretreatment body mass index [BMI] ≥30 kg/m2); also used in overweight patients (pretreatment BMI ≥27 kg/m2) who have at least one weight-related condition (e.g., hypertension, type 2 diabetes mellitus, dyslipidemia).

Manufacturer states that Saxenda preparation is not intended for use in the treatment of type 2 diabetes mellitus.(r24) In addition, Saxenda should not be used in combination with any other GLP-1 receptor agonist or with insulin.

Safety and efficacy in combination with other weight-loss products (prescription or OTC drugs, dietary or herbal supplements) not established.

Safety and efficacy not established in patients with a history of pancreatitis. (See Pancreatitis and Pancreatic Precancerous Changes under Cautions.)

Safety and efficacy in combination with insulin not established in the management of obesity; do not use with insulin for obesity management.

Saxenda and Victoza both contain liraglutide; do not use concomitantly.

Liraglutide Dosage and Administration

General

  • Perform regular monitoring (e.g., blood glucose determinations, HbA1c) to determine therapeutic response in patients with type 2 diabetes mellitus.

  • When used for obesity, evaluate body weight after 16 weeks. Discontinue treatment in patients who do not experience a meaningful weight loss (≥4% baseline weight); such patients unlikely to achieve and sustain meaningful weight loss with continued liraglutide therapy.

Administration

Administer liraglutide or the fixed combination of insulin degludec and liraglutide by sub-Q injection using a prefilled injection pen; do not administer IV or IM.

If a dose of liraglutide or the fixed combination of insulin degludec and liraglutide is missed, resume the regular schedule with the next scheduled dose; do not take an extra dose or increase the dose to replace a missed dose. If >3 days have elapsed since last dose, restart liraglutide or the fixed combination of insulin degludec and liraglutide at initial dosage and retitrate. (See Dosage under Dosage and Administration.)

Administer liraglutide and insulin as separate injections in patients receiving both drugs for diabetes mellitus; do not mix insulin and liraglutide. For patients receiving liraglutide in whom it is appropriate to add therapy with insulin degludec, these drugs are commercially available in fixed combination as Xultophy. May inject liraglutide and insulin in the same body regions; however, do not administer injections adjacent to each other.

Sub-Q Administration

Liraglutide: Administer once daily at any time of day without regard to meals.

Fixed combination of insulin degludec and liraglutide: Administer at the same time each day without regard to meals.

Administer liraglutide or the fixed combination of insulin degludec and liraglutide into abdomen, thigh, or upper arm.

Dosage

Dosage of the fixed combination of insulin degludec and liraglutide is expressed in terms of units of insulin degludec on the dose counter display of the Xultophy injection pen; each dosage unit delivers 1 unit of insulin degludec and 0.036 mg of liraglutide.

Pediatric Patients

Type 2 Diabetes Mellitus
Liraglutide
Sub-Q

Children and adolescents ≥10 years of age: Initially, 0.6 mg daily. After ≥1 week, may increase to 1.2 mg daily if additional glycemic control required. If needed, may further increase to 1.8 mg daily after ≥1 week of treatment with 1.2-mg daily dosage.

If >3 days have elapsed since the last dose, reinitiate at 0.6-mg dosage to minimize adverse GI effects and titrate dosage at the discretion of the clinician.

Adults

Type 2 Diabetes Mellitus
Liraglutide
Sub-Q

Initially, 0.6 mg daily. The 0.6-mg dosage is not effective for glycemic control in adults; intended only as a starting dose to reduce GI intolerance.

After 1 week, increase dosage to 1.2 mg daily. If clinical response is inadequate, may increase dosage to 1.8 mg daily after ≥1 week of treatment with 1.2-mg daily dosage.

If >3 days have elapsed since the last dose, reinitiate at 0.6-mg dosage to minimize adverse GI effects and titrate dosage at the discretion of the clinician.

Insulin Degludec/Liraglutide Fixed-combination Therapy
Sub-Q

Patients naive to basal insulin or GLP-1 receptor agonist: Initially, 10 units (10 units of insulin degludec with 0.36 mg of liraglutide) once daily.

Patients currently receiving basal insulin or a GLP-1 receptor agonist: Discontinue therapy with basal insulin GLP-1 receptor agonist. Initially, 16 units (16 units of insulin degludec with 0.58 mg of liraglutide) once daily.

Dosage of the fixed combination of insulin degludec and liraglutide may be increased or decreased by 2 units (of insulin degludec) every 3–4 days as needed. May be increased to a maximum daily dosage of 50 units (50 units of insulin degludec with 1.8 mg of liraglutide).

If >3 days have elapsed since the last dose, reinitiate fixed combination at starting dose to minimize adverse GI effects due to liraglutide component.

Obesity
Sub-Q

Initially, 0.6 mg daily.

Increase daily dosage by 0.6 mg at weekly intervals to maintenance dosage of 3 mg daily. (See Table 1.)

Table 1. Dosage Escalation Schedule for the Treatment of Obesity in Adults24

Week

Daily Dose

1

0.6 mg

2

1.2 mg

3

1.8 mg

4

2.4 mg

5 and onward

3 mg

If dosage increase not tolerated (e.g., adverse GI effects), may delay dosage escalation for approximately 1 week. If 3-mg daily dosage not tolerated, discontinue therapy; efficacy not established at dosages <3 mg daily.

If >3 days have elapsed since the last dose, reinitiate at 0.6-mg dosage to minimize adverse GI effects; retitrate to maintenance dosage of 3 mg once daily.

Special Populations

Liraglutide: No special population dosage recommendations. Use caution when initiating liraglutide or escalating dosage in patients with renal impairment. (See Renal Effects under Cautions.)

Fixed combination of insulin degludec and liraglutide: Data lacking on use in patients with hepatic impairment. Limited experience with use of the fixed combination in patients with mild or moderate renal impairment; intensify glucose monitoring and individualize dosage as required.

Cautions for Liraglutide

Contraindications

  • Personal or family history of MTC.

  • MEN 2.

  • Prior serious hypersensitivity to liraglutide or any component in the formulation.

  • Pregnancy (when used for obesity management). (See Pregnancy under Cautions.)

Warnings/Precautions

Warnings

Risk of Thyroid C-Cell Tumors

Dose-dependent and treatment-duration-dependent thyroid C-cell tumors found at clinically relevant exposures in rats and mice. Cases of MTC reported in patients receiving liraglutide during postmarketing experience; data insufficient to establish or exclude a causal relationship between MTC and liraglutide use in humans. Unknown whether liraglutide causes thyroid C-cell tumors, including MTC, in humans; relevance to humans could not be ruled out by clinical or nonclinical studies. Therefore, do not use as first-line treatment for diabetes mellitus until additional studies completed.

Very elevated serum calcitonin values may suggest MTC; such values generally exceed 50 ng/L in patients with MTC. Uncertain value of routine monitoring of serum calcitonin or thyroid ultrasound examinations; further evaluate patients if serum calcitonin is elevated or thyroid nodules noted on physical examination or neck imaging.

To specifically evaluate the risk of MTC, manufacturer is required to establish a cancer registry to monitor the rate of this type of cancer in the US over a period of 15 years.

Sensitivity Reactions

Hypersensitivity Reactions

Serious hypersensitivity reactions (anaphylaxis, angioedema) reported. Asthma, bronchial hyperreactivity, bronchospasm, oropharyngeal swelling, facial swelling, pharyngeal edema, and type IV hypersensitivity reactions also reported. Anaphylactic reactions with additional symptoms (e.g., hypotension, palpitations, dyspnea, edema) reported; may be potentially life-threatening.

Discontinue liraglutide-containing therapy and other suspect drugs and promptly seek medical advice if hypersensitivity reaction occurs. Use with caution in patients with a history of angioedema with another GLP-1 receptor agonist.

Other Warnings and Precautions

Use of Fixed Combinations

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

Pancreatitis and Pancreatic Precancerous Changes

Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, reported during postmarketing experience. Pancreatitis also reported during clinical trials. FDA has been evaluating unpublished findings suggesting an increased risk of pancreatitis and precancerous cellular changes in patients with type 2 diabetes mellitus receiving incretin mimetics. FDA will notify healthcare professionals of its conclusions and recommendations when the review is complete or when the agency has additional information to report.

FDA has recommended that clinicians continue to follow the recommendations in the prescribing information for incretin mimetics. Observe patients carefully for manifestations of pancreatitis after drug initiation and dosage increases. 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. Manufacturer states that if pancreatitis is suspected, promptly discontinue liraglutide and initiate appropriate management. If pancreatitis is confirmed, do not restart liraglutide.

Safety and efficacy of liraglutide not established in patients with a history of pancreatitis; not known whether such patients would have an increased risk of pancreatitis while taking liraglutide.

Acute Gallbladder Disease

May increase the risk of acute gallbladder disease. Cholelithiasis and cholecystitis reported in clinical trials; most cases required cholecystectomy.

Although substantial or rapid weight loss can increase risk of cholelithiasis, the incidence of acute gallbladder disease was greater with liraglutide than with placebo in obesity clinical trials, even after accounting for the degree of weight loss. If cholelithiasis suspected, gallbladder studies and appropriate clinical follow-up are recommended.

Sharing of Injection Pens

Do not share injection pens containing liraglutide (Victoza, Saxenda) or the fixed combination of liraglutide and insulin degludec (Xultophy) among patients, even if the needle has been changed; sharing poses risk for transmission of blood-borne pathogens.

Use with Drugs Known to Cause Hypoglycemia

Patients receiving liraglutide in combination with an insulin secretagogue (e.g., a sulfonylurea) or insulin may have an increased risk of hypoglycemia; reduction in sulfonylurea or insulin dosage may be necessary. Risk of hypoglycemia higher with liraglutide in pediatric patients ≥10 years of age with type 2 diabetes mellitus regardless of concomitant antidiabetic therapy.

Manufacturer states that insulin should not be used concomitantly in patients receiving liraglutide for the management of obesity.

Monitor blood glucose parameters prior to starting and during treatment in patients with type 2 diabetes mellitus receiving liraglutide for management of obesity. If needed, adjust dosage of coadministered antidiabetic drugs based on results of glucose monitoring and risk of hypoglycemia.

Monitor patients with type 2 diabetes mellitus for an increase in blood glucose when liraglutide is discontinued.

Elevated Heart Rate

Increases in heart rate observed with liraglutide therapy for type 2 diabetes mellitus or obesity management. Resting heart rate >100 bpm reported. Tachycardia reported in 0.6% of patients receiving liraglutide for management of obesity versus 0.1% of placebo recipients. Clinical importance of elevated heart rate unknown, especially in patients with cardiovascular or cerebrovascular disease who had limited exposure to liraglutide in obesity clinical trials.

Monitor heart rate regularly; if sustained increase in resting heart rate occurs during therapy, discontinue liraglutide.

Renal Effects

Acute renal failure and worsening of chronic renal failure (sometimes requiring hemodialysis) reported with GLP-1 receptor agonists, including liraglutide, during postmarketing experience. Some patients did not have known underlying renal disease. Other factors (nausea, vomiting, diarrhea, or dehydration) were present in most patients. Some patients received liraglutide in combination with one or more agents known to affect renal function or hydration status.

Not found to be directly nephrotoxic in preclinical or clinical studies.

Renal effects usually reversible with supportive treatment and discontinuance of potentially causative agents, including liraglutide. Use caution when initiating liraglutide or escalating dosage in patients with renal impairment.

Suicidality

Suicidal ideation observed in clinical trials for obesity; suicide attempt reported in one patient.

Monitor patients receiving liraglutide for emergence or worsening of depression, suicidal thoughts or behavior (suicidality), and/or any unusual changes in mood or behavior. Discontinue in patients who experience suicidal thoughts or behaviors.

Avoid use in patients with a history of suicidal attempts or active suicidal ideation.

Immunogenicity

Development of antibodies to liraglutide reported. Development of cross-reactive antibodies to native GLP-1 peptide has occurred; potential for clinically important neutralization of native GLP-1 unknown. Antibody formation has not been associated with reduced efficacy of liraglutide or an increase in adverse events potentially related to immunogenicity (e.g., urticaria, angioedema). However, presence of antibodies has been associated with a higher incidence of injection site reactions and reports of low blood glucose, usually mild and resolving with continued treatment.

Specific Populations

Pregnancy

Data are lacking on the use of liraglutide (Victoza) in pregnant women. Reproduction studies in rats using liraglutide have shown teratogenic effects. Studies in rabbits have shown reduced growth and major abnormalities. Use liraglutide for the management of diabetes mellitus during pregnancy only when potential benefits justify possible risks to fetus.

Weight loss offers no potential benefit to pregnant women and may result in fetal harm. Manufacturer states that liraglutide is contraindicated for the management of obesity in pregnant women. Discontinue liraglutide for obesity management if patient is or plans to become pregnant.

Lactation

Liraglutide is distributed into milk in rats; not known whether distributed into milk in humans. Discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Pediatric Use

Safety and efficacy of liraglutide for the management of type 2 diabetes mellitus not established in children or adolescents <10 years of age.

Safety and efficacy of liraglutide for chronic weight management not established, and use not recommended, in children or adolescents <18 years of age.

Safety and efficacy of the fixed combination of insulin degludec and liraglutide not established in pediatric patients.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.

Hepatic Impairment

Limited experience in patients with hepatic impairment; use caution.

Renal Impairment

In a clinical study of 26 weeks' duration, patients with moderate renal impairment (eGFR 30–59 mL/minute per 1.73 m2) who received liraglutide 1.8 mg once daily had no worsening of renal function. Experience with liraglutide in patients with renal impairment or end-stage renal disease is limited. Use caution when initiating or escalating doses of liraglutide in patients with renal impairment.

Patients with Gastroparesis

Slows gastric emptying and potentially may affect absorption of concomitantly administered oral drugs. (See Orally Administered Drugs under Interactions.) Has not been studied in patients with preexisting gastroparesis.

Common Adverse Effects

Liraglutide for management of type 2 diabetes mellitus: Nausea, diarrhea, vomiting, constipation, upper respiratory tract infection, headache, influenza, urinary tract infection, dizziness, sinusitis, nasopharyngitis, back pain.

Liraglutide for management of obesity: Nausea, hypoglycemia (in patients with both obesity and type 2 diabetes mellitus), headache, diarrhea, constipation, dizziness, fatigue, vomiting, gastroenteritis, abdominal pain, urinary tract infection, abdominal distention, dyspepsia, upper abdominal pain, flatulence, decreased appetite, increased lipase, GERD, insomnia, anxiety, viral gastroenteritis, dry mouth, asthenia, injection site reaction, eructation, injection site erythema.

Fixed combination of insulin degludec and liraglutide: Nasopharyngitis, headache, nausea, diarrhea, increased lipase, upper respiratory tract infection.

Interactions for Liraglutide

No formal drug interaction studies to date with fixed-combination preparation.

Low potential for pharmacokinetic interactions related to CYP metabolism.

Orally Administered Drugs

Possible decreased rate and extent of absorption of concomitantly administered oral drugs; use caution with concomitantly administered oral drugs.

Specific Drugs

Drug

Interaction

Comments

Acetaminophen

Potential decreased peak plasma acetaminophen concentration and absorption rate; no change in overall AUC

Atorvastatin

Potential decreased peak plasma atorvastatin concentration and absorption rate; no change in overall AUC

Digoxin

Decreased peak plasma digoxin concentration and absorption rate following single digoxin dose

Griseofulvin

Increased peak plasma griseofulvin concentration following single griseofulvin dose

Hormonal contraceptives, oral

Potential reduced peak plasma concentrations and rates of absorption of ethinyl estradiol and levonorgestrel; increased AUC of levonorgestrel but no effect on ethinyl estradiol AUC

Insulin

Risk of hypoglycemia increased when used in conjunction with basal insulin

Insulin detemir: No pharmacokinetic interaction observed following administration of separate sub-Q injections of insulin detemir and liraglutide

Dosage reduction of insulin may be required

Insulin secretagogue (e.g., sulfonylurea)

Risk of hypoglycemia increased

Dosage reduction of sulfonylurea may be required

Lisinopril

Decreased peak plasma lisinopril concentration, AUC, and absorption rate following single lisinopril dose

Liraglutide Pharmacokinetics

Absorption

Bioavailability

Absolute: Approximately 55% after sub-Q administration; exposures similar following sub-Q injection into upper arm, abdomen, or thigh.

Peak plasma concentration achieved in 11 hours (range: 8-12 hours) following sub-Q administration.

Duration

Sustained glucose-lowering activity for 24 hours after a dose of liraglutide at steady state.

Plasma Concentrations

No QTc (QT interval corrected for rate, Bazett’s formula) prolongation at steady-state concentrations after liraglutide dosages up to 1.8 mg daily.

Distribution

Plasma Protein Binding

>98%.

Elimination

Metabolism

Endogenously metabolized in a similar manner to large proteins without a specific organ as a major route of elimination. Dipeptidyl peptidase-4 (DPP-4) and neutral endopeptidase (NEP) likely involved in its degradation.

Elimination Route

Only a minor portion of liraglutide-related metabolites excreted in urine (6%) or feces (5%).

Half-life

13 hours after sub-Q administration.

Stability

Storage

Parenteral

Injection

Liraglutide: Before use, 2–8°C. After first use, can be stored at 15–30ºC or 2–8°C. Do not freeze and do not use if frozen; protect from heat and light. Discard injection pen 30 days after first use.

Fixed combination of insulin degludec and liraglutide: Before use, 2–8°C. After first use, can be stored at 15–30ºC or 2–8°C. Do not freeze and do not use if frozen; protect from heat and light. Discard injection pen 21 days after first use.

Actions

  • An acylated long-acting human GLP-1 receptor agonist; synthetic (recombinant DNA origin) peptide precursor has 97% amino acid sequence homology to endogenous human GLP-1(7-37).

    Binds to and activates the GLP-1 receptor in pancreatic β cells.

  • Increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations. This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia.

  • Suppresses glucagon secretion in a glucose-dependent manner but does not impair normal glucagon response to hypoglycemia.

  • Delays gastric emptying, reducing the rate at which postprandial glucose appears in the circulation.

  • Effectively reduces fasting and postprandial plasma glucose concentrations in patients with type 2 diabetes.

  • GLP-1 is a physiological regulator of appetite. Weight loss effects of liraglutide are mediated by decreased calorie intake; drug does not increase energy expenditure.

Advice to Patients

  • When liraglutide is used in fixed combination with other drugs, importance of informing patients of important cautionary information about the concomitant agent(s).

  • Importance of reading manufacturer’s medication guide and the injection pen's patient instructions for use before starting therapy with liraglutide or the fixed combination of insulin degludec and liraglutide and of reviewing this information each time the prescription is renewed. Importance of clinicians instructing patients in proper injection technique to reduce administration errors (e.g., needle sticks, incomplete dosing).

  • Importance of informing patients that liraglutide causes benign and malignant thyroid C-cell tumors in mice and rats and that relevance of this finding to humans is unknown. Importance of counseling patients to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia, dyspnea) or a personal or family history of thyroid cancer, including MTC or MEN 2, to their clinician.

  • Importance of informing patients of potential risk of acute pancreatitis, which may be severe or fatal, with liraglutide therapy. Importance of patient informing clinicians about a history of pancreatitis. 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 instructing patients to discontinue liraglutide or the fixed combination of insulin degludec and liraglutide promptly and contact their clinician if persistent, severe abdominal pain occurs.

  • Importance of informing patients of the risk of gallbladder disease, which can require cholecystectomy. Importance of informing patients that substantial or rapid weight loss increases the risk of cholelithiasis; however, cholelithiasis can occur in the absence of weight loss. Patients should be instructed to contact their clinician if they experience symptoms of gallbladder disease (e.g., abdominal pain, fever, jaundice, clay-colored stools).

  • Importance of informing patient of risk of hypoglycemia, particularly if concomitant therapy with an insulin secretagogue (e.g., a sulfonylurea) or insulin is used. Importance of reviewing signs, symptoms, and management of hypoglycemia.

  • Risk of increased resting heart rate; importance of advising patients that their heart rate should be measured periodically during therapy. Patients should be instructed to contact their clinician if they experience sustained palpitations or tachycardia at rest.

  • Importance of informing patients of risk of dehydration because of adverse GI reactions; advise patients to take precautions to avoid fluid depletion. Importance of informing patients of potential risk of worsening renal function, which may require dialysis in some cases.

  • Importance of informing patients of possibility of serious hypersensitivity reactions; instruct patients to discontinue liraglutide-containing therapy and promptly seek medical advice if hypersensitivity symptoms occur.

  • Potential risk of suicidality; importance of patients being alert to and immediately reporting emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Importance of patient discontinuing liraglutide if suicidal thoughts or behaviors are experienced.

  • Importance of informing patients that they should never share an injection pen containing liraglutide or the fixed combination of insulin degludec and liraglutide with another person, even if the needle is changed; sharing of the pen may pose a risk of transmission of infection.

  • Importance of instructing patients with diabetes mellitus regarding self-monitoring of blood glucose, periodic HbA1c monitoring, adherence to meal planning, and regular physical exercise.

  • Importance of informing patients of the most common side effects, including headache, nausea, and diarrhea. Nausea is most common when first starting liraglutide, but decreases over time in most patients and does not typically require discontinuance of the drug.

  • Importance of reading manufacturer’s patient information (e.g., medication guide) and the injection pen user manual before starting liraglutide therapy and of reviewing this information each time the prescription is renewed.

  • Importance of cautioning patients not to take an extra dose of liraglutide or the fixed combination of insulin degludec and liraglutide to make up for a missed dose. If a dose is missed, patients should resume the once-daily regimen with the next scheduled dose.

  • Importance of informing patients that if >3 days have passed since the last dose of liraglutide, the drug should be reinitiated at dosage of 0.6 mg once daily to mitigate GI symptoms associated with reinitiation of treatment, then retitrated. (See Dosage under Dosage and Administration.)

  • Importance of informing patients that if >3 days have passed since the last dose of the fixed combination of insulin degludec and liraglutide, the drug should be reinitiated at the starting dose to mitigate GI symptoms. (See Dosage under Dosage and Administration.)

  • Importance of instructing patients to discontinue use of liraglutide for the management of obesity if 4% weight loss not achieved after 16 weeks of therapy.

  • Response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels towards the normal range.

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

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., gallstones, hypertension, pancreatitis, history of alcoholism, high triglyceride concentrations, digestion problems, severe kidney disease, kidney transplant).

  • Importance of informing patients of other important precautionary information. (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.

Liraglutide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use

6 mg/mL

Victoza (available as prefilled cartridge pen)

Novo Nordisk

6 mg/mL

Saxenda (available as prefilled cartridge pen)

Novo Nordisk

Liraglutide Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use

3.6 mg/mL with Insulin Degludec 100 units/mL

Xultophy (available as prefilled injection pens)

Novo Nordisk

AHFS DI Essentials™. © Copyright 2022, Selected Revisions June 21, 2021. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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