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Liraglutide

Medically reviewed by Drugs.com. Last updated on Aug 17, 2020.

Pronunciation

(lir a GLOO tide)

Index Terms

  • NN2211

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Pen-injector, Subcutaneous:

Saxenda: 18 mg/3 mL (3 mL) [contains phenol, propylene glycol]

Victoza: 18 mg/3 mL (3 mL) [contains phenol, propylene glycol]

Brand Names: U.S.

  • Saxenda
  • Victoza

Pharmacologic Category

  • Antidiabetic Agent, Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist

Pharmacology

Liraglutide is a long acting analog of human glucagon-like peptide-1 (GLP-1) (an incretin hormone) which increases glucose-dependent insulin secretion, decreases inappropriate glucagon secretion, increases B-cell growth/replication, slows gastric emptying, and decreases food intake. Liraglutide administration results in decreases in hemoglobin A1c by approximately 1%.

Distribution

Vd: SubQ: ~13 to 25 L; IV: 0.07 L/kg

Metabolism

Endogenously metabolized by dipeptidyl peptidase 4 (DPP-4) and endogenous endopeptidases (Croom 2009); metabolism occurs slower than that seen with native GLP-1

Excretion

Urine (6%, as metabolites); feces (5%, as metabolites)

Time to Peak

Plasma: SubQ: 8 to 12 hours

Half-Life Elimination

~13 hours

Protein Binding

>98%

Special Populations Note

Body weight: Exposure decreases with an increase in baseline body weight; however, the 1.2 mg and 1.8 mg daily doses of liraglutide provided adequate systemic exposures over the body weight range of 40 to 160 kg.

Use: Labeled Indications

Chronic weight management (Saxenda): As an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of ≥30 kg/m2 (obesity) or ≥27 kg/m2 (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, dyslipidemia).

Diabetes mellitus, type 2, treatment (Victoza): As an adjunct to diet and exercise to improve glycemic control in children ≥10 years of age, adolescents, and adults with type 2 diabetes mellitus; risk reduction of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

Contraindications

Prior serious hypersensitivity to liraglutide or any component of the formulation; history of or family history of MTC; patients with multiple endocrine neoplasia syndrome type 2 (MEN2); pregnancy (Saxenda).

Canadian labeling: Additional contraindications (not in US labeling): Pregnancy (Saxenda, Victoza); breastfeeding

Dosing: Adult

Note: Due to lack of additive glycemic benefit, avoid concomitant use with a dipeptidyl peptidase-4 inhibitor (ADA/EASD [Davies 2018]; Nauck 2017). May require a dose reduction of insulin and/or insulin secretagogues to avoid hypoglycemia.

Diabetes mellitus, type 2, treatment:

Note: May be used as an adjunctive agent or alternative monotherapy for select patients, including those who fail initial therapy with lifestyle intervention and metformin or who cannot take metformin. Liraglutide may be preferred as an additional antidiabetic agent or alternative first-line agent in patients with atherosclerotic cardiovascular disease and/or in patients with an HbA1c relatively far from goal (HbA1c >9% and type 1 diabetes is not likely) (ADA 2020; Marso 2016; Wexler 2020).

SubQ: Initial: 0.6 mg once daily for 1 week, then increase to 1.2 mg once daily; if optimal glycemic response is not achieved after an additional week of treatment, may increase further to 1.8 mg once daily. Note: The lower initial dose (0.6 mg daily) is intended to reduce GI symptoms; it does not provide effective glycemic control.

Obesity and select overweight patients:

Note: For use as an adjunct to diet and exercise in obese patients or overweight patients with ≥1 weight-associated comorbidity (eg, hypertension, dyslipidemia). Considered a preferred pharmacologic weight-loss option in obese and overweight patients with type 2 diabetes mellitus, particularly in patients with atherosclerotic cardiovascular disease (AACE/ACE [Garvey 2016]; ES [Apovian 2015]; ES [Bray 2018]; Marso 2016; Perreault 2020).

SubQ: Initial: 0.6 mg once daily for 1 week; increase by 0.6 mg daily at weekly intervals to a target dose of 3 mg once daily. If the patient cannot tolerate an increased dose during dose escalation, consider delaying dose escalation for 1 additional week. According to the manufacturer, efficacy has not been established at doses <3 mg/day; however, some experts will continue a patient on the maximum tolerated dose (even if <3 mg/day) if goal weight loss is achieved on that dose (Perreault 2020).

Note: Evaluate change in body weight after 12 weeks at maximum tolerated dose or 16 weeks after initiation of therapy; discontinue if at least 4% to 5% of baseline body weight loss has not been achieved (ADA 2020; manufacturer's labeling).

Missed doses: In the event of a missed dose, the once-daily regimen can be resumed with the next scheduled dose (an extra dose or an increase in the next dose should not be attempted); if >3 days have passed since the last liraglutide dose, reinitiate therapy at 0.6 mg/day to avoid GI symptoms and titrate according to clinical judgment considering previous GI tolerability.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Diabetes mellitus, type 2; adjunct to diet and exercise: Children ≥10 years and Adolescents: Victoza: SubQ: Initial: 0.6 mg once daily for at least 1 week; may increase by 0.6 mg/day increments at weekly intervals to achieve glycemic control (week 2: increase to 1.2 mg once daily; week 3: increase to 1.8 mg once daily); maximum daily dose: 1.8 mg/day. In clinical trials, all patients were on concomitant stable doses of metformin (1,000 to 2,000 mg/day) with or without basal insulin; patients on basal insulin had insulin dose reductions (by 20%) during liraglutide therapy titration (Tamborlane 2019).

Missed doses: If more than 3 days of therapy are missed, therapy should be restarted at the initial dose (0.6 mg/day) and retitrated to avoid GI symptoms.

Obesity; adjunct to strict lifestyle interventions:

Children ≥12 years and Adolescents ≤17 years: Limited data available (Fox 2019; Srivastava 2019): SubQ: Initial: 0.6 mg once daily; increase by 0.6 mg/day increments at weekly intervals up to target dose of 3 mg once daily. Dosing based on a double-blind, parallel-group, placebo-controlled trial including 14 subjects in liraglutide treatment group (age range: 12 to 17 years; Tanner stage: 2 to 5) with a BMI corresponding to both a 95th percentile for age and sex and an adult BMI of 30 to 45 kg/m2. After 6 weeks of therapy, results showed a decrease in mean BMI z-score and body weight with treatment and placebo; however, the difference between treatment and placebo did not reach statistical significance; safety analysis reported similar safety and tolerability profile as adults treated for obesity (Danne 2017)

Adolescents ≥18 years: Saxenda: SubQ: Initial: 0.6 mg once daily for 1 week; increase by 0.6 mg/day increments at weekly intervals to a target dose of 3 mg once daily. If the patient cannot tolerate an increased dose during dose escalation, consider delaying dose escalation for one additional week. If the 3 mg daily dose is not tolerated, discontinue use as efficacy has not been established at lower doses. After 16 weeks of therapy, assess body weight; if patient has not lost ≥4% of baseline bodyweight, discontinue therapy since patient is unlikely to achieve meaningful and sustainable results with liraglutide.

Missed doses: If more than 3 days of therapy are missed, therapy should be restarted at the initial dose (0.6 mg/day) and retitrated to avoid GI symptoms.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Administration

SubQ: Inject subcutaneously in the upper arm, thigh, or abdomen. Do not inject intravenously or intramuscularly. Administer without regard to meals or time of day. Change needle with each administration. Use only if clear, colorless, and free of particulate matter. Do not share pens between patients even if needle is changed. If using concomitantly with insulin, administer as separate injections (do not mix); may inject in the same body region as insulin, but not adjacent to one another.

Dietary Considerations

Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy.

Storage

Prior to initial use, store at 2°C to 8°C (36°F to 46°F); after initial use, may be stored at 2°C to 8°C (36°F to 46°F) or at 15°C to 30°C (59°F to 86°F). Do not freeze (discard if freezing occurs) or store directly adjacent to the refrigerator cooling element. Protect from heat and light. Pen should be discarded 30 days after initial use.

Drug Interactions

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Exceptions: Danazol. Monitor therapy

Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Insulins: Liraglutide may enhance the hypoglycemic effect of Insulins. Management: Consider reducing the liraglutide dose if coadministered with insulin. Prescribing information for the Saxenda brand of liraglutide recommends a dose decrease of 50%. Monitor blood glucose for hypoglycemia. Consider therapy modification

Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Ritodrine: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Monitor therapy

Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Consider therapy modification

Sulfonylureas: Glucagon-Like Peptide-1 Agonists may enhance the hypoglycemic effect of Sulfonylureas. Management: Consider sulfonylurea dose reductions when used in combination with glucagon-like peptide-1 agonists. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Adverse Reactions

Obesity:

>10%:

Cardiovascular: Increased heart rate (>10 bpm from baseline: 34%; >20 bpm from baseline: 5%)

Endocrine & metabolic: Hypoglycemia (monotherapy: 7% to 13%; patients with type 2 diabetes: combination therapy with sulfonylurea: 28%; severe hypoglycemia [requiring the assistance of another person] in combination therapy with a sulfonylurea: <1%; patients without type 2 diabetes: 2%)

Gastrointestinal: Constipation (19% [placebo: 9%]), diarrhea (21% [placebo: 10%]), nausea (39% [placebo: 14%]), vomiting (16% [placebo: 4%])

Local: Injection site reaction (including erythema, pruritus, rash) (1% to 14%) (Carvallo 2020; Neel 2019)

Nervous system: Headache (14%)

1% to 10%:

Cardiovascular: Tachycardia (6%; one resting heart rate >100 bpm)

Endocrine & metabolic: Altered hormone level (1%; increased serum calcitonin)

Gastrointestinal: Abdominal distension (5%), abdominal pain (5% [placebo: 3%]), cholelithiasis (2% [placebo: <1%]), dyspepsia (10% [placebo: 3%]), eructation (5%), flatulence (4%), gastroenteritis (5%), gastroesophageal reflux disease (5%), increased serum lipase (2% to 5%), upper abdominal pain (5%), viral gastroenteritis (3%), xerostomia (2%)

Genitourinary: Urinary tract infection (4%)

Immunologic: Antibody development (3%; neutralizing: 1%)

Nervous system: Dizziness (7%), fatigue (8%)

Neuromuscular & skeletal: Asthenia (2%)

<1%:

Cardiovascular: First degree atrioventricular block, left bundle branch block, right bundle branch block, systolic hypotension

Gastrointestinal: Benign gastrointestinal neoplasm (colorectal), cholecystitis [placebo: 0.4%]

Hematologic & oncologic: Malignant neoplasm, malignant neoplasm of breast, malignant neoplasm of colon or rectum, papillary thyroid carcinoma

Nervous system: Suicidal ideation

Type 2 diabetes mellitus: Incidence reported with adult patients in monotherapy trials unless otherwise specified.

>10%:

Endocrine & metabolic: Hypoglycemia (children and adolescents: 21%; literature suggests an increased risk of hypoglycemia in pediatric patients regardless of concomitant use of other antidiabetic agents [Danne 2017; Mastrandea 2019; Tamborlane 2019])

Gastrointestinal: Diarrhea (10% to 12% [placebo: 4%]), nausea (18% to 20% [placebo: 5%])

Nervous system: Headache (10% to 11%)

Respiratory: Upper respiratory tract infection (7%)

1% to 10%:

Endocrine & metabolic: Increased amylase (1%)

Gastrointestinal: Cholecystitis (1% [placebo: <1%]), cholelithiasis (2% [placebo: 1%]), constipation (5% [placebo: 1%]), dyspepsia (4% to 7% [placebo: 1%]), increased serum lipase (8%), vomiting (6% to 9% [placebo: 2%])

Hepatic: Hyperbilirubinemia (monotherapy and combination trials: 4%)

Immunologic: Antibody development (≤9%; neutralizing antibodies: 2%)

Local: Injection site reaction (including erythema, rash) (monotherapy and combination trials: 2%)

Neuromuscular & skeletal: Back pain (4% to 5%)

Respiratory: Nasopharyngitis (9% to 10%)

<1%: Hematologic & oncologic: Papillary thyroid carcinoma

Postmarketing (any indication):

Dermatologic: Psoriasiform eruption (rare: <1%) (Bovijn 2019), pustular rash (exanthematous pustulosis; rare: <1%) (Cogen 2019), vesicular eruption (vesiculopustular dermatosis; rare: <1%) (Besemer 2012)

Endocrine & metabolic: Thyroid disease (C-cell hyperplasia)

Gastrointestinal: Acute pancreatitis (including hemorrhagic pancreatitis and necrotizing pancreatitis; rare: <1%) (FDA 2013), cholangitis (rare: <1%) (Faillie 2016), cholestasis (Faillie 2016; Pi-Sunyer 2015), pancreatic adenocarcinoma (rare: <1%) (Alves 2012), pancreatitis (chronic; rare: <1%) (Giorda 2014)

Hematologic & oncologic: Medullary thyroid carcinoma

Hepatic: Hepatitis (Kern 2014)

Hypersensitivity: Anaphylaxis (rare: <1%) (FDA 2017), angioedema (rare: <1%) (FDA 2017)

Renal: Acute interstitial nephritis (rare: <1%) (Gariani 2014), acute tubular necrosis (rare: <1%) (Kaakeh 2012)

ALERT: U.S. Boxed Warning

Thyroid C-cell tumor risk:

Liraglutide causes dose-dependent and treatment duration–dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, because the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.

Liraglutide is 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 the potential risk for MTC with the use of liraglutide and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with liraglutide.

Warnings/Precautions

Concerns related to adverse effects:

• Antibody formation: Use may be associated with the development of anti-liraglutide antibodies. Antibody formation was not associated with a loss of efficacy; however, patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1C.

• Cardiovascular effects: Increased resting heart rate has been observed in placebo-controlled trials; monitoring is recommended. When used for chronic weight management, the manufacturer recommends discontinuation in patients who experience a sustained increase in resting heart rate.

• Gallbladder disease: Use of glucagon-like peptide-1 (GLP-1) agonists may increase risk of gallbladder and bile duct disease (Faillie 2016). Cholelithiasis and cholecystitis have been reported in patients treated with liraglutide with the majority of patients requiring hospitalization or cholecystectomy; gallbladder studies and further clinical assessment are indicated if cholelithiasis is suspected.

• GI symptoms: Most common reactions are GI related; these symptoms may be dose related and may decrease in frequency/severity with gradual titration and continued use. Discontinue use if volume depletion develops (eg, due to nausea, vomiting, diarrhea) (AACE [Garvey 2016]).

• Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported with use; permanently discontinue therapy in the event of a hypersensitivity reaction. Use with caution in patients with a history of anaphylaxis or angioedema to other GLP-1 receptor agonists; potential for cross-sensitivity is unknown.

• Pancreatitis: Cases of acute and chronic pancreatitis (including fatal and nonfatal, hemorrhagic or necrotizing pancreatitis) have been reported; monitor for signs and symptoms of pancreatitis (eg, persistent severe abdominal pain which may radiate to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue use. Do not resume unless an alternative etiology of pancreatitis is confirmed. It is not known if liraglutide increases risk for development of pancreatitis in patients with a history of pancreatitis.

• Psychiatric effects: Suicidal behavior, with one case of attempted suicide, has been reported in patients treated for obesity; monitor for new or worsening depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. Discontinue use if suicidal thoughts or behaviors occur. Avoid use in patients with history of suicidal attempts or active suicidal ideation.

• Renal effects: Acute renal failure and chronic renal failure exacerbation (including severe cases requiring hemodialysis) have been reported; some cases have been reported in patients with no known preexisting renal disease. Reports primarily occurred in patients with nausea, vomiting, diarrhea, or dehydration. Renal dysfunction was usually reversible with appropriate corrective measures, including discontinuation of liraglutide. Risk may be increased in patients receiving concomitant medications affecting renal function and/or hydration status.

• Thyroid tumors: [US Boxed Warning] Dose-dependent and treatment duration-dependent thyroid C-cell tumors have developed in animal studies with liraglutide therapy; it is unknown whether liraglutide will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. Patients should be counseled on the potential risk of MTC with the use of liraglutide and informed of symptoms of thyroid tumors (eg, neck mass, dysphagia, dyspnea, persistent hoarseness). Use is contraindicated in patients with a personal or a family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN2). Cases of MTC in humans have been reported in patients treated with liraglutide. Consultation with an endocrinologist is recommended in patients who develop elevated calcitonin concentrations or have thyroid nodules detected during imaging studies or physical exam. Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with liraglutide.

Disease-related concerns:

• Bariatric surgery:

– Dehydration: Evaluate, correct, and maintain postsurgical fluid requirements and volume status prior to initiating therapy, and closely monitor the patient for the duration of therapy; acute and chronic kidney failure exacerbation may occur. A majority of cases occurred in patients with nausea, vomiting, diarrhea, and/or dehydration. Nausea is common and fluid intake may be more difficult after gastric bypass, sleeve gastrectomy, and gastric band (Mechanick 2013).

– Excessive glucagon-like peptide-1 exposure: Closely monitor for efficacy and assess for signs and symptoms of pancreatitis if therapy is initiated after surgery; gastric bypass and sleeve gastrectomy (but not gastric band) significantly increase endogenous postprandial GLP-1 concentrations (Korner 2009; Peterli 2012). Administration of exogenous GLP-1 agonists may be redundant to surgery effects.

• Gastroparesis: Slows gastric emptying; has not been studied in patients with preexisting gastroparesis.

• Hepatic impairment: Use with caution in patients with hepatic impairment; limited experience.

• Renal impairment: Use with caution in patients with renal impairment, particularly during initiation of therapy and dose escalation. A single-dose pharmacokinetic study suggests that liraglutide pharmacokinetics are unaffected by kidney dysfunction (Jacobsen 2009). Post hoc analyses of the LEADER trial, which included patients with type 2 diabetes at high risk for cardiovascular events, suggest equal safety and efficacy of unadjusted dosing in patients with eGFR <60 mL/minute/1.73 m2 compared to patients with eGFR ≥60 mL/minute/1.73 m2. However, patients requiring renal replacement therapy were not included in this analysis, and too few patients with eGFR <30 mL/minute/1.73 m2 were included to compare differences between those with severe versus moderate chronic kidney disease (Mann 2018; Mann 2020).

Dosage form specific issues:

• Multiple dose injection pens: According to the Centers for Disease Control and Prevention (CDC), pen-shaped injection devices should never be used for more than one person (even when the needle is changed) because of the risk of infection. The injection device should be clearly labeled with individual patient information to ensure that the correct pen is used (CDC 2012).

Other warnings/precautions:

• Appropriate use: Diabetes mellitus: Victoza is not for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis; not a substitute for insulin. Saxenda is not indicated for the treatment of type 2 diabetes.

• Patient education: Diabetes self-management education is essential to maximize the effectiveness of therapy.

Monitoring Parameters

Plasma glucose, HbA1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2020]); renal function; signs/symptoms of pancreatitis; triglycerides; signs/symptoms of gallbladder disease; emergence of worsening depression, suicidal thoughts/behavior, changes in behavior; heart rate; body weight (at week 16 when used for chronic weight management).

Pregnancy Considerations

Use of liraglutide for chronic weight management is contraindicated in pregnant women (lack of potential benefit and possible fetal harm). An increased risk of adverse maternal and fetal outcomes is associated with obesity; however, medications for weight loss therapy are not recommended at conception or during pregnancy (ACOG 156 2015).

Poorly controlled diabetes during pregnancy can be associated with an increased risk of adverse maternal and fetal outcomes, including diabetic ketoacidosis, preeclampsia, spontaneous abortion, preterm delivery, delivery complications, major birth defects, stillbirth, and macrosomia (ACOG 201 2018). To prevent adverse outcomes, prior to conception and throughout pregnancy, maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ADA 2020; Blumer 2013).

Agents other than liraglutide are currently recommended to treat diabetes in pregnant women (ADA 2020).

Patient Education

What is this drug used for?

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

• It is used to lower the chance of heart attack, stroke, and death in some people.

• It is used to help you lose weight.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Diarrhea

• Constipation

• Nausea

• Vomiting

• Lack of appetite

• Stuffy nose

• Sore throat

• Back pain

• Abdominal pain

• Loss of strength and energy

• Injection site irritation

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Thyroid cancer like new lump or swelling in the neck, pain in the front of the neck, persistent cough, persistent change in voice like hoarseness, or trouble swallowing or breathing.

• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting.

• Gallstones like pain in the upper right abdominal area, right shoulder area, or between the shoulder blades; yellow skin; or fever with chills.

• Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain.

• Dizziness

• Passing out

• Fast heartbeat

• Abnormal heartbeat

• Mood changes

• Behavioral changes

• Depression

• Thoughts of suicide

• Slurred speech

• Low blood sugar like dizziness, headache, fatigue, feeling weak, shaking, fast heartbeat, confusion, increased hunger, or sweating

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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