liraglutide (Rx)

Brand and Other Names:Victoza, Saxenda
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

SC solution multidose pen

  • 18mg/3mL (Victoza); delivers doses of 0.6mg, 1.2mg, or 1.8mg
  • 18mg/3mL (Saxenda); delivers doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg, or 3mg

Type 2 Diabetes Mellitus

Victoza only

0.6 mg SC qDay for 1 week initially, THEN increase to 1.2 mg qDay

If glycemic control not achieved, can increase to 1.8 mg qDay

Initial dose of 0.6 mg SC qDay is only to decrease GI adverse effects and does not provide glycemic control

Indications

  • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • To reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease

Obesity

Saxenda only

Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a body mass index (BMI) of ≥30 (obesity) or adults with a BMI of ≥27 (overweight) who have at least 1 weight-related condition (eg, hypertension, type 2 diabetes, dyslipidemia)

Initiate at 0.6 mg SC qDay for 1 week; increase by 0.6 mg/day in weekly intervals until a dose of 3 mg/day is achieved

If patients do not tolerate an increased dose during dose escalation, consider delaying dose escalation for ~1 additional week

Discontinue if a patient cannot tolerate the 3 mg dose, as efficacy has not been established at lower doses (eg, 0.6, 1.2, 1.8, 2.4 mg)

Dosage Modifications (Saxenda)

Renal impairment

  • Mild-to-severe, including patients with end-stage renal disease (ESRD): Limited experience
  • There have been postmarketing reports of acute renal failure and worsening of chronic renal failure with liraglutide, which may sometimes require hemodialysis; use with caution in these patients

Hepatic impairment

  • Mild-to-severe: Use caution; limited experience

Dosage Modifications (Victoza)

Renal impairment

  • Mild-to-severe: No dosage adjustment necessary
  • Patients with ESRD: Limited experience; there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis; use caution in patients who experience dehydration

Hepatic impairment

  • Mild-to-severe: Limited experience; no dosage adjustment necessary

Dosing Considerations

Saxenda slows gastric emptying; has not been studied in patients with pre-existing gastroparesis

Limitations of use for Victoza

  • Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis (not effective for these conditions)
  • Has not been studied in combination with prandial insulin

Limitations of use for Saxenda

  • Not indicated for the treatment of type 2 diabetes mellitus
  • Saxenda and Victoza both contain liraglutide, and therefore should not be used together or in combination with any other GLP-1 receptor agonist
  • Not studied in patients taking insulin; do not use with insulin
  • Safety and effectiveness in combination with other products intended for weight loss, including prescription drugs, OTCs, and herbal products, have not been established

Dosage Forms & Strengths

SC solution multidose pen

  • 18mg/3mL (Victoza); delivers doses of 0.6mg, 1.2mg, or 1.8mg

Type 2 Diabetes Mellitus

Victoza only

Indicated as an adjunct to diet and exercise to improve glycemic control in patients aged ≥10 years with type 2 diabetes mellitus

<10 years: Safety and efficacy not studied

≥10 years

  • Victoza only
  • Indicated as an adjunct to diet and exercise to improve glycemic control in patients aged ≥10 years with type 2 diabetes mellitus
  • 0.6 mg SC qDay
  • After at least 1 week at 0.6 mg qDay, may increase dose to 1.2 mg/day if additional glycemic control required
  • If additional glycemic control required, may increase to 1.8 mg qDay after at least 1 week after 1.2 mg qDay dose

Dosage Modifications (Saxenda)

Renal impairment

  • Mild-to-severe, including patients with end-stage renal disease (ESRD): Limited experience
  • There have been postmarketing reports of acute renal failure and worsening of chronic renal failure with liraglutide, which may sometimes require hemodialysis; use with caution in these patients

Hepatic impairment

  • Mild-to-severe: Use caution; limited experience

Dosage Modifications (Victoza)

Renal impairment

  • Mild-to-severe: No dosage adjustment necessary
  • Patients with ESRD: Limited experience; there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis; use caution in patients who experience dehydration

Hepatic impairment

  • Mild-to-severe: Use caution; limited experience

Dosing Considerations

Saxenda slows gastric emptying; has not been studied in patients with pre-existing gastroparesis

Limitations of use for Victoza

  • Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis (not effective for these conditions)
  • Has not been studied in combination with prandial insulin
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Interactions

Interaction Checker

and liraglutide

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10% (Victoza)

            Nausea (26%)

            Diarrhea (17%)

            Vomiting (11%)

            >10% (Saxenda)

            Nausea (39.3%)

            Hypoglycemia in T2DM (23%)

            Diarrhea (20.9%)

            Constipation (19.4%)

            Vomiting (15.7%)

            Headache (13.6%)

            1-10% (Victoza)

            Constipation (10%)

            Headache (9%)

            Antiliraglutide antibodies (7%)

            Injection-site reactions (2%)

            1-10% (Saxenda)

            Decreased appetite (10%)

            Dyspepsia (9.6%)

            Fatigue (7.5%)

            Dizziness (6.9%)

            Abdominal pain (5.4%)

            Increased lipase (5.3%)

            Upper abdominal pain (5.1%)

            Gastroesophageal reflux disease (4.7%)

            Gastroenteritis (4.7%)

            Abdominal distension (4.5%)

            Eructation (4.5%)

            Urinary tract infection (4.3%)

            Flatulence (4%)

            Viral gastroenteritis (2.8%)

            Injection site erythema (2.5%)

            Injection site reaction (2.5%)

            Insomnia (2.4%)

            Dry mouth (2.3%)

            Asthenia (2.1%)

            Anxiety (2%)

            <1% (Victoza)

            Urticaria

            Upper respiratory tract infection

            UTI

            Dizziness

            Sinusitis

            Nasopharyngitis

            Back pain

            Hypertension

            Hypoglycemia (mostly in combination therapy)

            Pancreatitis

            Papillary thyroid carcinoma

            Thyroid C-cell hyperplasia

            Postmarketing Reports

            Dehydration resulting from nausea, vomiting, and diarrhea

            Increased serum creatinine, acute renal failure, and worsening chronic renal failure, sometimes requiring hemodialysis

            Hypersensitivity reactions (anaphylactic and angioedema)

            Allergic reactions: Rash, pruritus

            Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis

            Breast cancer

            Colorectal neoplasms

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            Warnings

            Black Box Warnings

            Risk of thyroid C-cell tumors

            • Causes thyroid C-cell tumors in rodents; human risk could not be determined
            • Contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
            • Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with liraglutide
            • Counsel patients regarding the potential risk of MTC with therapy

            Contraindications

            Hypersensitivity to liraglutide or its components

            Personal or family history of MTC

            MEN 2

            Saxenda only: Pregnancy

            Cautions

            Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed; studied in a limited number of patients with a history of pancreatitis; unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis

            Acute gallbladder disease reported; if cholelithiasis is suspected, gallbladder studies and follow-up appropriately

            May cause 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; if serum calcitonin is elevated, evaluate further; patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated

            Renal Impairment reported in association with nausea, vomiting, diarrhea, or dehydration, which may sometimes require hemodialysis; altered renal function has been reversed in many of reported cases with supportive treatment and discontinuation of potentially causative agents; use caution when initiating or escalating doses of in these patients

            There have been postmarketing reports of serious hypersensitivity reactions (eg, anaphylactic reactions, angioedema)

            Never share pen between patients even if needle is changed

            Saxenda only

            • Resting heart rate may increase by 2-3 bpm; up to 10-20 bpm increases also reported
            • Suicidal ideation; monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior; discontinue in patients who experience suicidal thoughts or behaviors; avoid in patients with a history of suicidal attempts or active suicidal ideation

            Drug interactions overview

            • Patients receiving liraglutide in combination with an insulin secretagogue (eg, sulfonylurea) or insulin may have an increased risk of hypoglycemia; in pediatric patients aged ≥10 years, risk of hypoglycemia was higher with liraglutide regardless of concomitant antidiabetic therapies
            • May cause a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications; exercise caution when oral medications are concomitantly administered with liraglutide
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            Pregnancy & Lactation

            Pregnancy

            Victoza

            • Based on animal reproduction studies, there may be risks to the fetus from exposure during pregnancy
            • Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
            • Animal data
              • Animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy
              • Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 1.8 mg/day
              • In pregnant rabbits administered liraglutide during organogenesis, decreased fetal weight and an increased incidence of major fetal abnormalities were seen at exposures below the human exposures at the MRHD

            Saxenda

            • Contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm
            • There are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage
            • If patient wishes to become pregnant, or pregnancy occurs, discontinue treatment
            • A minimum weight gain, and no weight loss, recommended for all pregnant women, including those who are already overweight or obese, due to necessary weight gain that occurs in maternal tissues during pregnancy

            Clinical considerations

            • Disease-associated maternal and/or embryo/fetal risk
            • Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications
            • Poorly controlled diabetes increases fetal risk for major birth defects, still birth, and macrosomia related morbidity

            Lactation

            There are no data on the presence of drug in human milk, the effects on the breastfed infant, or the effects on milk production

            Present in milk of lactating rats

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Incretin mimetic; analogue of human glucagonlike peptide-1 (GLP-1); acts as GLP-1 receptor agonist to increase insulin secretion in the presence of elevated blood glucose; delays gastric emptying to decrease postprandial glucose; also decreases glucagon secretion

            Absorption

            Peak plasma time: 11 hr (Saxenda)

            Peak plasma concentration: 35 ng/mL (Victoza)

            AUC: 960 ng·hr/mL (Victoza)

            Average steady state concentration over 24 hr: 128 ng/mL (at 1.8 mg dose)

            Absolute bioavailability: 55%

            Distribution

            Protein bound: >98%

            Vd: 13 L (Victoza); 20-25 L (Saxenda); 0.07 L/kg (IV)

            Metabolism

            Endogenously metabolized to large proteins without a specific organ route

            Elimination

            Half-life: 13 hr

            Mean apparent clearance: 1.2 L/hr (Victoza); 0.9-1.4 L/hr (Saxenda)

            Excretion (metabolites): 5% feces, 6% urine

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            Administration

            SC Administration

            Administer SC in abdomen, thigh, or upper arm; rotate injection site

            Administer SC qDay at any time, independent of meals

            Must not be administered IV or IM

            Injection site and time of administration can be changed without dose adjustment

            Visually inspect each injection; solution should be used only if it is clear, colorless, and contains no particles

            Missed dose

            • If dose missed, resume the once-daily regimen with the next scheduled dose; do not give an extra dose or a higher dose
            • If missed dose more than 3 days elapsed since the last dose, initiate therapy at 0.6 mg/day to avoid GI symptoms

            Storage

            All formulations

            • Unused pens: Refrigerate at 2-8°C (36-46°F); do not freeze; do not use if frozen
            • Used injectable pens: Store at room temperature (15-30°C [59-86°F]) or refrigerate (2-8°C [36-46°F]); protect from excessive heat and sunlight; discard 30 days after first use
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            Images

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.