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liraglutide (Rx)Brand and Other Names:Victoza, Saxenda

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

SC solution muliti-dose pen

  • 18mg/3mL (Victoza); delivers doses of 0.6mg, 1.2mg, or 1.8 mg
  • 18mg/3mL (Saxenda); delivers doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg, or 3 mg
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Diabetes Mellitus, Type 2

Victoza: 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

Limitations of use for Victoza

  • Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
  • Has not been studied in patients with a history of pancreatitis; consider other antidiabetic therapies in patients with a history of pancreatitis
  • Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis
  • Has not been studied in combination with prandial insulin

Obesity

Approved by the FDA December 23, 2014

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)

Saxenda: 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

Limitations of use for Saxenda

  • Not indicated for treatment of type 2 diabetes
  • Should not be used in combination with any other GLP-1 receptor agonist
  • Should not be used with insulin
  • Effects on cardiovascular morbidity and mortality have not been established
  • Safety and efficacy of coadministration with other products for weight loss have not been established
  • Has not been studied in patients with a history of pancreatitis

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

liraglutide and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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

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            Warnings

            Black Box Warnings

            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

            Contraindications

            Hypersensitivity

            Personal or family history of medullary thyroid carcinoma

            Multiple endocrine neoplasia type 2

            Pregnancy (Saxenda)

            Cautions

            Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with liraglutide

            Acute gallbladder disease reported

            Resting heart rate may increase by 2 to 3 bpm; up to 10-20 bpm increases also reported

            Not studied with insulin

            Gastrointestinal reactions are the most common reactions

            Hepatic impairment

            Counsel patients regarding the risk of medullary thyroid carcinoma (MTC) and the symptoms of thyroid tumors; routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with liraglutide; significantly elevated serum calcitonin may indicate MTC; patients with MTC usually have values >50 ng/L; if serum calcitonin is measured and found to be elevated, evaluate patient 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; use caution when initiating or escalating doses of in these patients

            Lower dose of insulin secretagogue (eg, sulfonylurea) when used in combination, because serious hypoglycemia may result

            Use may be associated with weight loss

            Not for use in patients with type 1 diabetes mellitus or for treatment of diabetic ketoacidosis

            Not a substitute for insulin

            Patients with a history of angioedema to other GLP-1 receptor agonists

            No studies have evaluated evidence of macrovascular risk reduction

            Suicidal ideation (Saxenda)

            Never share pen between patients even if needle is changed

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Unknown if excreted in human milk; either discontinue drug or nursing

            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

            Absolute bioavailability: 55%

            Peak plasma time: 8-12 hr  

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

            Distribution

            Protein bound: >98%

            Vd: 13 L (SC); 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 (SC)

            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

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

            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, initiate therapy at 0.6 mg/day to avoid GI symptoms

            Storage

            Store in refrigerator (36-46°F); do not freeze; do not use if frozen

            After first use, may store at room temperature (59-86°F) or refrigerate (36-46°F)

            Injection pen expires 30 days after first use

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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