liraglutide

REMS

VictozaType 2 diabetes mellitus (as adjunct to diet and exercise).
To reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal MI, nonfatal stroke) in patients with type 2 diabetes mellitus and established cardiovascular disease.
SaxendaChronic weight management in adults who are obese (body mass index [BMI] ≥30 kg/m²) or are overweight (BMI ≥27 kg/m²) with ≥1 weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes) (as adjunct to reduced-calorie diet and increased physical activity).
SaxendaChronic weight management in children ≥12 yr old with a body weight >60 kg and an initial BMI corresponding to ≥30 kg/m² for adults (obese) by international cutoffs (Cole Criteria) (as adjunct to reduced-calorie diet and increased physical activity).

Action ⬆ ⬇

Acts as an acylated human glucagon-like peptide-1 (GLP-1, an incretin) receptor agonist; increases intracellular cyclic AMP leading to insulin release when glucose is elevated, which then subsides as blood glucose decreases toward euglycemia. Also decreases glucagon secretion and delays gastric emptying. Also helps to suppress appetite, leading to decreased caloric intake.

Therapeutic effects:

Improved glycemic control.
Reduction in body weight.
Reduction in cardiovascular death, nonfatal MI, or nonfatal stroke.

Pharmacokinetics ⬆ ⬇

Absorption: 55% absorbed following SUBQ injection.

Distribution: Unknown.

Protein Binding: >98%.

Metabolism/Excretion: Endogenously metabolized.

Half-Life: 13 hr.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
SUBQ	within 4 wk‡ within 2 wk‡	8 wk‡ 40 wk‡	unknown‡‡

‡↓in A1c.

‡↓in body weight.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Personal or family history of medullary thyroid carcinoma
;
Multiple endocrine neoplasia syndrome type 2
;
Type 1 diabetes (Victoza only);
Diabetic ketoacidosis (Victoza only);
Concurrent use with other weight-loss products (Saxenda only);
History of suicidal attempts or suicidal thoughts (Saxenda only);
Undergoing elective surgery or procedure requiring general anesthesia or deep sedation;
Severe GI disease (including severe gastroparesis);
OB: Weight loss not recommended during pregnancy (Saxenda only);
Lactation: Lactation;
Pedi: Children ≥12 yr with type 2 diabetes (safety and effectiveness not established) (Saxenda only).

Use Cautiously in:

History of pancreatitis;
History of angioedema or anaphylaxis to another GLP-1 receptor agonist;
Hepatic impairment;
Renal impairment;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk (Victoza only);
Pedi: Safety and effectiveness not established in children <12 yr (Saxenda) and children <10 yr (Victoza); ↑ risk of hypoglycemia with use of either Saxenda or Victoza in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: tachycardia

Derm: cutaneous amyloidosis, pruritus, rash

Endo: hypoglycemia, THYROID C-CELL TUMORS

GI: diarrhea, nausea, vomiting, cholecystitis, cholelithiasis, constipation, PANCREATITIS

GU: acute renal failure

Local: injection site reactions

Neuro: headache, SUICIDAL BEHAVIOR/IDEATION (SAXENDA ONLY)

Resp: aspiration

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

Insulin secretagogues, including sulfonylureas and insulin, may ↑ risk of serious hypoglycemia; use cautiously and consider ↓ dose of agent ↑ insulin secretion.
May alter absorption of concurrently administered oral medications due to delayed gastric emptying.

Route/Dosage ⬆ ⬇

Victoza

Type 2 Diabetes Mellitus
SC (Adults ): 0.6 mg once daily for 1 wk, then 1.2 mg once daily for 1 wk; may then ↑ dose, if needed, up to 1.8 mg once daily.
SC (Children ≥10 yr): 0.6 mg once daily for 1 wk; may then ↑, if needed, to 1.2 mg once daily; after 1 wk, if additional glycemic control needed, may then ↑ to 1.8 mg once daily.
Reduction in Risk of Major Adverse Cardiovascular Events
SC (Adults ): 0.6 mg once daily for 1 wk, then 1.2 mg once daily for 1 wk; may then ↑, if needed, up to 1.8 mg once daily.

Saxenda

SC (Adults ): 0.6 mg once daily for 1 wk (Wk 1), then 1.2 mg once daily for 1 wk (Wk 2), then 1.8 mg once daily for 1 wk (Wk 3), then 2.4 mg once daily for 1 wk (Wk 4), then 3 mg once daily. Discontinue if patient cannot tolerate dose of 3 mg once daily.
SC (Children ≥12 yr): 0.6 mg once daily for 1 wk (Wk 1), then 1.2 mg once daily for 1 wk (Wk 2), then 1.8 mg once daily for 1 wk (Wk 3), then 2.4 mg once daily for 1 wk (Wk 4), then 3 mg once daily. If patient cannot tolerate dose of 3 mg once daily, ↓ to 2.4 mg once daily; discontinue if patient cannot subsequently tolerate dose of 2.4 mg once daily.

Availability ⬆ ⬇

(Generic available)

Solution for injection (Saxenda) (prefilled pens): 18 mg/3 mL (delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg)
Solution for injection (Victoza) (prefilled pens): 18 mg/3 mL (delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg)
In combination with: insulin degludec (Xultophy). See Appendix [not included in this PDA edition]

Assessment ⬆ ⬇

Assess for thyroid C-cell tumors (mass in neck, dysphagia, dyspnea, persistent hoarseness). Monitor for elevated serum calcitonin. If noted, refer to an endocrinologist.
Monitor for pancreatitis during therapy (persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, discontinue liraglutide; if confirmed, do not restart liraglutide.
Monitor for hypersensitivity reactions (swelling of face, lips, tongue, or throat; fainting or feeling dizzy; very rapid heartbeat; problems breathing or swallowing; severe rash or itching). If hypersensitivity reaction occurs, discontinue liraglutide, treat per standard of care, and monitor until symptoms resolve.
Victoza: Observe patient taking concurrent insulin for signs and symptoms of hypoglycemic reactions (sweating, hunger, weakness, dizziness, tremor, tachycardia, anxiety).
Saxenda: Monitor for weight loss and adjust concurrent medications (antihypertensives, antidiabetics, lipid-lowering agents) as needed. Assess for suicidal thoughts or behaviors (depression, anxiety, agitation, irritability).

Lab Test Considerations:

Monitor A1c periodically during therapy to evaluate effectiveness.
Monitor renal function and triglycerides.

Implementation ⬆ ⬇

Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
SC: Administer once daily at any time of the day, without regard to food. Inject at a 90° angle into abdomen, thigh, or upper arm. Apply light pressure but do not rub injection site. Solution should be clear and colorless; do not administer solutions that are discolored or contain particulate matter. Rotate injection sites within the same region to ↓ risk of cutaneous amyloidosis. Use a new needle for each injection. Store in refrigerator before 1st dose; after 1st dose, may be stored for 30 days at room temperature or in refrigerator.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Explain this medication controls hyperglycemia but does not cure diabetes. Therapy is long term. Emphasize the importance of routine follow-up exams. Advise patient if a dose is missed to omit and take next dose as scheduled; do not double doses. If missed >3 days, reinitiate with 0.6 mg dose; titrate at direction of health care provider.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Educate on use of the pen injector. Pen should never be shared between patients, even if needle is changed.
Inform patient that nausea is the most common side effect but usually ↓ over time.
Advise patient to never mix another insulin and liraglutide together. Give as two separate injections. Both injections may be given in the same body area but should not be given right next to each other.
Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 teaspoons of sugar, honey, or corn syrup dissolved in water and notify health care provider. Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hypoglycemic or hyperglycemic episodes.
Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness, and health care provider should be notified if significant changes occur.
Advise patient to discontinue liraglutide and seek medical advice immediately if signs/symptoms of thyroid tumors (mass in neck, difficulty swallowing or breathing, persistent hoarseness) occur.
Advise patient to discontinue liraglutide and seek medical advice immediately if signs and symptoms of pancreatitis or hypersensitivity reactions (anaphylaxis) occur.
Advise patient to inform health care provider of medication regimen before treatment or surgery.
Advise patients taking Saxenda about suicidal behavior or thoughts. Discontinue if occur, and seek medical advice.
Advise adult patients to discontinue Saxenda if they have not lost ≥4% of body weight by 16 wk of treatment. Instruct caregivers of pediatric patients >12 yr to discontinue Saxenda if they have not achieved a BMI ↓ of ≥1% from baseline after 12 wk on the maintenance dose.
Rep: Insulin is the preferred method of controlling blood glucose during pregnancy. Counsel women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Saxenda is contraindicated in pregnancy, as weight loss during pregnancy may cause fetal harm.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇