liraglutide

REMS

Victoza:

Type 2 diabetes mellitus (as adjunct to diet and exercise).
To reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal MI, or nonfatal stroke) in patients with type 2 diabetes mellitus and established cardiovascular disease.

Saxenda:

Chronic 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).

Saxenda:

Chronic weight management in children ≥12 yrs 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).

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)
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.

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).

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).

Drug-Drug:

Concurrent use with agents that increase insulin secretion, including sulfonylureas and insulin may ↑ the risk of serious hypoglycemia; use cautiously and consider ↓ dose of agent increasing insulin secretion.
May alter absorption of concomitantly administered oral medications due to delayed gastric emptying.

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]

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 ↑ dose, if needed, to 1.2 mg once daily; after 1 wk, if additional glycemic control needed, may then ↑ dose 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 ↑ dose, 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.

Acts as an acylated human glucagon-like peptide-1 (GLP-1, an incretin) receptor agonist; increases intracellular cyclic AMP (cAMP) 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 myocardial infarction, or nonfatal stroke.

Therapeutic Classification: antidiabetics

Pharmacologic Classification:

Absorption: 55% absorbed following SUBQ injection.

Distribution: Unknown.

Protein Binding: >98%.

Metabolism/Excretion: Endogenously metabolized.

Half-life: 13 hr.

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

†↓ in A1c.

‡↓ in body weight.

Instruct patient on use of pen injector and to take liraglutide as directed. If a dose is missed, omit and take next dose as scheduled; do not double doses. If >3 days dosing missed, reinitiate with 0.6 mg dose; titrate at direction of health care professional. Pen should never be shared between patients, even if needle is changed. Store pen in refrigerator; do not freeze. After initial use, pen may be stored at room temperature or refrigerated up to 30 days. Keep pen cap on when not in use. Protect from excessive heat and sunlight. Remove and safely discard needle after each injection and store pen without needle attached. Advise patient to read the Patient Medication Guide before starting liraglutide and with each Rx refill.
Inform patient that nausea is the most common side effect, but usually decreases over time.
Advise patient taking insulin and liraglutide to never mix insulin and liraglutide together. Give as 2 separate injections. Both injections may be given in the same body area, but should not be given right next to each other.
Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long-term.
Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water and notify health care professional.
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 professional should be notified if significant changes occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to discontinue liraglutide and notify health care professional immediately if signs of pancreatitis (nausea, vomiting, abdominal pain) occur.
Advise patient to inform health care professional of medication regimen before treatment or surgery.
Inform patient of risk of benign and malignant thyroid C-cell tumors. Advise patient to notify health care professional if symptoms of thyroid tumors (lump in neck, hoarseness, trouble swallowing, shortness of breath) or if signs of allergic reaction (swelling of face, lips, tongue, or throat; fainting or feeling dizzy; very rapid heartbeat; problems breathing or swallowing; severe rash or itching) occur.
Rep: Insulin is the preferred method of controlling blood glucose during pregnancy. Counsel females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Saxenda is contraindicated in pregnancy, as weight loss during pregnancy may cause fetal harm.
Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
Emphasize the importance of routine follow-up exams.

NDC Code^*

0169- Novo Nordisk
0169-2800- Saxenda 0169-2800-15- 5 SYRINGE, PLASTIC in 1 CARTON (0169-2800-15) > 3 mL in 1 SYRINGE, PLASTIC

0169- Novo Nordisk
0169-2800- Saxenda 0169-2800-90- 1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-90) > 3 mL in 1 SYRINGE, PLASTIC

0169- Novo Nordisk
0169-2800- Saxenda 0169-2800-97- 1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-97) > 3 mL in 1 SYRINGE, PLASTIC

0169- Novo Nordisk
0169-4060- Victoza 0169-4060-12- 2 SYRINGE, PLASTIC in 1 CARTON (0169-4060-12) > 3 mL in 1 SYRINGE, PLASTIC

0169- Novo Nordisk
0169-4060- Victoza 0169-4060-13- 3 SYRINGE, PLASTIC in 1 CARTON (0169-4060-13) > 3 mL in 1 SYRINGE, PLASTIC

0169- Novo Nordisk
0169-4060- Victoza 0169-4060-90- 1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-90) > 3 mL in 1 SYRINGE, PLASTIC

0169- Novo Nordisk
0169-4060- Victoza 0169-4060-99- 1 SYRINGE, PLASTIC in 1 CARTON (0169-4060-99) > 3 mL in 1 SYRINGE, PLASTIC

50090- A-S Medication Solutions
50090-4503- Victoza 50090-4503-0- 3 SYRINGE, PLASTIC in 1 CARTON (50090-4503-0) > 3 mL in 1 SYRINGE, PLASTIC

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆