Liraglutide

Dosage Forms & Strengths

SC solution multidose 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

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

Indications (Victoza)

• 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

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

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

• There are no adequate studies of Victoza in pregnant women. Most experts agree that insulin is the drug of choice in pregnant women with diabetes.
• There are no adequate studies of Victoza in nursing mothers, and it is not known whether Victoza is excreted in human breast milk.

Liraglutide may be found in some form under the following brand names:

• Saxenda

• Victoza

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines that increase insulin production such as:

• any type of insulin
• chlorpropamide (Diabinese)
• glimepiride (Amaryl), glimepiride/pioglitazone (Duetact) and glimepiride/rosiglitazone (Avandaryl)
• glipizide (Glucotrol, Glucotrol XL) and glipizide/metformin (Metaglip)
• glyburide (DiaBeta, Micronase, Glynase) and glyburide/metformin (Glucovance)
• nateglinide (Starlix)
• repaglinide (Prandin)
• tolazamide (Tolinase)
• tolbutamide (Orinase)

This is not a complete list of liraglutide drug interactions. Liraglutide can potentially interact with oral medicines as it slows gastric (stomach) emptying. This can impact the absorption of oral medications that are taken at the same time. Ask your healthcare provider or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of liraglutide, there are no specific foods that you must exclude from your diet when receiving this medication.

Before use:

• Store your new, unused liraglutide pen in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC).
• Do not freeze liraglutide or use liraglutide if it has been frozen. Do not store liraglutide near the refrigerator cooling element.

Pen in use:

• Store your liraglutide pen for 30 days either at 59ºF to 86ºF (15ºC to 30ºC), or in a refrigerator at 36ºF to 46ºF (2°C to 8°C).
• When carrying the pen away from home, store the pen at a temperature between 59ºF to 86ºF (15ºC to 30ºC) and keep it dry.
• If liraglutide has been exposed to temperatures above 86ºF (30ºC), it should be thrown away.
• Protect your liraglutide pen from heat and sunlight.
• Keep the pen cap on when your liraglutide pen is not in use.
• Use your liraglutide pen within 30 days after the first day it is stored outside the refrigerator. After these 30 days, throw away your liraglutide pen even if some medicine is left in the pen.
• Do not use liraglutide after the expiration date printed on the carton.

Do not store the liraglutide pen with the needle attached. Always safely remove and safely throw away the needle after each injection. This may help prevent contamination, infection and leakage. It also helps to make sure that you get the correct dose of liraglutide. 

Keep your liraglutide pen, pen needles, and all medicines out of the reach of children.

WARNING: RISK OF THYROID C-CELL TUMORS

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, as human relevance could not be ruled out by clinical or nonclinical studies. 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). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

• An acylated long-acting human glucagon-like peptide-1 (GLP-1) receptor agonist; synthetic (recombinant DNA origin) peptide precursor has 97% amino acid sequence homology to endogenous human GLP-1(7-37).1 10

  Activates the GLP-1 receptor in pancreatic β cells.1 14

• Increases intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated glucose concentrations.1 9 14 20 24 This insulin secretion subsides as blood glucose concentrations decrease and approach euglycemia.1

• Suppresses glucagon secretion in a glucose-dependent manner but does not impair normal glucagon response to hypoglycemia.1 9 14 20 24

• Delays gastric emptying, reducing the rate at which postprandial glucose appears in the circulation.1 9

• Effectively reduces fasting and postprandial plasma glucose concentrations in patients with type 2 diabetes.2 3 4 5 6 7 9 18 20

• GLP-1 is a physiological regulator of appetite.24 Weight loss effects of liraglutide are mediated by decreased calorie intake; drug does not increase energy expenditure.24

• Saxenda
• Victoza

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 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, dyslipidemia)

Diabetes mellitus, type 2 (Victoza): As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Refer to adult dosing.

Administration advice:
-For subcutaneous use only; do not administer IV or IM
-Inject subcutaneously once a day into the abdomen, thigh, or upper arm; may be given at any time of day without regard to meals.
-Never share a pen between patients, even if the needle is changed; do not reuse or share needles or syringes between patients as this presents a risk for transmission of blood-borne pathogens
-If it is more than 12 hours since a dose should have been used, skip the missed dose and resume dosing with next scheduled dose, an extra dose or increase in dose should not be taken to make up for a missed dose.
-To mitigate gastrointestinal symptoms, the starting dose is 0.6 mg once daily; patients must be titrated to effective doses.
-If more than 3 days/doses are missed this drug should be reinitiated at 0.6 mg to mitigate any gastrointestinal symptoms; the dose can be titrated at the physician's discretion.
-If concomitantly given with insulin, administer as separate injections; may be given in the same body region, but not adjacent to each other.
-Pens and needles should not be shared with another person.

Storage requirements:
-Refrigerate prior to first use (36 to 46F; 2 to 8C); do not freeze and do not use if it has been frozen
-After first use, may store at controlled room temperature (59 to 86F; 15 to 30C) or refrigerate; use within 30 days
-Keep pen cap on when not in use, do not store pen with needle attached
-Protect from excessive heat and sunlight

Reconstitution/preparation techniques: Patients should receive proper training from their healthcare provider prior to first use. See product labeling for specific instructions.

Compatibility: Do not mix with other medicinal products.

General:
-This drug has not been studied in patients with a history of pancreatitis, consider alternative therapy.
-This drug should not be used to treat patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-This drug is not recommended as a first-line therapy in patients with type 2 diabetes mellitus.
-Saxenda(R) is not indicated for the treatment of type 2 diabetes mellitus.
-Saxenda(R) should not be used in combination with any other GLP-1 receptor agonists or used with insulin.

Monitoring:
-Blood glucose and hemoglobin A1C measurements should be measured periodically to assess efficacy
-Observe for signs and symptoms of pancreatitis

Patient advice:
-Patients should be advised to never share a pen with another person, even if the needle is changed; patients should understand that sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens.
-Counsel patients to report symptoms of thyroid tumors such as a lump in their neck, persistent hoarseness, dysphagia, or dyspnea.
-Patients should be aware of the potential for gastrointestinal reactions and take measures to ensure adequate fluid intake to avoid dehydration and to seek medical advice for persistent and severe events.
-Patients should be instructed to seek medical advice during periods of stress, such as fever, trauma, infection, or surgery as medical management of diabetes may change.
-Inform patients that hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.
-Patients should be aware of signs and symptoms of hypoglycemia and how it should be managed; patients should be advised to take precautions to avoid hypoglycemia while driving and using machines.