Victoza

What is Victoza?

• VICTOZA (liraglutide injection) is a glucagon-like peptide-1 (GLP-1) receptor agonist used to treat type 2 diabetes.

What are the uses of this medicine?

VICTOZA is an injectable prescription medicine used:

• along with diet and exercise to lower blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes mellitus.
• to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.

Limitations of Use:

• VICTOZA is not for use in people with type 1 diabetes.
• It should not be used with other medicines that contain liraglutide.
• It is not known if VICTOZA is safe and effective to lower blood sugar (glucose) in children under 10 years of age.

How does this medicine work?

• Liraglutide (lir" a gloo' tide) is a glucagon-like peptide-1 (GLP-1) analogue that acts like the native gastrointestinal hormone (incretin) to increase insulin secretion.
• Liraglutide reproduces the activity of GLP-1, binding to specific receptors on pancreatic beta cells and increasing insulin secretion, which can lead to improvement of glycemic control in patients with type 2 diabetes.
• Liraglutide is a recombinant DNA produced polypeptide that shares 97% homology to endogenous human GLP-1(7-37), which represents 20% of circulating GLP-1 activity in serum.
• Unlike GPL-1(7-37), however, liraglutide is resistant to DPP-4 degradation and thus has a prolonged duration of activity. Liraglutide, like other GLP-1 analogues, must be given parenterally.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• are allergic to liraglutide or any of the ingredients in VICTOZA.

What drug interactions can this medicine cause?

• VICTOZA delays gastric emptying and may impact absorption of concomitantly administered oral medications.
• When initiating VICTOZA, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.

Is this medicine FDA approved?

Initial U.S. Approval: 2010

How should this medicine be used?

Recommended dosage: Adult Dosage:

• Initiate at 0.6 mg daily for one week then increase to 1.2 mg daily.
• If additional glycemic control is required, increase the dose to 1.8 mg daily after one week of treatment with the 1.2 mg daily dose.

Pediatric Dosage:

• Initiate at 0.6 mg daily for at least one week.
• If additional glycemic control is required increase the dose to 1.2 mg daily and if additional glycemic control is still required, increase the dose to 1.8 mg daily after at least one week of treatment with the 1.2 mg daily dose.

Administration:

• Use VICTOZA exactly as your healthcare provider tells you to.
• Your healthcare provider should show you how to use VICTOZA before you use it for the first time.
• Use VICTOZA 1 time each day, at any time of the day.
• VICTOZA may be taken with or without food.
• VICTOZA is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject VICTOZA into a muscle (intramuscularly) or vein (intravenously).
• Do not mix insulin and VICTOZA together in the same injection.
• You may give an injection of VICTOZA and insulin in the same body area (such as your stomach area), but not right next to each other.
• If you miss a dose of VICTOZA, take the missed dose at the next scheduled dose. Do not take 2 doses of VICTOZA at the same time.
• If you take too much VICTOZA, call your healthcare provider right away. Taking too much VICTOZA may cause severe nausea, severe vomiting, and low blood sugar (hypoglycemia).
• Change (rotate) your injection site with each injection. Do not use the same site for each injection.
• Do not share your VICTOZA pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
• The VICTOZA pen you are using should be thrown away 30 days after you start using it.

Your dose of VICTOZA and other diabetes medicines may need to change because of:

• change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 6 mg/mL solution in a pre-filled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg

This medicine is available in fallowing brand namesː

• VICTOZA

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• diarrhea
• vomiting
• decreased appetite
• indigestion
• constipation

VICTOZA may cause serious side effects, including:

• Possible thyroid tumors, including cancer
• inflammation of your pancreas (pancreatitis)
• low blood sugar (hypoglycemia)
• kidney problems (kidney failure)
• serious allergic reactions
• gallbladder problems

What special precautions should I follow?

• Liraglutide increases Risk of Thyroid C-cell Tumors. Malignant thyroid C-cell carcinomas were detected in rats and mice. It is unknown whether VICTOZA will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.
• Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Never share a VICTOZA pen between patients, even if the needle is changed.
• Adult patients taking an insulin secretagogue or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher with VICTOZA regardless of insulin and/or metformin use. Reduction in the dose of insulin secretagogues or insulin may be necessary.
• There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in VICTOZA-treated patients. usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of VICTOZA in patients with renal impairment.
• Postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema). Discontinue VICTOZA and promptly seek medical advice.
• VICTOZA-treated patients versus 1.9% of placebo-treated patients reported an acute event of gallbladder disease, such as cholelithiasis or cholecystitis. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea
• severe vomiting
• severe hypoglycemia

Management of overdosage:

• In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

Can this medicine be used in pregnancy?

• VICTOZA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• The safety and effectiveness of VICTOZA as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older.
• The safety and effectiveness of VICTOZA have not been established in pediatric patients less than 10 years of age.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: liraglutide
• Inactive Ingredients: disodium phosphate dihydrate, propylene glycol, phenol and water for injection

Who manufactures and distributes this medicine?

• Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark

Victoza® is a registered trademark of Novo Nordisk A/S.

What should I know about storage and disposal of this medication?

• Prior to first use, VICTOZA should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC).
• Do not store in the freezer or directly adjacent to the refrigerator cooling element.
• Do not freeze VICTOZA and do not use VICTOZA if it has been frozen.

• After first use of the VICTOZA pen, the pen can be stored for 30 days at controlled room temperature (59°F to 86°F; 15°C to 30°C) or in a refrigerator (36°F to 46°F; 2°C to 8°C).
• Keep the pen cap on when not in use.
• Protect VICTOZA from excessive heat and sunlight.
• Always remove and safely discard the needle after each injection and store the VICTOZA pen without an injection needle attached.
• This will reduce the potential for contamination, infection, and leakage while also ensuring dosing accuracy.
• Always use a new needle for each injection to prevent contamination.

• Dailymed label info on Victoza
• FDA Victoza

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