Indications and Usage
Victoza® (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes mellitus.
Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans,
prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh
the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate
glycemic control on diet and exercise.
Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic
or necrotizing pancreatitis has been observed in patients treated with Victoza®.
Victoza® has not been studied in patients with a history of pancreatitis. It is unknown
whether patients with a history of pancreatitis are at increased risk for pancreatitis while using
Victoza®. Other antidiabetic therapies should be considered in patients with
a history of pancreatitis.
Victoza® is not a substitute for insulin. Victoza® should not be used
in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not
be effective in these settings.
Victoza® has not been studied in combination with prandial insulin.
Important Safety Information
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 Victoza® 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. Victoza® 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.
Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.
Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly
if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies
in patients with a history of pancreatitis.
When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia
can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
Renal impairment has been reported postmarketing, 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.
Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing
use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical
There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza®
or any other antidiabetic drug.
The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than
in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide
antibody formation. Immunogenicity-related events, including urticaria, were more common among Victoza®-treated
patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.
Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended
for use in pediatric patients.
There is limited data in patients with renal or hepatic impairment.
Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck,
dysphagia, dyspnea, or persistent hoarseness).
Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons
should be referred to an endocrinologist for further evaluation.
Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®,
if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist
for further evaluation.
After initiation of Victoza®, and after dose increases, observe patients carefully for signs and symptoms
of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may
or may not be accompanied by vomiting).
In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another
person for treatment occurred in 11 Victoza®-treated patients and in two exenatide-treated patients. Of these
11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was
concomitantly using a sulfonylurea, two were concomitantly using metformin and two were using Victoza® as
monotherapy. In the 26-week open label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic
events was comparable among the treatment groups.
The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for
comparator-treated patients in the 5 controlled trials of 26 weeks duration or longer. This difference was
driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated
patients and 0.5% of comparator-treated patients. The most common adverse reactions leading to withdrawal
for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1%
Victoza® causes a delay in gastric emptying, and thereby has the potential to impact absorption of concomitantly
administered oral medications. Caution should be exercised when oral medications are concomitantly administered
Victoza® slows gastric emptying. Victoza® has not been studied in patients with pre-existing gastroparesis.
In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥5% of patients treated with
Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%),
diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting
(10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%),
nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%),
urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%),
pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%),
depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), hypertension (4.5%, 5.6%, and 6.9%).
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