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 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 [see Contraindications (4), Warnings and Precautions and Nonclinical Toxicology].
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VICTOZA SUMMARY
Victoza contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor.
Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use
- 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.
- In clinical trials of Victoza, there were more cases of pancreatitis with Victoza than with comparators. Victoza has not been studied sufficiently in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis while using Victoza. Use with caution 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.
- The concurrent use of Victoza and insulin has not been studied.
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NEWS HIGHLIGHTSMedia Articles Related to Victoza (Liraglutide)
Type 2 Diabetes Treatment Victoza Helps Type 1, Too
Source: MedicineNet glucagon Specialty [2011.06.08]
Title: Type 2 Diabetes Treatment Victoza Helps Type 1, Too
Category: Health News
Created: 6/8/2011 11:01:00 AM
Last Editorial Review: 6/8/2011 12:00:00 AM
Published Studies Related to Victoza (Liraglutide)
Liraglutide: a review of its use in the management of type 2 diabetes mellitus. [2011.12.03]
Liraglutide (Victoza(R)) is a subcutaneously administered glucagon-like peptide-1 (GLP-1) receptor agonist produced by recombinant DNA technology and used as an adjunct to diet and exercise in the treatment of adults with type 2 diabetes mellitus. This article reviews the clinical efficacy and tolerability of liraglutide in adults with type 2 diabetes, and provides a summary of its pharmacological properties...
The Pharmacokinetics, Pharmacodynamics, and Tolerability of Liraglutide, a Once-Daily Human GLP-1 Analogue, After Multiple Subcutaneous Administration in Healthy Chinese Male Subjects. [2011.12]
In this single-center, randomized, double-blind, within dose group, placebo-controlled, dose escalation trial, the pharmacokinetics, pharmacodynamics, tolerability, and safety of liraglutide were evaluated in 37 healthy Chinese subjects. Subjects were randomized to 1 of 3 dose groups (0.6, 1.2, or 1.8 mg), and within each group, randomized to liraglutide or placebo (3:1)...
Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. [2011.08.16]
Objective:Having demonstrated short-term weight loss with liraglutide in this group of obese adults, we now evaluate safety/tolerability (primary outcome) and long-term efficacy for sustaining weight loss (secondary outcome) over 2 years.Design:A randomized, double-blind, placebo-controlled 20-week study with 2-year extension (sponsor unblinded at 20 weeks, participants/investigators at 1 year) in 19 European clinical research centers.Subjects:A total of 564 adults (n=90-98 per group; body mass index 30-40 kg m(-2)) enrolled, 398 entered the extension and 268 completed the 2-year trial...
The effect of the once-daily human glucagon-like peptide 1 analog liraglutide on the pharmacokinetics of acetaminophen. [2011.08]
INTRODUCTION: Acetaminophen is a commonly used analgesic and antipyretic drug, and is frequently used to study gastric emptying. Due to its high permeability and high solubility, acetaminophen can be used as a pharmacologic model for medications with similar characteristics. The objective of this study was to assess the effect of liraglutide on the pharmacokinetics (PK) of acetaminophen in patients with type 2 diabetes... CONCLUSION: The overall exposure of acetaminophen following a 1 g dose was comparable for subjects taking liraglutide or placebo, and the clinical impact of the lower C(max) and delay in absorption of acetaminophen was considered to be transient and small, and without clinical relevance. No adjustment for acetaminophen is recommended when used concomitantly with liraglutide.
Review of the therapeutic uses of liraglutide. [2011.07]
BACKGROUND: Glucagon-like peptide (GLP-1) is a neuroendocrine hormone that increases blood glucose and is a drug target for treatment of type 2 diabetes. Liraglutide, a subcutaneous, once-daily GLP-1 agonist, is approved for the treatment of type 2 diabetes in the United States and Europe. It also has been studied for weight loss. OBJECTIVE: The purpose of this article is to review all of the relevant literature on the chemistry, pharmacology, pharmacokinetics, metabolism, clinical trials, safety, drug interactions, cost, and place in therapy of liraglutide... CONCLUSION: Liraglutide safely and effectively reduces HbA(1c) in patients with type 2 diabetes. The most recent American Diabetes Association guidelines recommended a GLP-1 agonist along with metformin as a second-tier therapy for type 2 diabetes. Although the American Association of Clinical Endocrinologists/American College of Endocrinologists' guidelines recommended it for first-line monotherapy in patients with HbA(1c) between 6.5% and 7.5% and with metformin if HbA(1c) is between 7.6% and 8.5%, liraglutide should be considered for patients who cannot tolerate first-line agents or if an additional agent is needed to help reach target HbA(1c) goals. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.
Clinical Trials Related to Victoza (Liraglutide)
A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese Volunteers [Recruiting]
This trial is conducted in Europe. The aim of this clinical trial is to investigate the
effect of liraglutide on gastric emptying, energy expenditure and appetite, and to evaluate
liraglutide pharmacokinetics in non-diabetic obese volunteers. The trial is designed as a
two-period, six-sequenced, crossover trial where the trial participant will enter two
treatment periods with a wash-out period of 6-8 weeks.
Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes [Recruiting]
This trial is conducted in Europe and the United States of America (USA). The aim of this
clinical trial is to investigate the safety, tolerability, pharmacokinetics (the
determination of the concentration of the administered medication in blood over time) and
pharmacodynamics (the determination of the effect over time and the duration of action) of
multiple doses of liraglutide in the pediatric population (children). The trial consists of
two parts: I and II.
Part I, involving children with type 2 diabetes, will investigate the safety and
tolerability of liraglutide in children receiving an escalating weekly dose over 5 weeks
compared with placebo. Part II involves a reference group of children and adults with type 2
diabetes who will also receive an escalating weekly dose of liraglutide over 3 or 4 weeks,
each reference group being compared with placebo.
Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects [Recruiting]
The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes [Recruiting]
The objective of this study is to investigate the effects of physical training in patients
with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (VictozaŽ)
in a 16-weeks double-blinded, randomized placebo-controlled clinical trial.
Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients
when training is combined with liraglutide (VictozaŽ) treatment.
Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients [Recruiting]
Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect
against diabetic nephropathy. We hypothesise that this is also the case in humans. This
study will investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys
in type 2 diabetic patients. Impact on basic kidney physiological will be determined and
kidney injury markers will be measured as surrogate parameters of kidney protection.
Reports of Suspected Victoza (Liraglutide) Side Effects
Nausea (686),
Blood Glucose Increased (317),
Decreased Appetite (266),
Pancreatitis (247),
Diarrhoea (245),
Weight Decreased (241),
Vomiting (236),
Pancreatitis Acute (165),
Headache (146),
Constipation (125), more >>
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Page last updated: 2011-12-09
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