Indications and Usage
About Victoza®
What is Victoza®?
Victoza® is a once-daily medication that may help to improve blood sugar levels in adults with type 2 diabetes.
Victoza
® is not
insulin. It is used along with healthy eating and staying active to help keep blood sugar under control.
How does Victoza® work?
Victoza
® is very similar to a
hormone in your body called GLP-1. After you eat, GLP-1 helps your
pancreas
release the right amount of insulin to help sugar enter into your
body’s cells. GLP-1 also prevents the liver from releasing too much
sugar. People with type 2 diabetes produce less insulin and may have
problems with GLP-1. When your blood sugar is high, Victoza
® helps your body release more insulin by acting as GLP-1. Victoza
® lowers your blood sugar at the right time to help keep your blood sugar from becoming too low (resulting in
hypoglycemia).
While not a weight-loss product, Victoza® may help you lose weight. Medical studies showed that most people taking Victoza® lost weight. However, not all people who took Victoza®
lost weight. Individual results may vary. You should discuss healthy
eating, as well as safe and sensible ways to stay active, with your
diabetes care team.
How is Victoza® different from other treatments for type 2 diabetes?
Victoza® is an injectable medication
used to treat type 2 diabetes, but it is not insulin. It is used along
with healthy eating and staying active to help keep blood sugar under
control.
Victoza® may be taken with other diabetes medications, including those you may already be taking. However, Victoza® is not insulin, does not contain insulin, and should not be taken with insulin.
Victoza® is injected once each day, at
any time during the day. So it is best to take it at a time that you
will remember to take it with or without food.
Victoza® comes in a prefilled pen.
Needles are sold separately and may require a prescription in some
states. Your healthcare provider must teach you how to inject Victoza® before you use it for the first time.
What are possible side effects with Victoza®?
The most common side effects with Victoza® include headache, nausea, and diarrhea. Nausea is most common when first starting Victoza®, but it decreases over time in most people.
Your risk for getting low blood sugar is higher if you take Victoza
® with another medication that can cause low blood sugar, such as a
sulfonylurea.
Using the Victoza® Pen
.
Instructions for Use can help you become more confident about using Victoza
® by showing you how to use your Victoza
® Pen the right way.
What are the Victoza® Pen needles like?
There are two disposable needles from Novo Nordisk that are recommended for use with the Victoza® Pen:
NovoTwist® is a "single-twist" needle that can quickly attach to the Pen
NovoFine® is a needle that screws tightly onto the Pen
Both needles are available in 30-gauge and 32-gauge Tip sizes and work with the Victoza® Pen.*
Of people surveyed, 90% found the NovoFine® 30-gauge needle (one of the needles that can be used with the Victoza® Pen) to be practically pain-free. The needle recommended for use with the Victoza®
Pen is an even thinner 32-gauge Tip pen needle, which is the thinnest
needle from Novo Nordisk that is available in the United States. Because
a thinner needle has a higher gauge number, a 32-gauge needle is
thinner than a 30-gauge needle.
How do I take care of Victoza® Pen?
Always protect Victoza® Pen from heat and sunlight, and be sure to keep the cap on when your Victoza® Pen is not in use. Use a Victoza® Pen for only 30 days; it should be thrown away after 30 days, even if some medication is left in the Pen. The Victoza® Pen should only be used with Novo Nordisk disposable needles. After removing needle, put the cap on your Victoza® Pen and store your Victoza® Pen without the needle attached. Never try to refill your Victoza® Pen—it is prefilled and disposable.
How should u store theVictoza® Pen?
Your new, unused Victoza® Pen should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C). If Victoza® is stored outside of refrigeration (by mistake) prior to first use, it should be used or thrown away within 30 days. Victoza® should not be frozen.
After first use, store your Victoza® Pen for up to 30 days at 59°F to 86°F (15°C to 30°C), or in a refrigerator at 36°F to 46°F (2°C to 8°C).
How many doses of medication are available in each Victoza® Pen?
Your Victoza® Pen contains 18 mg of Victoza® and will deliver doses of 0.6 mg, 1.2 mg, or 1.8 mg. The number of doses that you can take with a Victoza® Pen depends on the dose of medication that is prescribed for you. Your healthcare provider will tell you how much Victoza® to take.
Indications and Usage
Victoza® is an injectable
prescription medicine that may improve blood sugar (glucose) in adults
with type 2 diabetes when used along with diet and exercise.
Victoza® is not recommended as the first medication to treat diabetes. Victoza® is not insulin and has not been studied in combination with insulin. Victoza® is not for people with type 1 diabetes or people with diabetic ketoacidosis. It is not known if Victoza® is safe and effective in children. Victoza® is not recommended for use in children.
Important Safety Information
In animal studies, Victoza® caused thyroid tumors—including thyroid cancer—in some rats and mice. It is not known whether Victoza®
causes thyroid tumors or a type of thyroid cancer called medullary
thyroid cancer (MTC) in people which may be fatal if not detected and
treated early. Do not use Victoza® if you or
any of your family members have a history of MTC or if you have Multiple
Endocrine Neoplasia syndrome type 2 (MEN 2). While taking Victoza, tell
your doctor if you get a lump or swelling in your neck, hoarseness,
trouble swallowing, or shortness of breath. These may be symptoms of
thyroid cancer.
Inflammation of the pancreas (pancreatitis) may be severe and lead to death. Before taking Victoza®,
tell your doctor if you have had pancreatitis, gallstones, a history of
alcoholism, or high blood triglyceride levels since these medical
conditions make you more likely to get pancreatitis.
Stop taking Victoza® and call your
doctor right away if you have pain in your stomach area that is severe
and will not go away, occurs with or without vomiting, or is felt going
from your stomach area through to your back. These may be symptoms of
pancreatitis.
It is unknown if Victoza® will harm your unborn baby or if Victoza® passes into your breast milk.
Your risk for getting hypoglycemia, or low blood sugar, is higher if you take Victoza®
with another medicine that can cause low blood sugar, such as a
sulfonylurea. The dose of your sulfonylurea medicine may need to be
lowered while taking Victoza®.
Victoza® may cause nausea, vomiting, or
diarrhea leading to dehydration, which may cause kidney failure. This
can happen in people who have never had kidney problems before. Drinking
plenty of fluids may reduce your chance of dehydration.
The most common side effects with Victoza® include headache, nausea, and diarrhea. Nausea is most common when first starting Victoza®,
but decreases over time in most people. Immune system related
reactions, including hives, were more common in people treated with
Victoza® compared to people treated with other diabetes drugs in medical studies.
Victoza® 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.
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.
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.
If pancreatitis is suspected, Victoza® should be discontinued. Victoza® should not be re-initiated if pancreatitis is confirmed.
When Victoza® is
used with an insulin secretagogue (e.g. a sulfonylurea) serious
hypoglycemia can occur. Consider lowering the dose of the insulin
secretagogue to reduce the risk of hypoglycemia.
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, 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.
Victoza® should be used with caution in patients with renal impairment and in patients with 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 2 diabetes treatment,
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 clinical trials of at least 26 weeks
duration, hypoglycemia requiring the assistance of another person for
treatment occurred in 7 Victoza®-treated patients and in no comparator-treated patients. Six of these 7 patients treated with Victoza® were also taking a sulfonylurea.
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% for comparator).
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
with Victoza®.
Victoza® slows gastric emptying. Victoza® has not been studied in patients with pre-existing gastroparesis.
In a 52-week monotherapy study (n=745), the adverse reactions reported in ≥5% of patients treated with Victoza®
or ≥5% of patients treated with glimepiride were nausea (28.4% vs
8.5%), diarrhea (17.1% vs 8.9%), vomiting (10.9% vs 3.6%), constipation
(9.9% vs 4.8%), upper respiratory tract infection (9.5% vs 5.6%),
headache (9.1% vs 9.3%), influenza (7.4% vs 3.6%), urinary tract
infection (6.0% vs 4.0%), dizziness (5.8% vs 5.2%), sinusitis (5.6% vs
6.0%), nasopharyngitis (5.2% vs 5.2%), back pain (5.0% vs 4.4%), and
hypertension (3.0% vs 6.0%).
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