Liraglutide - Victoza- @-Hypoglycemics (Jan 2010)
Drug Name:Liraglutide - Victoza- @-Hypoglycemics (Jan 2010)
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Oral Medications
Victoza causes a delay of gastric emptying, and thereby has the potential
to impact the absorption of concomitantly administered oral medications.
In clinical pharmacology trials, Victoza did not affect the absorption of the
tested orally administered medications to any clinically relevant degree.
Nonetheless caution should be exercised when oral medications are
concomitantly administered with Victoza.
Indication:
Proprietary Name- Victoza
Established Name - Liraglutide
Applicant- Novo Nordisk Inc
Indication-
Indicated as an adjunct to diet and excercise to improve Glycemic control
in adult in Type 2 Diabetic Mellitus
Approved by FDA on 25-1-2010 (Ref- FDA approved List- 2010)
Adverse Reaction:
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
Contra-Indications:
CONTRAINDICATIONS
Victoza is contraindicated in patients with a personal or family history
of medullary thyroid carcinoma or in patients with Multiple Endocrine
Neoplasia syndrome type 2
Victoza is contraindicated in patients with a prior serious hypersensitivity
reaction to Victoza or any of the product components
WARNINGS AND PRECAUTIONS·
Pancreatitis: 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
Never share a Victoza pen between patients, even if the needle is changed
Serious Hypoglycemia: Can occur when Victoza is used with an insulin
secretagogue (e.g. a sulfonylurea) or insulin.
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
renal impairment .
Hypersensitivity: Postmarketing reports of serious hypersensitivity reactions
(e.g., anaphylactic reactions and angioedema).
The patient should discontinue Victoza and other suspect medications
and promptly seek medical advice
Macrovascular Outcomes: There have been no studies establishing
conclusive evidence of macrovascular risk reduction with Victoza or
any other antidiabetic drug
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
Victoza is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an
adjunct to diet and exercise to improve glycemic control in adults with
type 2 diabetes mellitus
Important Limitations of Use
Not recommended as first-line therapy for patients inadequately controlled
on diet and exercise
Has not been studied in patients with a history of pancreatitis.
Consider other antidiabetic therapies in patients with a history of pancreatitis
Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Has not been studied in combination with prandial insulin.
DOSAGE AND ADMINISTRATION
Administer once daily at any time of day, independently of meals
Inject subcutaneously in the abdomen, thigh or upper arm
The injection site and timing can be changed without dose adjustment .
Patient Information:
1. Risk of Thyroid C-cell Tumors
Inform patients that liraglutide causes benign and malignant thyroid
C-cell tumors in mice and rats and that the human relevance of this
finding has not been determined.
Counsel patients to report symptoms of thyroid tumors
(e.g., a lump in the neck, hoarseness, dysphagia, or dyspnea)
to their physician
2 Dehydration and Renal Failure
Patients treated with Victoza should be advised of the potential risk of
dehydration due to gastrointestinal adverse reactions and take precautions
to avoid fluid depletion.
Patients should be informed of the potential risk for worsening renal function,
which in some cases may require dialysis.
3. Pancreatitis
Patients should be informed of the potential risk for pancreatitis.
Explain that persistent severe abdominal pain that may radiate to the
back and which may or may not be accompanied by vomiting, is the
hallmark symptom of acute pancreatitis
Instruct patients to discontinue Victoza promptly and contact their physician
if persistent severe abdominal pain occurs
4. Never Share a Victoza Pen Between Patients
Advise patients that they must never share a Victoza pen with another person,
even if the needle is changed, because doing so carries a risk for transmission
of blood-borne pathogens.
5 Hypersensitivity Reactions
Patients should be informed that serious hypersensitivity reactions have been
reported during postmarketing use of Victoza. If symptoms of hypersensitivity
reactions occur, patients must stop taking Victoza and seek medical advice
promptly
6. Instructions
Patients should be informed of the potential risks and benefits of Victoza and
of alternative modes of therapy.
Patients should also be informed about the importance of adherence to dietary
instructions, regular physical activity, periodic blood glucose monitoring
and testing, recognition and management of hypoglycemia and hyperglycemia,
and assessment for diabetes complications.
During periods of stress such as fever, trauma, infection, or surgery, medication
requirements may change and patients should be advised to seek medical
advice promptly.
Reference ID:
Pharmacology/ Pharmacokinetics:
1 Mechanism of Action
Liraglutide is an acylated human Glucagon-Like Peptide-1 (GLP-1) receptor
agonist with 97% amino acid sequence homology to endogenous human
GLP-1(7-37). GLP-1(7-37) represents <20% of total circulating endogenous
GLP-1. Like GLP-1(7-37), liraglutide activates the GLP-1 receptor,
a membrane-bound cell-surface receptor coupled to adenylyl cyclase
by the stimulatory G-protein, Gs, in pancreatic beta cells
2. Pharmacokinetics
Absorption -
Following subcutaneous administration, maximum concentrations
of liraglutide are achieved at 8-12 hours post dosing. The mean peak (Cmax)
and total (AUC) exposures of liraglutide were 35 ng/mL and 960 ng·h/mL,
respectively, for a subcutaneous single dose of 0.6 mg.
After subcutaneous single dose administrations, Cmax and AUC
of liraglutide increased proportionally over the therapeutic dose range of
0.6 mg to 1.8 mg. At 1.8 mg Victoza, the average steady state concentration
of liraglutide over 24 hours was approximately 128 ng/mL
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy
Pregnancy Category C.
There are no adequate and well-controlled studies of Victoza in pregnant women
Victoza should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
2 Nursing Mothers
It is not known whether Victoza is excreted in human milk. Because many drugs
are excreted in human milk and because of the potential for tumorigenicity
shown for liraglutide in animal studies, a decision should be made whether
to discontinue nursing or to discontinue Victoza, taking into account the
importance of the drug to the mother.
3. Pediatric Use
Safety and effectiveness of Victoza have not been established in pediatric patients.
Victoza is not recommended for use in pediatric patients.
4 Geriatric Use
In the Victoza clinical trials, a total of 797 (20%) of the patients were
65 years of age and over and 113 (2.8%) were 75 years of age and over.
No overall differences in safety or effectiveness were observed between
these patients and younger patients, but greater sensitivity of some older
individuals cannot be ruled out.
