VICTOZA- liraglutide injection

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

LIRAGLUTIDE (UNII: 839I73S42A) (LIRAGLUTIDE - UNII:839I73S42A)

Disponible des:

A-S Medication Solutions

Vía de administración:

SUBCUTANEOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

VICTOZA is indicated: infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies ( 14.3 )] . Limitations of Use : VICTOZA should not be used in patients with type 1 diabetes mellitus. VICTOZA contains liraglutide and should not be coadministered with other liraglutide-containing products. VICTOZA is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). VICTOZA is contraindicated in patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in VICTOZA. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with VICTOZA [see Warnings and Precautions (5.6)]. Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to VICTOZA during pregnancy. VICTOZA should be used during pregnancy only if the potentia

Resumen del producto:

Product: 50090-2853 NDC: 50090-2853-0 3 mL in a SYRINGE, PLASTIC / 3 in a CARTON

Estat d'Autorització:

New Drug Application

Informació per a l'usuari

VICTOZA- LIRAGLUTIDE INJECTION
A-S Medication Solutions
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MEDICATION GUIDE
VICTOZA® (VIC-tow-za)
(liraglutide) injection, for subcutaneous use
Read this Medication Guide before you start using VICTOZA and each
time you get a refill. There may be
new information. This information does not take the place of talking
to your healthcare provider about your
medical condition or your treatment.
What is the most important information I should know about VICTOZA?
VICTOZA may cause serious side effects, including:
•
Possible thyroid tumors, including cancer. Tell your healthcare
provider if you get a lump or swelling
in your neck, hoarseness, trouble swallowing, or shortness of breath.
These may be symptoms of
thyroid cancer. In studies with rats and mice, VICTOZA and medicines
that work like VICTOZA
caused thyroid tumors, including thyroid cancer. It is not known if
VICTOZA will cause thyroid
tumors or a type of thyroid cancer called medullary thyroid carcinoma
(MTC) in people.
•
Do not use VICTOZA if you or any of your 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).
What is VICTOZA?
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.
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.
Who should not use VICTOZA?
Do not use VICTOZA if:
•
you or any of your family have ever had a type of thyroid cancer
called medullary thyroid carcinoma
(MTC) or if you have an endocrine syste

Fitxa tècnica

VICTOZA- LIRAGLUTIDE INJECTION
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VICTOZA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VICTOZA.
VICTOZA (LIRAGLUTIDE) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2010
WARNING: RISK OF THYROID C-CELL TUMORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
VICTOZA is a glucagon-like peptide-1 (GLP-1) receptor agonist
indicated:
•
•
Limitations of Use:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
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 (3).
CONTRAINDICATIONS
VICTOZA is contraindicated in patients with a personal or family
history of medullary thyroid carcinoma or
®
LIRAGLUTIDE CAUSES 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 THE
HUMAN
RELEVANCE OF LIRAGLUTIDE-INDUCED RODENT THYROID C-CELL TUMORS HAS NOT
BEEN
DETERMINED (5.1, 13.1).
VICTOZA IS CONTRAINDICATED IN PATIENTS WITH A PERSONAL OR FAMILY
HISTORY OF MTC OR
IN PATIENTS WITH MULTIPLE ENDOCRINE NEOPLASIA SYNDROME TYPE 2 (MEN 2).
COUNSEL
PATIENTS REGARDING THE POTENTIAL RISK OF MTC AND THE SYMPTOMS OF
THYROID TUMORS
(4, 5.1).
Dosage and Administration (2.1)…………………………06/2022
Warnings and Precautions (5.7)……………………..…….06/2022
as an adjunct to diet and exercise to improve glycemic control in
patients 10 years and older with
type 2 diabetes mellitus (1).
to reduce the risk of major adverse cardiovascular events in adults
with type 2 diabetes mellitus and
established cardiovascular disease (1).
Not for treatment of type 1 diabetes mellitus.
Should not be coadministered with other liraglutide-containing
products.
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