OZEMPIC- semaglutide injection, solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

SEMAGLUTIDE (UNII: 53AXN4NNHX) (SEMAGLUTIDE - UNII:53AXN4NNHX)

可用日期:

Novo Nordisk

INN（国际名称）:

SEMAGLUTIDE

组成:

SEMAGLUTIDE 1.34 mg in 1 mL

给药途径:

SUBCUTANEOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

OZEMPIC is indicated: Limitations of Use OZEMPIC is contraindicated in patients with: Risk Summary There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations) . Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. OZEMPIC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal clinical exposure based on AUC. In rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses or structural abnormalities were observed at clinical exposure (rabbit) and ≥2-fold the MRHD (monkey). These findings coincided wi

產品總結:

How Supplied Injection: clear, colorless solution of 0.68 mg/mL, 1.34 mg/mL or 2.68 mg/mL of semaglutide available in pre-filled, disposable, single-patient-use pens in the following packaging configurations: Dose per Injection Use For Total Strength per Total Volume Doses per Pen Carton Contents NDC 0.25 mg 0.5 mg Initiation Maintenance 2 mg/3 mL 4 doses of 0.25 mg and 2 doses of 0.5 mg or 4 doses of 0.5 mg 1 pen 6 NovoFine® Plus needles 0169-4181-13 1 mg Maintenance 4 mg/3 mL 4 doses of 1 mg 1 pen 4 NovoFine® Plus needles 0169-4130-13 2 mg Maintenance 8 mg/3 mL 4 doses of 2 mg 1 pen 4 NovoFine® Plus needles 0169-4772-12 The 2 mg/1.5 mL (1.34 mg/mL) strength (NDC 0169-4132-12) is not currently marketed by Novo Nordisk Inc. Each OZEMPIC pen is for use by a single patient. An OZEMPIC pen must never be shared between patients, even if the needle is changed [see Warnings and Precautions (5.4)] . Recommended Storage Prior to first use, OZEMPIC should be stored in a refrigerator between 36ºF to 46ºF (2ºC to 8ºC) (Table 10). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze OZEMPIC and do not use OZEMPIC if it has been frozen. After first use of the OZEMPIC pen, the pen can be stored for 56 days at controlled room temperature (59°F to 86°F; 15°C to 30°C) or in a refrigerator (36°F to 46°F; 2°C to 8°C). Do not freeze. Keep the pen cap on when not in use. OZEMPIC should be protected from excessive heat and sunlight. Always remove and safely discard the needle after each injection and store the OZEMPIC pen without an injection needle attached. Always use a new needle for each injection. The storage conditions are summarized in Table 10: Prior to first use After first use Refrigerated 36°F to 46°F (2°C to 8°C) Room Temperature 59°F to 86°F (15°C to 30°C) Refrigerated 36°F to 46°F (2°C to 8°C) Until expiration date 56 days

授权状态:

New Drug Application

资料单张

Novo Nordisk
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MEDICATION GUIDE
Medication Guide
OZEMPIC® (oh-ZEM-pick)
(semaglutide)
injection, for subcutaneous use
Do not share your OZEMPIC pen with other people, even if the needle
has been changed. You may give
other people a serious infection, or get a serious infection from
them.
Read this Medication Guide before you start using OZEMPIC 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 OZEMPIC?
OZEMPIC 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 rodents, OZEMPIC and
medicines that work like
OZEMPIC caused thyroid tumors, including thyroid cancer. It is not
known if OZEMPIC will
cause thyroid tumors or a type of thyroid cancer called medullary
thyroid carcinoma (MTC) in
people.
•
Do not use OZEMPIC 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 OZEMPIC?
OZEMPIC is an injectable prescription medicine used:
•
along with diet and exercise to improve blood sugar (glucose) in
adults 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.
It is not known if OZEMPIC can be used in people who have had
pancreatitis.
OZEMPIC is not for use in people with type 1 diabetes.
It is not known if OZEMPIC is safe and effective for use in children
under 18 years of age.
Do not use OZEMPIC if:
•
you or any of your family have ever had a type of thyroid cancer
called medullary thyroi

产品特点

OZEMPIC- SEMAGLUTIDE INJECTION, SOLUTION
NOVO NORDISK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OZEMPIC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OZEMPIC.
OZEMPIC (SEMAGLUTIDE) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2017
WARNING: RISK OF THYROID C-CELL TUMORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
INDICATIONS AND USAGE
OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist
indicated as:
•
•
Limitations of Use:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Injection: 2 mg/3 mL (0.68 mg/mL) available in:
•
Injection: 4 mg/3 mL (1.34 mg/mL) available in:
•
Injection: 8 mg/3 mL (2.68 mg/mL) available in:
•
CONTRAINDICATIONS
®
IN RODENTS, SEMAGLUTIDE CAUSES THYROID C-CELL TUMORS. IT IS UNKNOWN
WHETHER
OZEMPIC CAUSES THYROID C-CELL TUMORS, INCLUDING MEDULLARY THYROID
CARCINOMA
(MTC), IN HUMANS AS THE HUMAN RELEVANCE OF SEMAGLUTIDE-INDUCED RODENT
THYROID
C-CELL TUMORS HAS NOT BEEN DETERMINED (5.1, 13.1).
OZEMPIC 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 SYMPTOMS OF THYROID
TUMORS (4,
5.1).
an adjunct to diet and exercise to improve glycemic control in adults
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).
Has not been studied in patients with a history of pancreatitis.
Consider another antidiabetic therapy
(1, 5.2).
Not for treatment of type 1 diabetes mellitus (1).
Administer once weekly at any time of day, with or without meals
(2.1).
Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to
0.5 mg once weekly (2.2).
If additional glycemic control is needed, increase the dosage to 1 mg
once weekly after at least 4
weeks on the 0.5