ONGLYZA- saxagliptin tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

saxagliptin hydrochloride (UNII: Z8J84YIX6L) (saxagliptin anhydrous - UNII:8I7IO46IVQ)

Commercializzato da:

Cardinal Health 107, LLC

INN (Nome Internazionale):

saxagliptin hydrochloride

Composizione:

saxagliptin anhydrous 5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14) ]. ONGLYZA is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. ONGLYZA is contraindicated in patients with a history of a serious hypersensitivity reaction to ONGLYZA, such as anaphylaxis, angioedema, or exfoliative skin conditions [see Warnings and Precautions (5.4) and Adverse Reactions (6.2) ]. Limited data with ONGLYZA in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriages. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ]. No adverse developmental effects independent of maternal toxicity were observed when saxagliptin was administered to pregnant rats and rabbits during the period of organogenesis and in pregnant and lactating rats during

Dettagli prodotto:

How Supplied ONGLYZA (saxagliptin) tablets have markings on both sides and are available in the strengths and packages listed in Table 16. Table 16: ONGLYZA Tablet Presentations Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

New Drug Application

Foglio illustrativo

Cardinal Health 107, LLC
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MEDICATION GUIDE
ONGLYZA® (on-GLY-zah)
(saxagliptin)
tablets, for oral use
What is the most important information I should know about ONGLYZA?
Serious side effects can happen to people taking ONGLYZA, including:
1) Inflammation of the pancreas (pancreatitis) which may be severe and
lead to death.
Certain medical problems make you more likely to get pancreatitis.
Before you start taking ONGLYZA:
Tell your healthcare provider if you have ever had
•
inflammation of your pancreas (pancreatitis)
•
a history of alcoholism
•
stones in your gallbladder (gallstones)
•
high blood triglyceride levels
It is not known if having these medical problems will make you more
likely to get pancreatitis with
ONGLYZA.
Stop taking ONGLYZA and contact your healthcare provider right away if
you have pain in your stomach
area (abdomen) that is severe and will not go away. The pain may be
felt going from your abdomen through
to your back. The pain may happen with or without vomiting. These may
be symptoms of pancreatitis.
2) Heart failure. Heart failure means your heart does not pump blood
well enough.
Before you start taking ONGLYZA:
Tell your healthcare provider if you
•
have ever had heart failure or have problems with your kidneys.
Contact your healthcare provider right away if you have any of the
following symptoms:
•
increasing shortness of breath or trouble
breathing, especially when you lie down
•
•
an unusually fast increase in weight
•
swelling or fluid retention, especially in the feet,
ankles or legs
unusual tiredness
These may be symptoms of heart failure.
What is ONGLYZA?
•
ONGLYZA is a prescription medicine used with diet and exercise to
control high blood sugar
(hyperglycemia) in adults with type 2 diabetes.
•
ONGLYZA lowers blood sugar by helping the body increase the level of
insulin after meals.
•
ONGLYZA is unlikely by itself to cause your blood sugar to be lowered
to a dangerous level
(hypoglycemia) because it does not work well when your blood sugar is
low.

Scheda tecnica

ONGLYZA- SAXAGLIPTIN TABLET, FILM COATED
CARDINAL HEALTH 107, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONGLYZA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ONGLYZA.
ONGLYZA (SAXAGLIPTIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
INDICATIONS AND USAGE
ONGLYZA is a dipeptidyl peptidase-4 (DPP4) inhibitor indicated as an
adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus.
(1.1, 14)
Limitation of use:
•
DOSAGE AND ADMINISTRATION
•
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DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
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ADVERSE REACTIONS
•
®
Not used for the treatment of type 1 diabetes mellitus or diabetic
ketoacidosis. (1.2)
Recommended dosage is 2.5 mg or 5 mg once daily taken regardless of
meals. (2.1)
Patients eGFR <45 mL/min/1.73 m (with moderate or severe renal
impairment, or end-stage renal
disease): Recommended dosage is 2.5 mg once daily regardless of meals.
(2.2)
2
Assess renal function before starting ONGLYZA and periodically
thereafter. (2.2)
2.5 mg daily is recommended for patients also taking strong cytochrome
P450 3A4/5 (CYP3A4/5)
inhibitors (e.g., ketoconazole). (2.3, 7.1)
Tablets: 5 mg and 2.5 mg. (3)
History of a serious hypersensitivity reaction (e.g., anaphylaxis,
angioedema, exfoliative skin
conditions) to ONGLYZA. (4)
_Pancreatitis:_ If pancreatitis is suspected, promptly discontinue
ONGLYZA. (5.1)
_Heart Failure:_ Consider the risks and benefits of ONGLYZA in
patients who have known risk factors for
heart failure. Monitor patients for signs and symptoms. (5.2)
_Hypoglycemia:_ In add-on to sulfonylurea, add-on to insulin, and
add-on to metformin plus
sulfonylurea trials, confirmed hypoglycemia was more common in
patients treated with ONGLYZA
compared to placebo.
When used with an insulin secretagogue (e.g., sulfonylurea) or
insulin, a lower dose of insulin
secretagogue or insulin may be required to minimize the risk