ONGLYZA- saxagliptin tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

AstraZeneca Pharmaceuticals LP

INN (International ime):

saxagliptin hydrochloride

Sastav:

saxagliptin anhydrous 5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 the pre- and postnatal period [see Data ]. The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with an HbA1c greater than 7 and has been reported to be as high as 20 to 25% in women with an HbA1c greater than 10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Disease-associated maternal and/or embryo/fetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Animal Data In embryo-fetal development studies, saxagliptin was administered to pregnant rats and rabbits during the period of organogenesis, corresponding to the first trimester of human pregnancy. No adverse developmental effects were observed in either species at exposures 1503- and 152-times the 5 mg clinical dose in rats and rabbits, respectively, based on AUC. Saxagliptin crosses the placenta into the fetus following dosing in pregnant rats. In a prenatal and postnatal development study, no adverse developmental effects were observed in maternal rats administered saxagliptin from gestation day 6 through lactation day 21 at exposures up to 470-times the 5 mg clinical dose, based on AUC. There is no information regarding the presence of ONGLYZA in human milk, the effects on the breastfed infant, or the effects on milk production. Saxagliptin is present in the milk of lactating rats [see Data ]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ONGLYZA and any potential adverse effects on the breastfed infant from ONGLYZA or from the underlying maternal condition. Saxagliptin is secreted in the milk of lactating rats at approximately a 1:1 ratio with plasma drug concentrations. Safety and effectiveness of ONGLYZA in pediatric patients under 18 years of age have not been established. Additionally, studies characterizing the pharmacokinetics of ONGLYZA in pediatric patients have not been performed. In the seven, double-blind, controlled clinical safety and efficacy trials of ONGLYZA, a total of 4751 (42.0%) of the 11301 patients randomized to ONGLYZA were 65 years and over, and 1210 (10.7%) were 75 years and over. No overall differences in safety or effectiveness were observed between subjects ≥65 years old and younger subjects. While this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. Saxagliptin and its active metabolite are eliminated in part by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly based on renal function [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ]. In a 12-week randomized placebo-controlled trial, ONGLYZA 2.5 mg was administered to 85 subjects with moderate (n=48) or severe (n=18) renal impairment or end-stage renal disease (ESRD) (n=19) [see Clinical Studies (14) ]. The incidence of adverse events, including serious adverse events and discontinuations due to adverse events, was similar between ONGLYZA and placebo. The overall incidence of reported hypoglycemia was 20% among subjects treated with ONGLYZA 2.5 mg and 22% among subjects treated with placebo. Four ONGLYZA-treated subjects (4.7%) and three placebo-treated subjects (3.5%) reported at least one episode of confirmed symptomatic hypoglycemia (accompanying fingerstick glucose ≤50 mg/dL).

Proizvod sažetak:

How Supplied ONGLYZA (saxagliptin) tablets have markings on both sides and are available in the strengths and packages listed in Table 16. 5 mg pink biconvex, round “5” on one side and “4215” on the reverse, in blue ink Bottles of 30 Bottles of 90 0310-6105-30 0310-6105-90 2.5 mg pale yellow to light yellow biconvex, round “2.5” on one side and “4214” on the reverse, in blue ink Bottles of 30 Bottles of 90 0310-6100-30 0310-6100-90 Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Status autorizacije:

New Drug Application

Uputa o lijeku

AstraZeneca Pharmaceuticals LP
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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
•
swelling or fluid retention, especially in the
feet, ankles or legs
•
an unusually fast increase in weight
•
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

Svojstava lijeka

ONGLYZA- SAXAGLIPTIN TABLET, FILM COATED
ASTRAZENECA PHARMACEUTICALS LP
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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
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CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
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•
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ADVERSE REACTIONS
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®
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 th