SAXAGLIPTIN tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

SAXAGLIPTIN HYDROCHLORIDE (UNII: Z8J84YIX6L) (SAXAGLIPTIN ANHYDROUS - UNII:8I7IO46IVQ)

Dostępny od:

Aurobindo Pharma Limited

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14) ]. Saxagliptin tablets are not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. Saxagliptin is contraindicated in patients with a history of a serious hypersensitivity reaction to saxagliptin tablets, such as anaphylaxis, angioedema, or exfoliative skin conditions [see  Warnings and Precautions (5.4) and Adverse Reactions (6.2) ]. Risk Summary Limited data with saxagliptin 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. Clinical Considerations 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. Data 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. Risk Summary There is no information regarding the presence of saxagliptin 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 saxagliptin and any potential adverse effects on the breastfed infant from saxagliptin or from the underlying maternal condition. Data Saxagliptin is secreted in the milk of lactating rats at approximately a 1:1 ratio with plasma drug concentrations. Safety and effectiveness of saxagliptin in pediatric patients under 18 years of age have not been established. Additionally, studies characterizing the pharmacokinetics of saxagliptin in pediatric patients have not been performed. In the seven, double-blind, controlled clinical safety and efficacy trials of saxagliptin, a total of 4751 (42.0%) of the 11301 patients randomized to saxagliptin 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, saxagliptin 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 saxagliptin and placebo. The overall incidence of reported hypoglycemia was 20% among subjects treated with saxagliptin 2.5 mg and 22% among subjects treated with placebo. Four saxagliptin-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).

Podsumowanie produktu:

How Supplied Saxagliptin tablets are available in the following strengths and packages. Saxagliptin Tablets , 2.5 mg are pale yellow to light yellow, biconvex, round, film-coated tablet, debossed with “L6” on one side and plain on other side.                                               Bottles of 30                        NDC 65862-825-30                  Bottles of 90                        NDC 65862-825-90                  Bottles of 100                      NDC 65862-825-01                  Bottles of 500                      NDC 65862-825-05 Saxagliptin Tablets, 5 mg are pink, biconvex, round, film-coated tablet, debossed with “L7” on one side and plain on other side.                  Bottles of 30                        NDC 65862-826-30                  Bottles of 90                        NDC 65862-826-90                  Bottles of 100                      NDC 65862-826-01                  Bottles of 500                      NDC 65862-826-05 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

SAXAGLIPTIN - SAXAGLIPTIN TABLET, FILM COATED
Aurobindo Pharma Limited
----------
MEDICATION GUIDE
Saxagliptin Tablets, for oral use
(SAX-a-GLIP-tin)
The 2.5 mg tablets contain FD&C Yellow No. 5 (tartrazine) which may
cause allergic-type reactions
(including bronchial asthma) in certain susceptible persons. Although
the overall incidence of FD&C
Yellow No. 5 (tartrazine) sensitivity in the general population is
low, it is frequently seen in patients who
also have aspirin hypersensitivity.
What
is
the
most
important
information
I
should
know
about
saxagliptin
tablets?
Serious
side
effects
can
happen
to
people
taking
saxagliptin
tablets,
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
saxagliptin
tablets:
Tell your healthcare provider if you have ever had
•
inflammation of your pancreas (pancreatitis)
•
stones in your gallbladder (gallstones)
•
a history of alcoholism
•
high blood triglyceride levels
It is not known if having these medical problems will make you more
likely to get pancreatitis with
saxagliptin
tablets.
Stop taking saxagliptin tablets 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
saxagliptin
tablets:
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

Charakterystyka produktu

SAXAGLIPTIN - SAXAGLIPTIN TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SAXAGLIPTIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SAXAGLIPTIN TABLETS.
SAXAGLIPTIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
INDICATIONS AND USAGE
Saxagliptin 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:
Not used for the treatment of type 1 diabetes mellitus or diabetic
ketoacidosis. (1.2)
DOSAGE AND ADMINISTRATION
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)
Assess renal function before starting saxagliptin tablets 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)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 2.5 mg. (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis,
angioedema, exfoliative skin conditions)
to saxagliptin tablets. (4)
WARNINGS AND PRECAUTIONS
_ _
_Pancreatitis:_ If pancreatitis is suspected, promptly discontinue
saxagliptin. (5.1)
_Heart Failure:_ Consider the risks and benefits of saxagliptin 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 saxagliptin 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 of
hypoglycemia. (5