FARXIGA- dapagliflozin tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

DAPAGLIFLOZIN PROPANEDIOL (UNII: 887K2391VH) (dapagliflozin - UNII:1ULL0QJ8UC)

Dostupné z:

AstraZeneca Pharmaceuticals LP

INN (Medzinárodný Name):

DAPAGLIFLOZIN PROPANEDIOL

Zloženie:

dapagliflozin 5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

FARXIGA (dapagliflozin) is indicated: Limitations of Use Based on animal data showing adverse renal effects, FARXIGA is not recommended during the second and third trimesters of pregnancy. Limited data with FARXIGA in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes and untreated heart failure in pregnancy (see Clinical Considerations) . In animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when dapagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy, at all doses tested; the lowest of which provided an exposure 15-times the 10 mg clinical dose (see Data). The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a HbA1c greater than 7% and has been reported to be as high as 20 to 25% in women with 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 embryofetal risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Animal Data Dapagliflozin dosed directly to juvenile rats from postnatal day (PND) 21 until PND 90 at doses of 1, 15, or 75 mg/kg/day, increased kidney weights and increased the incidence of renal pelvic and tubular dilatations at all dose levels. Exposure at the lowest dose tested was 15-times the 10 mg clinical dose (based on AUC). The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within a 1-month recovery period. In a prenatal and postnatal development study, dapagliflozin was administered to maternal rats from gestation day 6 through lactation day 21 at doses of 1, 15, or 75 mg/kg/day, and pups were indirectly exposed in utero and throughout lactation. Increased incidence or severity of renal pelvic dilatation was observed in 21-day-old pups offspring of treated dams at 75 mg/kg/day (maternal and pup dapagliflozin exposures were 1415-times and 137-times, respectively, the human values at the 10 mg clinical dose, based on AUC). Dose-related reductions in pup body weights were observed at greater or equal to 29-times the 10 mg clinical dose (based on AUC). No adverse effects on developmental endpoints were noted at 1 mg/kg/day (19-times the 10 mg clinical dose, based on AUC). These outcomes occurred with drug exposure during periods of renal development in rats that corresponds to the late second and third trimester of human development. In embryofetal development studies in rats and rabbits, dapagliflozin was administered throughout organogenesis, corresponding to the first trimester of human pregnancy. In rats, dapagliflozin was neither embryolethal nor teratogenic at doses up to 75 mg/kg/day (1441-times the 10 mg clinical dose, based on AUC). Dose-related effects on the rat fetus (structural abnormalities and reduced body weight) occurred only at higher dosages, equal to or greater than 150 mg/kg (more than 2344-times the 10 mg clinical dose, based on AUC), which were associated with maternal toxicity. No developmental toxicities were observed in rabbits at doses up to 180 mg/kg/day (1191-times the 10 mg clinical dose, based on AUC). Risk Summary There is no information regarding the presence of dapagliflozin in human milk, the effects on the breastfed infant, or the effects on milk production. Dapagliflozin is present in the milk of lactating rats (see Data) . However, due to species-specific differences in lactation physiology, the clinical relevance of these data is not clear. Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. Because of the potential for serious adverse reactions in breastfed infants, advise women that use of FARXIGA is not recommended while breastfeeding. Data Dapagliflozin was present in rat milk at a milk/plasma ratio of 0.49, indicating that dapagliflozin and its metabolites are transferred into milk at a concentration that is approximately 50% of that in maternal plasma. Juvenile rats directly exposed to dapagliflozin showed risk to the developing kidney (renal pelvic and tubular dilatations) during maturation. Safety and effectiveness of FARXIGA in pediatric patients under 18 years of age have not been established. No FARXIGA dosage change is recommended based on age. A total of 1424 (24%) of the 5936 FARXIGA-treated patients were 65 years and older and 207 (3.5%) patients were 75 years and older in a pool of 21 double-blind, controlled, clinical studies assessing the efficacy of FARXIGA in improving glycemic control in type 2 diabetes mellitus. After controlling for level of renal function (eGFR), efficacy was similar for patients under age 65 years and those 65 years and older. In patients ≥65 years of age, a higher proportion of patients treated with FARXIGA for glycemic control had adverse reactions of hypotension [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] . In the DAPA-CKD, DAPA-HF and DELIVER studies, safety and efficacy were similar for patients age 65 years and younger and those older than 65. In the DAPA-HF study, 2714 (57%) out of 4744 patients with HFrEF were older than 65 years. In the DELIVER study, 4759 (76%) out of 6263 patients with heart failure (LVEF >40%) were older than 65 years. In the DAPA-CKD study, 1818 (42%) out of 4304 patients with CKD were older than 65 years. FARXIGA was evaluated in 4304 patients with chronic kidney disease (eGFR 25 to 75 mL/min/1.73 m2 ) in the DAPA-CKD study. FARXIGA was also evaluated in 1926 patients with an eGFR of 30 to 60 mL/min/1.73 m2 in the DAPA-HF study. The safety profile of FARXIGA across eGFR subgroups in these studies was consistent with the known safety profile [see Adverse Reactions (6.1) and Clinical Studies (14.3 and 14.4)]. FARXIGA was evaluated in two glycemic control studies that included patients with type 2 diabetes mellitus with moderate renal impairment (an eGFR of 45 to less than 60 mL/min/1.73 m2 [see Clinical Studies (14.1)] , and an eGFR of 30 to less than 60 mL/min/1.73 m2 , respectively). Patients with diabetes and renal impairment using FARXIGA may be more likely to experience hypotension and may be at higher risk for acute kidney injury secondary to volume depletion. In the study of patients with an eGFR 30 to less than 60 mL/min/1.73 m2 , 13 patients receiving FARXIGA experienced bone fractures compared to none receiving placebo. Use of FARXIGA for glycemic control in patients without established CV disease or CV risk factors is not recommended when eGFR is less than 45 mL/min/1.73 m2 [see Dosage and Administration (2.2)] . Efficacy and safety studies with FARXIGA did not enroll patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis. No dose adjustment is recommended for patients with mild, moderate, or severe hepatic impairment. However, the benefit-risk for the use of dapagliflozin in patients with severe hepatic impairment should be individually assessed since the safety and efficacy of dapagliflozin have not been specifically studied in this population [see Clinical Pharmacology (12.3)] .

Prehľad produktov:

How Supplied FARXIGA (dapagliflozin) tablets have markings on both sides and are available in the strengths and packages listed in Table 18. 5 mg yellow, biconvex, round “5” engraved on one side and “1427” engraved on the other side Bottles of 30 0310-6205-30 Bottles of 90 0310-6205-90 10 mg yellow, biconvex, diamond-shaped “10” engraved on one side and “1428” engraved on the other side Bottles of 30 0310-6210-30 Bottles of 90 0310-6210-90 Hospital Unit Dose Blister Pack: Carton containing 30 tablets (3 blister cards x 10 tablets per card) 0310-6210-39 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Stav Autorizácia:

New Drug Application

Príbalový leták

AstraZeneca Pharmaceuticals LP
----------
MEDICATION GUIDE
FARXIGA® [FAR-SEE-GUH]
(dapagliflozin)
tablets, for oral use
What is the most important information I should know about FARXIGA?
FARXIGA can cause serious side effects, including:
•
Diabetic ketoacidosis (increased ketones in your blood or urine) in
people with type 1 diabetes and
other ketoacidosis. FARXIGA can cause ketoacidosis that can be
life-threatening and may lead to
death. Ketoacidosis is a serious condition which needs to be treated
in a hospital. People with type
1 diabetes have a high risk of getting ketoacidosis. People with type
2 diabetes or pancreas
problems also have an increased risk of getting ketoacidosis.
Ketoacidosis can also happen in
people who: are sick, cannot eat or drink as usual, skip meals, are on
a diet high in fat and low in
carbohydrates (ketogenic diet), take less than the usual amount of
insulin or miss insulin doses,
drink too much alcohol, have a loss of too much fluid from the body
(volume depletion), or who
have surgery. Ketoacidosis can happen even if your blood sugar is less
than 250 mg/dL. Your
healthcare provider may ask you to periodically check ketones in your
urine or blood.
Stop taking FARXIGA and call your healthcare provider or get medical
help right away if you get
any of the following. If possible, check for ketones in your urine or
blood, even if your blood sugar
is less than 250 mg/dL.
o
nausea
o
vomiting
o
stomach area (abdominal) pain
o
tiredness
o
trouble breathing
o
ketones in your urine or blood
•
Dehydration. FARXIGA can cause some people to become dehydrated (the
loss of body water and
salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or
weak, especially when you
stand up (orthostatic hypotension). There have been reports of sudden
kidney injury in people with
Type 2 diabetes who are taking FARXIGA. You may be at a higher risk of
dehydration if you:
∘
take medicines to lower your blood pressure, including water pills
(diuretics)
∘
are on a low salt diet
∘
have kidney

Súhrn charakteristických

FARXIGA- DAPAGLIFLOZIN TABLET, FILM COATED
ASTRAZENECA PHARMACEUTICALS LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FARXIGA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FARXIGA.
FARXIGA (DAPAGLIFLOZIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Indications and Usage (1) 09/2023
Dosage and Administration (2.3) 09/2023
Warnings and Precautions (5.1) 09/2023
INDICATIONS AND USAGE
FARXIGA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor
indicated:
•
•
•
•
Limitations of use:
•
•
•
DOSAGE AND ADMINISTRATION
•
EGFR
(ML/MIN/1.73 M )
RECOMMENDED DOSE
EGFR 45 OR GREATER
To improve glycemic control, the recommended starting dose is
5 mg orally once daily. Dose can be increased to 10 mg orally once
daily for additional glycemic control.
For all other indications, the recommended starting dose is 10 mg
orally once daily.
EGFR 25 TO LESS THAN 45
10 mg orally once daily
EGFR LESS THAN 25
Initiation is not recommended; however, patients may continue
10 mg orally once daily to reduce the risk of eGFR decline, ESKD, CV
death and hHF.
•
DOSAGE FORMS AND STRENGTHS
•
®
To reduce the risk of sustained eGFR decline, end-stage kidney
disease, cardiovascular death, and
hospitalization for heart failure in adults with chronic kidney
disease at risk of progression. (1)
To reduce the risk of cardiovascular death, hospitalization for heart
failure, and urgent heart failure
visit in adults with heart failure. (1)
To reduce the risk of hospitalization for heart failure in adults with
type 2 diabetes mellitus and either
established cardiovascular disease or multiple cardiovascular risk
factors. (1)
As an adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus.
(1)
Not recommended for use to improve glycemic control in patients with
type 1 diabetes mellitus. (1)
Not recommended for use to improve glycemic control in adults with
type 2 diabetes mellitus with an
eGF