JANUVIA- sitagliptin tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

SITAGLIPTIN PHOSPHATE (UNII: TS63EW8X6F) (SITAGLIPTIN - UNII:QFP0P1DV7Z)

Disponível em:

A-S Medication Solutions

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use JANUVIA should not be used in patients with type 1 diabetes. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA. [See Warnings and Precautions (5.1).] History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [See Warnings and Precautions (5.5) ; Adverse Reactions (6.2).] Risk Summary The limited available data with JANUVIA in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations]. No adverse developmental effects were observed when sitagliptin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 30-times and 20-times, respectively, the 100 mg clinical dose, based on AUC [see Data] . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a Hemoglobin A1c >7% and has been reported to be as high as 20-25% in women with a Hemoglobin A1c >10%. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. Data Animal Data In embryo-fetal development studies, sitagliptin administered to pregnant rats and rabbits during organogenesis (gestation day 6 to 20) did not adversely affect developmental outcomes at oral doses up to 250 mg/kg (30-times the 100 mg clinical dose) and 125 mg/kg (20-times the 100 mg clinical dose), respectively, based on AUC. Higher doses in rats associated with maternal toxicity increased the incidence of rib malformations in offspring at 1000 mg/kg, or approximately 100-times the clinical dose, based on AUC. Placental transfer of sitagliptin was observed in pregnant rats and rabbits. Sitagliptin administered to female rats from gestation day 6 to lactation day 21 caused no functional or behavioral toxicity in offspring of rats at doses up to 1000 mg/kg. Risk Summary There is no information regarding the presence of JANUVIA in human milk, the effects on the breastfed infant, or the effects on milk production. Sitagliptin is present in rat milk and therefore possibly present in human milk [see Data] . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for JANUVIA and any potential adverse effects on the breastfed infant from JANUVIA or from the underlying maternal condition. Data Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1. The safety and effectiveness of JANUVIA have not been established in pediatric patients. Three 20-week double-blind, placebo-controlled studies each with 34-week extensions were conducted to evaluate the efficacy and safety of sitagliptin in 410 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes, with or without insulin therapy (HbA1c 6.5-10% for patients not on insulin, HbA1c 7-10% for patients on insulin). At study entry, patients in study 1 were not treated with oral antihyperglycemic agents; patients in studies 2 and 3 were on maximally tolerated metformin therapy. The primary efficacy endpoint was the change from baseline in HbA1c after 20 weeks of therapy. The pre-specified primary efficacy analyses included data from study 1 and pooled data from studies 2 and 3, regardless of glycemic rescue or treatment discontinuation. In both efficacy analyses, the effect of treatment with sitagliptin was not significantly different from placebo. In study 1, the mean baseline HbA1c was 7.5%, and 12% of patients were on insulin therapy. At week 20, the change from baseline in HbA1c in patients treated with JANUVIA (N=95) was 0.06% compared to 0.23% in patients treated with placebo (N=95), a difference of -0.17% (95% CI: -0.62, 0.28). In studies 2 and 3, the mean baseline HbA1c was 8.0%, 15% of patients were on insulin and 72% were on metformin HCl doses of greater than 1,500 mg daily. At week 20, the change from baseline in HbA1c in patients treated with sitagliptin (N=107) was -0.23% compared to 0.09% in patients treated with placebo (N=113), a difference of -0.33% (95% CI: -0.70, 0.05). Of the total number of subjects (N=3884) in pre-approval clinical safety and efficacy studies of JANUVIA, 725 patients were 65 years and over, while 61 patients were 75 years and over. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. Because sitagliptin is substantially excreted by the kidney, and because aging can be associated with reduced renal function, renal function should be assessed more frequently in elderly patients [see Dosage and Administration (2.2), Warnings and Precautions (5.3)] . Sitagliptin is excreted by the kidney, and sitagliptin exposure is increased in patients with renal impairment. Lower dosages are recommended in patients with eGFR less than 45 mL/min/1.73 m2 (moderate and severe renal impairment, as well as in ESRD patients requiring dialysis). [See Dosage and Administration (2.2); Clinical Pharmacology (12.3).]

Resumo do produto:

Product: 50090-1036 NDC: 50090-1036-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-1036-2 90 TABLET, FILM COATED in a BOTTLE

Status de autorização:

New Drug Application

Folheto informativo - Bula

A-S Medication Solutions
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MEDICATION GUIDE
JANUVIA® (JAH-NEW-VEE-AH)
(SITAGLIPTIN)
TABLETS, FOR ORAL USE
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 07/2023
Read this Medication Guide carefully before you start taking JANUVIA
and each time you get a refill.
There may be new information. This information does not take the place
of talking with your doctor
about your medical condition or your treatment. If you have any
questions about JANUVIA, ask your
doctor or pharmacist.
What is the most important information I should know about JANUVIA?
JANUVIA can cause serious side effects, including:
•
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 JANUVIA, tell your doctor if you have ever
had:
•
pancreatitis
•
high blood triglyceride levels
•
stones in your gallbladder
(gallstones)
•
kidney problems
•
a history of
alcoholism
Stop taking JANUVIA and call your doctor 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.
•
Heart failure. Heart failure means your heart does not pump blood well
enough.
Before you start taking JANUVIA, tell your doctor if you have ever had
heart failure or have
problems with your kidneys. Contact your doctor 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 JANUVIA?
•
JANUVIA is a prescription medicine used along with diet and exercise
to lower blood sugar in
adults with type 2 diabetes.
•
JANUVIA is not for people with type 1 diabetes.
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Características técnicas

JANUVIA- SITAGLIPTIN TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JANUVIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JANUVIA.
JANUVIA (SITAGLIPTIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
JANUVIA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an
adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus. (1)
Limitations of Use:
JANUVIA should not be used in patients with type 1 diabetes (1)
JANUVIA has not been studied in patients with a history of
pancreatitis. (1, 5.1)
DOSAGE AND ADMINISTRATION
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be
taken with or without food. (2.1)
Dosage adjustment is recommended for patients with eGFR less than 45
mL/min/1.73 m . (2.2)
DOSAGE ADJUSTMENT IN PATIENTS WITH RENAL IMPAIRMENT (2.2)
eGFR greater than or equal to 30 mL/min/1.73 m to
less than 45 mL/min/1.73 m
eGFR less than 30 mL/min/1.73 m (including
patients with end stage renal disease [ESRD] on
dialysis)
50 mg once daily
25 mg once daily
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 50 mg, and 25 mg (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction to sitagliptin, such as
anaphylaxis or angioedema (5.5, 6.2)
WARNINGS AND PRECAUTIONS
_Pancreatitis:_ There have been postmarketing reports of acute
pancreatitis, including fatal and non-fatal
hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected,
promptly discontinue JANUVIA.
(5.1)
_Heart failure_: Heart failure has been observed with two other
members of the DPP-4 inhibitor class.
Consider risks and benefits of JANUVIA in patients who have known risk
factors for heart failure. Monitor
patients for signs and symptoms. (5.2)
_Acute Renal Failure:_ Has been reported postmarketing, sometimes
requiring dialysis. Assessment of
renal function is recommended prior to initiating JANUVIA and
periodically thereafter. (5.