OSENI- alogliptin and pioglitazone tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

ALOGLIPTIN BENZOATE (UNII: EEN99869SC) (ALOGLIPTIN - UNII:JHC049LO86), PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S)

Dostopno od:

Takeda Pharmaceuticals America, Inc.

INN (mednarodno ime):

ALOGLIPTIN BENZOATE

Sestava:

ALOGLIPTIN 12.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use OSENI should not be used in patients with type 1 diabetes mellitus. Serious hypersensitivity reaction to alogliptin or pioglitazone or any of the excipients in OSENI, such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see Warnings and Precautions (5.3), Adverse reactions (6.2)] . Do not initiate in patients with NYHA Class III or IV heart failure [see Boxed Warning] . Risk Summary Limited data with OSENI in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations]. In animal reproduction studies, no adverse developmental effects were observed when pioglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 5 and 35 times the 45 mg clinical dose, respectively, based on body surface area. No adverse developmental effects were observed when alogliptin was administered to pregnant rats and rabbits during organogenesis at exposures 180 and 149 times the 25 mg clinical dose, respectively, based on plasma drug exposure (AUC) [see Data] . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >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 2-4% 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 Alogliptin and Pioglitazone Co-administration of 100 mg/kg alogliptin and 40 mg/kg pioglitazone (39 and 10 times the 25 mg and 45 mg clinical doses, respectively, based on body surface area) to pregnant rats during organogenesis slightly augmented pioglitazone-related fetal effects of delayed development and reduced fetal weights but did not result in embryofetal mortality or teratogenicity. Alogliptin Alogliptin administered to pregnant rabbits and rats during the period of organogenesis did not cause adverse developmental effects at doses of up to 200 mg/kg and 500 mg/kg, or 149 times and 180 times, the 25 mg clinical dose, respectively, based on plasma drug exposure (AUC). Placental transfer of alogliptin into the fetus was observed following oral dosing to pregnant rats. No adverse developmental outcomes were observed in offspring when alogliptin was administered to pregnant rats during gestation and lactation at doses up to 250 mg/kg (~95 times the 25 mg clinical dose, based on AUC). Pioglitazone Pioglitazone administered to pregnant rats during organogenesis did not cause adverse developmental effects at a dose of 20 mg/kg (~5-times the 45 mg clinical dose), but delayed parturition and reduced embryofetal viability at 40 and 80 mg/kg, or ≥9-times the 45 mg clinical dose, by body surface area. In pregnant rabbits administered pioglitazone during organogenesis, no adverse developmental effects were observed at 80 mg/kg (~35-times the 45 mg clinical dose), but reduced embryofetal viability at 160 mg/kg, or ~69-times the 45 mg clinical dose, by body surface area. When pregnant rats received pioglitazone during late gestation and lactation, delayed postnatal development, attributed to decreased body weight, occurred in offspring at maternal doses of 10 mg/kg and above or ≥2 times the 45 mg clinical dose, by body surface area. Risk Summary There is no information regarding the presence of pioglitazone or alogliptin in human milk, the effects on the breastfed infant, or the effects on milk production. Pioglitazone and alogliptin are present in rat milk; however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for OSENI and any potential adverse effects on the breastfed infant from OSENI or from the underlying maternal condition. Discuss the potential for unintended pregnancy with premenopausal women as therapy with pioglitazone, like other thiazolidinediones, may result in ovulation in some anovulatory women. Safety and effectiveness of OSENI in pediatric patients have not been established. OSENI is not recommended for use in pediatric patients based on adverse effects observed in adults, including fluid retention and congestive heart failure, fractures and urinary bladder tumors [see Warnings and Precautions (5.1, 5.5, 5.6, 5.7)] . Alogliptin and Pioglitazone Of the total number of patients (N=1533) in clinical safety and efficacy studies treated with alogliptin and pioglitazone, 248 (16.2%) patients were 65 years and older and 15 (1%) patients were 75 years and older. No overall differences in safety or effectiveness were observed between these patients and younger patients. While this and other reported clinical experiences have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be excluded. Alogliptin Of the total number of patients (N=9052) in clinical safety and efficacy studies treated with alogliptin, 2257 (24.9%) patients were ≥65 years old and 386 (4.3%) patients were ≥75 years old. No overall differences in safety or effectiveness were observed between patients ≥65 years old and younger patients. Pioglitazone A total of 92 patients (15.2%) treated with pioglitazone in the three pooled, 16 to 26 week, double-blind, placebo-controlled, monotherapy trials were ≥65 years old and two patients (0.3%) were ≥75 years old. In the two pooled 16 to 24 week add-on to sulfonylurea trials, 201 patients (18.7%) treated with pioglitazone were ≥65 years old and 19 (1.8%) were ≥75 years old. In the two pooled 16 to 24 week add-on to metformin trials, 155 patients (15.5%) treated with pioglitazone were ≥65 years old and 19 (1.9%) were ≥75 years old. In the two pooled 16 to 24 week add-on to insulin trials, 272 patients (25.4%) treated with pioglitazone were ≥65 years old and 22 (2.1%) were ≥75 years old. In PROactive, 1068 patients (41%) treated with pioglitazone were ≥65 years old and 42 (1.6%) were ≥75 years old. In pharmacokinetic studies with pioglitazone, no significant differences were observed in pharmacokinetic parameters between elderly and younger patients. These clinical experiences have not identified differences in effectiveness and safety between the elderly (≥65 years) and younger patients although small sample sizes for patients ≥75 years old limit conclusions [see Clinical Pharmacology (12.3)] . Alogliptin A total of 602 patients with moderate renal impairment (eGFR ≥30 and <60 mL/min/1.73 m2 ) and four patients with severe renal impairment/end-stage renal disease (eGFR <30 mL/min/1.73 m2 or <15 mL/min/1.73 m2 , respectively) at baseline were treated with alogliptin in clinical trials in patients with type 2 diabetes. Reductions in HbA1c were generally similar in this subgroup of patients. The overall incidence of adverse reactions was generally balanced between alogliptin and placebo treatments in this subgroup of patients. In the EXAMINE trial of high CV risk type 2 diabetes patients, 694 patients had moderate renal impairment and 78 patients had severe renal impairment or end-stage renal disease at baseline. The overall incidences of adverse reactions, serious adverse reactions and adverse reactions leading to study drug discontinuation were generally similar between the treatment groups. Alogliptin No dose adjustments are required in patients with mild to moderate hepatic impairment (Child-Pugh Grade A and B) based on insignificant change in systemic exposures (e.g., AUC) compared to subjects with normal hepatic function in a pharmacokinetic study. Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh Grade C). Use caution when administering alogliptin to patients with liver disease [see Warnings and Precautions (5.4)]. Pioglitazone No dose adjustments are required in patients with hepatic impairment (Child-Pugh Grade B and C) based on insignificant change in systemic exposures (e.g., AUC) compared to subjects with normal hepatic function in a pharmacokinetic study. However, use with caution in patients with liver disease [see Warnings and Precautions (5.4)].

Povzetek izdelek:

OSENI tablets are available in the following strengths and packages: 25 mg/15 mg tablet: yellow, round, biconvex and film-coated with both "A/P" and "25/15" printed on one side, available in: NDC 64764-251-03 Bottles of 30 tablets NDC 64764-251-04 Bottles of 90 tablets NDC 64764-251-05 Bottles of 500 tablets 25 mg/30 mg tablet: peach, round, biconvex and film-coated with both "A/P" and "25/30" printed on one side, available in: NDC 64764-253-03 Bottles of 30 tablets NDC 64764-253-04 Bottles of 90 tablets NDC 64764-253-05 Bottles of 500 tablets 25 mg/45 mg tablet: red, round, biconvex, film-coated and with both "A/P" and "25/45" printed on one side, available in: NDC 64764-254-03 Bottles of 30 tablets NDC 64764-254-04 Bottles of 90 tablets NDC 64764-254-05 Bottles of 500 tablets 12.5 mg/30 mg tablet: pale peach, round, biconvex and film-coated with both "A/P" and "12.5/30" printed on one side, available in: NDC 64764-123-03 Bottles of 30 tablets NDC 64764-123-04 Bottles of 90 tablets NDC 64764-123-05 Bottles of 500 tablets Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.

Status dovoljenje:

New Drug Application

Navodilo za uporabo

Takeda Pharmaceuticals America, Inc.
----------
MEDICATION GUIDE
OSENI (OH-SENN-EE)
(ALOGLIPTIN AND PIOGLITAZONE)
TABLETS
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
xx/202x
Read this Medication Guide carefully before you start taking OSENI 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
OSENI, ask your doctor or
pharmacist.
What is the most important information I should know about OSENI?
OSENI can cause serious side effects, including:
1.
Heart failure: Heart failure means your heart does not pump blood well
enough. OSENI can cause
heart failure and cause your body to keep extra fluid (fluid
retention), which leads to swelling
(edema) and weight gain. Extra body fluid can make some heart problems
worse or lead to heart
failure.
Before you start taking OSENI:
Tell your doctor if you have ever had heart failure or have problems
with your kidneys.
Call your doctor 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.
2.
Inflammation of the pancreas (pancreatitis): Alogliptin, one of the
medicines in OSENI, may cause
pancreatitis, which may be severe. Certain medical conditions make you
more likely to get
pancreatitis.
Before you start taking OSENI:
Tell your doctor if you have ever had:
•
pancreatitis
•
high blood
triglyceride
levels
•
kidney problems
•
stones in your gallbladder (gall
stones)
•
liver problems
•
a history of alcoholism
Stop taking OSENI 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 h

Lastnosti izdelka

OSENI- ALOGLIPTIN AND PIOGLITAZONE TABLET, FILM COATED
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OSENI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OSENI.
OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
WARNING: CONGESTIVE HEART FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
THIAZOLIDINEDIONES, INCLUDING PIOGLITAZONE, CAUSE OR EXACERBATE
CONGESTIVE HEART
FAILURE IN SOME PATIENTS. (5.1)
AFTER INITIATION OF OSENI AND AFTER DOSE INCREASES, MONITOR PATIENTS
CAREFULLY FOR
SIGNS AND SYMPTOMS OF HEART FAILURE (E.G., EXCESSIVE, RAPID WEIGHT
GAIN, DYSPNEA
AND/OR EDEMA). IF HEART FAILURE DEVELOPS, IT SHOULD BE MANAGED
ACCORDING TO CURRENT
STANDARDS OF CARE AND DISCONTINUATION OR DOSE REDUCTION OF
PIOGLITAZONE IN OSENI
MUST BE CONSIDERED. (5.1)
OSENI IS NOT RECOMMENDED IN PATIENTS WITH SYMPTOMATIC HEART FAILURE.
(5.1)
INITIATION OF OSENI IN PATIENTS WITH ESTABLISHED NEW YORK HEART
ASSOCIATION (NYHA)
CLASS III OR IV HEART FAILURE IS CONTRAINDICATED. (4, 5.1)
INDICATIONS AND USAGE
OSENI is a combination of alogliptin, a dipeptidyl peptidase-4
inhibitor, and pioglitazone, a
thiazolidinedione, indicated as an adjunct to diet and exercise to
improve glycemic control in adults with
type 2 diabetes mellitus. (1)
Limitations of Use: Should not be used in patients with type 1
diabetes mellitus. (1)
DOSAGE AND ADMINISTRATION
Individualize the starting dose of OSENI based on the patient's
current regimen and concurrent medical
condition but do not exceed a daily dose of alogliptin 25 mg and
pioglitazone 45 mg. (2.1)
Can be taken with or without food. (2.1)
Limit initial dose of pioglitazone to 15 mg once daily in patients
with NYHA Class I or II heart failure. (2.1)
Adjust dose if moderate renal impairment. (2.2)
DEGREE OF RENAL IMPAIRMENT
CREATININE CLEARANCE
(ML/MIN)
RECOMMENDED DOSING
Moderate
≥30 to <60
12.5 mg/30 mg
once daily
OSENI is not reco