ALOGLIPTIN tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

Alogliptin Benzoate (UNII: EEN99869SC) (Alogliptin - UNII:JHC049LO86)

Dostopno od:

Padagis Israel Pharmaceuticals Ltd

INN (mednarodno ime):

Alogliptin Benzoate

Sestava:

Alogliptin 6.25 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Alogliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Alogliptin tablet is not recommended for use in patients with type 1 diabetes mellitus. Alogliptin tablets is contraindicated in patients with a history of serious hypersensitivity to alogliptin or any of the excipients in Alogliptin tablets. Reactions such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see Warnings and Precautions (5.3), Adverse Reactions (6.2)] . Risk Summary Limited data with alogliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see Clinical Considerations]. 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 mellitus with a HbA1c >7 and has been reported to be as high as 20-25% in women with 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 mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes mellitus increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. Data Animal Data 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). Risk Summary There is no information regarding the presence of alogliptin in human milk, the effects on the breastfed infant, or the effects on milk production. Alogliptin is present in rat milk: however, due to species specific differences in lactation physiology, animal lactation data may not reliably predict levels in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for alogliptin tablets and any potential adverse effects on the breastfed infant from alogliptin tablets or from the underlying maternal condition. The safety and effectiveness of alogliptin tablets have not been established in pediatric patients. Effectiveness of alogliptin tablets was not demonstrated in a 52 week, randomized, double-blind, placebo-controlled trial (NCT02856113) in 151 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes mellitus. Of the total number of patients (N=9052) in clinical safety and efficacy trials treated with alogliptin tablets, 2,257 (24.9%) patients were 65 years and older and 386 (4.3%) patients were 75 years and older. No overall differences in safety or effectiveness were observed between patients 65 years and over and younger patients. A total of 602 adult patients with moderate renal impairment (eGFR ≥30 and <60 mL/min/1.73 m2 ) and 4 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 tablets in clinical trials in patients with type 2 diabetes mellitus. In the EXAMINE trial of high CV risk type 2 diabetes mellitus patients, 694 patients had moderate renal impairment and 78 patients had severe renal impairment or end-stage renal disease at baseline. The recommended dose is 12.5 mg once daily in patients with moderate renal impairment and 6.25 mg once daily in patients with severe renal impairment, as well as in patients with ESRD requiring dialysis. Alogliptin tablets may be administered without regard to the timing of the dialysis. No dose adjustments are required in patients with mild to moderate hepatic impairment (Child-Pugh Grade A and B) [see Clinical Pharmacology (12.3)] . Alogliptin tablets have not been studied in patients with severe hepatic impairment (Child-Pugh Grade C). Use caution when administering alogliptin tablets to patients with liver disease [see Warnings and Precautions (5.4)] .

Povzetek izdelek:

Alogliptin tablets are available as film-coated tablets containing 25 mg, 12.5 mg or 6.25 mg of alogliptin as follows: 25 mg tablet: light red, oval, biconvex, film-coated, with "TAK ALG-25" printed on one side, available in: 12.5 mg tablet: yellow, oval, biconvex, film-coated, with "TAK ALG-12.5" printed on one side, available in: 6.25 mg tablet: light pink, oval, biconvex, film-coated, with "TAK ALG-6.25" printed on one side, available in: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Status dovoljenje:

New Drug Application Authorized Generic

Navodilo za uporabo

Padagis Israel Pharmaceuticals Ltd
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
ALO332 R8
July 2023
MEDICATION GUIDE
Alogliptin Tablets
Read this Medication Guide carefully before you start taking
alogliptin tablets 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 treatment. If you have any
questions about alogliptin tablets, ask
your doctor or pharmacist.
What is the most important information I should know about alogliptin
tablets?
Serious side effects can happen to people taking alogliptin tablets,
including:
1.
Inflammation of the pancreas (pancreatitis): Alogliptin tablets may
cause pancreatitis which may
be severe.
Certain medical conditions make you more likely to get pancreatitis.
Before you start taking alogliptin tablets:
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 alogliptin tablets 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.
2.
Heart failure: Heart failure means your heart does not pump blood well
enough.
Before you start taking alogliptin tablets:
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 lying
down
•
an unusually fast increase in
weight
•
swelling of feet, ankles, or legs
•
unusual tiredness
These may be symptoms of heart failure.
What are alogliptin tablets?
•
Alogliptin tablets are a prescription medicine used along with diet
and exercise to improve bloo

Lastnosti izdelka

ALOGLIPTIN- ALOGLIPTIN TABLET, FILM COATED
PADAGIS ISRAEL PHARMACEUTICALS LTD
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALOGLIPTIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ALOGLIPTIN TABLETS.
ALOGLIPTIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
Alogliptin tablets are 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: Should not be used in patients with type 1
diabetes mellitus. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage in patients with normal renal function or mild
renal impairment is 25 mg
orally once daily. (2.1)
Can be taken with or without food. (2.1)
Adjust dosage if moderate or severe renal impairment or end-stage
renal disease (ESRD). (2.2)
DEGREE OF RENAL IMPAIRMENT
CREATININE CLEARANCE
(ML/MIN)
RECOMMENDED DOSAGE
Moderate
≥30 to <60
12.5 mg once daily
Severe/ESRD
<30
6.25 mg once daily
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 12.5 mg and 6.25 mg (3)
CONTRAINDICATIONS
History of serious hypersensitivity to alogliptin or any of the
excipients in Alogliptin tablets. (4)
WARNINGS AND PRECAUTIONS
Pancreatitis: There have been postmarketing reports of acute
pancreatitis. If pancreatitis is suspected,
promptly discontinue alogliptin tablets. (5.1)
Heart failure: Consider the risks and benefits of alogliptin tablets
prior to initiating treatment in patients
at risk for heart failure. If heart failure develops, evaluate and
manage according to current standards
of care and consider discontinuation of alogliptin tablets. (5.2)
Hypersensitivity: There have been postmarketing reports of serious
hypersensitivity reactions in
patients treated with alogliptin tablets such as anaphylaxis,
angioedema and severe cutaneous adverse
reactions, including Stevens-Johnson syndrome. If hypersensitivity
reactions occur, discontinue
alogliptin tablets, treat p