NESINA- alogliptin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALOGLIPTIN BENZOATE (UNII: EEN99869SC) (ALOGLIPTIN - UNII:JHC049LO86)

Available from:

Takeda Pharmaceuticals America, Inc.

INN (International Name):

ALOGLIPTIN BENZOATE

Composition:

ALOGLIPTIN 6.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NESINA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use NESINA is not recommended for use in patients with type 1 diabetes mellitus. NESINA is contraindicated in patients with a history of serious hypersensitivity to alogliptin or any of the excipients in NESINA. 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 NESINA 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

Product summary:

NESINA 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].

Authorization status:

New Drug Application

Patient Information leaflet

Takeda Pharmaceuticals America, Inc.
----------
MEDICATION GUIDE
NESINA [NES-SEE′-NA]
(ALOGLIPTIN)
TABLETS
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
NES011 R11
July 2023
Read this Medication Guide carefully before you start taking NESINA
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
NESINA, ask your doctor or pharmacist.
What is the most important information I should know about NESINA?
Serious side effects can happen to people taking NESINA, including:
1.
Inflammation of the pancreas (pancreatitis): NESINA may cause
pancreatitis which may be severe.
Certain medical conditions make you more likely to get pancreatitis.
Before you start taking NESINA:
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 NESINA 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 NESINA:
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 is NESINA?
•
NESINA is a prescription medicine used along with diet and exercise to
improve blood sugar
MEDICATION GUIDE
NESINA [NES-SEE′-NA]
(ALOGLIPTIN)
TABLETS
(glucose) control in adul

Summary of Product characteristics

NESINA- ALOGLIPTIN TABLET, FILM COATED
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NESINA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NESINA.
NESINA (ALOGLIPTIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
NESINA 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: 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 NESINA. (4)
WARNINGS AND PRECAUTIONS
Pancreatitis: There have been postmarketing reports of acute
pancreatitis. If pancreatitis is suspected,
promptly discontinue NESINA. (5.1)
Heart failure: Consider the risks and benefits of NESINA 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 NESINA. (5.2)
Hypersensitivity: There have been postmarketing reports of serious
hypersensitivity reactions in
patients treated with NESINA such as anaphylaxis, angioedema and
severe cutaneous adverse
reactions, including Stevens-Johnson syndrome. If hypersensitivity
reactions occur, discontinue NESINA,
treat promptly, and monitor until signs and symptoms resolve. (5.3)
Hepatic effects: Postmarketing reports of