NESINA Film-coated tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Takeda Pharmaceuticals America, Inc.

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1. Indications and Usage

1.1 Monotherapy and Combination Therapy NESINA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)]. ...

2. Dosage and Administration

2.1 Recommended Dosing The recommended dose of NESINA is 25 mg once daily. NESINA may be taken with or without food. 2.2 Patients with Renal Impairment No dose adjustment of NESINA is necessary for patients ...

3. Dosage Forms and Strengths

25 mg tablets are light red, oval, biconvex, film-coated, with TAK ALG-25 printed on one side. 12.5 mg tablets are yellow, oval, biconvex, film-coated, with TAK ALG-12.5 printed on one side. 6.25 mg tablets ...

4. Contraindications

History of a serious hypersensitivity reaction to alogliptin-containing products, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.

5. Warnings and Precautions

5.1 Pancreatitis Acute pancreatitis has been reported in the postmarketing setting and in randomized clinical trials. In glycemic control trials in patients with type 2 diabetes, acute pancreatitis was ...

6. Adverse Reactions

The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis [see Warnings and Precautions (5.1)] Heart Failure [see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during the postmarketing use of NESINA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

NESINA is primarily renally excreted. Cytochrome (CYP) P450-related metabolism is negligible. No significant drug-drug interactions were observed with the CYP-substrates or inhibitors tested or with renally ...

8.1. Pregnancy

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 ...

8.2. Lactation

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, ...

8.4. Pediatric Use

Safety and effectiveness of NESINA in pediatric patients have not been established.

8.5. Geriatric Use

Of the total number of patients (N=9052) in clinical safety and efficacy studies treated with NESINA, 2257 (24.9%) patients were 65 years and older and 386 (4.3%) patients were 75 years and older. No overall ...

8.6. Renal Impairment

A total of 602 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 ...

8.7. Hepatic Impairment

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 ...

10. Overdosage

The highest doses of NESINA administered in clinical trials were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes (equivalent to 32 ...

11. Description

NESINA tablets contain the active ingredient alogliptin, which is a selective, orally bioavailable inhibitor of the enzymatic activity of dipeptidyl peptidase-4 (DPP-4). Chemically, alogliptin is prepared ...

12.1. Mechanism of Action

Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the bloodstream from the small intestine ...

12.2. Pharmacodynamics

Single-dose administration of NESINA to healthy subjects resulted in a peak inhibition of DPP-4 within two to three hours after dosing. The peak inhibition of DPP-4 exceeded 93% across doses of 12.5 mg ...

12.3. Pharmacokinetics

The pharmacokinetics of NESINA has been studied in healthy subjects and in patients with type 2 diabetes. After administration of single, oral doses up to 800 mg in healthy subjects, the peak plasma alogliptin ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Rats were administered oral doses of 75, 400 and 800 mg/kg alogliptin for two years. No drug-related tumors were observed up to 75 mg/kg or approximately 32 times the maximum recommended clinical dose ...

14. Clinical Studies

NESINA has been studied as monotherapy and in combination with metformin, a sulfonylurea, a thiazolidinedione (either alone or in combination with metformin or a sulfonylurea) and insulin (either alone ...

16.1. How Supplied

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, ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients of the potential risks and benefits of NESINA. Patients should be informed that acute pancreatitis has been ...