Recommended Topic Related To:

Oseni

"The U.S. Food and Drug Administration today approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochlor"...

Oseni

Indications
Dosage
How Supplied

INDICATIONS

Monotherapy and Combination Therapy

OSENI is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings when treatment with both alogliptin and pioglitazone is appropriate [see Clinical Studies].

Limitation of Use

OSENI should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

Use with caution in patients with liver disease [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Recommendations for All Patients

OSENI should be taken once daily and can be taken with or without food. The tablets must not be split before swallowing.

The recommended starting dose for OSENI (alogliptin and pioglitazone):

  • for patients inadequately controlled on diet and exercise is 25 mg/15 mg or 25 mg/30 mg,
  • for patients inadequately controlled on metformin monotherapy is 25 mg/15 mg or 25 mg/30 mg,
  • for patients on alogliptin who require additional glycemic control is 25 mg/15 mg or 25 mg/30 mg,
  • for patients on pioglitazone who require additional glycemic control is 25 mg/15 mg, 25 mg/30 mg, or 25 mg/45 mg as appropriate based upon current therapy,
  • for patients switching from alogliptin coadministered with pioglitazone, OSENI may be initiated at the dose of alogliptin and pioglitazone based upon current therapy,
  • for patients with congestive heart failure (NYHA Class I or II) is 25 mg/15 mg.

The OSENI dose can be titrated up to a maximum of 25 mg/45 mg once daily based on glycemic response as determined by hemoglobin A1c (A1C).

After initiation of OSENI or with dose increase, monitor patients carefully for adverse reactions related to fluid retention as has been seen with pioglitazone, (e.g., weight gain, edema, and signs and symptoms of congestive heart failure) [see BOXED WARNING and WARNINGS AND PRECAUTIONS].

Patients with Renal Impairment

No dose adjustment of OSENI is necessary for patients with mild renal impairment (creatinine clearance [CrCl] > 60 mL/min).

The dose of OSENI is 12.5 mg/15 mg, 12.5 mg/30 mg, or 12.5 mg/45 mg once daily for patients with moderate renal impairment (CrCl > 30 to < 60 mL/min).

OSENI is not recommended for patients with severe renal impairment or ESRD [see CLINICAL PHARMACOLOGY]. Coadministration of pioglitazone and alogliptin 6.25 mg once daily based on individual requirements may be considered in these patients.

Because there is a need for dose adjustment based upon renal function, assessment of renal function is recommended prior to initiation of OSENI therapy and periodically thereafter.

Coadministration with Strong CYP2C8 Inhibitors

Coadministration of pioglitazone and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately 3-fold. Therefore, the maximum recommended dose of OSENI is 25 mg/15 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

  • 25 mg/15 mg tablets are yellow, round, biconvex, film-coated, with both “A/P” and “25/15” printed on one side.
  • 25 mg/30 mg tablets are peach, round, biconvex, film-coated, with both “A/P” and “25/30” printed on one side.
  • 25 mg/45 mg tablets are red, round, biconvex, film-coated, with both “A/P” and “25/45” printed on one side.
  • 12.5 mg/15 mg tablets are pale yellow, round, biconvex, film-coated, with both “A/P” and “12.5/15” printed on one side.
  • 12.5 mg/30 mg tablets are pale peach, round, biconvex, film-coated, with both “A/P” and “12.5/30” printed on one side.
  • 12.5 mg/45 mg tablets are pale red, round, biconvex, film-coated, with both “A/P” and “12.5/45” printed on one side.

Storage And Handling

OSENI tablets are available in the following strengths and packages:

25 mg/15 mg tablet: yellow, round, biconvex, 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, 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, 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/15 mg tablet: pale yellow, round, biconvex, film-coated, with both “A/P” and “12.5/15” printed on one side, available in:

NDC 64764-121-03 Bottles of 30 tablets
NDC
64764-121-04 Bottles of 90 tablets
NDC 64764-121-05 Bottles of 500 tablets

12.5 mg/30 mg tablet: pale peach, round, biconvex, 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

12.5 mg/45 mg tablet: pale red, round, biconvex, film-coated, with both “A/P” and “12.5/45” printed on one side, available in:

NDC 64764-124-03 Bottles of 30 tablets
NDC
64764-124-04 Bottles of 90 tablets
NDC
64764-124-05 Bottles of 500 tablets

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59°- 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protect from moisture and humidity.

Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Revised: January 2013

Last reviewed on RxList: 2/11/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.