Alogliptin

What is Alogliptin?

• Alogliptin (Nesina) is a dipeptidyl peptidase-4 (DPP-4) inhibitor used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

What are the uses of this medicine?

• This medicine is used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• Limitations of Use: Not for treatment of type 1 diabetes or diabetic ketoacidosis.

How does this medicine work?

• Alogliptin (al" oh glip' tin) is an inhibitor of dipeptidyl peptidase-4, which is the major enzyme responsible for the degradation of glucagon-like peptide-1 (GLP-1), an important gastrointestinal hormone (incretin) that increases glucose dependent insulin secretion by the pancreas.
• By prolonging the effect of GLP-1, alogliptin increases insulin levels and lowers blood glucose and helps in glycemic control in patients with type 2 diabetes.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

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

What drug interactions can this medicine cause?

• No specific drug-drug interaction studies have been performed with Nesina.

Is this medicine FDA approved?

• Initial U.S. Approval: 2013

How should this medicine be used?

Recommended Dosage:

• The recommended dose of Nesina is 25 mg once daily.

Patients with Renal Impairment

• No dose adjustment of Nesina is necessary for patients with mild renal impairment (creatinine clearance [CrCl] ≥60 mL/min).
• The dose of Nesina is 12.5 mg once daily for patients with moderate renal impairment (CrCl ≥30 to <60 mL/min).
• The dose of Nesina is 6.25 mg once daily for patients with severe renal impairment (CrCl ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (CrCl <15 mL/min or requiring hemodialysis).

Administration

• Take Nesina exactly as your doctor tells you to take it.
• Take Nesina 1 time each day with or without food.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose, and take the next dose at your regular time. Do not take 2 doses of Nesina at the same time.
• If you take too much Nesina, call your doctor or go to the nearest hospital emergency room right away.
• If your body is under stress, such as from fever, infection, accident or surgery, the dose of your diabetes medicines may need to be changed. Call your doctor right away.
• Stay on your diet and exercise programs and check your blood sugar as your doctor tells you to.
• Your doctor may do certain blood tests before you start Nesina and during treatment as needed. Your doctor may change your dose of Nesina based on the results of your blood tests due to how well your kidneys are working.
• Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Tablets: 25 mg, 12.5 mg and 6.25 mg

This medicine is available in fallowing brand namesː

• Nesina

What side effects can this medication cause?

The most common side effects of this medicine include:

• stuffy or runny nose and sore throat
• headache
• cold-like symptoms (upper respiratory tract infection)

Nesina can cause serious side effects, including:

• Allergic (hypersensitivity) reactions
• Liver problems
• Low blood sugar (hypoglycemia)
• Joint pain
• Skin reaction

What special precautions should I follow?

• Acute pancreatitis has been reported in the postmarketing setting and in randomized clinical trials. There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Nesina.
• Consider the risks and benefits of Nesina prior to initiating treatment in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment, and observe these patients for signs and symptoms of heart failure during therapy. If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of Nesina.
• 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. In such cases, promptly discontinue Nesina, assess for other potential causes, institute appropriate monitoring and treatment and initiate alternative treatment for diabetes.
• Postmarketing reports of hepatic failure, sometimes fatal. Causality cannot be excluded. If liver injury is detected, promptly interrupt Nesina and assess patient for probable cause, then treat cause if possible, to resolution or stabilization. Do not restart Nesina if liver injury is confirmed and no alternative etiology can be found.
• Hypoglycemia may occur when an insulin secretagogue (e.g., sulfonylurea) or insulin is used in combination with Nesina, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia.
• Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.
• There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue Nesina.
• There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Nesina or any other antidiabetic drug

What to do in case of emergency/overdose?

• No serious adverse reactions have been reported.

Management of overdosage:

• In the event of an overdose, it is reasonable to institute the necessary clinical monitoring and supportive therapy as dictated by the patient's clinical status.
• Per clinical judgment, it may be reasonable to initiate removal of unabsorbed material from the gastrointestinal tract.
• Alogliptin is minimally dialyzable; over a three-hour hemodialysis session, approximately 7% of the drug was removed.
• Therefore, hemodialysis is unlikely to be beneficial in an overdose situation.
• It is not known if Nesina is dialyzable by peritoneal dialysis.

Can this medicine be used in pregnancy?

• Limited data with Nesina in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

• Active ingredient: alogliptin
• Inactive ingredients: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium and magnesium stearate. In addition, the film-coating contains the following inactive ingredients: hypromellose, titanium dioxide, ferric oxide (red or yellow) and polyethylene glycol and is marked with gray F1 printing ink

Who manufactures and distributes this medicine?

• Distributed by: Takeda Pharmaceuticals America, Inc. Lexington, MA 02421. Nesina is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and is used under license by Takeda Pharmaceuticals America, Inc.

What should I know about storage and disposal of this medication?

• Store Nesina at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Nesina and all medicines out of the reach of children.

• Dailymed label info on Alogliptin
• FDA Alogliptin