Januvia

JANUVIA is a once-daily pill that, along with diet and exercise, helps lower blood sugar in people with type 2 diabetes. It is a type of prescription diabetes medicine called a DPP-4 inhibitor (blocker). DPP-4 blockers increase the ability to control blood sugar levels. The doctor may prescribe JANUVIA alone or with some other diabetes medications to help control blood sugar.

What is Januvia and what is it used for?

Januvia (Sitagliptin) contains the active substance sitagliptin, which belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors). These medicines lower blood sugar levels in adult patients with type 2 diabetes mellitus (diabetes).

This medicine helps to increase the amount of insulin that is produced after a meal and reduces the amount of sugar that is produced by the body.

Your doctor has prescribed this medicine to lower your blood sugar level; your blood sugar level is too high because you have type 2 diabetes. This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulfonylurea derivatives, or glitazones) that lower blood sugar levels and that you may already be using for your diabetes along with a diet and exercise schedule.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not produce enough insulin and the insulin that your body does produce does not work as well as it should. Your body can also make too much sugar. If this happens, this sugar (glucose) builds up in the blood. This can lead to serious medical problems such as heart disease, kidney disease, blindness, and amputation.

In adult patients with type 2 diabetes mellitus, Januvia is indicated for the improvement of blood glucose regulation:

 • for patients in whom diet and exercise alone cannot adequately control the glucose level and for whom metformin is unsuitable because it is contraindicated or not tolerated.

as oral dual therapy in combination with:

• metformin when diet and exercise plus metformin alone cannot adequately control the glucose level.

• a sulfonylurea derivative when diet and exercise plus the maximum tolerated dose of a sulfonylurea derivative alone cannot adequately control the glucose level and when metformin is unsuitable because it is contraindicated or not tolerated.

• a peroxisome proliferator-activated receptor gamma (PPARγ)-agonist (a thiazolidinedione) when the use of a PPARγ-agonist is indicated and when diet and exercise plus the PPARγ-agonist alone cannot adequately control the glucose level.

as oral triple therapy in combination with:

• a sulfonylurea derivative and metformin, when diet and exercise plus treatment with these two drugs cannot adequately control the glucose level.

• a PPARγ-agonist and metformin, when the use of a PPARγ-agonist is indicated and when diet and exercise plus combined therapy with these drugs cannot adequately control the glucose level.

Januvia is also indicated as an addition to insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glucose regulation

Dosage

The dose is 100 mg sitagliptin 1 dd. When used in combination with metformin and/or a PPAR? agonist, the dose of metformin and/or the PPAR? agonist should remain unchanged and Januvia should be administered simultaneously.

If Januvia is used in combination with a sulfonylurea derivative or insulin, a lower dose of the sulfonylurea derivative or insulin may be considered to reduce the risk of hypoglycemia.

If a dose of Januvia is missed, it should be taken as soon as the patient remembers. No double dose should be taken on the same day.

Special populations

Renal impairment

When considering the use of sitagliptin in combination with another antidiabetic drug, the conditions for use of this drug in patients with renal impairment should be checked.

For patients with mild renal impairment (creatinine clearance [CrCl] ? 50 ml/min), the dose does not need to be adjusted.

For patients with moderate renal impairment (CrCl ? 30 to < 50 ml/min), the dose of Januvia is 50 mg 1 dd.

For patients with severe renal impairment (CrCl < 30 ml/min) or end-stage renal failure (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of Januvia is 25 mg 1 dd. Administration can be done regardless of the time of dialysis.

Since the dose must be adjusted based on renal function, it is recommended to assess renal function before starting Januvia and periodically thereafter.

Liver impairment

For patients with mild to moderate liver impairment, the dose does not need to be adjusted. Januvia has not been studied in patients with severe liver impairment and caution is advised (see section 5.2).

However, since sitagliptin is primarily renally excreted, it is not expected that severe liver impairment will affect the pharmacokinetics of sitagliptin.

Elderly

The dose does not need to be adjusted based on age. There are limited safety data available in patients ? 75 years; caution should be exercised with this group.

Pediatric patients

The safety and efficacy of sitagliptin in children and adolescents up to 18 years have not been established. No data are available.

Method of administration

Januvia can be taken with or without food.

Tablet core:

Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg of sitagliptin.

• microcrystalline cellulose (E460)
• calcium hydrogen phosphate, anhydrous (E341)
• sodium croscarmellose (E468)
• magnesium stearate (E470b)
• sodium stearyl fumarate
• Film coating:
• poly(vinyl alcohol)
• macrogol 3350
• talc (E553b)
• titanium dioxide (E171)
• red iron oxide (E172)
• yellow iron oxide (E172)

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