Saterex, 30 mg 28 pcs.

Gozogliptin is an active, highly selective inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme for the treatment of type 2 diabetes.

Indications

Diabetes mellitus type 2 (in combination with diet therapy and exercise):
– as monotherapy in case of ineffectiveness of diet therapy and exercise in patients with contraindications to the use of metformin;
– in combination with metformin as starter therapy, or when diet and exercise in combination with monotherapy with one of the listed drugs does not result in adequate glycemic control.

Active ingredient

Gozogliptin

How to take, the dosage

Saterex® is taken orally once a day in the morning or evening, regardless of meals. The tablets should be swallowed whole, without chewing, with water.

Interaction

Gozogliptin has a low potential for drug interaction.

Special Instructions

Saterex® is contraindicated in patients with type 1 diabetes mellitus or for treatment of diabetic ketoacidosis.

Contraindications

– Hypersensitivity to gozogliptin or any component of the drug.
– Diabetes mellitus type 1.
– Diabetic ketoacidosis.
– Severe liver function disorders.
– Severe chronic renal insufficiency.
– Childhood under 18 years of age (efficacy and safety of administration is not established).
– Pregnancy, breast-feeding.

With caution
In patients with a history of pancreatitis. It is recommended to use Saterex® with caution in patients with moderate chronic renal insufficiency.

Side effects

When using Saterex® as monotherapy or in combination with metformin, most adverse events (AEs) were mild, transient, and did not require discontinuation of therapy. No correlation between the incidence of adverse events and age, sex, ethnicity, duration of use or dosing regimen was found.
The following criteria were used to assess the incidence of NIH: very common (≥ 1/10); common (≥ 1/100, < 1/10), infrequent (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare, including individual reports (≤ 1/10000).
When using gosogliptin in doses of 20 mg and 30 mg once daily, the rate of therapy withdrawal due to the development of NS was 1.3%. According to the results of clinical studies, the frequency of symptomatic hypoglycemia episodes in patients receiving gosogliptin did not exceed 1 % and, as a rule, was associated with dietary disturbances and increased physical activity. No cases of severe hypoglycemia were observed in the gosogliptin groups.

When Saterex® was used in doses of 20 mg and 30 mg once daily as monotherapy
On gosogliptin monotherapy, associated or possibly associated NTs were observed in 2.7% of patients. There were no severe NTs registered during clinical trials.

The following NTs were observed:
Immune system disorders: infrequent – allergic dermatitis.
Nervous system disorders: infrequent – dizziness, headache, somnolence.
Gastrointestinal tract disorders: infrequent – constipation.
Liver and biliary tract disorders: infrequent – increased liver enzymes activity (ALT, AST). General disorders and disorders at the site of administration: infrequent – asthenia and fatigue.

During combination of Saterex® at a dose of 20 mg and 30 mg once daily with metformin

During combination therapy with metformin with unmodified release (1000-2000 mg/day) the drug-related or possibly drug-related adverse events were observed in 3.3% of patients.

The following NCDs were observed:
Nervous system disorders: infrequent – headache.
Gastrointestinal tract disorders: infrequent – diarrhea, dyspepsia, pancreatitis.
Liver and gallbladder disorders: infrequent – cholecystitis, steatosis, increased liver enzymes activity (ALT, AST), increased bilirubin, gallbladder polyp.
Renal and urinary tract disorders: infrequent – urinary tract infections.
General disorders and disorders at the injection site: infrequent – peripheral edema, back pain.

Overdose

Clinical studies of Saterex® in healthy volunteers showed good tolerability of gosogliptin in doses up to 300 mg. No studies of doses above 300 mg have been performed.