Fitaro(Semaglutide Injection)

Therapeutic Group: Anti Diabetic

Presentation

FitaroTM 0.25 mg injection: Each pre-filled syringe contains Semaglutide INN 0.25 mg in 0.5 ml solution for injection. FitaroTM 0.50 mg injection: Each pre-filled syringe contains Semaglutide INN 0.50 mg in 0.5 ml solution for injection. FitaroTM 1 mg injection: Each pre-filled syringe contains Semaglutide INN 1 mg in 0.5 ml solution for injection. FitaroTM 1.7 mg injection: Each pre-filled syringe contains Semaglutide INN 1.7 mg in 0.75 ml solution for injection. FitaroTM 2.4 mg injection: Each pre-filled syringe contains Semaglutide INN 2.4 mg in 0.75 ml solution for injection.

Description

Semaglutide is a GLP-1 analogue with 94% sequence as same as human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP- receptor. GLP-1 is a physiological regulator of appetite and caloric intake. It is also present in several areas of brain that involved in appetite regulation. Semaglutide lowers body weight through decreased calorie intake and by an overall reduced appetite. It also stimulates insulin secretion and reduces glucagon secretion in a glucose dependent manner.

Indications

An adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of :

• 30 kg/m2 or greater (Obesity) or

• 27 kg/m2 or greater (Overweight) in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus or dyslipidemia).

Dosage & Administration

The starting dose is 0.25 mg Semaglutide once weekly for 4 weeks subcutaneously. Then in 4 weeks intervals dose should be increased until a dose of 2.4 mg is reached. Patient should follow the dose escalation schedule given below.

Side Effects

The most common adverse reactions are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease.

Precautions

Pancreatitis: Semaglutide should be discontinued promptly if pancreatitis is suspected and it should not be restart if pancreatitis is confirmed.
Acute Gallbladder Disease: If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
Hypoglycemia: Concomitant use with an insulin secretagogues or insulin may increase the risk of hypoglycemia. Reducing the dose of
insulin secretagogue or insulin may be necessary.
Diabetic Retinopathy: Patient with diabetic retinopathy should be monitored.
Heart Rate: Heart rate should be monitor at regular intervals.
Suicidal behavior and Ideation: Monitor should be done for depression or suicidal thoughts. If symptoms develop, semaglutide should be discontinued.

Use in Pregnancy & Lactation

Semaglutide should not be used during pregnancy. If a patient wishes to become pregnant Semaglutide should be discontinued at least 2 months before a planned pregnancy. As a risk to a breast-fed child cannot be excluded, Semaglutide should not be used during breast-feeding.
Paediatric population: The safety and efficacy of Semaglutide in children and adolescents below 18 years have not yet been established. No data are available.

Drug Interaction

Semaglutide lowers blood glucose and can cause hypoglycemia. The risk of hypoglycemia is increased when it is used in combination with insulin secretagogues (sulfonylureas) or insulin. So when initiating Semaglutide, the dose of concomitantly administered insulin secretagogue (sulfonylureas) or insulin should be reduce.

Over Dose

The most commonly reported adverse reaction was nausea, vomiting and hypoglycemia. All patients recovered without complications. In the event of overdose appropriate supportive treatment should be initiated according to the patients clinical sign and symptoms.

Storage

Store at 2 0C to 8 0C (in a refrigerator). Do not freeze. Keep out of reach of children.

Commercial Pack

FitaroTM 0.25 mg injection: Each box contains 1 pre-filled syringe of Semaglutide 0.25 mg Injection. FitaroTM 0.50 mg injection: Each box contains 1 pre-filled syringe of Semaglutide 0.50 mg Injection. FitaroTM 1 mg injection: Each box contains 1 pre-filled syringe of Semaglutide 1 mg Injection. FitaroTM 1.7 mg injection: Each box contains 1 pre-filled syringe of Semaglutide 1.7 mg Injection. FitaroTM 2.4 mg injection: Each box contains 1 pre-filled syringe of Semaglutide 2.4 mg Injection.