Semaglo OB SC Injection
Semaglutide for Obesity (Weight management)
2.4 mg/0.75 ml
Ziska Pharmaceuticals Ltd.
| Pack size | 2.4 mg pre-filled |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 1500.00 AED |
Available as:
Indications
Semaglo OB SC Injection is used for:
Chronic weight management
Adult Dose
Chronic weight management
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).
Initiate at 0.25 mg once weekly for 4 weeks. In 4-week intervals, increase the dose until a dose of 2.4 mg is reached.
The maintenance dosage in adults is either 2.4 mg (recommended) or 1.7 mg once-weekly
If unable to tolerate a dose during escalation, consider delaying dose escalation for 4 weeks
If unable to tolerate maintenance dose of 2.4 mg once-weekly, may temporarily decreased to 1.7 mg once weekly, for a maximum of 4 weeks; after 4 weeks, increase back to maintenance 2.4 mg once-weekly; discontinue if not tolerated after second attempt
In patients with type 2 diabetes, monitor blood glucose before initiating and during treatment
Hepatic impairment
No dosage adjustment required
Child Dose
Weight Management
Indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in pediatric patients aged >12 years with an initial BMI at >95th percentile standardized for age and sex (obesity)
Refer to prescribing information for BMI cut-offs for obesity by sex and age for pediatric patients aged >12 years (CDC Criteria)
Once weekly SC dose escalation schedule
Weeks 1-4: 0.25 mg SC qWeek
Weeks 5-8: 0.5 mg SC qWeek
Weeks 9-12: 1 mg SC qWeek
Week 13-16: 1.7 mg SC qWeek
Maintenance dosage
Week 17 and onward: 2.4 mg SC qWeek
Unable to tolerate maintenance 2.4 mg once-weekly dosage: May reduce maintenance dosage to 1.7 mg SC qWeek
Unable to tolerate 1.7 mg-dose: Discontinue treatment
Renal Dose
Renal impairment
No dosage adjustment required
Administration
Administer SC to abdomen, thigh, or upper arm
The time of day and the injection site can be changed without dose adjustment
Administer once weekly, on the same day each week, at any time of day, with or without meals
Contra Indications
Personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2
Known hypersensitivity to semaglutide or to any of the product components
Precautions
Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia.
Reducing the dose of insulin secretagogue or insulin may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the
signs and symptoms of hypoglycemia.
Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of in patients reporting severe adverse
gastrointestinal reactions or in those with renal impairment reporting severe adverse gastrointestinal reactions.
Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue if suspected and
promptly seek medical advice.
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with semaglutide. Patients with a history of diabetic
retinopathy should be monitored.
Heart Rate Increase: Monitor heart rate at regular intervals.
Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue if symptoms develop.
Results from several large epidemiological studies suggest that exposure to Semaglutide in adults with type 2 diabetes is associated with an approximately two-fold increase in the risk of developing Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) compared with people not taking the medicine.
Data from clinical trials also point to a slightly higher risk of developing the condition in people taking semaglutide, compared with people taking placebo.
Pregnancy-Lactation
Pregnancy
May cause fetal harm. When pregnancy is recognized, discontinue.
Data are insufficient regarding use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy; should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Discontinue treatment in women at least 2 months before a planned pregnancy, owing to the long washout period for semaglutide
Clinical Considerations
Appropriate weight gain based on prepregnancy weight is currently recommended for all pregnant patients, including those who already are overweight or obese, because of the obligatory weight gain that occurs in maternal tissues during pregnancy
Lactation
There are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production
In lactating rats, semaglutide was detected in milk at levels 3- to 12-fold lower than in maternal plasma
Interactions
Coadministration with insulin secretagogues (eg, sulfonylureas) or insulin may increase the risk of hypoglycemia; consider a lower dose of the secretagogue or insulin to reduce risk of hypoglycemia in this setting; inform patients using concomitant medications of risk of hypoglycemia and educate them on signs and symptoms of hypoglycemia
Exercise caution when semaglutide is concomitantly administered with oral medications; semaglutide causes a delay of gastric emptying, thereby potentially impacting oral absorption of such medications
Adverse Effects
Side effects of Semaglutide for Obesity (Weight management) :
>10%
Nausea (44%)
Diarrhea (30%)
Vomiting (24%)
Constipation (24%)
Abdominal pain (20%)
Headache (14%)
Fatigue (11%)
1-10%
Dyspepsia (9%)
Dizziness (8%)
Abdominal distension (7%)
Eructation (7%)
Retinal disorders (6.9%)
Hypoglycemia in T2DM (6%)
Flatulence (6%)
Gastroenteritis (6%)
GERD (5%)
Gastritis (4%)
Gastroenteritis viral (4%)
Hair loss (3%)
Cholelithiasis (1.6%)
Injection site reactions (1.4%)
<1%
Hypotension and syncope
Appendicitis
Acute kidney injury
Cholecystitis
Rare
Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Mechanism of Action
Glucagon-like peptide-1 (GLP-1) agonist
Weight management: GLP-1 is a physiological regulator of appetite and caloric intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation
Note
Semaglo OB 2.4 mg/0.75 ml SC Injection manufactured by Ziska Pharmaceuticals Ltd.. Its generic name is Semaglutide for Obesity (Weight management). Semaglo OB is availble in Bangladesh.
Farmaco BD drug index information on Semaglo OB SC Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
Some other brands of Semaglutide for Obesity (Weight management) :
Pre filled Injection
Fitaro 1
1 mg/.5 ml
Incepta Pharmaceuticals Ltd.
Pre Filled Injection
Fitaro 1.7
1.7 mg/.75 ml
Incepta Pharmaceuticals Ltd.
Pre filled Injection
Fitaro 2.4
2.4 mg/.75 ml
Incepta Pharmaceuticals Ltd.
Pre-filled Injection
Fitaro 0.25
0.25 mg/ 0.5 ml
Incepta Pharmaceuticals Ltd.
Pre Filled Injection
Fitaro 0.5
0.50 mg/0.5 ml
Incepta Pharmaceuticals Ltd.