Reglutide 1.34mg/ml Injection

Uses:

Type 2 Diabetes Mellitus

Mode of Action:

• GLP-1 Agonist: Enhances glucose-dependent insulin secretion, suppresses glucagon secretion, and slows gastric emptying.

Side Effects of Reglutide Injection

• Common (>10%): Nausea, hypoglycemia.
• 1-10%: Vomiting, diarrhea, abdominal pain, constipation, dyspepsia, flatulence, reflux.
• <1%: Gastritis, cholelithiasis, fatigue, dysgeusia, dizziness, injection site reaction.

Quick Suggestions:

Regular Eating Habits:

• Eat at regular intervals.
• Avoid taking a long gap between meals or snacks.

Blood Sugar Monitoring:

• Monitor your blood sugar level regularly, especially during periods of significant fluctuations.

Physical Activity:

• Invest in at least 150 minutes of moderate-intensity physical activity per week.
• Include 15 minutes of exercise every week.

Gradual Weight Loss:

• Lose weight gradually to achieve a healthy body mass index (BMI) between 18.5 and 24.9.

Nutritional Choices:

• Replace refined carbohydrate-containing foods with whole-grain options.
• Increase the consumption of fruits, vegetables, and other fiber-enriched foods.

Reduced Saturated Fat:

• Reduce the intake of saturated fat from foods like chips, crisps, pastries, biscuits, and samosas.

Healthy Cooking Oils:

• Choose cooking oils containing omega-3 fatty acids for daily cooking.

Stress Management:

• Avoid stress as it may elevate blood sugar levels.
• Adopt stress management techniques such as mindfulness, yoga, or meditation.

Low-Fat Dairy:

• Opt for low-fat dairy products, such as low-fat yogurt, fat-free milk, and cheese.

Alcohol Avoidance:

• Avoid drinking alcohol while on SEMAGLUTIDE to reduce the risk of hypoglycemia and lactic acidosis.

Smoking Cessation:

• Try to quit smoking.

Control Carbohydrate Intake:

• Reduce the intake of carbohydrate-rich foods like potatoes, rice, mangoes, bread, and sugar.

Continued SEMAGLUTIDE Use:

• Keep taking SEMAGLUTIDE even if your blood sugar levels are controlled until your doctor advises otherwise.

Regular Blood Sugar Monitoring:

• Monitor your blood sugar frequently as recommended by your healthcare provider.

Pancreatic Enzyme Monitoring:

• Regularly monitor pancreatic enzymes, such as lipase and amylase.

Meal Planning:

• Take short, frequent meals.
• Avoid prolonged fasting when taking SEMAGLUTIDE.

Hypoglycemia Awareness:

• Be aware of hypoglycemia symptoms, including sweating, dizziness, palpitations, shivering, intense thirst, dry mouth, dry skin, and frequent urination.

Emergency Measures:

• Carry 5-6 candies, three glucose biscuits, or three teaspoons of honey/sugar at all times, especially during long travels.
• Consume these immediately if experiencing hypoglycemia symptoms and contact your physician.

Indications:

Type 2 Diabetes Mellitus:

• An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Cardiovascular Risk Reduction:

• To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

Chronic Weight Management:

• An adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with:
  • BMI of 30 kg/m² or greater (Obesity) OR
  • BMI of 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).

Pharmacology

• GLP-1 analog with 94% sequence similarity to human GLP-1.
• Acts as a GLP-1 receptor agonist.
• Stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner.
• Inhibits inappropriate glucagon secretion.
• Minor delay in gastric emptying.
• Reduces body weight and fat mass by reducing appetite.

Dosage & Administration:

Subcutaneous Injection:

• Starting dose: 0.25 mg once weekly for 4 weeks, then dose escalation over subsequent weeks.
• Maintenance dose: 2.4 mg once weekly.

Administration:

• SC Administration: Weekly injection in the abdomen, thigh, or upper arm.
• Dosage: Start with 0.25 mg weekly for 4 weeks, then increase to 0.5 mg weekly. Can further increase to 1 mg weekly if needed.
• Hepatic Impairment: No dosage adjustment is required.
• Renal Impairment: No dosage adjustment is required.

Interaction

• Hypoglycemia Risk: Coadministration with insulin secretagogues or insulin may increase the risk.
• Oral Medications: Caution with concomitant oral medications due to delayed gastric emptying.

Contraindications

Do not use in patients with:

• Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Hypersensitivity to Semaglutide.

Pregnancy & Lactation

• Limited data; potential risks to the fetus. Use only if benefits justify risks.
• Discontinue treatment at least 2 months before a planned pregnancy.

Precautions & Warnings

• Thyroid C-Cell Tumors:
  • Unknown if Fitaro causes thyroid C-cell tumors; monitor for signs.
• Pancreatitis:
  • Observe for signs; discontinue if suspected.
• Diabetic Retinopathy Complications:
  • Monitor for progression in patients with a history of diabetic retinopathy.
• Hypersensitivity:
  • Discontinue in case of hypersensitivity reactions.
• Use in Special Populations:
  • Pediatric use not established.
  • Geriatric use: No overall differences in safety or efficacy.
  • No dose adjustment for renal or hepatic impairment.

Storage Conditions

• Store in the refrigerator at 2°C to 8°C.
• After the first use, store for 56 days in the refrigerator.
• Do not freeze.
• Unused cartridges may be used until the expiration date if kept in the refrigerator.
• Keep away from heat and light; keep the pen cap on when not in use.