Fitaro 1.7mg/0.75ml Injection

Composition

0.25 mg Injection:

• Each pre-filled syringe contains Semaglutide INN 0.25 mg in 0.5 ml solution for injection.

0.50 mg Injection:

• Each pre-filled syringe contains Fitaro INN 0.50 mg in 0.5 ml solution for injection.

1 mg Injection:

• Each pre-filled syringe contains Fitaro INN 1 mg in 0.5 ml solution for injection.

1.7 mg Injection:

• Each pre-filled syringe contains Fitaro INN 1.7 mg in 0.75 ml solution for injection.

2.4 mg Injection:

• Each pre-filled syringe contains Fitaro INN 2.4 mg in 0.75 ml solution for injection.

How does Fitaro 1.7mg/0.75ml Injection work?

Semaglutide is a medication that belongs to a class of drugs called glucagon-like peptide-1 receptor agonists (GLP-1 RAs). GLP-1 RAs mimic the action of glucagon-like peptide-1, a naturally occurring hormone that helps regulate blood sugar levels by stimulating insulin release and suppressing glucagon secretion. This results in lower blood sugar levels after meals and reduced appetite.

Side Effects

Possible side effects include hypersensitivity reactions, pancreatitis, and complications related to diabetic retinopathy.

Quick Suggestions:

• Eat at regular intervals.
• Avoid taking a long gap between meals or snacks.
• Monitor your blood sugar level regularly, especially during periods of significant fluctuations.
• Invest in at least 150 minutes of moderate-intensity physical activity per week.
• Include 15 minutes of exercise every week.
• Lose weight gradually to achieve a healthy body mass index (BMI) between 18.5 and 24.9.
• Replace refined carbohydrate-containing foods with whole-grain options.
• Increase the consumption of fruits, vegetables, and other fiber-enriched foods.
• Reduce the intake of saturated fat from foods like chips, crisps, pastries, biscuits, and samosas.
• Choose cooking oils containing omega-3 fatty acids for daily cooking.
• Avoid stress as it may elevate blood sugar levels.
• Adopt stress management techniques such as mindfulness, yoga, or meditation.
• Opt for low-fat dairy products, such as low-fat yogurt, fat-free milk, and cheese.
• Avoid drinking alcohol while on SEMAGLUTIDE to reduce the risk of hypoglycemia and lactic acidosis.
• Try to quit smoking.
• Reduce the intake of carbohydrate-rich foods like potatoes, rice, mangoes, bread, and sugar.
• Keep taking SEMAGLUTIDE even if your blood sugar levels are controlled until your doctor advises otherwise.
• Monitor your blood sugar frequently as recommended by your healthcare provider.
• Regularly monitor pancreatic enzymes, such as lipase and amylase.
• Take short, frequent meals.
• Avoid prolonged fasting when taking SEMAGLUTIDE.
• Be aware of hypoglycemia symptoms, including sweating, dizziness, palpitations, shivering, intense thirst, dry mouth, dry skin, and frequent urination.
• 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:

Semaglutide is used to treat adults (aged 18 years and older) with type 2 diabetes when diet and exercise is not enough to control blood sugar levels.

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:

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:

Injection Sites:

• Administer subcutaneously to the abdomen, thigh, or upper arm.

Frequency:

• Administer once weekly.

Day of Administration:

• Administer on the same day each week.
• The day of weekly administration can be changed if necessary, as long as the time between two doses is at least 2 days (>48 hours).

Timing:

• Administer at any time of the day.

Meal Consideration:

• Can be administered with or without meals.

Injection Site Rotation:

• Use a different injection site each week when injecting in the same body region.
• This rotation helps prevent irritation or changes at the injection site.

Interaction

Initiating Fitaro with Insulin Secretagogue or Insulin:

• Consider reducing the dose of concomitantly administered insulin secretagogue or insulin to reduce the risk of hypoglycemia.
• Caution with concomitant use of oral medications.

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

Not recommended for pregnant women, nursing mothers

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.
• Keep away from heat and light; keep the pen cap on when not in use.

Disposal

Unused cartridges may be used until the expiration date if kept in the refrigerator.