Fitaro 0.5 Injection

Indications

For Diabetes: Fitaro is prescribed for:

• Serving as an adjunct to diet and exercise to enhance glycemic control in adults diagnosed with type 2 diabetes mellitus.
• Reducing the risk of significant adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease.

For Obesity:
Fitaro is indicated as an adjunct to a calorie-restricted diet and increased physical activity for long-term weight management in adult patients who have an initial body mass index (BMI) of:

• 30 kg/m² or higher (Obesity)
• 27 kg/m² or higher (Overweight) with at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia).

Always consult a registered healthcare professional before taking this medication.

Pharmacology

Semaglutide is a GLP-1 analogue with a 94% sequence similarity to human GLP-1. It acts as a GLP-1 receptor agonist, selectively binding to and activating the GLP-1 receptor. This action lowers blood glucose levels in a glucose-dependent manner by promoting insulin secretion and inhibiting glucagon secretion when blood glucose levels are elevated. Additionally, the mechanism involves a slight delay in gastric emptying. In cases of hypoglycemia, Semaglutide decreases insulin secretion while maintaining glucagon secretion. It also aids in reducing body weight and body fat by curbing appetite.

Dosage & Administration

For Diabetes:

Semaglutide Tablet:
Administer Semaglutide at least 30 minutes prior to the first meal, beverage, or other oral medications of the day, using no more than 4 ounces (118 ml) of plain water.

• Starter Dose: Initiate with 3 mg once daily for 30 days.
• Maintenance Dose: After 30 days on the 3 mg dose, increase to 7 mg once daily.
• For Additional Glycemic Control: If further glycemic control is needed after at least 30 days on the 7 mg dose, it can be increased to 14 mg once daily.

Semaglutide Injection:
Begin with a dose of 0.25 mg once weekly. After 4 weeks, increase to 0.5 mg weekly. If further glycemic control is required, the dose can be raised to 1 mg once weekly after at least 4 weeks at the 0.5 mg level. Higher weekly doses than 1 mg are not recommended. The injection should be administered subcutaneously in the abdomen, thigh, or upper arm, and can be taken at any time, with or without meals. The injection site may vary without adjusting the dose. Semaglutide should not be given intravenously or intramuscularly. The weekly administration day can be modified as long as there is a minimum of 3 days (over 72 hours) between doses.

Switching Between Formulations:

• Patients on a 0.5 mg weekly injection may transition to a 7 mg or 14 mg tablet, starting the tablet up to 7 days after the last injection. There is no equivalent tablet dose for the 1 mg injection.
• Those taking the 14 mg tablet can switch to the 0.5 mg weekly injection the day after their last tablet dose.

For Obesity:
The starting dose is 0.25 mg Semaglutide administered weekly for 4 weeks. If the patient cannot tolerate a dose during escalation, consider delaying the increase for another 4 weeks. If the 2.4 mg maintenance dose is not tolerated, it may be temporarily reduced to 1.7 mg weekly for a maximum of 4 weeks before increasing back to 2.4 mg. Weekly doses exceeding 2.4 mg are not advised. The administration protocol is the same as for diabetes treatment.

Always consult a registered healthcare professional before taking this medication.

Interactions

Fitaro can delay gastric emptying, which may affect the absorption rate of concurrently administered oral medications. Caution is advised for patients taking oral medications that require rapid gastrointestinal absorption.

Contraindications

Do not use Fitaro if there is a known hypersensitivity to the active ingredient or any of its excipients.

Side Effects

Hypoglycemia may occur, particularly when combined with insulin or sulfonylurea. Common adverse effects include gastrointestinal disorders, nausea, diarrhea, vomiting, abdominal pain, and constipation, which are typically mild to moderate and short-lived. Other potential reactions include allergic responses, injection site reactions, lipodystrophy, itching, and rash.

Pregnancy & Lactation

Semaglutide is contraindicated during pregnancy. If planning to become pregnant, discontinue Semaglutide at least 2 months before. Due to potential risks to breastfeeding infants, Semaglutide should not be used while nursing.

Precautions & Warnings

• Diabetic Ketoacidosis: Fitaro is not intended for use in type 1 diabetes or for treating diabetic ketoacidosis.
• Pancreatitis: Discontinue immediately if pancreatitis is suspected; do not restart if confirmed.
• Diabetic Retinopathy: Monitor patients with diabetic retinopathy closely.

Use in Special Populations:

• Pediatric Population: Safety and efficacy for children and adolescents under 18 have not been established.
• Elderly: No dosage adjustment based on age is required.
• Renal Impairment: No dosage modification needed for mild to severe renal impairment; however, it is not recommended for end-stage renal disease.
• Hepatic Impairment: No dosage adjustment needed, but caution is advised.

Overdose Effects

Reported overdose levels of up to 4 mg in a single dose or weekly have occurred in clinical trials, with nausea being the most frequently reported adverse reaction. There is no specific antidote for Fitaro overdose. In the event of an overdose, provide supportive care according to the patient’s clinical presentation.

Dose Adjustment:

When adding Fitaro to existing metformin or thiazolidinedione therapy, continue the current doses of those medications unchanged. If added to sulfonylurea or insulin therapy, consider reducing those doses to lower the risk of hypoglycemia. Self-monitoring of blood glucose is not necessary for adjusting the Fitaro dose but is essential for adjusting sulfonylurea and insulin doses when starting Fitaro.

Missed Dose:

If a dose is missed, take it as soon as possible within 5 days. If more than 5 days have elapsed, skip the missed dose and resume the regular schedule.

Therapeutic Class

GLP-1 Receptor Agonists

Storage Conditions

Store at a temperature between 2 °C to 8 °C (refrigerated). Do not freeze. Keep out of reach of children.