Fitaro0.25 mg/0.5 ml

Fitaro 0.25 mg/0.5 ml is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular ... Read moreFitaro 0.25 mg/0.5 ml is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.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).

0.25 mg infection: Each pre-filled syringe contains Semoglutldo INN 0.25 mg in 0.5 ml solution for injection0.50 mg injection: Each pre-filled syringe contains Fitaro 0.25 mg/0.5 ml INN 0 50 mg in 0.5 ml solution for injection1 mg Injection: Each pre-filled syringe contains Fitaro 0.25 mg/0.5 ml INN 1 mg in 0.5 ml solution for injection1.7 mg injection: Each pre-filled syringe contains Fitaro 0.25 mg/0.5 ml INN 1.7 mg in 0.75 ml solution for injection2.4 mg injection: Each pre-filled syringe contains Fitaro 0.25 mg/0.5 ml INN 2.4 mg in 0.75 ml solution for Injection

Subcutaneous injection:The starting dose: 0.25 mg Fitaro 0.25 mg/0.5 ml once weekly for 4 weeks subcutaneously. Then in 4 weeks intervals, the dose should be increased until a dose of 2.4 mg is reached. The patient should follow the dose escalation schedule given below.Dose Escalation- Week 1 through 4: 0.25 mg Week 5 through 8: 0.5 mg Week 9 through 12: 1 mg Week 13 through 16: 1.7 mg Maintenance dose- Week 17 and onwards: 2.4 mg If patients do not tolerate a dose during dose escalation, consider delaying dose escalation for 4 weeks. If patients do not tolerate the maintenance dose 2.4 mg, the dose can be temporarily decreased to 1.7 mg once weekly for maximum 4 weeks. After 4 weeks increase the dose to 2.4 mg. Fitaro 0.25 mg/0.5 ml is to be administered once weekly at any time of the day with or without meals. Fitaro 0.25 mg/0.5 ml is to be injected subcutaneously in the abdomen, thigh or in the upper arm. Missed dose: If one dose is missed and the next scheduled dose is more than 2 days away (48 hours), administer Fitaro 0.25 mg/0.5 ml as soon as possible. It one dose is missed and the next scheduled dose is less than 2 days away (48 hours), do not administer the dose. Resume dosing on the regular scheduled day of the week.Tablet: Instruct patients to take Fitaro 0.25 mg/0.5 ml at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces of plain water only. Waiting less than 30 minutes, or taking with food, beverages (other than plain water) or other oral medications will lessen the effect of Fitaro 0.25 mg/0.5 ml. Waiting more than 30 minutes to eat may increase the absorption of Fitaro 0.25 mg/0.5 ml.Swallow tablets whole. Do not cut, crush, or chew tablets. Start Fitaro 0.25 mg/0.5 ml with 3 mg once daily for 30 days. After 30 days on the 3 mg dose, increase the dose to 7 mg once daily. Dose may be increased to 14 mg once daily if additional glycemic control is needed after at least 30 days on the 7 mg dose.

Initiating Fitaro 0.25 mg/0.5 ml concomitant with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia. In clinical pharmacology trials, Fitaro 0.25 mg/0.5 ml did not affect the absorption of orally administered medications to any clinically relevant degree. Nonetheless, caution should be exercised when oral medications are concomitantly administered with Fitaro 0.25 mg/0.5 ml.

Fitaro 0.25 mg/0.5 ml is contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) and hypersensitivity to Fitaro 0.25 mg/0.5 ml. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Fitaro 0.25 mg/0.5 ml.

It is not known if Fitaro 0.25 mg/0.5 ml will cause thyroid tumors or medullary thyroid carcinoma (MTC) in people. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

Risk of Thyroid C-Cell Tumors: It is unknown whether Fitaro 0.25 mg/0.5 ml causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.Pancreatitis: After initiation of Fitaro 0.25 mg/0.5 ml, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Fitaro 0.25 mg/0.5 ml should be discontinued and appropriate management initiated; if confirmed, Fitaro 0.25 mg/0.5 ml should not be restarted.Diabetic Retinopathy Complications: The effect of long-term glycemic control with Fitaro 0.25 mg/0.5 ml on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for the progression of diabetic retinopathy.Never Share Fitaro 0.25 mg/0.5 ml Pen Between Patients: Fitaro 0.25 mg/0.5 ml pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for the transmission of blood-borne pathogens.Hypoglycemia with Concomitant Use of Insulin: Secretagogues or Insulin Patients receiving Fitaro 0.25 mg/0.5 ml in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or another concomitantly administered insulin secretagogue) or insulin.Acute Kidney Injury: There have been post-marketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptoragonists.Hypersensitivity: Do not use in patients with previous hypersensitivity to Fitaro 0.25 mg/0.5 ml. If hypersensitivity reactions occur, discontinue the use of Fitaro 0.25 mg/0.5 ml; treat promptly per standard of care, and monitor until signs and symptoms resolve.

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

Store your Fitaro 0.25 mg/0.5 ml in the refrigerator at 2°C to 8°C. After the first use of the Fitaro 0.25 mg/0.5 ml, the pen can be stored for 56 days in a refrigerator (2°C to 8°C). Do not freeze Fitaro 0.25 mg/0.5 ml. Do not use Fitaro 0.25 mg/0.5 ml if it has been frozen. Unused Fitaro 0.25 mg/0.5 ml cartridges may be used until the expiration date printed on the label, if kept in the refrigerator (2°C to 8°C). Keep Fitaro 0.25 mg/0.5 ml away from heat and out of the light. Keep the pen cap on when not in use.

GLP-1 receptor agonists

Fitaro 0.25 mg/0.5 ml is a GLP-1 analogue with 94% sequence homology to human GLP-1. Fitaro 0.25 mg/0.5 ml acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of Fitaro 0.25 mg/0.5 ml is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, Fitaro 0.25 mg/0.5 ml is stabilized against degradation by the DPP-4 enzyme. Fitaro 0.25 mg/0.5 ml reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

There are limited data with Fitaro 0.25 mg/0.5 ml use in pregnant women. Fitaro 0.25 mg/0.5 ml should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no data on the presence of Fitaro 0.25 mg/0.5 ml in human milk, the effects on the breastfed infant, or the effects on milk production. Discontinue Fitaro 0.25 mg/0.5 ml in women at least 2 months before a planned pregnancy due to the long washout period for Fitaro 0.25 mg/0.5 ml.

Pediatric Use: The safety and efficacy of Fitaro 0.25 mg/0.5 ml have not been established in pediatric patients (younger than 18 years).Geriatric Use: No overall differences in safety or efficacy were detected between geriatric patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.Renal Impairment: No dose adjustment of Fitaro 0.25 mg/0.5 ml is recommended for patients with renal impairment.Hepatic Impairment: No dose adjustment of Fitaro 0.25 mg/0.5 ml is recommended for patients with hepatic impairment.