Insulin efsitora alfa

ONSWIK™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ONSWIK™ is a long-acting insulin analog indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Not recommended for use in patients with type 1 diabetes mellitus due to increased risk of severe hypoglycemia. Limitations of Use ONSWIK is not recommended for use in patients with type 1 diabetes mellitus due to increased risk of severe hypoglycemia.

The primary activity of ONSWIK is the regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis and enhances protein synthesis. The protracted time-action profile of ONSWIK results from reduced renal clearance due to its relatively large molecular size, inhibition of degradation due to binding at the neonatal Fc receptor, and reduced affinity relative to human insulin for the insulin receptor, which decreases receptor-mediated clearance. Once insulin efsitora alfa-gobe is engaged with the insulin receptor, it results in the same pharmacological effects as human insulin.

See Full Prescribing Information for general dosing and important administration instructions. Administer once weekly on the same day each week. The scheduled injection day may be changed, provided 4 days have elapsed since the last dose. Once the injection day is changed, continue administering ONSWIK on the new chosen day. Individualize and adjust the dosage based on metabolic needs, glucose monitoring results and glycemic control goal. Inject subcutaneously into the abdomen, upper arm, thigh, or buttocks. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. May administer alone or in any combination with oral and injectable antidiabetic medicines and bolus insulin. See Full Prescribing Information for recommended starting dosage in insulin naïve patients and patients already on a daily basal insulin.

ONSWIK is contraindicated: during episodes of hypoglycemia. in patients with hypersensitivity to insulin efsitora alfa-gobe or any of the excipients in ONSWIK. Serious hypersensitivity reactions, including anaphylaxis, have occurred with insulin and insulin analogs. During episodes of hypoglycemia. Hypersensitivity to insulin efsitora alfa-gobe or any of the excipients in ONSWIK

Hypoglycemia Due to Medication Errors and Accidental Overdose: Accidental mix-ups between insulin products can occur. Advise patients to always check the product label before each injection to confirm they are using ONSWIK and not another insulin or injectable antidiabetic medicine. Do not transfer ONSWIK into a syringe as overdosage and severe hypoglycemia can result. Do not repeat the one-time starting dose after the first injection. Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to insulin dosage, co-administered glucose-lowering medications, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.

The following adverse reactions are described below or elsewhere in the prescribing information: Hypoglycemia Due to Medication Errors and Accidental Overdose. Severe Hypoglycemia in Patients with Type 1 Diabetes Mellitus. Hypoglycemia. Hypersensitivity Reactions. Hypokalemia. Common adverse reactions include hypoglycemia, hypersensitivity reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.

Table 5 includes clinically significant drug interactions with ONSWIK. Table 5: Clinically Significant Drug Interactions with ONSWIK Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents (including glucagon-like peptide-1 (GLP - 1) receptor agonists, glucose-dependent insulinotropic polypeptide (GIP) and GLP - 1 receptor agonists, and sodium-glucose co-transporter 2 (SGLT2) inhibitors), angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, monoamine oxidase inhibitors, pentoxifylline, salicylates, selective serotonin re-uptake inhibitors (SSRIs), somatostatin analogs, and sulfonamide antibiotics. Intervention: Dose reductions of ONSWIK and increased frequency of glucose monitoring may be required when ONSWIK is co - administered with these drugs.

Store ONSWIK refrigerated at 2°C to 8°C (36°F to 46°F) at all times. If refrigeration is unavailable, the pen can be stored at room temperature up to 30°C (86°F) for up to a total of 14 days. Dispose of ONSWIK that has been left at room temperature for longer than 14 days. Do not freeze ONSWIK. Table 11: Storage Conditions for ONSWIK KwikPens a ONSWIK can only be used for a total of 112 days (16 weeks) of which 14 days can be at room temperature. b Combined time outside of refrigeration (unopened or opened) must not exceed 14 days.