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INSULIN GLARGINE is a brand name for Insulin Glargine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Insulin Glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use Insulin Glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis. Insulin Glargine-yfgn is a long-acting human insulin analog indicated to…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. 2 ) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day.
1 ) Do not dilute or mix with any other insulin or solution. 1 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. 3 ) and how to change to Insulin Glargine-yfgn from other insulins. 4 ) Closely monitor glucose when switching to Insulin Glargine-yfgn and during initial weeks thereafter.
1 Important Administration Instructions Always check insulin labels before administration. 4) ]. Visually inspect Insulin Glargine-yfgn vials and prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
Administer Insulin Glargine-yfgn subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
2) , and Adverse Reactions (6) ]. 2 ) ]. Do not administer intravenously or via an insulin pump. Do not dilute or mix Insulin Glargine-yfgn with any other insulin or solution. The Insulin Glargine-yfgn prefilled pen dials in 1-unit increments.
Use the Insulin Glargine-yfgn prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose. 2 General Dosing Instructions Administer Insulin Glargine-yfgn subcutaneously once daily at any time of day but at the same time every day.
Individualize and adjust the dosage of Insulin Glargine-yfgn based on the patient’s metabolic needs, blood glucose monitoring results and glycemic control goal. , macronutrient content or timing of food intake), during acute illness, or changes in renal or hepatic function.
2) ]. In patients with type 1 diabetes, Insulin Glargine-yfgn must be used concomitantly with short-acting insulin. 3 Initiation of Insulin Glargine-yfgn Therapy Recommended Starting Dosage in Patients with Type 1 Diabetes The recommended starting dosage of Insulin Glargine-yfgn in patients with type 1 diabetes is approximately one-third of the total daily insulin requirements.
6) ] Adverse reactions commonly associated with insulin glargine products include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
2) ] . 1 kg/m 2 . Ninety-seven percent were White, 2% were Black or African American and less than 1% were Asian. Approximately 3% of the patients in studies B and C were Hispanic. 3) ] . 2 kg/m 2 . Eighty-seven percent were White, 8% were Black or African American, and 3% were Asian.
Approximately 9% of patients in Study F were Hispanic. The frequencies of adverse reactions during insulin glargine clinical studies in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below (Tables 1, 2, 3, and 4).
1 Severe Hypoglycemia Hypoglycemia was the most commonly observed adverse reaction in patients treated with insulin glargine. Tables 5, 6, and 7 summarize the incidence of severe hypoglycemia in the insulin glargine clinical studies.
Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg/dL (≤ 56 mg/dL in the 5-year study and ≤ 36 mg/dL in the ORIGIN study) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.
Percentages of insulin glargine-treated adult patients who experienced severe symptomatic hypoglycemia in the insulin glargine clinical studies [see Clinical Studies (14) ] were comparable to percentages of NPH-treated patients for all treatment regimens (see Tables 5 and 6).
5 WARNINGS AND PRECAUTIONS Never share an Insulin Glargine-yfgn prefilled pen, insulin syringe, or needle between patients, even if the needle is changed. , insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring.
2 ) Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitant drugs, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness.
3 ) Hypoglycemia due to medication errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. 4 ) Hypersensitivity reactions : Severe, life-threatening, generalized allergy, including anaphylaxis, can occur.
Discontinue Insulin Glargine-yfgn. Monitor and treat if indicated. 5 ) Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. 6 ) Fluid retention and heart failure with concomitant use of thiazolidinediones (TZDs) : Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation of TZD if heart failure occurs.
1 Never Share an Insulin Glargine-yfgn Prefilled Pen, Insulin Syringe, or Needle Between Patients Insulin Glargine-yfgn prefilled pens must never be shared between patients, even if the needle is changed. Patients using Insulin Glargine-yfgn vials must never re-use or share needles or syringes with another person.
Sharing poses a risk for transmission of blood-borne pathogens. 3) ] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6) ] .
3) ]. 5) ]. During episodes of hypoglycemia ( 4 ) Hypersensitivity to insulin glargine products or any excipient in Insulin Glargine-yfgn ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 units/kg or up to 10 units once daily. 3 ) ].
When switching from:
Once-daily insulin glargine 300 units/mL to once-daily Insulin Glargine-yfgn (100 units/mL), the recommended starting Insulin Glargine-yfgn dosage is 80% of the insulin glargine, 300 units/mL dosage that is being discontinued. Once-daily NPH insulin to once-daily Insulin Glargine-yfgn, the recommended starting Insulin Glargine-yfgn dosage is the same as the dosage of NPH that is being discontinued.
Twice-daily NPH insulin to once-daily Insulin Glargine-yfgn, the recommended starting Insulin Glargine-yfgn dosage is 80% of the total NPH dosage that is being discontinued.
In the pediatric clinical study, pediatric patients with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia in the two treatment groups compared to the adult studies with type 1 diabetes. 9 Table 7 displays the proportion of patients who experienced severe symptomatic hypoglycemia in the insulin glargine and Standard Care groups in the ORIGIN study [see Clinical Studies (14) ] .
8 Peripheral Edema Some patients taking insulin glargine products have experienced sodium retention and edema, particularly if previously poor metabolic control was improved by intensified insulin therapy. 2) ] . Insulin Initiation and Intensification of Glucose Control Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy.
However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy. Weight Gain Weight gain has occurred with insulin including insulin glargine products and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Hypersensitivity Reactions Local Reactions Patients taking insulin glargine experienced injection site reactions, including redness, pain, itching, urticaria, edema, and inflammation. 7%). The reports of pain at the injection site did not result in discontinuation of therapy.
Systemic Reactions Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock have occurred with insulin, including insulin glargine products and may be life threatening.
2 Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.
For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other insulin glargine products may be misleading. All insulin products can elicit the formation of insulin antibodies.
The presence of such insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose. In clinical studies of insulin glargine, increases in titers of antibodies to insulin were observed in NPH insulin and insulin glargine treatment groups with similar incidences.
3 Postmarketing Experience The following adverse reactions have been identified during postapproval use of insulin glargine products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Medication errors have been reported in which rapid-acting insulins and other insulins, have been accidentally administered instead of insulin glargine products. Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia.
For patients with type 2 diabetes, dosage adjustments of concomitant oral and antidiabetic products may be needed. 3 Hypoglycemia Hypoglycemia is the most common adverse reaction associated with insulins, including insulin glargine products.
Severe hypoglycemia can cause seizures, may be life-threatening or cause death. , driving or operating other machinery). Hypoglycemia can happen suddenly, and symptoms may differ in each patient and change over time in the same patient.
, beta-blockers) [see Drug Interactions (7) ] , or who experience recurrent hypoglycemia. The long-acting effect of insulin glargine products may delay recovery from hypoglycemia. Risk Factors for Hypoglycemia The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal.
2 )]. , macronutrient content or timing of meals), changes in level of physical activity, or changes to concomitant drugs [ see Drug Interactions (7) ]. 7) ]. Risk Mitigation Strategies for Hypoglycemia Patients and caregivers must be educated to recognize and manage hypoglycemia.
Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.
4 Hypoglycemia Due to Medication Errors Accidental mix-ups among insulin products have been reported. 3) ] . 1) ] . If hypersensitivity reactions occur, discontinue Insulin Glargine-yfgn; treat per standard of care and monitor until symptoms and signs resolve.
Insulin Glargine-yfgn is contraindicated in patients who have had hypersensitivity reactions to insulin glargine products or one of the excipients. 6 Hypokalemia All insulins, including insulin glargine products, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.
Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. , patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations). 7 Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, when used in combination with insulin.
Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Insulin Glargine-yfgn, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.