Insulin Glargine Solostar

2 DOSAGE AND ADMINISTRATION Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. 4 ) 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. 2 ) Closely monitor glucose when changing to Insulin glargine and during initial weeks thereafter.

1 Important Administration Instructions Administer Insulin glargine subcutaneously once daily at any time of day but at the same time every day. Prior to initiation of Insulin glargine, train patients on proper use and injection technique.

Patient should follow the Instructions for Use to correctly administer Insulin glargine. Administer Insulin glargine 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) , Adverse Reactions (6) ] . 2) ] . Visually inspect Insulin glargine vials and SoloStar prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.

The Insulin glargine SoloStar prefilled pen dials in 1-unit increments. Use Insulin glargine SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose. Refrigerate unused (unopened) Insulin glargine vials and SoloStar ® prefilled pens.

Do not administer intravenously or via an insulin pump. Do not dilute or mix Insulin glargine with any other insulin or solution. 1) ] . 2 General Dosing Instructions Individualize and adjust the dosage of Insulin glargine based on the individual'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) ] . 3 Initiation of Insulin Glargine Therapy Type 1 Diabetes In patients with type 1 diabetes, Insulin glargine must be used concomitantly with short-acting insulin.

The recommended starting dose of Insulin glargine in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.

2 units/kg or up to 10 units once daily. One may need to adjust the amount and timing of short- or rapid-acting insulins and dosages of any oral antidiabetic drugs. 4 Changing to Insulin Glargine from Other Insulin Therapies If changing patients from once-daily TOUJEO (insulin glargine) 300 units/mL to once-daily Insulin glargine, the recommended initial Insulin glargine dose is 80% of the TOUJEO dose that is being discontinued.

3) ]. If changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with Insulin glargine, a change in the dose of the basal insulin may be required and the amount and timing of the shorter-acting insulins and doses of any oral antidiabetic drugs may need to be adjusted.

If changing patients from once-daily NPH insulin to once-daily Insulin glargine, the recommended initial Insulin glargine dose is the same as the dose of NPH that is being discontinued. If changing patients from twice-daily NPH insulin to once-daily Insulin glargine, the recommended initial Insulin glargine dosage is 80% of the total NPH dose that is being discontinued.

3) ].

6) ] Adverse reactions commonly associated with Insulin glargine 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.

The data in Table 1 reflect the exposure of 2327 patients with type 1 diabetes to Insulin glargine or NPH. 5 years. 7% were Hispanic. 1 kg/m 2 . The data in Table 2 reflect the exposure of 1563 patients with type 2 diabetes to Insulin glargine or NPH.

3 years. 8% were Black or African American and 9% were Hispanic. 2 kg/m 2 . The frequencies of adverse events during Insulin glargine clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

3) ] . Tables 5, 6, and 7 summarize the incidence of severe hypoglycemia in the Insulin glargine individual clinical trials. 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 trial and ≤36 mg/dL in the ORIGIN trial) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.

Percentages of Insulin glargine–treated adult patients experiencing severe symptomatic hypoglycemia in the Insulin glargine clinical trials [see Clinical Studies (14) ] were comparable to percentages of NPH-treated patients for all treatment regimens (see Tables 5 and 6 ).

In the pediatric phase 3 clinical trial, children and adolescents with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia in the two treatment groups compared to the adult trials with type 1 diabetes. 9 Table 7 displays the proportion of patients experiencing severe symptomatic hypoglycemia in the Insulin glargine and Standard Care groups in the ORIGIN Trial [see Clinical Studies (14) ] .

8 Peripheral Edema Some patients taking Insulin glargine have experienced sodium retention and edema, particularly if previously poor metabolic control is 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 some insulin therapies including Insulin glargine and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Allergic Reactions Local allergy As with any insulin therapy, patients taking Insulin glargine may experience 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 allergy Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including Insulin glargine and may be life threatening.

2 Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity. 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 phase 3 clinical trials 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.

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 other insulins, particularly rapid-acting insulins, have been accidentally administered instead of Insulin glargine [see Patient Counseling Information (17) ] .

To avoid medication errors between Insulin glargine and other insulins, patients should be instructed to always verify the insulin label before each injection. 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.

5 WARNINGS AND PRECAUTIONS Never share an Insulin glargine SoloStar prefilled pen 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, coadministered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness.

1 ) Medication Errors : Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. 3 ) Hypersensitivity reactions : Severe, life-threatening, generalized allergy, including anaphylaxis, can occur.

Discontinue Insulin glargine. Monitor and treat if indicated. 1 ) 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 SoloStar Prefilled Pen, Syringe, or Needle Between Patients Insulin glargine SoloStar prefilled pens must never be shared between patients, even if the needle is changed. Patients using Insulin glargine 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) ] .

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 insulin, including Insulin glargine. 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 individual and change over time in the same individual. , beta-blockers) [see Drug Interactions (7) ] , or in patients who experience recurrent 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 coadministered medication [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. The long-acting effect of Insulin glargine may delay recovery from hypoglycemia.

4 Medication Errors Accidental mix-ups among insulin products, particularly between long-acting insulins and rapid-acting insulins, have been reported. 3) ] . 5 Hypersensitivity and Allergic Reactions Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Insulin glargine.

1) ] . Insulin glargine is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or one of the excipients [see Contraindications (4) ] . 6 Hypokalemia All insulin products, including Insulin glargine, 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, particularly when used in combination with insulin.

Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Insulin glargine, 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.

5) ] During episodes of hypoglycemia ( 4 ) Hypersensitivity to Insulin glargine or one of its excipients ( 4 )