BASAGLAR KwikPen (Page 2 of 7)

5.4 Medication Errors

Accidental mix-ups between insulin glargine product, 100 units/mL, and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between BASAGLAR and other insulins, instruct patients to always check the insulin label before each injection.

5.5 Hypersensitivity and Allergic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including BASAGLAR. If hypersensitivity reactions occur, discontinue BASAGLAR; treat per standard of care and monitor until symptoms and signs resolve [see Adverse Reactions (6.1)]. BASAGLAR is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or one of the excipients [see Contraindications (4)].

5.6 Hypokalemia

All insulin products, including BASAGLAR, 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. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).

5.7 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 BASAGLAR, 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.

6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere:

  • Hypoglycemia [see Warnings and Precautions (5.3)].
  • Hypersensitivity and allergic reactions [see Warnings and Precautions (5.5)].
  • Hypokalemia [see Warnings and Precautions (5.6)].

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Two clinical trials with BASAGLAR were conducted: one in type 1 diabetes and one in type 2 diabetes.

The type 1 diabetes population had the following characteristics: Mean age was 41 years and mean duration of diabetes was 16 years. 58% were male. 75% were Caucasian, 2% Black or African American and 4% American Indian or Alaskan native. 4% were Hispanic. At baseline, mean eGFR was 109 mL/min/1.73m2. 73.5 percent of patients had eGFR>90 mL/min/1.73m2. The mean BMI was approximately 26 kg/m2. HbA1c at baseline was 7.8%. The data in Table 1 reflect exposure of 268 patients to BASAGLAR with a mean exposure duration of 49 weeks.

The type 2 diabetes population had the following characteristics: Mean age was 59 years and mean duration of diabetes was 11 years. 50% were male. 78% were Caucasian, 8% Black or African American and 5% American Indian or Alaskan native. 28% were Hispanic. At baseline, mean eGFR was 109 mL/min/1.73m2. 67.5 percent of patients had eGFR>90 mL/min/1.73m2. The mean BMI was approximately 32 kg/m2. HbA1c at baseline was 8.3%. The data in Table 2 reflect exposure of 376 patients to BASAGLAR with a mean exposure duration of 22 weeks.

Common adverse reactions were defined as reactions occurring in ≥5% of the population studied. Common adverse reactions during clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus (other than hypoglycemia) are listed in Table 1 and Table 2, respectively.

Table 1: Adverse reactions occurring in ≥5% of adult patients with type 1 diabetes treated with BASAGLAR in a 52-week trial

a Infections other than nasopharyngitis or upper respiratory tract infection.

BASAGLAR + Insulin Lispro, %(n=268)
Infectiona 24
Nasopharyngitis 16
Upper respiratory tract infection 8
Table 2: Adverse reactions occurring in ≥5% of adult patients with type 2 diabetes treated with BASAGLAR in a 24-week trial

a Infections other than nasopharyngitis or upper respiratory tract infection.

BASAGLAR + Oral Antidiabetic Medication, %(n=376)
Infectiona 17
Nasopharyngitis 6
Upper respiratory tract infection 5

The frequencies of adverse reactions during a clinical trial of 5 years duration with another insulin glargine product, 100 units/mL, in patients with type 2 diabetes mellitus are listed in Table 3.

Table 3: Common adverse reactions in 5-year trial of adult patients with type 2 diabetes (adverse reactions with incidence ≥10% and higher with another insulin glargine product, 100 units/mL, than comparator)
Another Insulin Glargine Product, %(n=514) NPH, %(n=503)
Hypertension 20 19
Sinusitis 19 18
Cataract 18 16
Bronchitis 15 14
Back pain 13 12
Cough 12 7
Urinary tract infection 11 10
Diarrhea 11 10
Depression 11 10
Headache 10 9

The frequencies of adverse reactions during clinical trials with another insulin glargine product, 100 units/mL, in children and adolescents with type 1 diabetes mellitus are listed in Table 4.

Table 4: Adverse reactions in a 28-week clinical trial of children and adolescents with type 1 diabetes (adverse reactions with frequency ≥5% and the same or higher with another insulin glargine product, 100 units/mL, than comparator)
Another Insulin Glargine Product, % (n=174) NPH, % (n=175)
Rhinitis 5 5

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including BASAGLAR [see Warnings and Precautions (5.3)]. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for BASAGLAR with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice.

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.

The incidence of severe symptomatic hypoglycemia in patients receiving BASAGLAR with type 1 diabetes mellitus and type 2 diabetes mellitus [see Clinical Studies (14)] was 4% at 52 weeks and 1% at 24 weeks, respectively.

The incidence of severe symptomatic hypoglycemia in a clinical trial with another insulin glargine product, 100 units/mL, in children and adolescents age 6 to 15 years with type 1 diabetes [see Clinical Studies (14)] was 23% at 26 weeks.

Table 5 displays the proportion of patients experiencing severe symptomatic hypoglycemia in another insulin glargine product, 100 units/mL, and Standard Care groups in the ORIGIN Trial [see Clinical Studies (14)].

Table 5: Severe Symptomatic Hypoglycemia in the ORIGIN Trial
ORIGIN Trial Median duration of follow-up: 6.2 years
Another Insulin Glargine Product, 100 units/mL(N=6231) Standard Care(N=6273)
Percent of patients 6 2

Allergic Reactions

Some patients taking insulin therapy, including BASAGLAR have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported [see Warnings and Precautions (5.5)].

Peripheral Edema

Some patients taking BASAGLAR have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Lipodystrophy

Administration of insulin subcutaneously, including BASAGLAR, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients [see Dosage and Administration (2.1)].

Weight gain

Weight gain has occurred with some insulin therapies including BASAGLAR and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

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