Basaglar

Last updated on RxList: 7/29/2021
Basaglar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Basaglar?

Basaglar (insulin glargine injection) is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

What Are Side Effects of Basaglar?

Common side effects of Basaglar include:

Dosage for Basaglar

The dose of Basaglar is individualized based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use.

What Drugs, Substances, or Supplements Interact with Basaglar?

Basaglar may interact with antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs, sulfonamide antibiotics, atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens, protease inhibitors, somatropin, sympathomimetic agents, thyroid hormones, alcohol, beta-blockers, clonidine, lithium salts, guanethidine, and reserpine. Tell your doctor all medications and supplements you use.

Basaglar During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or become pregnant while taking Basaglar. Insulin needs may change during pregnancy. It is unknown if Basaglar passes into breast milk. Insulin needs may change while a woman is breastfeeding. Consult your doctor before breastfeeding.

Additional Information

Our Basaglar (insulin glargine injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Diabetes is defined best as... See Answer
Basaglar Consumer Information

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

  • rapid weight gain, swelling in your feet or ankles;
  • shortness of breath; or
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • low blood sugar;
  • itching, mild skin rash; or
  • thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Basaglar (Basaglar Insulin Glargine Subcutaneous Injection)

SLIDESHOW

Diabetes: What Raises and Lowers Your Blood Sugar Level? See Slideshow
Basaglar Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere:

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 a52-week trial

  BASAGLAR + Insulin Lispro, %
(n=268)
Infectiona 24
Nasopharyngitis 16
Upper respiratory tract infection 8
a Infections other than nasopharyngitis or upper respiratory tract infection.

Table 2: Adverse reactions occurring in ≥5% of adult patients with type 2 diabetes treated with BASAGLAR in a 24-week trial

  BASAGLAR + Oral Antidiabetic Medication, %
(n=376)
Infectiona 17
Nasopharyngitis 6
Upper respiratory tract infection 5
a Infections other than nasopharyngitis or upper respiratory tract infection.

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 withincidence ≥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]. 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] 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] 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].

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].

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].

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.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity.

In a 52-week study of type 1 diabetes patients, 42% of patients who received BASAGLAR once daily were positive for anti-drug antibodies (ADA) at least once during the study, including 17% that were positive at baseline and 25% of patients who developed ADA during the study. Sixty-five percent of the ADA positive patients on BASAGLAR with antibody testing at week 52 remained ADA positive at week 52.

In a 24-week study of type 2 diabetes patients, 17% of patients who received BASAGLAR once daily were positive for ADA at least once during the study. Among the subjects who were positive, 5% had ADA at baseline and 12% developed antibodies during the study. The percent binding of patients positive at baseline on BASAGLAR did not increase significantly during the study. Fifty-one percent of the ADA positive patients on BASAGLAR with antibody testing at week 24 remained ADA positive at week 24. There was no evidence that these antibodies had an impact on efficacy and safety outcomes.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to BASAGLAR with the incidence of antibodies in other studies or to other products may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of another insulin glargine product, 100 units/mL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.

Medication errors have been reported in which other insulin products, particularly rapid-acting insulins, have been accidentally administered instead of an insulin glargine product. To avoid medication errors between insulin glargine products and other insulin products, patients should be instructed to always verify the insulin label before each injection.

Read the entire FDA prescribing information for Basaglar (Basaglar Insulin Glargine Subcutaneous Injection)

© Basaglar Patient Information is supplied by Cerner Multum, Inc. and Basaglar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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