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Semglee

Last reviewed on RxList: 6/18/2020
Semglee Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Semglee?

Semglee (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 Semglee?

Side effects of Semglee include:

  • low blood sugar (hypoglycemia),
  • allergic reactions,
  • injection site reactions,
  • changes in body fat distribution (lipodystrophy),
  • itching,
  • rash,
  • fluid retention (edema),
  • and weight gain

Dosage for Semglee

The dose of Semglee is individualized based on the patient's metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use.

Semglee In Children

The safety and effectiveness of Semglee to improve glycemic control in pediatric patients with type 1 diabetes mellitus have been established in pediatric patients. The use of Semglee for this indication is based upon an adequate and well-controlled trial of another insulin glargine product in pediatric patients age 6 to 15 years with type 1 diabetes and additional data in adults with type 1 diabetes.

In the pediatric clinical trial, pediatric patients with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in trials with type 1 diabetes.

The safety and effectiveness of Semglee in pediatric patients younger than 6 years of age with type 1 diabetes and pediatric patients with type 2 diabetes have not been established.

What Drugs, Substances, or Supplements Interact with Semglee?

Semglee may interact with other medicines such as:

  • antidiabetic agents,
  • ACE inhibitors,
  • angiotensin II receptor blocking agents,
  • disopyramide,
  • fibrates,
  • fluoxetine,
  • monoamine oxidase inhibitors (MAOIs),
  • pentoxifylline,
  • pramlintide,
  • salicylates,
  • somatostatin analog (e.g., octreotide),
  • sulfonamide antibiotics,
  • atypical antipsychotics,
  • corticosteroids,
  • danazol,
  • diuretics,
  • estrogens,
  • glucagon,
  • isoniazid,
  • niacin,
  • oral contraceptives,
  • phenothiazines,
  • progestogens (e.g., in oral contraceptives),
  • protease inhibitors,
  • somatropin,
  • sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline),
  • thyroid hormones
  • ,
  • alcohol,
  • beta-blockers,
  • clonidine,
  • lithium salts,
  • guanethidine, and
  • reserpine

Tell your doctor all medications and supplements you use.

Semglee During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Semglee. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy. It is unknown if Semglee passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Semglee (insulin glargine injection), for Subcutaneous Use 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.

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.

SLIDESHOW

Type 1 Diabetes: What Are The Symptoms? See Slideshow
Semglee 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 Semglee (Insulin Glargine Injection)

QUESTION

Diabetes is defined best as... See Answer
Semglee Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere:

  • Hypoglycemia [see WARNINGS AND PRECAUTIONS]
  • Medication Errors [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity and allergic reactions [see WARNINGS AND PRECAUTIONS]
  • Hypokalemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials 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 trial of another drug and may not reflect the rates observed in practice.

The data in Table 1 reflect the exposure of 280 patients with type 1 diabetes to SEMGLEE with mean exposure duration of 50 weeks. The type 1 diabetes study population had the following characteristics: the majority of patients were male, 60.2%, mean age was 42 years, the majority of patients were Caucasian, 94.6%, mean BMI was 26.5 kg/m2, mean duration of diabetes prior to entry into the study was 19 years, mean HbA1c at baseline was 7.4%.

The data in Table 2 reflect the exposure of 276 patients with type 2 diabetes to SEMGLEE with mean exposure duration of 22 weeks. The type 2 diabetes study population had the following characteristics: the majority of patients were male, 55.7%, mean age was 55 years, more than half, 52.7%, of the patients were Caucasian, 26.6% were Hispanic, and 9.8% were Black, mean BMI was 31.5 kg/m2, the mean duration of diabetes prior to entry into the study was 12 years, mean HbA1c at baseline was 8.1%.

Common adverse reactions (ARs) were defined as those occurring in ≥5% of SEMGLEE treated patients in clinical trials. Common ARs (other than hypoglycemia) from the type 1 diabetes mellitus and type 2 diabetes mellitus trials 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 SEMGLEE in a 52-Week Trial

SEMGLEE + Insulin Lispro, %
(n= 280)
Upper respiratory tract infection10
Nasopharyngitis9

Table 2: Adverse Reactions Occurring in ≥ 5% of Adult Patients with Type 2 Diabetes Treated with SEMGLEE in a 24-Week Trial

SEMGLEE + Oral Diabetic Medication, %
(n= 276)
Upper respiratory tract infection6

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

Table 3: Adverse Reactions Occurring in ≥ 10% of Adult Patients with Type 2 Diabetes in a 5 Year Trial

Another Insulin Glargine Product, %
(n = 514)
Upper respiratory tract infection29
Edema peripheral20
Hypertension20
Influenza19
Sinusitis19
Cataract18
Bronchitis15
Arthralgia14
Pain in extremity13
Back pain13
Cough12
Urinary tract infection11
Diarrhea11
Depression11
Headache10

The frequencies of adverse reactions during another insulin glargine product clinical trial of 28 weeks duration in children and adolescents with type 1 diabetes mellitus are listed in Table 4.

Table 4: Adverse Reactions (with Frequency ≥ 5% and the Same or Higher with Another Insulin Glargine Product, 100 units/mL, than Comparator) in a 28-week Clinical Trial of Pediatric Patients with Type 1 Diabetes

Another Insulin Glargine Product, %
(n = 174)
Rhinitis5

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including SEMGLEE [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 SEMGLEE 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.

In SEMGLEE trials, an episode of hypoglycemia was classified as severe if it required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions and resulted in neurological recovery, regardless of the availability of a blood glucose measurement. The incidence of severe symptomatic hypoglycemia in patients receiving SEMGLEE with type 1 diabetes mellitus and type 2 diabetes mellitus [see Clinical Studies] was 4% at 52 weeks and 0% at 24 weeks, respectively.

In a clinical trial with another insulin glargine product, 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 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 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
N = 6231
Standard Care
N = 6273
Percent of patients62

Allergic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including SEMGLEE and may be life threatening.

Injection Site Reactions

Patients taking SEMGLEE may experience injection site reactions, including redness, pain, itching, urticaria, edema, and inflammation. In clinical studies in adult patients, there was a higher incidence of injection site pain in patients treated with another insulin glargine product (2.7%) compared to NPH insulin-treated patients (0.7%). The incidence of injection site reactions in patients receiving SEMGLEE was 0.7% at 24 weeks.

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.

Lipodystrophy

Long term use of insulin, including SEMGLEE, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue) and may affect insulin absorption [see DOSAGE AND ADMINISTRATION].

Peripheral Edema

Insulin, including SEMGLEE, may cause sodium retention and edema. The incidence of peripheral edema in patients receiving SEMGLEE was 1.4% in the type 1 diabetes mellitus trial and 0.7% in the type 2 diabetes mellitus trial.

Weight Gain

Weight gain can occur with insulin therapy, including SEMGLEE, and has been attributed to the anabolic effects of insulin. The average weight gain in patients receiving SEMGLEE was 1 kg at 52 weeks in the type 1 diabetes mellitus trial and 0.7 kg at 24 weeks in the type 2 diabetes mellitus trial.

Immunogenicity

As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form. 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 SEMGLEE with the incidence of antibodies in other studies or to other products may be misleading. The presence of such insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose.

In a 52 weeks study of type 1 diabetes mellitus patients, changes from baseline in terms of anti-drug antibody (ADA) percentage binding and the incidence of ADA (positive or negative response) for total ADAs and insulin cross-reactive ADAs, were similar in patients who received SEMGLEE compared with another insulin glargine product.

In a 24 weeks study of type 2 diabetes mellitus patients, immunogenicity profiles were comparable between patients who received SEMGLEE or another insulin glargine product, with most patients showing negative responses for total ADAs and insulin cross-reactive ADAs. Immunogenicity profiles were also similar between insulin-naïve and insulin non-naïve patients in the study.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of another insulin glargine product. 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 insulin products, particularly rapid-acting insulins, have been accidentally administered instead of insulin glargine.

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.

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

Related Resources for Semglee

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

SLIDESHOW

Type 1 Diabetes: What Are The Symptoms? See Slideshow

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