Applies to insulin degludec: parenteral injection.

Side effects include:

Insulin degludec: Hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, weight gain, nasopharyngitis, headache, upper respiratory tract infection, sinusitis, gastroenteritis, diarrhea.

Fixed combination of insulin degludec and liraglutide: Nasopharyngitis, headache, nausea, diarrhea, increased lipase concentrations, upper respiratory tract infection.

For Healthcare Professionals

Applies to insulin degludec: subcutaneous solution.

General

The most commonly reported adverse reactions include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.^[Ref]

Metabolic

Weight gain, attributed to the anabolic effects of insulin, has been reported. In 52-week clinical trials, an average weight gain of 1.8 kg and 3 kg was reported in patients with type 1 diabetes and type 2 diabetes, respectively.^[Ref]

Very common (10% or more): Hypoglycemia

Frequency not reported: Weight gain^[Ref]

Cardiovascular

In clinical trials, peripheral edema was reported in 3% and 0.9% of patients with type 1 diabetes and type 2 diabetes, respectively.^[Ref]

Common (1% to 10%): Peripheral edema^[Ref]

Local

Injection site reactions have included injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass. These reactions are usually mild and transient and disappear with continued treatment.^[Ref]

Common (1% to 10%): Injection site reactions^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity (manifested with swelling of tongue and lips, diarrhea, nausea, tiredness, and itching) and urticaria^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Lipodystrophy, urticaria

Postmarketing reports: Localized cutaneous amyloidosis (at injection site)^[Ref]

Immunologic

Frequency not reported: Anti-insulin antibodies^[Ref]

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. It is for these reasons, comparisons with antibodies in other studies or to other products may be misleading.

In a study of adult insulin-experienced type 1 diabetes patients, 68.9% of patients receiving this were positive at baseline for anti-insulin degludec antibodies and 12.3% of the patients developed anti-insulin degludec antibodies at least once during the study. In pediatric insulin-experienced patients with type 1 diabetes, 84.1% of those were positive at baseline for anti-insulin degludec antibodies and 5.8% of patients developed anti-insulin degludec antibodies at least once during the study. Between 96.7% and 99.7% of patients who were positive for anti-insulin degludec antibodies were also positive for anti-human insulin antibodies.^[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (23.9%), upper respiratory tract infection (11.9%)

Common (1% to 10%): Sinusitis^[Ref]

Nervous system

Very common (10% or more): Headache (11.8%)^[Ref]

Gastrointestinal

Common (1% to 10%): Gastroenteritis, diarrhea^[Ref]