Insulin Aspart/insulin Degludec Side Effects
Applies to insulin aspart/insulin degludec: subcutaneous solution.
Important warnings
This medicine can cause some serious health issues
Never share an injection pen with another person, even if the needle has been changed.
Get emergency medical help if you have signs of an allergic reaction: hives, itching, skin rash; wheezing, tiredness, trouble breathing; feeling like you might pass out; nausea, diarrhea; swelling of your face, lips, tongue, or throat.
Call your doctor if you have:
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fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or
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low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling.
Common side effects may include:
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itching, mild skin rash; or
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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.
For healthcare professionals
Applies to insulin aspart/insulin degludec: subcutaneous solution.
General
The most frequently reported adverse reactions include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.[Ref]
Metabolic
- Very common (10% or more): Hypoglycemia (up to 95%)
- Frequency not reported: Weight gain[Ref]
Weight gain, attributed to the anabolic effects of insulin, has been reported. In clinical trials, an average weight gain of 1.6 kg and 2.8 kg was reported in patients with type 1 diabetes and type 2 diabetes, respectively.[Ref]
Immunologic
The detection of antibodies is 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 medications, and underlying disease. Therefore, comparison of the incidence of antibodies may be misleading. In a study in insulin-experienced patients with type 1 diabetes receiving insulin degludec/insulin aspart, 13% were positive for anti-insulin aspart antibodies at least once during the study, including 6.4% who were positive at baseline. For insulin degludec, in adult insulin experienced type 1 diabetes patients, 63.5% of patients receiving this insulin were positive at baseline for anti-insulin degludec antibodies and 15.4% developed anti-insulin degludec antibodies at least once during the study. In immunogenic trials, 99.4% to 100% of patients who were positive for anti-insulin degludec antibodies were also positive for anti-human insulin antibodies.[Ref]
Cardiovascular
- Common (1% to 10%): Peripheral edema[Ref]
In clinical trials, peripheral edema was reported in 2.2% and 1.8% of patients with type 1 diabetes and type 2 diabetes, respectively.[Ref]
Hypersensitivity
- Uncommon (0.1% to 1%): Hypersensitivity manifested with swelling of tongue and lips, diarrhea, nausea, tiredness and itching; urticaria[Ref]
Local
- Common (1% to 10%): Injection site reactions including hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass
- Uncommon (0.1% to 1%): Lipodystrophy[Ref]
Respiratory
- Very common (10% or more): Nasopharyngitis (up to 24.6%)
- Common (1% to 10%): Upper respiratory tract infection[Ref]
Nervous system
- Common (1% to 10%): Headache
References
1. (2015) "Product Information. Ryzodeg 70/30 FlexTouch (insulin aspart-insulin degludec)." Novo Nordisk Pharmaceuticals Inc
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Further information
Insulin aspart/insulin degludec side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.