Tresiba FlexTouch Adverse Reactions

Summary of the Safety Profile: The most frequently reported adverse reaction during treatment is hypoglycemia (see Description of Selected Adverse Reactions as follows).
Tabulated List of Adverse Reactions: Adverse reactions listed as follows are based on clinical trial data and classified according to MedDRA System Organ Class. Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).

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Description of Selected Adverse Reactions: Immune System Disorders: With insulin preparations, allergic reactions may occur. Immediate-type allergic reactions to either insulin itself or the excipients may potentially be life-threatening. With insulin degludec, hypersensitivity (manifested with swelling of tongue and lips, diarrhea, nausea, tiredness and itching) and urticaria were reported rarely.
Hypoglycemia: Hypoglycemia may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. The symptoms of hypoglycemia usually occur suddenly.
They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Lipodystrophy: Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site. Continuous rotation of the injection site within the particular injection area may help to reduce the risk of developing these reactions.
Injection Site Reactions: Injection site reactions (including injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth and injection site mass) occurred in patients treated with insulin degludec. These reactions are usually mild and transitory, and they normally disappear during continued treatment.
Pediatric Population: Insulin degludec has been administered to children and adolescents up to 18 years for the investigation of pharmacokinetic properties (see Pharmacology: Pharmacokinetics). Safety and efficacy have not been established in children and adolescents.
Other Special Populations: Based on results from clinical trials, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.