(6.1)].
Severehypoglycemia can cause seizures, may lead to unconsciousness,may be life-threatening, or cause death. Hypoglycemia can impairconcentration ability and reaction time; this may place an individualand others at risk in situations where these abilities are important(e.g. driving or operating other machinery). FIASP®, or any insulin,should not be used during episodes of hypoglycemia [see Contraindications(4)].
Hypoglycemia can happen suddenly and symptoms may differin each individual and change over time in the same individual.
Symptomatic awareness of hypoglycemia may be less pronouncedin patients with longstanding diabetes, in patients with diabetic nervedisease, in patients using medications that block the sympatheticnervous system (e.g., beta-blockers) [see Drug Interactions (7)], orin patients who experience recurrent hypoglycemia.
Risk Factors for Hypoglycemia
The risk of hypoglycemia after an injection is related to the durationof action of the insulin and, in general, is highest when the glucoselowering effect of the insulin is maximal. The timing of hypoglycemiausually reflects the time-action profile of the administered insulinformulation. As with all insulin preparations, the glucose loweringeffect time course of FIASP® may vary in different individuals orat different times in the same individual and depends on manyconditions, including the area of injection as well as the injection siteblood supply and temperature [see Clinical Pharmacology (12.2)].
Other factors which may increase the risk of hypoglycemia includechanges in meal pattern (e.g., macronutrient content or timingof meals), changes in level of physical activity, or changes toco-administered medication [see Drug Interactions (7)].
Patients withrenal or hepatic impairment may be at higher risk of hypoglycemia[see Use in Specific Populations (8.6, 8.7)].
Risk Mitigation Strategies for HypoglycemiaPatients and caregivers must be educated to recognize and managehypoglycemia. Self-monitoring of blood glucose plays anessentialrole in the prevention and management of hypoglycemia. In patientsat higher risk for hypoglycemia and patients who have reducedsymptomatic awareness of hypoglycemia, increased frequency ofblood glucose monitoring is recommended.
5.4 Hypoglycemia Due to Medication Errors
Accidental mix-ups between insulin products have been reported.
To avoid medication errors between FIASP® and other insulins,instruct patients to always check the insulin label before eachinjection.
5.5 Hypokalemia
All insulin products, including FIASP®, can cause a shift inpotassium from the extracellular to intracellular space, possiblyleading to hypokalemia. Untreated hypokalemia may causerespiratory paralysis, ventricular arrhythmia and death. Monitorpotassium levels in patients at risk for hypokalemia if indicated (e.g.,
patients using potassium-lowering medications, patients takingmedications sensitive to potassium concentrations).
5.6 Hypersensitivity and Allergic Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis,can occur with insulin products, including FIASP® [see AdverseReactions (6.1)].
If hypersensitivity reactions occur, discontinueFIASP®; treat per standard of care and monitor until symptoms andsigns resolve. FIASP® is contraindicated in patients who have hadhypersensitivity reactions to insulin aspart, |
