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FIASP(insulin aspart injection)for subcutaneous orintravenous(七)
ybe misleading.
In a 26-week study in adult subjects with type 1 diabetes (Study A[see Clinical Studies (14)]), among the 763 subjects who received FIASP®, 97.2% were positive for cross-reacting anti-insulinantibodies (AIA) at least once during the study, including 90.3% thatwere positive at baseline. A total of 24.8% of patients who received
FIASP® were positive for anti-drug (insulin aspart) antibodies(ADA) at least once during the study, including 17.3% that werepositive at baseline.
7 DRUG INTERACTIONS
Table 4 includes clinically significant drug interactions with FIASP®.
Table 4. Clinically Significant Drug Interactions with
FIASP®
Drugs That May Increase the Risk of HypoglycemiaDrugs:
Antidiabetic agents, ACE inhibitors, angiotensinII receptor blocking agents, disopyramide,fibrates, fluoxetine, monoamine oxidaseinhibitors, pentoxifylline, pramlintide, salicylates,somatostatin analogs (e.g., octreotide), andsulfonamide antibiotics.
Intervention:
Dose reductions and increased frequency of
glucose monitoring may be required when
FIASP® is co-administered with these drugs.
Drugs That May Decrease the Blood Glucose LoweringEffect of FIASP®
Drugs:
Atypical antipsychotics (e.g., olanzapine andclozapine), corticosteroids, danazol, diuretics,estrogens, glucagon, isoniazid, niacin, oralcontraceptives, phenothiazines, progestogens(e.g., in oral contraceptives), protease inhibitors,somatropin, sympathomimetic agents (e.g.,albuterol, epinephrine, terbutaline), and thyroidhormones.
Intervention:
Dose increases and increased frequency ofglucose monitoring may be required whenFIASP® is co-administered with these drugs.
Drugs That May Increase or Decrease the Blood GlucoseLowering Effect of FIASP®
Drugs:
Alcohol, beta-blockers, clonidine, and lithiumsalts. Pentamidine may cause hypoglycemia,which may sometimes be followed byhyperglycemia.
Intervention:
Dose adjustment and increased frequency ofglucose monitoring may be required whenFIASP® is co-administered with these drugs.
Drugs That May Blunt Signs and Symptoms ofHypoglycemiaDrugs: Beta-blockers, clonidine, guanethidine, andreserpine.
Intervention:
Increased frequency of glucose monitoring maybe required when FIASP® is co-administered with
these drugs.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no available data with FIASP® in pregnant women to informa drug-associated risk for major birth defects and miscarriage.
Available information from published randomized controlled trialswith insulin aspart use during the second trimester of pregnancyhave not reported an association with insulin aspart and major birthdefects or adverse maternal or fetal outcomes [see Data]. Thereare risks to the mother and fetus associated with poorly controlled
diabetes in pregnancy [see Clinical Considerations].
In animal reproduction studies, administration of subcutaneousinsulin aspart to pregnant rats and rabbits during the period oforganogenesis did not cause adversedevelopmental effects atexposures 8- times and equal to the human subcutaneous dose of1.0 unit/kg/day, respectively. Pre- and post-implantation losses
and visceral/skeletal abnormalities were seen at higher exposures,which are considered secondary to maternal hypoglycemia. Theseeffects were similar to those observed in rats adm |
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