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Fiasp

WARNINGS

Included as part of the “PRECAUTIONS” Section

PRECAUTIONS

Never Share A FIASP FlexTouch Pen Between Patients

FIASP FlexTouch disposable prefilled pen should never be shared between patients, even if the
needle is changed. Patients using FIASP vials should never share needles or syringes with
another person. Sharing poses a risk for transmission of blood-borne pathogens.

Hyperglycemia Or Hypoglycemia With Changes In Insulin Regimen

Changes in insulin, insulin strength, manufacturer, type, or method of administration may affect
glycemic control and predispose to hypoglycemia or hyperglycemia. These changes should be
made cautiously and only under close medical supervision and the frequency of blood glucose
monitoring should be increased. For patients with type 2 diabetes, dosage adjustments in
concomitant oral anti-diabetic treatment may be needed.

Hypoglycemia

Hypoglycemia is the most common adverse reaction of all insulin therapies, including FIASP
[see ADVERSE REACTIONS]. Severe hypoglycemia can cause seizures, may lead to
unconsciousness, may be life-threatening, or cause death. Hypoglycemia can impair
concentration ability and reaction time; this may place an individual and 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].

Hypoglycemia can happen suddenly and symptoms may differ in each individual and change
over time in the same individual. Symptomatic awareness of hypoglycemia may be less
pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in
patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see DRUG INTERACTIONS], or in patients who experience recurrent hypoglycemia.

Risk Factors For Hypoglycemia

The risk of hypoglycemia after an injection is related to the duration of action of the insulin and,
in general, is highest when the glucose lowering effect of the insulin is maximal. The timing of
hypoglycemia usually reflects the time-action profile of the administered insulin formulation. As
with all insulin preparations, the glucose lowering effect time course of FIASP may vary in
different individuals or at different times in the same individual and depends on many
conditions, including the area of injection as well as the injection site blood supply and
temperature [see CLINICAL PHARMACOLOGY].

Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g.,
macronutrient content or timing of meals), changes in level of physical activity, or changes to coadministered
medication [see DRUG INTERACTIONS]. Patients with renal or hepatic impairment
may be at higher risk of hypoglycemia [see Use In Specific Populations].

Risk Mitigation Strategies For Hypoglycemia

Patients and caregivers must be educated to recognize and manage hypoglycemia. Selfmonitoring
of blood glucose plays an essential role in the prevention and management of
hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced
symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is
recommended.

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 each
injection.

Hypokalemia

All insulin products, including FIASP, can cause a shift in potassium from the extracellular to
intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause
respiratory paralysis, ventricular arrhythmia and death. Monitor potassium levels in patients at
risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients
taking medications sensitive to potassium concentrations).

Hypersensitivity And Allergic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin
products, including FIASP [see ADVERSE REACTIONS]. If hypersensitivity reactions occur,
discontinue FIASP; treat per standard of care and monitor until symptoms and signs resolve.
FIASP is contraindicated in patients who have had hypersensitivity reactions to insulin aspart, or
one of the excipients in FIASP [see CONTRAINDICATIONS].

Fluid Retention And Heart Failure With Concomitant Use Of PPAR-Gamma
Agonists

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-
gamma agonists, can cause dose-related fluid retention, particularly when used in combination
with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin,
including FIASP, and a PPAR-gamma agonist should be observed for signs and symptoms of
heart failure. If heart failure develops, it should be managed according to current standards of
care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

Patient Counseling Information

Advise the patient to read the FDA-Approved Patient Labeling (PATIENT INFORMATION and
Instructions for Use
).

Never Share A FIASP FlexTouch Pen Device Between Patients

Advise patients that they should never share a FIASP FlexTouch pen device with another person,
even if the needle is changed, because doing so carries a risk for transmission of blood-borne
pathogens. Advise patients using FIASP vials not to share needles or syringes with another
person. Sharing poses a risk for transmission of blood-borne pathogens [see WARNINGS AND PRECAUTIONS].

Hypoglycemia

Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct
patients on self-management procedures including glucose monitoring, proper injection
technique, and management of hypoglycemia and hyperglycemia, especially at initiation of
FIASP therapy. Instruct patients on handling of special situations such as intercurrent conditions
(illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent
administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct
patients on the management of hypoglycemia [see WARNINGS AND PRECAUTIONS].

Inform patients that their ability to concentrate and react may be impaired as a result of
hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning
signs of hypoglycemia to use caution when driving or operating machinery.

Hypersensitivity Reactions

Advise patients that hypersensitivity reactions have occurred with FIASP. Inform patients on the
symptoms of hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].

Hypoglycemia Due To Medication Errors

Instruct patients to always check the insulin label before each injection to avoid mix-ups between
insulin products.

Women Of Reproductive Potential

Advise patients to inform their health care professional if they are pregnant or are contemplating
pregnancy.

Administration

FIASP must only be used if the solution is clear and colorless with no particles visible.
Patients must be advised that FIASP must NOT be diluted or mixed with any other insulin or
solution [see DOSAGE AND ADMINISTRATION].

Instruct patients on basal-bolus treatment who forget a mealtime dose to monitor their blood
glucose level to decide if an insulin dose is needed, and to resume their usual dosing schedule at
the next meal.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

In 52-week studies, Sprague-Dawley rats were dosed subcutaneously with insulin aspart at 10,
50, and 200 units/kg/day (approximately 2, 8, and 32 times the human subcutaneous dose of 1.0
units/kg/day, based on units/body surface area, respectively). At a dose of 200 units/kg/day,
insulin aspart increased the incidence of mammary gland tumors in females when compared to
untreated controls. The incidence of mammary tumors for insulin aspart was not significantly
different than for regular human insulin. The relevance of these findings to humans is not known.

Insulin aspart was not genotoxic in the following tests: Ames test, mouse lymphoma cell forward
gene mutation test, human peripheral blood lymphocyte chromosome aberration test, in vivo micronucleus test in mice, and in ex vivo UDS test in rat liver hepatocytes.

In fertility studies in male and female rats, at subcutaneous doses up to 200 units/kg/day
(approximately 32 times the human subcutaneous dose, based on units/body surface area), no
direct adverse effects on male and female fertility, or general reproductive performance of
animals was observed.

Use In Specific Populations

Pregnancy

Risk Summary

There are no available data with FIASP in pregnant women to inform a drug-associated risk for
major birth defects and miscarriage. Available information from published randomized
controlled trials with insulin aspart use during the second trimester of pregnancy have not
reported an association with insulin aspart and major birth defects or adverse maternal or fetal
outcomes [see Data]. There are risks to the mother and fetus associated with poorly controlled
diabetes in pregnancy [see Clinical Considerations].

In animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and
rabbits during the period of organogenesis did not cause adverse developmental effects at
exposures 8- times and equal to the human subcutaneous dose of 1.0 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. These effects were
similar to those observed in rats administered regular human insulin [see Data].

The estimated background risk of major birth defects is 6-10% in women with pre-gestational
diabetes with a HbA1c >7% and has been reported to be as high as 20-25% in women with a
HbA1c >10%. The estimated background risk of miscarriage for the indicated population is
unknown. In the U.S. general population, the estimated background risk of major birth defects
and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo-Fetal Risk

Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis,
preeclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications.
Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and
macrosomia related morbidity.

Data

Human Data

Published data from 5 randomized controlled trials of 441 pregnant women with diabetes
mellitus treated with insulin aspart starting during the late 2nd trimester of pregnancy did not
identify an association of insulin aspart with major birth defects or adverse maternal or fetal
outcomes. However, these studies cannot definitely establish the absence of any risk because of
methodological limitations, including a variable duration of treatment and small size of the
majority of the trials.

Animal Data

Fertility, embryo-fetal and pre-and postnatal development studies have been performed with
insulin aspart and regular human insulin in rats and rabbits. In a combined fertility and embryofetal
development study in rats, insulin aspart was administered before mating, during mating,
and throughout pregnancy. Further, in a pre- and postnatal development study insulin aspart was
given throughout pregnancy and during lactation to rats. In an embryo-fetal development study
insulin aspart was given to female rabbits during organogenesis. The effects of insulin aspart did
not differ from those observed with subcutaneous regular human insulin. Insulin aspart, like
human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in
rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1.0
unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day
(approximately three times the human subcutaneous dose of 1.0 unit/kg/day, based on human
exposure equivalents). No significant effects were observed in rats at a dose of 50 units/kg/day
and in rabbits at a dose of 3 units/kg/day. These doses are approximately 8 times the human
subcutaneous dose of 1.0 unit/kg/day for rats and equal to the human subcutaneous dose of 1.0
unit/kg/day for rabbits, based on human exposure equivalents. The effects are considered
secondary to maternal hypoglycemia.

Lactation

Risk Summary

There are no data on the presence of FIASP in human milk, the effects on the breastfed infant, or
the effect on milk production. One small published study reported that exogenous insulin,
including insulin aspart, was present in human milk. However, there is insufficient information
to determine the effects of insulin aspart on the breastfed infant and no available information on
the effects of insulin aspart on milk production. The developmental and health benefits of
breastfeeding should be considered along with the mother’s clinical need for insulin, any
potential adverse effects on the breastfed child from FIASP or insulin aspart or from the
underlying maternal condition.

Pediatric Use

The safety and effectiveness of FIASP in pediatric patients have not been established.

Geriatric Use

In the three controlled clinical studies, 192 of 1219 (16%) FIASP treated patients with type 1 or
type 2 diabetes were ≥ 65 years of age and 24 of 1219 (2%) were ≥ 75 years of age. No overall
differences in safety or effectiveness were observed between these elderly patients and younger
adult patients.

Nevertheless, caution should be exercised when FIASP is administered to geriatric patients. In
elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage
should be conservative to avoid hypoglycemia [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS and Clinical Studies].

Pharmacokinetic/pharmacodynamic study to assess the effect of age on the onset of FIASP
action has been performed [see CLINICAL PHARMACOLOGY].

Renal Impairment

Patients with renal impairment may be at increased risk of hypoglycemia and may require more
frequent FIASP dose adjustment and more frequent blood glucose monitoring [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Hepatic Impairment

Patients with hepatic impairment may be at increased risk of hypoglycemia and may require
more frequent FIASP dose adjustment and more frequent blood glucose monitoring [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

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