Fiasp, 100 units/ml 3 ml cartridges in Flextach syringe pens 5 pcs.

Pharmacotherapeutic group:mHypoglycemic agent, short-acting human insulin analogue.

ATX code: A10AB05.

Pharmacological properties:

The drug Fiasp® is an ultrafast-acting human insulin analog produced by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain.

The main pharmacological action of insulin aspart is regulation of glucose metabolism. Insulins, including insulin aspart, the active ingredient of Fiasp®, exert their specific action by binding to insulin receptors. The hypoglycemic effect of insulin aspart is due to an increase in tissue glucose utilization after insulin binds to muscle and fat cell receptors and to a decrease in liver glucose production. Insulin suppresses lipolysis in adipocytes, suppresses proteolysis and increases protein synthesis.

Pharmacodynamics

. Fiasp® is a direct-to-meal insulin aspart that contains nicotinamide (vitamin B3), which provides faster initial absorption of insulin, resulting in earlier onset of action and significantly earlier hypoglycemic effects compared to NovoRapid®.

The Fiasp® drug begins to act 5 minutes faster and the maximum glucose infusion level is reached 11 minutes earlier compared to NovoRapid®. Blood glucose concentration reduction values during the first 30 minutes (AUC_{GIR, 0-30 min}) were 51 mg/kg when using Fiasp® and 29 mg/kg when using NovoRapid®.

The total hypoglycemic and maximum (GIR_max) hypoglycemic effects were comparable when using Fiasp® and NovoRapid®. Total and maximum hypoglycemic effects of Fiasp® increase in proportion to increasing the dose within the therapeutic dose range.

The duration of action of the drug Fiasp® is shorter than that of NovoRapid® and lasts 3-5 hours. Late hypoglycemic effect of Fiasp® was 10% less compared to that of NovoRapid®.

The drug Fiasp® administered immediately before a meal leads to a significantly greater hypoglycemic effect after a standardized meal compared to the drug NovoRapid®. The difference in glucose increment reduction within two hours of a meal was statistically significant and greater with Fiasp® (-0.67 mmol/L [-1.29; -0.04]_{95% CI}). The difference in the rate of decrease in glucose concentration increase within one hour of meal was -1.18 mmol/L [-1.65; -0.71]_{95% CI}, consistent with the earlier absorption profile of Fiasp®.

The intraindividual variability in day-to-day hypoglycemic effects was low for Fiasp® for both early (AUC_{GIR, 0-1h}, CV~26%), total (AUC_{GIR, 0-12h}, CV~18%) and maximum (GIR_max, CV 19%) hypoglycemic effects.

Long-term subcutaneous insulin infusions (SPII)

During SPII, Fiasp® demonstrated a greater hypoglycemic effect after standardized meal intake with respect to one and two hour postmeal glucose concentration increments (difference: -0.50 mmol/L [-1.07; 0.07]_{95% CI} and -0.99 mmol/L [-1.95; -0.03]_{95% CI}, respectively, compared with NovoRapid®.

Elderly Patients

In elderly patients with type 1 diabetes mellitus (DM1), Fiasp® demonstrated earlier onset of action and significantly earlier hypoglycemic effects while maintaining similar overall and maximal hypoglycemic effects compared to NovoRapid®.

The total and maximal hypoglycemic effects with Fiasp® were comparable in elderly patients and younger adult patients.

Obesity

The effect of body mass index (BMI) on the pharmacodynamics of Fiasp® was studied in a cross-sectional analysis of pharmacodynamic studies. In patients with DM1, Fiasp® demonstrated earlier hypoglycemic effects while maintaining similar overall and maximal hypoglycemic effects compared to NovoRapid® regardless of BMI.

There was a tendency to decrease the hypoglycemic effect of Fiasp® with increasing BMI in patients with DM1.

Children and adolescents

As compared to NovoRapid® in children, the hypoglycemic effect of Fiasp® was higher by more than 30%, which was confirmed by mean changes in plasma glucose concentration at 1 and 2 hours after meal.

There is no clinically significant difference in pharmacodynamic properties of Fiasp® in children (6-11 years), adolescents (12-18 years) and adult patients with DM1.

Clinical efficacy and safety

The use of Fiasp® was studied in 2,068 randomized adult patients with DM1 (1,143 patients) and with type 2 diabetes (DM2) (925 patients) in three long-term (18-26 weeks of therapy) clinical trials (Trial) of efficacy and safety.

Patients with DM1

The drug Fiasp® was effective in achieving glycemic control when used during or after meals.

The decrease in HbA_1c was statistically more significant with Fiasp® at meal time compared to NovoRapid®.

In patients with DM1, Fiasp® provided greater overall glycemic control compared to NovoRapid®. Fiasp® compared to NovoRapid® provided better glycemic control after meals without increasing the overall risk of severe or confirmed hypoglycemia in patients with DM1 and DM2.

Patients with DM2

The drug Fiasp® has been effective in achieving glycemic control in patients with DM2.

The addition of Fiasp® to basal insulin administered once daily in conjunction with metformin resulted in greater reductions in HbA_1c and a statistically significant reduction in post-meal glucose concentrations in DM2 patients compared with basal insulin therapy administered once daily in conjunction with metformin.

Elderly Patients

In three controlled CIs, 192 of 1,219 (16%) patients with DM1 or DM2 treated with Fiasp® were ≥65 years of age and 24 of 1,219 (2%) were ≥75 years of age. Overall, there were no differences in safety or efficacy between older and younger adult patients.

PIPI

A randomized (2:1) double-blind, parallel-group, active-controlled, 6-week comparison study of Fiasp® and NovoRapid® for PIPI in adult patients with DM1 was conducted.

For both Fiasp® (n=25) and NovoRapid® (n=12), there were no episodes of infusion set occlusion, as confirmed by microscopic examination. Two patients in the Fiasp® group reported therapy-related reactions at the injection site.

Pharmacokinetics

Intake

. Subcutaneous (p/k) bolus injection of ultrafast-acting insulin aspart or PPIs using an insulin pump results in earlier onset of action and significantly earlier hypoglycemic effects compared to NovoRapid®.

Insulin appears in the bloodstream approximately 4 minutes after administration of Fiasp®. Onset of blood insulin was twice as fast (5 minutes earlier) and the time to reach 50% of maximum concentration was 9 minutes shorter with Fiasp® compared to NovoRapid®, resulting in a fourfold increase in available insulin during the first 15 minutes and twice as much during the first 30 minutes. Total insulin exposure (AUC_{insulin aspart, 0-12 hours}) and maximum insulin concentration (C_max) were comparable between Fiasp® and NovoRapid®. Total exposure and maximum insulin concentration increased in proportion to the Fiasp® p/k dose administered within the therapeutic dose range.

The absolute bioavailability of insulin aspart after b/c administration of Fiasp® to the anterior abdominal wall, deltoid and thigh was approximately 80%.

The rapid emergence of Fiasp® in the bloodstream was maintained regardless of the site of administration.

The time to maximum concentration and total exposure to insulin aspart were comparable when injected into the anterior abdominal wall, deltoid muscle area and thigh. Early insulin exposure and maximum concentration were comparable when injected into the anterior abdominal wall and shoulder, but lower when injected into the thigh.

PIPI

The onset of exposure (time to reach maximum concentration) for PIPI was 26 minutes shorter with Fiasp® compared with NovoRapid®, resulting in an approximately threefold increase in available insulin during the first 30 minutes. Exposure duration (time to late 50% C_max) was 35 minutes shorter with Fiasp® compared to NovoRapid®.

Distribution

Insulin aspart has a low affinity for binding to plasma proteins (<10%) similar to that observed with regular human insulin.

The volume of distribution (Vd) after intravenous (IV) administration is 0.22 L/kg (i.e. 15.4 L for a 70 kg person), which corresponds to the volume of extracellular fluid in the human body.

Metabolism

The metabolism of insulin aspart is similar to that of human insulin; all metabolites formed are inactive.

Elimation

Fiasp® has a half-life of 57 minutes after oral administration and is comparable to that of NovoRapid®.

The intravenous administration of Fiasp® is characterized by fast clearance (1.0 l/h/kg). The half-life after IV administration is 10 minutes.

Particular patient groups

Elderly patients

In comparison with NovoRapid® in elderly DM1 patients, Fiasp® demonstrated earlier onset of exposure and higher early insulin exposure while maintaining similar overall exposure and maximum concentration.

The total exposure to insulin aspart and maximum concentration after administration of Fiasp® was 30% higher in older patients compared to younger adult patients.

Pass

The effect of sex on the pharmacokinetics of Fiasp® was tested in a cross-sectional analysis of pharmacokinetic studies. Compared with NovoRapid®, Fiasp® demonstrated comparable early onset of exposure and higher early insulin exposure while maintaining similar overall exposure and maximum concentration for both women and men with DM1.

The early and maximum insulin exposures to Fiasp® were comparable in women and men with DM1. However, total insulin exposure was greater in women with DM1 compared to men with DM1.

Race and ethnicity

The effect of race and ethnicity (blacks vs. Caucasians, Hispanics vs. other ethnicities) on total insulin exposure to Fiasp® was based on results of a population pharmacokinetic analysis in patients with DM1. No difference in Fiasp® exposure was found between the racial and ethnic groups studied.

Help Failure

A single-dose pharmacokinetic study of aspart insulin was performed in 24 patients with normal to severe hepatic function. In patients with hepatic insufficiency, the absorption rate was reduced and was more variable.

Renal insufficiency

The effect of renal insufficiency on total insulin exposure to Fiasp® was based on results of a population pharmacokinetic analysis in patients with DM1. Renal function by creatinine clearance (CK) was defined as: normal – CK ≥ 90 ml/min (N=546), mild renal failure – CK 60-89 ml/min (N=115), moderate renal failure – CK 30-59 ml/min (N=21). When renal function decreased, a higher total exposure of Fiasp® was observed. However, some interindividual variability in total exposure was observed among patients with DM1 and mild to moderate renal failure. Thus, in patients with renal insufficiency, as with all insulin drugs, blood glucose concentrations should be monitored more closely and the dose of Fiasp® should be adjusted individually.

Children and adolescents

In comparison with NovoRapid® in children (6-11 years) and adolescents (12-18 years), Fiasp® demonstrated earlier onset of exposure and higher early insulin exposure while maintaining similar overall exposure and maximum concentration.

The onset of action and early exposure of Fiasp® are similar in children and adolescents to those in adults.

In children and adolescents, at a dose of 0.2 IU/kg body weight, total Fiasp® exposure was lower compared to adults, while the maximum plasma concentration of insulin aspart was similar.

Indications

Active ingredient

Composition

1 ml of the drug contains:

the active ingredient: insulin aspart* 100 IU (equivalent to 3.5 mg);

excipients: phenol, methacresol, glycerol, zinc (in the form of zinc acetate), disodium hydrophosphate dihydrate, arginine hydrochloride, nicotinamide, hydrochloric acid (for pH correction), sodium hydroxide (for pH correction), water for injection.

The pH of the solution is 7.1.

1 pre-filled syringe pen contains 3 ml of solution, which is equivalent to 300 IU.

1 bottle contains 10 ml of solution, which is equivalent to 1000 IU.

The activity of insulin analogues, including Fiasp®, is expressed in units (UD). 1 IU of Fiasp® corresponds to 1 international unit (IU) of human insulin or 1 IU of other fast-acting insulin analogues.

*1 IU of Aspart insulin contains 0.035 mg of anhydrous salt-free Aspart insulin.

How to take, the dosage

Doses

The drug Fiasp® is an insulin for oral administration in direct relation to food intake: It is administered 2 minutes before a meal. The drug may be administered within 20 minutes after the beginning of a meal.

In addition, Fiasp® may be used for PPIs on insulin pumps or administered intravenously by medical personnel.

The dose of Fiasp® is determined individually according to the patient’s needs.

Injection therapy: Fiasp® should be used in combination with medium- or long-acting insulin administered at least once daily. In basal pole therapy, approximately 50% of the insulin requirement may be provided by Fiasp® and the remaining insulin requirement may be provided by medium- or long-acting insulin.

PIP: Fiasp® may be used for PIP in insulin pumps. In this case, Fiasp® will provide both bolus (approximately 50%) and basal insulin requirements.

In order to achieve optimal glycemic control, it is recommended that blood glucose concentrations be measured regularly and insulin dosage adjusted.

The individual daily requirement for insulin in adults may vary and is usually 0.5 to 1 IU/kg body weight.

An increase in the patient’s physical activity, changes in dietary habits, or comorbidities may result in the need to adjust the dose. In these cases, more careful monitoring of blood glucose concentrations is recommended.

The duration of action of insulin aspart depends on the dose, site of administration, blood flow, body temperature, and level of physical activity of the patient.

The activity of insulin analogues, including Fiasp®, is expressed in units, 1 unit of Fiasp® corresponds to 1 international unit (1 IU) of human insulin or 1 unit of other fast acting insulins.

Starting insulin therapy

Patients with DM1

The recommended starting dose of Fiasp® in patients with DM1 who have not previously received insulin is approximately 50% of the total daily dose of insulin and should be divided between all meals, depending on portion size and food composition. The remaining need for insulin should be provided by medium- or long-acting insulin. As a general rule of thumb, 0.2 to 0.4 IU of insulin per 1 kg of body weight can be used to calculate the initial total daily dose of insulin in patients with DM1 who have not previously received insulin.

Patients with DM2

The recommended starting dose is 4 IU in one or more meals. The number of injections and subsequent titration will depend on the individual glycemic control goal.

Transferring from other insulin preparations

We recommend careful monitoring of blood glucose concentrations during transfer from other insulin preparations used in direct relation to food intake and during the first weeks of administration of the new medication.

The transfer from a meal-associated insulin medication may be done unit by unit. Because of the rapid onset of action of insulin, Fiasp® should be administered at the beginning of a meal or immediately after a meal (within 20 minutes of the start of the meal).

The patient should be switched to Fiasp® from another type or another type or manufacturer of insulin under close medical supervision. Dose adjustments may be necessary when transferring.

Correction of concomitant hypoglycemic therapy (dose and timing of medium- or long-acting insulin drugs, or other concomitant hypoglycemic drugs) may be necessary.

The use of the drug in special clinical groups of patients

Elderly patients (over 65 years)

The safety and efficacy of Fiasp® in elderly patients have been proven. Blood glucose concentration should be monitored carefully and insulin dose should be adjusted individually (see Pharmacological properties). The experience of therapeutic use of the drug in patients aged ≥75 years is limited.

Patients with renal or hepatic impairment

Hepatic or renal impairment may reduce the patient’s need for insulin. In patients with renal or hepatic impairment, blood glucose concentrations should be monitored carefully and the insulin dose adjusted individually (see Pharmacokinetics).

Children and adolescents

There have been no clinical studies of efficacy and safety of Fiasp® administration in children and adolescents under 18 years of age. The use of the drug Fiasp® is contraindicated in children and adolescents under 18 years of age.

How to use

The drug Fiasp® in a vial should be used in cases where syringe administration, IV administration or insulin pump administration of the drug is required. The pre-filled FlexTouch® syringe pen is intended for p/n injection, but IV administration is possible if needed, but only by qualified medical personnel.

Introduction by injection:

Fiasp® is injected by injection into the anterior abdominal wall, upper arm or thigh. The injection sites within the same anatomical area should be continuously changed to reduce the risk of lipodystrophy.

The duration of action of Fiasp® depends on the dose, site of administration, blood flow, temperature, and level of physical activity.

PIP:

Fiasp® (including in a prefilled FlexTouch® syringe pen) can be used for PIP in insulin pumps designed for insulin infusions. Fiasp® may be administered according to the insulin pump manufacturer’s instructions, preferably into the anterior abdominal wall. Infusion sites should be varied within the same anatomical area to reduce the risk of lipodystrophy. When using an insulin pump, Fiasp® should not be diluted or mixed with other insulin preparations.

Patients receiving FIP should be trained in the use of the insulin pump and its corresponding reservoir and tubing. The infusion set (tubing and cannula) should be replaced according to the recommendations in the infusion set instructions.

Patients receiving Fiasp® PIP should be trained to administer insulin injections and, in the event of insulin pump failure, have an alternative method of insulin therapy available.

Intravenous administration:

Fiasp® may be administered intravenously if needed, but only by qualified medical personnel.

Intravenous infusion systems with polypropylene containers with concentrations of Fiasp® (insulin aspart) between 0.5 U/ml and 1 U/ml are used. Fiasp® has been shown to be stable at room temperature for 24 hours in infusion solutions such as 0.9% sodium chloride solution or 5% dextrose solution. During insulin infusion, blood glucose concentration should be constantly monitored. Care should be taken to inject insulin directly into the infusion container and not into the inlet port.

Instructions for Use

The Fiasp® FlexTouch® pre-filled syringe pen is intended for use with NovoFain® or NovoFain® Plus injection needles.

The Fiasp® FlexTouch® allows doses from 1 to 80 IU in 1 IU increments.

The Fiasp® FlexTouch® syringe pen is color-coded and comes with detailed instructions for use.

The Fiasp® FlexTouch® needles and syringe pen are for individual use only. The pre-filled FlexTouch® syringe pen cartridge must not be refilled.

The Fiasp® vial product is intended for use with insulin syringes with the appropriate unit scale (U-100 or 100 units/ml) and for PPIs. Needles and syringes are for individual use only. Fiasp® may be used for PUIs in insulin pumps as described in

Term of Use and Dosage. Tubes with a polyethylene inner surface have been evaluated and found suitable for use with insulin pumps.

Phiasp® should not be used if the solution is no longer clear and colorless.

The drug Fiasp® should not be used if it has been frozen.

The patient should discard the needle after each injection.

Local requirements for disposal of used medical supplies should be followed.

Patients should be properly trained on how to use the Fiasp® FlexTouch® syringe pen. Instruct patients that when administering Fiasp®, they should press and hold the trigger until the dose counter reads “0” and then, without removing the needle from under the skin, slowly count to 6. The full dose will be administered 6 seconds after the dose counter returns to “0”.

If you remove the needle from under the skin earlier, you can see the insulin flowing from the tip of the needle. In this case, the full dose of the drug will not be administered (perhaps up to 20% of the full dose will not be administered). In this case, patients should have their blood glucose concentrations measured more frequently; an additional dose of insulin may need to be given.

Missed dose

Interaction

There are a number of medications that affect glucose metabolism.

Decreasing the need for insulin:

Peroral hypoglycemic drugs, monoamine oxidase inhibitors (MAOIs), nonselective beta-adrenoblockers, angiotensin-converting enzyme (ACE) inhibitors, salicylates, anabolic steroids, sulfonamides and glucagon-like peptide-1 (GTP-1) agonists.

The increased need for insulin:

The oral hormonal contraceptives, thiazide diuretics, glucocorticosteroids, thyroid hormones, sympathomimetics, somatropin, and danazol.

Beta-adrenoblockers may mask symptoms of hypoglycemia.

Octreotide/lanreotide can both increase and decrease the body’s need for insulin.

Ethanol (alcohol) can both increase and decrease the hypoglycemic effect of insulin.

Incompatibilities

Some medicinal products when added to Fiasp® may cause destruction of insulin aspart.

Fiasp® should not be diluted or mixed with other medicinal products. The exceptions are the solutions for infusion described in the section Dosage and administration.

Special Instructions

Hypoglycemia

Hypoglycemia may occur if the patient misses a meal or engages in unplanned vigorous physical activity.

Hypoglycemia can occur if the dose of insulin administered is too high relative to the patient’s need (see Side Effects and Overdose).

After significant improvement in glycemic control (e.g., with intensified insulin therapy), patients may experience changes in their typical hypoglycemic precursor symptoms, and patients should be informed. Common precursor symptoms may disappear with the long-term course of DM.

The timing of hypoglycemia usually corresponds to the action profile of the administered insulin drug. Fiasp® has a characteristic time-dependent action profile (see Pharmacokinetics) that affects the time of development of hypoglycemia. The consequence of pharmacodynamic features of Fiasp® is that the development of hypoglycemia with its use may begin earlier than with other insulin preparations administered with meals.

Because Fiasp® must be administered 2 minutes before or within 20 minutes after the start of a meal, the time of onset of action of the drug must be considered when using it in patients with concomitant diseases or therapy that may reduce the absorption rate of food.

Correcting the dose of the drug may be necessary if the patient has concomitant kidney disease, liver disease or disorders of adrenal, pituitary or thyroid function.

Hyperglycemia

Inadequate dosing of the drug or discontinuation of treatment, especially in patients who require insulin, can lead to hyperglycemia or diabetic ketoacidosis – conditions that can be fatal.

PII

Malfunctions in the insulin pump or infusion set can lead to rapid onset of hyperglycemia and ketosis. Prompt detection and correction of hyperglycemia or ketosis is necessary. Temporary therapy with the drug as a p/u injection may be required.

Companion diseases

Companion diseases, especially those with infection and fever, usually increase the body’s need for insulin. Dose adjustments may also be necessary if the patient has underlying kidney, liver, or adrenal, pituitary, or thyroid disorders.

The concomitant use of thiazolidinedione and insulin drugs

Cases of chronic heart failure (CHF) have been reported when treating patients with thiazolidinedione in combination with insulin drugs, especially if these patients have risk factors for CHF. This fact should be taken into account when prescribing combination therapy with thiazolidinediones and insulin drugs. When prescribing such combination therapy, medical examination of patients should be carried out to detect signs and CHF, increase in body weight and the presence of edema. If patients have worsening symptoms of heart failure, treatment with thiazolidinedione should be discontinued.

The initiation of insulin therapy and intensification of glycemic control

Intensification or dramatic improvement in glycemic control has been associated with temporary reversible refractive impairment, worsening of diabetic retinopathy, acute painful peripheral neuropathy, and peripheral edema. However, long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy and neuropathy.

Antibodies to insulin

Antibodies may form when insulin is used. In rare cases, antibody formation may require adjustment of insulin dose to prevent cases of hyperglycemia or hypoglycemia.

Prevent accidental errors when using insulin preparations

The patient should be instructed to check the labeling before each injection to prevent accidental confusion of Fiasp® with another insulin.

Patients should visually check the number of units dispensed before administering Fiasp® . Thus, only patients who can clearly distinguish the numbers on the dose scale may administer insulin on their own. Patients who are blind or visually impaired should be informed that they always need help from someone who is not visually impaired and has been trained in insulin administration techniques.

Long-Term Time Zone-Related Travel

Patients should consult with their physician before traveling for an extended period of time involving a change in time zones.

Synopsis

Contraindications

Hypersensitivity to insulin aspart or any of the excipients in the drug.

Above 18 years of age.

Side effects

The most common adverse reaction (AR) reported during treatment is hypoglycemia (see Description of Individual ARs).

The NRs reported in the phase III CI of Fiasp® and presented below are categorized into system-organ classes with the frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); infrequent (≥ 1/1,000 to < 1/100).

Table 1 Unwanted reactions according to CI data

MedDRA organ system

Very often

Often/p>

Infrequent

Immune system disorders

Hypersensitivity

Metabolic and nutritional disorders

Hypoglycemia

Skin and subcutaneous tissue disorders

Allergic skin reactions

Lipodystrophy

General disorders and disorders at the site of administration

/p>

Injection/infusion site reactions

/p>

Description of individual HP

Allergic reactions

Allergic skin reactions have been reported with Fiasp® (1.5% vs. 1.4% for the comparison drug), including eczema, rash, pruritus, urticaria, and dermatitis.

Infrequent generalized hypersensitivity reactions have been reported with Fiasp® (0.2% vs. 0.1% for the reference drug), manifested by generalized skin rash and facial edema. No anaphylactic reactions have been reported with the use of Fiasp®. In general, the development of anaphylactic reactions is possible when using insulin drugs. Allergic reactions of immediate type to both insulin itself and excipients may be potentially life-threatening.

Hypoglycemia

Hypoglycemia can occur if the insulin dose is too high relative to insulin requirements. Severe hypoglycemia can lead to loss of consciousness and/or seizures, temporary or permanent damage to brain function up to and including death. Symptoms of hypoglycemia usually develop suddenly. They may include “cold sweats,” pale skin, increased fatigue, nervousness or tremors, anxiety, unusual fatigue or weakness, disorientation, decreased concentration, drowsiness, marked hunger, visual disturbances, headache, nausea, and rapid heart rate. Hypoglycemia after Fiasp® injection/infusion may occur earlier compared to other types of insulin for administration due to the higher rate of onset of action of the drug.

Lipodystrophy

The development of lipodystrophy (including lipohypertrophy, lipoatrophy) at the injection/infusion site has been reported in patients receiving Fiasp® (0.2% versus 0% for the comparison drug). Consistent adherence to the rule of change of injection site within the same anatomical area reduces the risk of developing this HP.

Injection/infusion site reactions

The development of injection/infusion site reactions (including rash, redness, inflammation, hematoma, and itching) has been reported in patients receiving Fiasp® (1.0% vs. 0.7% for the comparison drug). These reactions are usually mild and transient and resolve during continuation of therapy.

Other special patient groups

Based on CI results, no differences in frequency, type, or severity of HF were found between elderly patients and patients with renal or hepatic impairment and the general patient population. There are limited data on the safety profile in elderly patients over 75 years of age or in patients with moderate to severe renal or hepatic impairment. In elderly patients, Fiasp® was used to study pharmacokinetic properties (see Pharmacokinetics).

Overdose

There is no specific dose required for an overdose of insulin, but hypoglycemia can develop gradually if a dose of the drug that is too high compared to the patient’s need has been administered.

– Mild hypoglycemia can be managed by the patient by ingesting glucose or sugary foods. Therefore, it is recommended that DM patients carry sugary foods with them at all times.

Pregnancy use

Pregnancy

The drug Fiasp® can be used during pregnancy.

The data from two randomized controlled clinical trials (322 + 27 pregnant women studied) showed no adverse effects of aspart insulin on pregnancy or fetal/newborn health compared to soluble human insulin.

The close monitoring of blood glucose concentrations and monitoring of pregnant women with diabetes mellitus (DM1, DM2 or gestational diabetes), throughout pregnancy and during possible gestation, is recommended. The need for insulin generally decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. Shortly after delivery, insulin requirements quickly return to pre-pregnancy levels.

Breast-feeding period

The drug Fiasp® may be used during breast-feeding because administration of insulin to a woman during breast-feeding does not pose a threat to the baby. However, it may be necessary to adjust the dose of the drug Fiasp®.