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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
FIASP (BLA-208751)
(INSULIN ASPART)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
06/21/2023 (SUPPL-20)
6 Adverse Reactions
Additions and revisions underlined:
The following clinically significant adverse reactions are described elsewhere in labeling:
Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen [see Warnings and Precautions (5.2)]
Hypoglycemia [see Warnings and Precautions (5.3)]
Hypokalemia [see Warnings and Precautions (5.5)]
Hypersensitivity and allergic reactions [see Warnings and Precautions (5.6)]
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONAdditions and revisions underlined:
Instruct patients to change FIASP in the pump reservoir at least every 6 days, or replace the PumpCart cartridge at least every 4 days or, or according to the pump user manual, whichever is shorter; infusion sets and infusion set insertion sites should be changed in accordance with the manufacturers’ user manual.
12/19/2019 (SUPPL-10)
6 Adverse Reactions
6.1 Clinical Trial Experience 6.2 Immunogenicity(Additions and/or revisions underlined)
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other insulin products may be misleading.
In a 26-week study in adult subjects with type 1 diabetes, among the 763 subjects who received FIASP, 97.2% were positive for cross-reacting anti-insulin antibodies (AIA) at least once during the study, including 90.3% that were 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 were positive at baseline.
In a 26-week study in pediatric subjects with type 1 diabetes (Study E), among the 519 subjects who received FIASP, 97.1% were positive for cross-reacting anti-insulin antibodies (AIA) at least once during the study, including 94.6% that were positive at baseline. A total of 19.1% of patients who received FIASP were positive for anti-drug (insulin aspart) antibodies (ADA) at least once during the study, including 16.0% that were positive at baseline.
8 Use in Specific Populations
8.4 Pediatric Use(Additions and/or revisions underlined)
The safety and effectiveness of FIASP have been established to improve glycemic control in pediatric patients with diabetes mellitus. Use of FIASP for this indication is supported by evidence from an adequate and well-controlled study in 777 pediatric patients with type 1 diabetes mellitus aged 2 to 17 years, and from studies in adults with diabetes mellitus.
Pediatric patients with type 1 diabetes treated with mealtime and postmeal FIASP reported a higher rate of blood glucose confirmed hypoglycemic episodes compared to patients treated with NovoLog; the imbalance was greater during the nocturnal period. Monitor blood glucose levels closely in pediatric patients.
12/19/2019 (SUPPL-11)
6 Adverse Reactions
6.1 Clinical Trial Experience(Extensive changes; please refer to label)
(Additions and/or revisions underlined)
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other insulin products may be misleading.
In a 26-week study in adult subjects with type 1 diabetes, among the 763 subjects who received FIASP, 97.2% were positive for cross-reacting anti-insulin antibodies (AIA) at least once during the study, including 90.3% that were 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 were positive at baseline.
In a 26-week study in pediatric subjects with type 1 diabetes (Study E), among the 519 subjects who received FIASP, 97.1% were positive for cross-reacting anti-insulin antibodies (AIA) at least once during the study, including 94.6% that were positive at baseline. A total of 19.1% of patients who received FIASP were positive for anti-drug (insulin aspart) antibodies (ADA) at least once during the study, including 16.0% that were positive at baseline.
8 Use in Specific Populations
8.4 Pediatric Use(Additions and/or revisions underlined)
The safety and effectiveness of FIASP have been established to improve glycemic control in pediatric patients with diabetes mellitus. Use of FIASP for this indication is supported by evidence from an adequate and well-controlled study in 777 pediatric patients with type 1 diabetes mellitus aged 2 to 17 years, and from studies in adults with diabetes mellitus.
Pediatric patients with type 1 diabetes treated with mealtime and postmeal FIASP reported a higher rate of blood glucose confirmed hypoglycemic episodes compared to patients treated with NovoLog; the imbalance was greater during the nocturnal period. Monitor blood glucose levels closely in pediatric patients.
10/21/2019 (SUPPL-13)
5 Warnings and Precautions
5.1 Never Share a FIASP FlexTouch Pen, PenFill Cartridge or PenFill Cartridge Device Between Patients(renaming of subsection title)
(additions and/or revisions are underlined)
FIASP FlexTouch disposable pen, PenFill cartridge and PenFill cartridge devices 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.
(additions and/or revisions are underlined)
Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia.
Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments in concomitant oral anti-diabetic treatment may be needed.
(newly added subsection)
Pump or infusion set malfunctions can lead to a rapid onset of hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary.
Interim therapy with subcutaneous injection of FIASP may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
6 Adverse Reactions
6.1 Clinical Trials Experience(additions and/or revisions are underlined)
…
In Study D, patients with type 1 diabetes treated with FIASP in a pump reported a higher rate of blood glucose confirmed hypoglycemic episodes (where self-measured glucose calibrated to plasma was less than 56 mg/dL) within first hour after a meal compared to patients treated with NovoLog.
Allergic Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including FIASP, and may be life threatening. In the clinical program, generalized hypersensitivity reactions (manifested by generalized skin rash and facial edema) were reported in 0.4% of patients treated with FIASP. Allergic skin manifestations reported with FIASP in 1.7% of patients from the clinical program include eczema, rash, rash pruritic, urticaria and dermatitis. In Study D, allergic reactions were reported in 4.2% of patients with type 1 diabetes treated with FIASP.
Lipodystrophy
Administration of insulin, including FIASP, has resulted in lipohypertrophy (enlargement or thickening of tissue) and lipoatrophy (depression in the skin). In the clinical program,
lipodystrophy was reported in 0.4% of patients treated with FIASP.
Injection/Infusion Site Reactions
As with other insulin therapy, patients may experience rash, redness, inflammation, pain, bruising or itching at the site of FIASP injection or infusion. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of FIASP. In the clinical program, injection site reactions occurred in 1.6% of patients treated with FIASP. In Study A, patients with type 1 diabetes treated with FIASP reported 2.2% injection site reactions. In Study D, infusion site reactions were reported in 10.2% of patients with type 1 diabetes treated with FIASP.
Weight Gain
Weight gain can occur with insulin therapy, including FIASP, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. In Study A, patients with type 1 diabetes treated with FIASP gained an average of 0.7 kg and in Study B, patients with type 2 diabetes treated with FIASP gained an average of 2.7 kg.
Peripheral Edema
Insulin, including FIASP, may cause sodium retention and edema, particularly if previous poor metabolic control is improved by intensified insulin therapy. In the clinical program, peripheral edema occurred in 0.8% of patients treated with FIASP.
(newly added subsection)
The following additional adverse reactions have been identified during post-approval use of insulin aspart. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION(additions and/or revisions are underlined)
Advise the patient to read the FDA-Approved Patient Labeling (Patient Information and Instructions for Use).
Never Share a FIASP FlexTouch Pen Device, PenFill Cartridge or PenFill Cartridge Device Between Patients
Advise patients that they should never share a FIASP FlexTouch pen device, PenFill cartridge or PenFill cartridge devices 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.
Hyperglycemia or 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.
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.
Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision.
Hypersensitivity Reactions
Advise patients that hypersensitivity reactions have occurred with FIASP. Inform patients on the symptoms of hypersensitivity reactions.
Hypoglycemia due to Medication Errors
Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products.
Patients Using Continuous Subcutaneous Insulin Pumps
Train patients in intensive insulin therapy with multiple injections and in the function of their pump and pump accessories.
Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate.
Refer to the continuous subcutaneous infusion pump user manual to see if FIASP can be used with the pump. See recommended reservoir and infusion sets in the insulin pump user manual.
Instruct patients to replace insulin in the reservoir at least every 6 days, or according to the pump user manual, whichever is shorter; infusion sets and infusion set insertion sites should be changed in accordance with the manufacturers’ user manual. By following this schedule, patients avoid insulin degradation, infusion set occlusion, and loss of the insulin preservative.
Instruct patients to discard insulin exposed to temperatures higher than 37°C (98.6°F).
Instruct patients to inform physician and select a new site for infusion if infusion site becomes erythematous, pruritic, or thickened.
Instruct patients on the risk of rapid hyperglycemia and ketosis due to pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin. Instruct patients on the risk of hypoglycemia from pump malfunction. If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their physician.
(additions and/or revisions are underlined)
How should I take FIASP?
Read the Instructions for Use that come with your FIASP.
Take FIASP exactly as your healthcare provider tells you to.
FIASP starts acting fast. You should take your dose of FIASP at the beginning of the meal or within 20 minutes after starting a meal.
Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
If you miss a dose of FIASP, monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal.
Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
Do not reuse or share needles with other people. You may give other people a serious infection or get a serious infection from them.
FIASP can be injected under the skin (subcutaneously) of your stomach area, upper legs, or upper arms, or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.
Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
Do not use the exact same spot for each injection.
Do not inject where the skin has pits, is thickened, or has lumps.
Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
…
Your insulin dose may need to change because of:
change in level of physical activity
increased stress
change in diet or exercise
weight gain or loss
illness
10/21/2019 (SUPPL-8)
5 Warnings and Precautions
5.1 Never Share a FIASP FlexTouch Pen, PenFill Cartridge or PenFill Cartridge Device Between Patients(renaming of subsection title)
(additions and/or revisions are underlined)
FIASP FlexTouch disposable pen, PenFill cartridge and PenFill cartridge devices 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.
(additions and/or revisions are underlined)
Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia.
Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments in concomitant oral anti-diabetic treatment may be needed.
(newly added subsection)
Pump or infusion set malfunctions can lead to a rapid onset of hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary.
Interim therapy with subcutaneous injection of FIASP may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.
6 Adverse Reactions
6.1 Clinical Trials Experience(additions and/or revisions are underlined)
…
In Study D, patients with type 1 diabetes treated with FIASP in a pump reported a higher rate of blood glucose confirmed hypoglycemic episodes (where self-measured glucose calibrated to plasma was less than 56 mg/dL) within first hour after a meal compared to patients treated with NovoLog.
Allergic Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including FIASP, and may be life threatening. In the clinical program, generalized hypersensitivity reactions (manifested by generalized skin rash and facial edema) were reported in 0.4% of patients treated with FIASP. Allergic skin manifestations reported with FIASP in 1.7% of patients from the clinical program include eczema, rash, rash pruritic, urticaria and dermatitis. In Study D, allergic reactions were reported in 4.2% of patients with type 1 diabetes treated with FIASP.
Lipodystrophy
Administration of insulin, including FIASP, has resulted in lipohypertrophy (enlargement or thickening of tissue) and lipoatrophy (depression in the skin). In the clinical program, lipodystrophy was reported in 0.4% of patients treated with FIASP.
Injection/Infusion Site Reactions
As with other insulin therapy, patients may experience rash, redness, inflammation, pain, bruising or itching at the site of FIASP injection or infusion. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation of FIASP. In the clinical program, injection site reactions occurred in 1.6% of patients treated with FIASP. In Study A, patients with type 1 diabetes treated with FIASP reported 2.2% injection site reactions. In Study D, infusion site reactions were reported in 10.2% of patients with type 1 diabetes treated with FIASP.
Weight Gain
Weight gain can occur with insulin therapy, including FIASP, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. In Study A, patients with type 1 diabetes treated with FIASP gained an average of 0.7 kg and in Study B, patients with type 2 diabetes treated with FIASP gained an average of 2.7 kg.
Peripheral Edema
Insulin, including FIASP, may cause sodium retention and edema, particularly if previous poor metabolic control is improved by intensified insulin therapy. In the clinical program, peripheral edema occurred in 0.8% of patients treated with FIASP.
(newly added subsection)
The following additional adverse reactions have been identified during post-approval use of insulin aspart. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION(additions and/or revisions are underlined)
Advise the patient to read the FDA-Approved Patient Labeling (Patient Information and Instructions for Use).
Never Share a FIASP FlexTouch Pen Device, PenFill Cartridge or PenFill Cartridge Device Between Patients
Advise patients that they should never share a FIASP FlexTouch pen device, PenFill cartridge or PenFill cartridge devices 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.
Hyperglycemia or 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.
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.
Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision.
Hypersensitivity Reactions
Advise patients that hypersensitivity reactions have occurred with FIASP. Inform patients on the symptoms of hypersensitivity reactions.
Hypoglycemia due to Medication Errors
Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products.
Patients Using Continuous Subcutaneous Insulin Pumps
Train patients in intensive insulin therapy with multiple injections and in the function of their pump and pump accessories.
Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate.
Refer to the continuous subcutaneous infusion pump user manual to see if FIASP can be used with the pump. See recommended reservoir and infusion sets in the insulin pump user manual.
Instruct patients to replace insulin in the reservoir at least every 6 days, or according to the pump user manual, whichever is shorter; infusion sets and infusion set insertion sites should be changed in accordance with the manufacturers’ user manual. By following this schedule, patients avoid insulin degradation, infusion set occlusion, and loss of the insulin preservative.
Instruct patients to discard insulin exposed to temperatures higher than 37°C (98.6°F).
Instruct patients to inform physician and select a new site for infusion if infusion site becomes erythematous, pruritic, or thickened.
Instruct patients on the risk of rapid hyperglycemia and ketosis due to pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin. Instruct patients on the risk of hypoglycemia from pump malfunction. If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their physician.
(additions and/or revisions are underlined)
How should I take FIASP?
Read the Instructions for Use that come with your FIASP.
Take FIASP exactly as your healthcare provider tells you to.
FIASP starts acting fast. You should take your dose of FIASP at the beginning of the meal or within 20 minutes after starting a meal.
Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
If you miss a dose of FIASP, monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal.
Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
Do not reuse or share needles with other people. You may give other people a serious infection or get a serious infection from them.
FIASP can be injected under the skin (subcutaneously) of your stomach area, upper legs, or upper arms, or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.
Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
Do not use the exact same spot for each injection.
Do not inject where the skin has pits, is thickened, or has lumps.
Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
…
Your insulin dose may need to change because of:
change in level of physical activity
increased stress
change in diet or exercise
weight gain or loss
illness
09/04/2018 (SUPPL-5)
Other
Instructions for Use FIASP® (fee’ asp)(Additions and/or revisions are underlined)
People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.