Afrezza (Insulin Human)

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Dosage & administration

* Only administer via oral inhalation using the AFREZZA inhaler (

2.2 Important Administration and Discard Instructions

Only administer AFREZZA via oral inhalation using the AFREZZA Inhaler. Administer AFREZZA at the beginning of each meal. Administer AFREZZA using a single inhalation per cartridge (if the dose is greater than the contents of a single cartridge, more than one cartridge is needed)

[see Dosage and Administration ].

For additional administration instructions on how to use the AFREZZA Inhaler

[see Dosage and Administration ]

and see the

Instructions for Use.

The AFREZZA Inhaler can be used for up to 15 days from the date of first use. After 15 days of use, the inhaler must be discarded and replaced with a new inhaler.

)
* Administer at the beginning of each meal (

2.2 Important Administration and Discard Instructions

Only administer AFREZZA via oral inhalation using the AFREZZA Inhaler. Administer AFREZZA at the beginning of each meal. Administer AFREZZA using a single inhalation per cartridge (if the dose is greater than the contents of a single cartridge, more than one cartridge is needed)

[see Dosage and Administration ].

For additional administration instructions on how to use the AFREZZA Inhaler

[see Dosage and Administration ]

and see the

Instructions for Use.

The AFREZZA Inhaler can be used for up to 15 days from the date of first use. After 15 days of use, the inhaler must be discarded and replaced with a new inhaler.

)
* See full prescribing information for the recommended starting mealtime dosage in insulin-naïve patients and patients who are using subcutaneous mealtime insulin or pre-mixed insulin (

2.3 Recommended Starting Mealtime Dosage

For insulin naïve patients, start on 4 units of AFREZZA at the beginning of each meal.

For patients using subcutaneous,

mealtime

(

prandial) insulin:

* Determine the appropriate AFREZZA dose for each meal by converting from the injected insulin dose using Figure 1.
* When switching from another insulin to AFREZZA, a different insulin dose may be needed requiring increased frequency of blood glucose monitoring

[see Warnings and Precautions ].

For patients using subcutaneous,

pre-mixed insulin

:

* Estimate the mealtime injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day. When switching from another insulin to AFREZZA, a different insulin dose may be needed. When switching a patient's insulin regimen, increase the frequency of blood glucose monitoring

[see Warnings and Precautions ].

* Convert each estimated injected mealtime dose to an appropriate AFREZZA dose using Figure 1.
* Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose.

For AFREZZA doses exceeding the contents of a single cartridge at mealtime, inhalations from more than one cartridge are necessary. To achieve the required total mealtime dose, use a combination of 4 unit, 8 unit, and 12 unit cartridges. Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1. For doses above 24 units, use combinations of different multiple cartridges.

Figure 1. Mealtime AFREZZA Starting Dose Conversion Table

Referenced Image

Figure 1

)
* Modify dosage based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal (

2.3 Recommended Starting Mealtime Dosage

For insulin naïve patients, start on 4 units of AFREZZA at the beginning of each meal.

For patients using subcutaneous,

mealtime

(

prandial) insulin:

* Determine the appropriate AFREZZA dose for each meal by converting from the injected insulin dose using Figure 1.
* When switching from another insulin to AFREZZA, a different insulin dose may be needed requiring increased frequency of blood glucose monitoring

[see Warnings and Precautions ].

For patients using subcutaneous,

pre-mixed insulin

:

* Estimate the mealtime injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day. When switching from another insulin to AFREZZA, a different insulin dose may be needed. When switching a patient's insulin regimen, increase the frequency of blood glucose monitoring

[see Warnings and Precautions ].

* Convert each estimated injected mealtime dose to an appropriate AFREZZA dose using Figure 1.
* Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose.

For AFREZZA doses exceeding the contents of a single cartridge at mealtime, inhalations from more than one cartridge are necessary. To achieve the required total mealtime dose, use a combination of 4 unit, 8 unit, and 12 unit cartridges. Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1. For doses above 24 units, use combinations of different multiple cartridges.

Figure 1. Mealtime AFREZZA Starting Dose Conversion Table

Referenced Image

Figure 1

)
* If blood glucose control is not achieved in patients requiring high AFREZZA doses, consider discontinuing AFREZZA (

2.4 Mealtime Dosage Modification

* Modify the AFREZZA dosage based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal.
* Dosage modifications may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness

[see Warnings and Precautions and Use in Specific Populations ].

* Carefully monitor blood glucose control in patients requiring high AFREZZA doses. If blood glucose control is not achieved with increased AFREZZA doses in these patients, consider discontinuing AFREZZA.

)

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Afrezza prescribing information

Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and COPD
[see Warnings and Precautions (
5.1 Acute Bronchospasm in Patients with Chronic Lung Disease
Because of the risk of acute bronchospasm, AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD
[see Contraindications ]
. Before initiating therapy with AFREZZA, evaluate all patients with a medical history, physical examination, and spirometry (FEV₁) to identify potential underlying lung disease.
Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and COPD. In a study of patients with asthma whose bronchodilators were temporarily withheld for assessment, bronchoconstriction and wheezing following AFREZZA dosing was reported in 29% (5 out of 17) and 0% (0 out of 13) of patients with and without a diagnosis of asthma, respectively. In this study, a mean decline in FEV₁of 400 mL was observed 15 minutes after a single AFREZZA dose in patients with asthma. In a subset study of patients with COPD (n=8), a mean decline in FEV₁of 200 mL was observed 18 minutes after a single AFREZZA dose.
)]
.
AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD
[see Contraindications (
4 CONTRAINDICATIONS
AFREZZA is contraindicated:
During episodes of hypoglycemia
[see Warning and Precautions ].
Chronic lung disease, such as asthma or chronic obstructive pulmonary disease (COPD), because of the risk of acute bronchospasm
[see Warnings and Precautions ]
Hypersensitivity to regular human insulin or any of the excipients in AFREZZA
[see Warnings and Precautions ]
During episodes of hypoglycemia
Chronic lung disease, such as asthma, or chronic obstructive pulmonary disease
Hypersensitivity to regular human insulin or any of the excipients in AFREZZA
)].
Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV
₁
) to identify potential lung disease in all patients
[see Dosage and Administration (
2.5 Dosage Modifications for Drug Interactions
Dosage modification may be needed when:
AFREZZA is used concomitantly with certain drugs that increase and/or decrease the glucose lowering effect
[see Drug Interactions ].
Switching from another insulin to AFREZZA
[see Dosage and Administration and Warnings and Precautions ]
), Warnings and Precautions (
5.1 Acute Bronchospasm in Patients with Chronic Lung Disease
Because of the risk of acute bronchospasm, AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD
[see Contraindications ]
. Before initiating therapy with AFREZZA, evaluate all patients with a medical history, physical examination, and spirometry (FEV₁) to identify potential underlying lung disease.
Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and COPD. In a study of patients with asthma whose bronchodilators were temporarily withheld for assessment, bronchoconstriction and wheezing following AFREZZA dosing was reported in 29% (5 out of 17) and 0% (0 out of 13) of patients with and without a diagnosis of asthma, respectively. In this study, a mean decline in FEV₁of 400 mL was observed 15 minutes after a single AFREZZA dose in patients with asthma. In a subset study of patients with COPD (n=8), a mean decline in FEV₁of 200 mL was observed 18 minutes after a single AFREZZA dose.
)].

AFREZZA^® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus.

Limitations of Use:

AFREZZA is not recommended for the treatment of diabetic ketoacidosis
[see Warning and Precautions (
5.6 Diabetic Ketoacidosis
In clinical trials enrolling patients with type 1 diabetes, diabetic ketoacidosis (DKA) was more common in AFREZZA-treated patients (0.43%; n=13) than in comparator-treated patients (0.14%; n=3). Patients with type 1 diabetes should always use AFREZZA in combination with basal insulin. In patients at risk for DKA, such as those with an acute illness or infection, increase the frequency of glucose monitoring and consider discontinuing AFREZZA and giving insulin using an alternate route of administration.
)]
.
The safety and effectiveness of AFREZZA in patients who smoke have not been established. The use of AFREZZA is not recommended in patients who smoke or who have recently stopped smoking.

Only administer via oral inhalation using the AFREZZA inhaler (
2.2 Important Administration and Discard Instructions
Only administer AFREZZA via oral inhalation using the AFREZZA Inhaler. Administer AFREZZA at the beginning of each meal. Administer AFREZZA using a single inhalation per cartridge (if the dose is greater than the contents of a single cartridge, more than one cartridge is needed)
[see Dosage and Administration ].
For additional administration instructions on how to use the AFREZZA Inhaler
[see Dosage and Administration ]
and see the
Instructions for Use.
The AFREZZA Inhaler can be used for up to 15 days from the date of first use. After 15 days of use, the inhaler must be discarded and replaced with a new inhaler.
)
Administer at the beginning of each meal (
2.2 Important Administration and Discard Instructions
Only administer AFREZZA via oral inhalation using the AFREZZA Inhaler. Administer AFREZZA at the beginning of each meal. Administer AFREZZA using a single inhalation per cartridge (if the dose is greater than the contents of a single cartridge, more than one cartridge is needed)
[see Dosage and Administration ].
For additional administration instructions on how to use the AFREZZA Inhaler
[see Dosage and Administration ]
and see the
Instructions for Use.
The AFREZZA Inhaler can be used for up to 15 days from the date of first use. After 15 days of use, the inhaler must be discarded and replaced with a new inhaler.
)
See full prescribing information for the recommended starting mealtime dosage in insulin-naïve patients and patients who are using subcutaneous mealtime insulin or pre-mixed insulin (
2.3 Recommended Starting Mealtime Dosage
For insulin naïve patients, start on 4 units of AFREZZA at the beginning of each meal.
For patients using subcutaneous,
mealtime
(
prandial) insulin:
- Determine the appropriate AFREZZA dose for each meal by converting from the injected insulin dose using Figure 1.
- When switching from another insulin to AFREZZA, a different insulin dose may be needed requiring increased frequency of blood glucose monitoring
  [see Warnings and Precautions ].
For patients using subcutaneous,
pre-mixed insulin
:
- Estimate the mealtime injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day. When switching from another insulin to AFREZZA, a different insulin dose may be needed. When switching a patient's insulin regimen, increase the frequency of blood glucose monitoring
  [see Warnings and Precautions ].
- Convert each estimated injected mealtime dose to an appropriate AFREZZA dose using Figure 1.
- Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose.
For AFREZZA doses exceeding the contents of a single cartridge at mealtime, inhalations from more than one cartridge are necessary. To achieve the required total mealtime dose, use a combination of 4 unit, 8 unit, and 12 unit cartridges. Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1. For doses above 24 units, use combinations of different multiple cartridges.
Figure 1. Mealtime AFREZZA Starting Dose Conversion Table
Figure 1
)
Modify dosage based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal (
2.3 Recommended Starting Mealtime Dosage
For insulin naïve patients, start on 4 units of AFREZZA at the beginning of each meal.
For patients using subcutaneous,
mealtime
(
prandial) insulin:
- Determine the appropriate AFREZZA dose for each meal by converting from the injected insulin dose using Figure 1.
- When switching from another insulin to AFREZZA, a different insulin dose may be needed requiring increased frequency of blood glucose monitoring
  [see Warnings and Precautions ].
For patients using subcutaneous,
pre-mixed insulin
:
- Estimate the mealtime injected dose by dividing half of the total daily injected pre-mixed insulin dose equally among the three meals of the day. When switching from another insulin to AFREZZA, a different insulin dose may be needed. When switching a patient's insulin regimen, increase the frequency of blood glucose monitoring
  [see Warnings and Precautions ].
- Convert each estimated injected mealtime dose to an appropriate AFREZZA dose using Figure 1.
- Administer half of the total daily injected pre-mixed dose as an injected basal insulin dose.
For AFREZZA doses exceeding the contents of a single cartridge at mealtime, inhalations from more than one cartridge are necessary. To achieve the required total mealtime dose, use a combination of 4 unit, 8 unit, and 12 unit cartridges. Examples of cartridge combinations for doses of up to 24 units are shown in Figure 1. For doses above 24 units, use combinations of different multiple cartridges.
Figure 1. Mealtime AFREZZA Starting Dose Conversion Table
Figure 1
)
If blood glucose control is not achieved in patients requiring high AFREZZA doses, consider discontinuing AFREZZA (
2.4 Mealtime Dosage Modification
- Modify the AFREZZA dosage based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal.
- Dosage modifications may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness
  [see Warnings and Precautions and Use in Specific Populations ].
- Carefully monitor blood glucose control in patients requiring high AFREZZA doses. If blood glucose control is not achieved with increased AFREZZA doses in these patients, consider discontinuing AFREZZA.
)

Inhalation Powder: single-use cartridges containing 4 units, 8 units or 12 units of insulin human as white powder to be administered via oral inhalation with the AFREZZA inhaler only

[see How Supplied/Storage and Handling (

16 HOW SUPPLIED/STORAGE AND HANDLING

AFREZZA (insulin human) Inhalation Powder is available as 4 unit, 8 unit and 12 unit single-use cartridges. Three cartridges are contained in a single cavity of a blister strip. Each card contains 5 blister strips (each containing three cartridges) separated by perforations for a total of 15 cartridges. Two cards of the same cartridge strength are packaged in a foil laminate overwrap (30 cartridges per foil package).

The cartridges are color-coded, blue for 4 units, green for 8 units and yellow for 12 units. Each cartridge is marked with “afrezza” and “4 units”, “8 units” or “12 units”.

The AFREZZA Inhaler is individually packaged in a clear overwrap. The inhaler is fully assembled with a removable mouthpiece cover. The AFREZZA Inhaler can be used for up to 15 days from the date of first use. After 15 days of use, the inhaler must be discarded and replaced with a new inhaler.

AFREZZA (insulin human) Inhalation Powder is available in the following configurations:

NDC	Cartridge Strength	Quantity of Cartridges per Strength	Total Quantity of Cartridges per Kit	Total Units in Kit	Number of Inhalers
47918-874-90	4 units	90	90	360 Units	2
47918-878-90	8 units	90	90	720 Units	2
47918-891-90	12 units	90	90	1080 Units	2
47918-898-18	8 units, 12 units	90	180	1800 Units	2
47918-880-18 (Titration Pack)	4 units, 8 units	90	180	1080 Units	2
47918-902-18 (Titration Pack)	4 units, 8 units, 12 units	60	180	1440 Units	2

Storage

:

Not in Use: Refrigerated Storage 2-8ºC (36-46ºF)

* If a foil package, blister card or strip is not refrigerated, the contents must be used within 10 days.
Sealed (Unopened) Foil Package	May be stored until the Expiration Date*
Sealed (Unopened) Blister Cards + Strips	Must be used within 1 month*

In Use: Room Temperature Storage 25ºC (77ºF), excursions permitted 15-30ºC (59-86ºF)

Sealed (Unopened) Blister Cards + Strips	Must be used within 10 days
Opened Strips	Must be used within 3 days

Do not put a blister card or strip back into the refrigerator after being stored at room temperature.

Inhaler Storage

:

Store refrigerated or at room temperature 2-25ºC (36-77ºF); excursions permitted. Inhaler may be stored refrigerated, but should be at room temperature before use.

Handling

:

Before use, cartridges should be at room temperature for 10 minutes.

)]

.

Risk Summary

Limited available data with AFREZZA use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. Available information from published studies with human insulin use during pregnancy has not reported a clear association with human insulin and adverse developmental outcomes (

see

Data

Human Data

There are limited data with AFREZZA use in pregnant women. Published data do not report a clear association with human insulin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when human insulin is used during pregnancy. However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and lack of blinding.

Animal Data

In pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 6 through 17 (organogenesis), no major malformations were observed at doses up to 100 mg/kg/day (21 times the human systemic exposure at a daily dose of 99 mg AFREZZA, based on AUC).

In pregnant rabbits given subcutaneous doses of 2, 10, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through 19 (organogenesis), adverse maternal effects were observed in all dose groups (at human systemic exposure following a daily dose of 99 mg AFREZZA, based on AUC).

In pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through lactation day 20 (weaning), decreased epididymis and testes weights were observed in F1 male offspring, however, no decrease in fertility was noted, and impaired learning were observed in F1 pups at ³ 30 mg/kg/day (6 times the human systemic exposure at a daily dose of 99 mg AFREZZA, based on AUC).

). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (

see

Clinical Considerations

Disease-associated maternal and/or embryo/fetal risk

Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, 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.

). In animal reproduction studies, there were no adverse developmental outcomes with subcutaneous administration of carrier particles (vehicle without insulin) to pregnant rats during organogenesis at doses 21 times the human daily dose of 99 mg AFREZZA, based on AUC

(see

Data

Human Data

There are limited data with AFREZZA use in pregnant women. Published data do not report a clear association with human insulin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when human insulin is used during pregnancy. However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and lack of blinding.

Animal Data

In pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 6 through 17 (organogenesis), no major malformations were observed at doses up to 100 mg/kg/day (21 times the human systemic exposure at a daily dose of 99 mg AFREZZA, based on AUC).

In pregnant rabbits given subcutaneous doses of 2, 10, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through 19 (organogenesis), adverse maternal effects were observed in all dose groups (at human systemic exposure following a daily dose of 99 mg AFREZZA, based on AUC).

In pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through lactation day 20 (weaning), decreased epididymis and testes weights were observed in F1 male offspring, however, no decrease in fertility was noted, and impaired learning were observed in F1 pups at ³ 30 mg/kg/day (6 times the human systemic exposure at a daily dose of 99 mg AFREZZA, based on AUC).

)

.

The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with HbA1c >7 and has been reported to be as high as 20-25% in women with 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.

AFREZZA is contraindicated:

During episodes of hypoglycemia
[see Warning and Precautions (
5.3 Hypoglycemia
Glucose monitoring is essential for patients receiving insulin therapy. Hypoglycemia is the most common adverse reaction associated with insulins, including AFREZZA. Severe hypoglycemia can cause seizures, 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).
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation. AFREZZA has a distinct time action profile
[see Clinical Pharmacology ]
, which impacts the timing of hypoglycemia. Hypoglycemia can happen suddenly, and symptoms may differ across patients and change over time in the same patient. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using certain medications
[see Drug Interactions ]
, or in patients who experience recurrent hypoglycemia.
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 co-administered 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 should be educated to recognize and manage hypoglycemia. Self-monitoring 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.
)].
Chronic lung disease, such as asthma or chronic obstructive pulmonary disease (COPD), because of the risk of acute bronchospasm
[see Warnings and Precautions (
5.1 Acute Bronchospasm in Patients with Chronic Lung Disease
Because of the risk of acute bronchospasm, AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD
[see Contraindications ]
. Before initiating therapy with AFREZZA, evaluate all patients with a medical history, physical examination, and spirometry (FEV₁) to identify potential underlying lung disease.
Acute bronchospasm has been observed in AFREZZA-treated patients with asthma and COPD. In a study of patients with asthma whose bronchodilators were temporarily withheld for assessment, bronchoconstriction and wheezing following AFREZZA dosing was reported in 29% (5 out of 17) and 0% (0 out of 13) of patients with and without a diagnosis of asthma, respectively. In this study, a mean decline in FEV₁of 400 mL was observed 15 minutes after a single AFREZZA dose in patients with asthma. In a subset study of patients with COPD (n=8), a mean decline in FEV₁of 200 mL was observed 18 minutes after a single AFREZZA dose.
)]
Hypersensitivity to regular human insulin or any of the excipients in AFREZZA
[see Warnings and Precautions (
5.7 Hypersensitivity Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including AFREZZA.
If hypersensitivity reactions occur, discontinue AFREZZA, treat per standard of care and monitor until symptoms and signs resolve
[see Adverse Reactions ]
. AFREZZA is contraindicated in patients who have had hypersensitivity reactions to AFREZZA or any of its excipients
[see Contraindications ]
.
)]

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