AFREZZA- insulin human powder, metered AFREZZA- insulin human kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INSULIN HUMAN (UNII: 1Y17CTI5SR) (INSULIN HUMAN - UNII:1Y17CTI5SR)

Available from:

Mannkind Corporation

INN (International Name):

Insulin Human

Composition:

Insulin Human 4

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] . - 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. AFREZZA is contraindicated: - During episodes of hypoglycemia [see Warning and Precautions (5.3)]. - 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)] - Hypersensitivity to regular human insulin or any of the excipients in AFREZZA [see Warnings and Precautions (5.7)] 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 ). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ). 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) . 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. 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. 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). Risk Summary There are no data on the presence of AFREZZA in human milk, the effects on the breastfed infant, or the effects on milk production. One small published study reported that exogenous subcutaneous insulin was present in human milk. No adverse effects in infants were noted. The carrier particles are present in rat milk (see Data ). Potential adverse reactions that are related to inhalational administration of AFREZZA are unlikely to be associated with potential exposure of AFREZZA through breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for AFREZZA and any potential adverse effects on the breastfed infant from AFREZZA or from the underlying maternal condition. Data Subcutaneous administration of the carrier particle in lactating rats resulted in excretion of the carrier particle in rat milk at levels that were approximately 10% of the maternal exposure. Given the results of the rat study, it is highly likely that the insulin and carrier in AFREZZA are excreted in human milk. The safety and effectiveness of AFREZZA to improve glycemic control in pediatric patients with diabetes mellitus has not been established. AFREZZA has not been studied in pediatric patients. In the AFREZZA clinical studies, 671 (12%) patients were 65 years of age or older, of which 42 (0.8%) were 75 years of age or older. In these studies, 381 (13%) of AFREZZA-treated patients were 65 years of age or older, of which 20 (0.7%) were 75 years of age or older. No overall differences in effectiveness of AFREZZA have been observed between patients 65 years of age and older and younger adult patients [see Clinical Studies (14)] . Clinical studies of AFREZZA did not include sufficient numbers of patients 65 years of age and older to determine whether there were differences in safety between these patients and younger adult patients. Pharmacokinetic and pharmacodynamic studies to assess the effect of age on pharmacokinetics or pharmacodynamics on insulin human, respectively, have not been conducted. The effect of hepatic impairment on the pharmacokinetics of AFREZZA has not been studied. Frequent glucose monitoring and a lower dosage may be necessary in AFREZZA-treated patients with hepatic impairment [see Warnings and Precautions (5.3)] . The effect of renal impairment on the pharmacokinetics of AFREZZA has not been studied. Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. Frequent glucose monitoring and a lower dosage may be necessary in AFREZZA-treated patients with renal impairment [see Warnings and Precautions (5.3)] . INSTRUCTIONS FOR USE AFREZZA® (uh-FREZZ-uh) (insulin human) inhalation powder, for oral inhalation use This “Instructions for Use” contains information on how to use AFREZZA® (insulin human) Inhalation Powder. Read this Instructions for Use before you start using AFREZZA and each time you get a new AFREZZA Inhaler. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Your healthcare provider should show you how to use your AFREZZA Inhaler the right way before you use it for the first time. Important information about AFREZZA: - AFREZZA comes in 3 strengths (see Figure A): 4 units (blue cartridge) 8 units (green cartridge) 12 units (yellow cartridge) - 4 units (blue cartridge) - 8 units (green cartridge) - 12 units (yellow cartridge) - If your prescribed AFREZZA dose is higher than 12 units, you will need to use more than 1 cartridge. - If you need to use more than 1 cartridge for your dose, throw away the used cartridge before getting a new one. You can tell when a cartridge has been used, because the cup has moved to the center. - Do not try to open the AFREZZA cartridges. The AFREZZA Inhaler opens the cartridge automatically during use. - AFREZZA cartridges should only be used with the AFREZZA Inhaler. Do not try to breathe in the AFREZZA insulin powder in any other way. Do not put cartridges in your mouth and do not swallow cartridges. - Use only 1 AFREZZA Inhaler at a time. The same inhaler should be used for the 4 unit, 8 unit or 12 unit cartridges. - Store the inhaler in a clean, dry place with the mouthpiece cover on until your next dose. - Throw away your AFREZZA Inhaler after 15 days and get a new one. If you are having problems with your AFREZZA Inhaler or if it breaks and you need a new one, call 1-877-323-8505. Know your AFREZZA Inhaler: Know your AFREZZA cartridges: Manufactured by: MannKind Corporation Danbury, CT 06810 US License No. #2190 © 2016 – 2023 MannKind Corporation This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 02/2023 AFREZZA is a registered trademark of MannKind Corporation Patent: www.mannkindcorp.com/patent-notices

Product summary:

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

Authorization status:

Biologic Licensing Application

Patient Information leaflet

AFREZZA- INSULIN HUMAN POWDER, METERED
AFREZZA- INSULIN HUMAN
Mannkind Corporation
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration
Revised 02/2023
MEDICATION GUIDE
AFREZZA® (uh-FREZZ-uh)
(insulin human)
inhalation powder, for oral inhalation use
What is the most important information I should know about AFREZZA?
AFREZZA can cause serious side effects, including:
•
Sudden lung problems (bronchospasms). Do not use AFREZZA if you have
long-term (chronic)
lung problems such as asthma or chronic obstructive pulmonary disease
(COPD). Before starting
AFREZZA, your healthcare provider will give you a breathing test to
check how your lungs are
working.
What is AFREZZA?
•
AFREZZA is a man-made insulin that is breathed-in through your lungs
(inhaled) and is used to
control high blood sugar in adults with diabetes mellitus.
•
AFREZZA is not for use to treat diabetic ketoacidosis. AFREZZA must be
used with basal
insulin in people who have type 1 diabetes mellitus.
•
It is not known if AFREZZA is safe and effective for use in people who
smoke. AFREZZA is not
for use in people who smoke or have recently stopped smoking (less
than 6 months).
•
It is not known if AFREZZA is safe and effective in children under 18
years of age.
Who should not use AFREZZA?
Do not use AFREZZA if you:
•
Have chronic lung problems such as asthma or COPD.
•
Are allergic to regular human insulin or any of the ingredients in
AFREZZA. See the end of this
Medication Guide for a complete list of ingredients in AFREZZA.
•
Are having an episode of low blood sugar (hypoglycemia).
What should I tell my healthcare provider before using AFREZZA?
Before using AFREZZA, tell your healthcare provider about all your
medical conditions, including if
you:
•
Have lung problems such as asthma or COPD
•
Have or have had lung cancer
•
Are using any inhaled medications
•
Smoke or have recently stopped smoking
•
Have kidney or liver problems
•
Are pregnant, planning to become pregnant, or are breastfeedi

Summary of Product characteristics

AFREZZA- INSULIN HUMAN POWDER, METERED
AFREZZA- INSULIN HUMAN
MANNKIND CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AFREZZA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AFREZZA.
AFREZZA (INSULIN HUMAN) INHALATION POWDER, FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 2014
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG
DISEASE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ACUTE BRONCHOSPASM HAS BEEN OBSERVED IN AFREZZA-TREATED PATIENTS WITH
ASTHMA
AND COPD. (5.1)
AFREZZA IS CONTRAINDICATED IN PATIENTS WITH CHRONIC LUNG DISEASE SUCH
AS ASTHMA OR
COPD. (4)
BEFORE INITIATING AFREZZA, PERFORM A DETAILED MEDICAL HISTORY,
PHYSICAL EXAMINATION,
AND SPIROMETRY (FEV ) TO IDENTIFY POTENTIAL LUNG DISEASE IN ALL
PATIENTS. (2.5), (5.1)
INDICATIONS AND USAGE
AFREZZA is a rapid acting inhaled human insulin indicated to improve
glycemic control in adult patients
with diabetes mellitus. (1)
Limitations of Use:
Not recommended for the treatment of diabetic ketoacidosis (1)
Not recommended in patients who smoke or who have recently stopped
smoking (1)
DOSAGE AND ADMINISTRATION
Only administer via oral inhalation using the AFREZZA inhaler (2.2)
Administer at the beginning of each meal (2.2)
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)
Modify dosage based on the patient's metabolic needs, blood glucose
monitoring results, and glycemic
control goal (2.3)
If blood glucose control is not achieved in patients requiring high
AFREZZA doses, consider
discontinuing AFREZZA (2.4)
DOSAGE FORMS AND STRENGTHS
Inhalation powder in single-use cartridges of: 4 units, 8 units, or 12
units (3)
CONTRAINDICATIONS
During episodes of hypoglycemia (4)
Chronic lung disease, such as asthma, or chronic obstructive pulmonary
disease (4)
Hypersensitivity to regular human insulin or any of