Starting and Adjusting Doses

Transcription

1 TM Starting and Adjusting Doses For appropriate type 1 and type 2 diabetes patients to get going on Afrezza TM Indications and Usage Afrezza is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use Afrezza is not a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes mellitus. Afrezza is not recommended for the treatment of diabetic ketoacidosis. The safety and efficacy of Afrezza in patients who smoke has not been established. The use of Afrezza is not recommended in patients who smoke or who have recently stopped smoking (less than 6 months). WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza. Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV 1 ) to identify potential lung disease in all patients. Access the Afrezza Risk Evaluation and Mitigation Strategy (REMS) program at Please see additional on pages 14 and 15 and accompanying full Prescribing Information, including Boxed WARNING, for Afrezza in pocket.

2 2 Important considerations before administration Contraindications Afrezza is contraindicated in patients: During episodes of hypoglycemia. With chronic lung disease (such as asthma or chronic obstructive pulmonary disease [COPD]) because of the risk of acute bronchospasm. With hypersensitivity to regular human insulin or any of the Afrezza excipients. 4 UNITS 8 UNITS 12 UNITS Single-use, color-coded cartridges are loaded into the specially designed inhaler. Inhaler and cartridges not actual size Patients require lung function assessment Afrezza is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients Before initiating Afrezza, perform a medical history, physical examination, and spirometry (FEV 1 ) in all patients to identify potential lung disease Pulmonary function should also be assessed with spirometry after the initial 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. More frequent lung function assessment should be considered in patients with pulmonary symptoms, eg, wheezing, bronchospasm, breathing difficulties, or cough Important administration instructions Keep the inhaler level with the white mouthpiece on top and purple base on the bottom after a cartridge has been inserted into the inhaler Loss of drug effect can occur if the inhaler is turned upside down, held with the mouthpiece pointing down, or shaken (or dropped) after the cartridge has been inserted but before the dose has been administered If any of the above occurs, the cartridge should be replaced before use See Patient Instructions for Use for complete administration instructions with illustrations. Please see on pages 14 and 15 and accompanying full Prescribing Information, including Boxed WARNING, for Afrezza in pocket. 3

3 Are your patients converting from injected mealtime insulin? If your patients have already been taking mealtime insulin, they probably have settled into a routine and use a fixed number of insulin units per meal or snack. There is not a straight conversion from an injected dose of insulin to an inhaled dose of Afrezza. You can determine the appropriate dose of Afrezza from the chart. You may need to adjust their Afrezza dose up or down. Afrezza is supplied in a range of cartridges/doses. The dose of Afrezza may need to change because of a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines they take. Mealtime Afrezza dose conversion Injected Mealtime Insulin Dose up to 4 units AFREZZA Dose 4 units 5 8 units 8 units 9 12 units 12 units 4 unit (blue) # of cartridges needed + 8 unit (green) or / 12 unit (yellow) < Afrezza dosing should be individualized. This table can help with initial mealtime dose when converting. Please have your patients read the Instructions for Use before they start using Afrezza and each time they get a new Afrezza inhaler units 16 units units 20 units units 24 units Warnings and Precautions Acute Bronchospasm: Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD. Prior to initiating therapy, patients should be evaluated with a medical history, physical examination and spirometry (FEV 1 ) to identify potential underlying lung disease. Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD. The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established. Please see on pages 14 and 15 and accompanying full Prescribing Information, including Boxed WARNING, for Afrezza in pocket. 4 5

4 Are your patients taking premixed insulin? For the Afrezza dose, start by estimating their mealtime injected dose by dividing half the total daily injected premixed insulin dose equally among the three meals of the day. Convert each of the estimated injected mealtime doses to an appropriate Afrezza dose using the chart. They can then administer half of the total daily injected premixed dose as an injected basal insulin dose. Mealtime Afrezza dose conversion Injected Mealtime Insulin Dose AFREZZA Dose 4 unit (blue) # of cartridges needed 8 unit (green) 12 unit (yellow) You may need to adjust their Afrezza dose up or down. Afrezza is supplied in a range of cartridges/doses. The dose of Afrezza may need to change because of a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines they take. up to 4 units 4 units 5 8 units 8 units 9 12 units 12 units + or / < Afrezza dosing should be individualized. This table can help with initial mealtime dose when converting. Warnings and Precautions (cont) Please have your patients read the Instructions for Use before they start using Afrezza and each time they get a new Afrezza inhaler units 16 units units 20 units units 24 units + Change in Insulin Regimen: Monitor blood glucose in all patients treated with insulin. Modify insulin regimen and dose cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin therapy, including Afrezza, and may be serious and life-threatening. Patients and caregivers must be educated on mitigating the risks associated with hypoglycemia. Please see on pages 14 and 15 and accompanying full Prescribing Information, including Boxed WARNING, for Afrezza in pocket. 6 7

5 Are your patients NEW TO mealtime insulin? If your patients have never used mealtime insulin before, you may start them with 4 units of Afrezza at each meal. 4 UNITS OF AFREZZA You may need to adjust their Afrezza dose up or down. Afrezza is supplied in a range of cartridges/doses. The dose of Afrezza may need to change because of a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines they take. Please have your patients read the Instructions for Use before they start using Afrezza and each time they get a new Afrezza inhaler. Warnings and Precautions (cont) 8 Decline in Pulmonary Function: Afrezza has been shown to cause a decrease in lung function as measured by FEV 1. In clinical trials lasting up to 2 years, Afrezza treated patients experienced a small (40 ml) but greater FEV 1 decline than comparator treated patients. Therefore, pulmonary function should be assessed with spirometry at baseline, after the initial 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. More frequent lung function assessment should be considered in patients with pulmonary symptoms, e.g., wheezing, bronchospasm, breathing difficulties, or cough. Please see on pages 14 and 15 and accompanying full Prescribing Information, including Boxed WARNING, for Afrezza in pocket. 9

6 ADJUSTING THE DOSE Adjust the dosage of Afrezza based on the individual s metabolic needs, blood glucose monitoring results, and glycemic control goal Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (ie, macronutrient content or timing of food intake), changes in renal or hepatic function, or during acute illness Carefully monitor blood glucose control in patients requiring high doses of Afrezza. If, in these patients, blood glucose control is not achieved with increased Afrezza doses, consider use of subcutaneous mealtime insulin Afrezza is available in the following configurations: NDC (90) 4 unit cartridges 2 inhalers NDC NDC cartridges: (60) 4 unit cartridges and (30) 8 unit cartridges 90 cartridges: (30) 4 unit cartridges and (60) 8 unit cartridges 2 inhalers 2 inhalers For doses exceeding 12 units Inhalations from multiple cartridges are necessary. To achieve the required total mealtime dose, patients should use a combination of 4 unit, 8 unit, and 12 unit cartridges. Dosage adjustment may be needed when Afrezza is coadministered with certain drugs NDC cartridges: (60) 8 unit cartridges and (30) 12 unit cartridges 2 inhalers Please refer to the Drug Interactions section of the Prescribing Information. TITRATION PACK NDC cartridges: (90) 4 unit cartridges and (90) 8 unit cartridges 2 inhalers Warnings and Precautions (cont) 10 Lung Cancer: In Afrezza clinical trials, 2 cases of lung cancer were reported in patients exposed to Afrezza while no cases were reported for the comparators. Two additional cases of lung cancer (squamous cell) were reported in non-smokers exposed to Afrezza after the trial completion. In patients with active lung cancer, a prior history of lung cancer, or in patients at risk of lung cancer, consider whether the benefits of Afrezza outweigh the risks. Please see on pages 14 and 15 and accompanying full Prescribing Information, including Boxed WARNING, for Afrezza in pocket. 11

7 HOW TO STORE Store unopened drug in the refrigerator. Your patients can store sealed, unopened foil packages in their refrigerators. They are good until the expiration date. Sealed, unopened blister cards and strips can be stored in the refrigerator. Patients should use supplies within 1 month. If not refrigerated, the product must be used within 10 days. Once a foil package has been opened: Sealed, unopened blister packs and strips should be used within 10 days. Opened strips should be used within 3 days. < Important: Do not put a blister card or strip back in the refrigerator after it has been stored at room temperature Never leave or store cartridges in the inhaler After use, replace the mouthpiece on the inhaler Discard the inhaler after 15 days of use and start a new one Before use, inhaler and cartridges should be at room temperature for at least 10 minutes 12 Warnings and Precautions (cont) Diabetic Ketoacidosis: Increase the frequency of glucose monitoring and consider an alternate route of administration of insulin in patients at risk for diabetic ketoacidosis (DKA). In clinical trials enrolling subjects with type 1 diabetes, DKA was more common in subjects receiving Afrezza (0.43%; n=13) than in subjects receiving comparators (0.14%; n=3). Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Afrezza, monitor and treat if indicated. Please see on pages 14 and 15 and accompanying full Prescribing Information, including Boxed WARNING, for Afrezza in pocket. 13

8 for Afrezza (insulin human) Inhalation Powder WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in patients with asthma and COPD using Afrezza. Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV 1 ) to identify potential lung disease in all patients. Access the Afrezza Risk Evaluation and Mitigation Strategy (REMS) program at Contraindications Afrezza is contraindicated in patients: During episodes of hypoglycemia. With chronic lung disease (such as asthma or chronic obstructive pulmonary disease [COPD]) because of the risk of acute bronchospasm. With hypersensitivity to regular human insulin or any of the Afrezza excipients. Warnings and Precautions Acute Bronchospasm: Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD. Prior to initiating therapy, patients should be evaluated with a medical history, physical examination and spirometry (FEV 1 ) to identify potential underlying lung disease. Acute bronchospasm has been observed following Afrezza dosing in patients with asthma and patients with COPD. The long-term safety and efficacy of Afrezza in patients with chronic lung disease has not been established. Change in Insulin Regimen: Monitor blood glucose in all patients treated with insulin. Modify insulin regimen and dose cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type, or method of administration may result in the need for a change in insulin dose or an adjustment in concomitant oral antidiabetic treatment. Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin therapy, including Afrezza, and may be serious and life-threatening. Patients and caregivers must be educated on mitigating the risks associated with hypoglycemia. Decline in Pulmonary Function: Afrezza has been shown to cause a decrease in lung function as measured by FEV 1. In clinical trials lasting up to 2 years, Afrezza treated patients experienced a small (40 ml) but greater FEV 1 decline than comparator treated patients. Therefore, pulmonary function should be assessed with spirometry at baseline, after the initial 6 months of therapy and annually thereafter even in the absence of pulmonary symptoms. More frequent lung function assessment should be considered in patients with pulmonary symptoms, e.g., wheezing, bronchospasm, breathing difficulties, or cough. Lung Cancer: In Afrezza clinical trials, 2 cases of lung cancer were reported in patients exposed to Afrezza while no cases were reported for the comparators. Two additional cases of lung cancer (squamous cell) were reported in non-smokers exposed to Afrezza after the trial completion. In patients with active lung cancer, a prior history of lung cancer, or in patients at risk of lung cancer, consider whether the benefits of Afrezza outweigh the risks. Diabetic Ketoacidosis: Increase the frequency of glucose monitoring and consider an alternate route of administration of insulin in patients at risk for diabetic ketoacidosis (DKA). In clinical trials enrolling subjects with type 1 diabetes, DKA was more common in subjects receiving Afrezza (0.43%; n=13) than in subjects receiving comparators (0.14%; n=3). Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Afrezza, monitor and treat if indicated. Hypokalemia: As with all insulins, Afrezza use can lead to life-threatening hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated. Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Fluid retention, which may lead to or exacerbate heart failure, can occur with concomitant use of TZDs and insulin. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dose reduction or discontinuation of TZD must be considered. Drug Interactions Certain drugs may affect glucose metabolism, increasing the risk of hypoglycemia or decreasing the blood glucose lowering effect of Afrezza. Dose adjustment and increased frequency of blood glucose monitoring may be required. The signs and symptoms of hypoglycemia may be reduced when taking Afrezza concomitantly with beta-blockers, clonidine, guanethidine, and reserpine. Adverse Reactions The most common adverse reactions associated with Afrezza include hypoglycemia, cough (including productive cough), throat pain or irritation, and headache. Please see accompanying full Prescribing Information, including Boxed WARNING, for Afrezza in pocket

9 Let s get going! Please see accompanying full Prescribing Information, including Boxed WARNING, for Afrezza in pocket MannKind Corporation. All rights reserved. US.AFR Afrezza, and the Afrezza and MannKind logos are registered trademarks, and the INsulin and OUTsulin avatars are copyrights and trademarks of MannKind Corporation.