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Exubera
Overview
What is Exubera?
EXUBERA consists of blisters containing human insulin inhalation powder, which are administered using the EXUBERA Inhaler. EXUBERA blisters contain human insulin produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of (K12). Chemically, human insulin has the empirical formula CHNOS and a molecular weight of 5808. Human insulin has the following primary amino acid sequence:
EXUBERA (insulin human [rDNA origin]) Inhalation Powder is a white to off-white powder in a unit dose blister (fill mass, see ). Each unit dose blister of EXUBERA contains a 1 mg or 3 mg dose of insulin (see ) in a homogeneous powder formulation containing sodium citrate (dihydrate), mannitol, glycine, and sodium hydroxide. After an EXUBERA blister is inserted into the inhaler, the patient pumps the handle of the inhaler and then presses a button, causing the blister to be pierced. The insulin inhalation powder is then dispersed into the chamber, allowing the patient to inhale the aerosolized powder.
Under standardized test conditions, EXUBERA delivers a specific emitted dose of insulin from the mouthpiece of the inhaler (see ). A fraction of the total particle mass is emitted as fine particles capable of reaching the deep lung. Up to 45% of the 1 mg blister contents, and up to 25% of the 3 mg blister contents, may be retained in the blister.
The actual amount of insulin delivered to the lung will depend on individual patient factors, such as inspiratory flow profile. , emitted aerosol metrics are unaffected at flow rates above 10 L/min.
What does Exubera look like?
What are the available doses of Exubera?
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What should I talk to my health care provider before I take Exubera?
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How should I use Exubera?
EXUBERA is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. EXUBERA has an onset of action similar to rapid-acting insulin analogs and has a duration of glucose-lowering activity comparable to subcutaneously administered regular human insulin. In patients with type 1 diabetes, EXUBERA should be used in regimens that include a longer-acting insulin. In patients with type 2 diabetes, EXUBERA can be used as monotherapy or in combination with oral agents or longer-acting insulins.
EXUBERA, like rapid-acting insulin analogs, has a more rapid onset of glucose-lowering activity compared to subcutaneously injected regular human insulin. EXUBERA has a duration of glucose-lowering activity comparable to subcutaneously injected regular human insulin and longer than rapid-acting insulin. EXUBERA doses should be administered immediately prior to meals (no more than 10 minutes prior to each meal).
In patients with type 1 diabetes, EXUBERA should be used in regimens that include a longer-acting insulin. For patients with type 2 diabetes, EXUBERA may be used as monotherapy or in combination with oral agents or longer-acting insulin.
Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function assessed prior to initiating therapy with EXUBERA. Periodic monitoring of pulmonary function is recommended for patients being treated with EXUBERA (see ).
EXUBERA is intended for administration by inhalation and must only be administered using the EXUBERA Inhaler. Refer to the for a description of the EXUBERA Inhaler and for instructions on how to use the inhaler.
What interacts with Exubera?
EXUBERA is contraindicated in patients hypersensitive to EXUBERA or one of its excipients.
EXUBERA is contraindicated in patients who smoke or who have discontinued smoking less than 6 months prior to starting EXUBERA therapy. If a patient starts or resumes smoking, EXUBERA must be discontinued immediately due to the increased risk of hypoglycemia, and an alternative treatment must be utilized (see ). The safety and efficacy of EXUBERA in patients who smoke have not been established.
EXUBERA is contraindicated in patients with unstable or poorly controlled lung disease, because of wide variations in lung function that could affect the absorption of EXUBERA and increase the risk of hypoglycemia or hyperglycemia.
What are the warnings of Exubera?
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
EXUBERA differs from regular human insulin by its rapid onset of action. When used as mealtime insulin, the dose of EXUBERA should be given within 10 minutes before a meal.
Hypoglycemia is the most commonly reported adverse event of insulin therapy, including EXUBERA. The timing of hypoglycemia may differ among various insulin formulations.
Patients with type 1 diabetes also require a longer-acting insulin to maintain adequate glucose control.
Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (e.g., regular, NPH, analogs), or species (animal, human) may result in the need for a change in dosage. Concomitant oral antidiabetic treatment may need to be adjusted.
Glucose monitoring is recommended for all patients with diabetes.
Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function assessed prior to initiating therapy with EXUBERA (see ).
The use of EXUBERA in patients with underlying lung disease, such as asthma or COPD, is not recommended because the safety and efficacy of EXUBERA in this population have not been established (see ).
In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator-treated patients. There has also been 1 postmarketing report of a primary lung malignancy in an Exubera-treated patient. In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years) for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for comparator-treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking.
What are the precautions of Exubera?
General
As with all insulin preparations, the time course of EXUBERA action may vary in different individuals or at different times in the same individual. Adjustment of dosage of any insulin may be necessary if patients change their physical activity or their usual meal plan. Insulin requirements may be altered during intercurrent conditions such as illness, emotional disturbances, or stress.
Hypoglycemia
As with all insulin preparations, hypoglycemic reactions may be associated with the administration of EXUBERA. Rapid changes in serum glucose concentrations may induce symptoms similar to hypoglycemia in persons with diabetes, regardless of the glucose value. Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta-blockers, or intensified diabetes control (see ). Such situations may result in severe hypoglycemia (and, possibly, loss of consciousness) prior to patients' awareness of hypoglycemia.
Renal Impairment
Studies have not been performed in patients with renal impairment. As with other insulin preparations, the dose requirements for EXUBERA may be reduced in patients with renal impairment (see ).
Hepatic Impairment
Studies have not been performed in patients with hepatic impairment. As with other insulin preparations, the dose requirements for EXUBERA may be reduced in patients with hepatic impairment (see ).
Allergy
In clinical studies, the overall incidence of allergic reactions in patients treated with EXUBERA was similar to that in patients using subcutaneous regimens with regular human insulin.
As with other insulin preparations, rare, but potentially serious, generalized allergy to insulin may occur, which may cause rash (including pruritus) over the whole body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized allergy, including anaphylactic reactions, may be life threatening. If such reactions occur from EXUBERA, EXUBERA should be stopped and alternative therapies considered.
Insulin antibodies may develop during treatment with all insulin preparations including EXUBERA. In clinical studies of EXUBERA where the comparator was subcutaneous insulin, increases in insulin antibody levels (as reflected by assays of insulin binding activity) were significantly greater for patients who received EXUBERA than for patients who received subcutaneous insulin only. No clinical consequences of these antibodies were identified over the time period of clinical studies of EXUBERA; however, the long-term clinical significance of this increase in antibody formation is unknown.
Respiratory
In clinical trials up to two years duration, patients treated with EXUBERA demonstrated a greater decline in pulmonary function, specifically the forced expiratory volume in one second (FEV) and the carbon monoxide diffusing capacity (DL), than comparator-treated patients. The mean treatment group difference in pulmonary function favoring the comparator group, was noted within the first several weeks of treatment with EXUBERA, and did not change over the two year treatment period (See ).
During the controlled clinical trials, individual patients experienced notable declines in pulmonary function in both treatment groups. A decline from baseline FEV of ≥ 20% at last observation occurred in 1.5% of EXUBERA-treated and 1.3% of comparator-treated patients. A decline from baseline DL of ≥ 20% at last observation occurred in 5.1% of EXUBERA-treated and 3.6% of comparator treated patients.
Because of the effect of EXUBERA on pulmonary function, all patients should have spirometry (FEV) assessed prior to initiating therapy with EXUBERA. Assessment of DL should be considered. The efficacy and safety of EXUBERA in patients with baseline FEV or DL < 70% predicted have not been established and the use of EXUBERA in this population is not recommended.
Assessment of pulmonary function (e.g., spirometry) is recommended after the first 6 months of therapy, and annually thereafter, even in the absence of pulmonary symptoms. In patients who have a decline of ≥ 20% in FEV from baseline, pulmonary function tests should be repeated. If the ≥ 20% decline from baseline FEV is confirmed, EXUBERA should be discontinued. The presence of pulmonary symptoms and lesser declines in pulmonary function may require more frequent monitoring of pulmonary function and consideration of discontinuation of EXUBERA.
The use of EXUBERA in patients with underlying lung disease, such as asthma or COPD, is not recommended because the efficacy and safety of EXUBERA in this population have not been established.
Bronchospasm has been rarely reported in patients taking EXUBERA. Patients experiencing such a reaction should discontinue EXUBERA and seek medical evaluation immediately. Re-administration of EXUBERA requires a careful risk evaluation, and should only be done under close medical monitoring with appropriate clinical facilities available.
EXUBERA has been administered to patients with intercurrent respiratory illness (e.g. bronchitis, upper respiratory tract infections, rhinitis) during clinical studies. In patients experiencing these conditions, 3–4% temporarily discontinued EXUBERA therapy. There was no increased risk of hypoglycemia or worsened glycemic control observed in EXUBERA-treated patients compared to patients treated with subcutaneous insulin. During intercurrent respiratory illness, close monitoring of blood glucose concentrations, and dose adjustment, may be required.
Information for Patients
Patients should be instructed on self-management procedures including glucose monitoring; proper EXUBERA inhalation technique; and hypoglycemia and hyperglycemia management. Patients must be instructed 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, or skipped meals. Refer patients to the for additional information.
Patients should be informed that in clinical studies, treatment with EXUBERA was associated with small, non-progressive mean declines in pulmonary function relative to comparator treatments. Because of the effect of EXUBERA on pulmonary function, pulmonary function tests are recommended prior to initiating treatment with EXUBERA. Following initiation of therapy, periodic pulmonary function tests are recommended (see ).
Patients should inform their physician if they have a history of lung disease, because the use of EXUBERA is not recommended in patients with underlying lung disease (e.g., asthma or COPD), and is contraindicated in patients with poorly controlled lung disease.
Women with diabetes should be advised to inform their doctor if they are pregnant or are contemplating pregnancy.
Drug Interactions
A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.
The following are examples of substances that may reduce the blood glucose-lowering effect of insulin that may result in hyperglycemia: corticosteroids, danazol, diazoxide, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), protease inhibitors, and atypical antipsychotic medications (e.g., olanzapine and clozapine).
The following are examples of substances that may increase the blood glucose-lowering effect of insulin and susceptibility to hypoglycemia: oral antidiabetic products, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, and sulfonamide antibiotics.
Beta-blockers, clonidine, lithium salts, and alcohol may either increase or reduce the blood glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine, and reserpine, the signs and symptoms of hypoglycemia may be reduced or absent.
Bronchodilators and other inhaled products may alter the absorption of inhaled human insulin (see ). Consistent timing of dosing of bronchodilators relative to EXUBERA administration, close monitoring of blood glucose concentrations and dose titration as appropriate are recommended.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year carcinogenicity studies in animals have not been performed. Insulin was not mutagenic in the Ames bacterial reverse mutation test in the presence and absence of metabolic activation.
In Sprague-Dawley rats, a 6-month repeat-dose toxicity study was conducted with insulin inhalation powder at doses up to 5.8 mg/kg/day (compared to the clinical starting dose of 0.15 mg/kg/day, the rat high dose was 39 times or 8.3 times the clinical dose, based on either a mg/kg or a mg/m body surface area comparison). In Cynomolgus monkeys, a 6-month repeat-dose toxicity study was conducted with inhaled insulin at doses up to 0.64 mg/kg/day. Compared to the clinical starting dose of 0.15 mg/kg/day, the monkey high dose was 4.3 times or 1.4 times the clinical dose, based on either a mg/kg or a mg/m body surface area comparison. These were maximum tolerated doses based on hypoglycemia.
Compared to control animals, there were no treatment-related adverse effects in either species on pulmonary function, gross or microscopic morphology of the respiratory tract or bronchial lymph nodes. Similarly, there was no effect on cell proliferation indices in alveolar or bronchiolar area of the lung in either species.
Because recombinant human insulin is identical to the endogenous hormone, reproductive/fertility studies were not performed in animals.
Pregnancy
Nursing Mothers
Many drugs, including human insulin, are excreted in human milk. For this reason, caution should be exercised when EXUBERA is administered to a nursing woman. Patients with diabetes who are lactating may require adjustments in EXUBERA dose, meal plan, or both.
Pediatric Use
Long-term safety and effectiveness of EXUBERA in pediatric patients have not been established (see ).
Geriatric Use
In controlled Phase 2/3 clinical studies (n=1975), EXUBERA was administered to 266 patients ≥65 years of age and 30 patients ≥75 years of age. The majority of these patients had type 2 diabetes. The change in HbA and rate of hypoglycemia did not differ by age.
What are the side effects of Exubera?
The safety of EXUBERA alone, or in combination with subcutaneous insulin or oral agents, has been evaluated in approximately 2500 adult patients with type 1 or type 2 diabetes who were exposed to EXUBERA. Approximately 2000 patients were exposed to EXUBERA for greater than 6 months and more than 800 patients were exposed for more than 2 years.
Non-Respiratory Adverse Events
Non-respiratory adverse events reported in ≥1% of 1977 EXUBERA-treated patients in controlled Phase 2/3 clinical studies, regardless of causality, include (but are not limited to) the following:
Metabolic and Nutritional:
Body as a whole:
Digestive:
Special senses:
The rates and incidence of hypoglycemia were comparable between EXUBERA and subcutaneous regular human insulin in patients with type 1 and type 2 diabetes. In type 2 patients who were not adequately controlled with single oral agent therapy, the addition of EXUBERA was associated with a higher rate of hypoglycemia than was the addition of a second oral agent.
A range of different chest symptoms were reported as adverse reactions and were grouped under the non-specific term chest pain. These events occurred in 4.7% of EXUBERA-treated patients and 3.2% of patients in comparator groups. The majority (>90%) of these events were reported as mild or moderate. Two patients in the EXUBERA and one in the comparator group discontinued treatment due to chest pain. The incidence of all-causality adverse events related to coronary artery disease, such as angina pectoris or myocardial infarction was comparable in the EXUBERA (0.7% angina pectoris; 0.7% myocardial infarction) and comparator (1.3% angina pectoris; 0.7% myocardial infarction) treatment groups.
Dry mouth was reported in 2.4% of EXUBERA-treated patients and 0.8% of patients in comparator groups. Nearly all (>98%) of dry mouth reported was mild or moderate. No patients discontinued treatment due to dry mouth.
Pediatric type 1 diabetics in EXUBERA groups experienced adverse events related to the ear more frequently than did pediatric type 1 diabetics in treatment groups receiving only subcutaneous insulin. These events included otitis media (EXUBERA 6.5%; SC 3.4%), ear pain (EXUBERA 3.9%; SC 1.4%), and ear disorder (EXUBERA 1.3%; SC 0%).
Respiratory Adverse Events
Table 6 shows the incidence of respiratory adverse events for each treatment group that were reported in ≥1% of any treatment group in controlled Phase 2 and 3 clinical studies, regardless of causality.
| Percent of Patients Reporting Event | |||||
|---|---|---|---|---|---|
| Adverse Event | Type 1 Diabetes | Type 2 Diabetes | |||
| EXUBERAN = 698 | SCN = 705 | EXUBERAN = 1279 | SCN = 488 | OAsN = 644 | |
| Respiratory Tract Infection | 43.3 | 42.0 | 29.2 | 38.1 | 19.7 |
| Cough Increased | 29.5 | 8.8 | 21.9 | 10.2 | 3.7 |
| Pharyngitis | 18.2 | 16.6 | 9.5 | 9.6 | 5.9 |
| Rhinitis | 14.5 | 10.9 | 8.8 | 10.5 | 3.0 |
| Sinusitis | 10.3 | 7.4 | 5.4 | 10.0 | 2.3 |
| Respiratory Disorder | 7.4 | 4.1 | 6.1 | 10.2 | 1.7 |
| Dyspnea | 4.4 | 0.9 | 3.6 | 2.5 | 1.4 |
| Sputum Increased | 3.9 | 1.3 | 2.8 | 1.0 | 0.5 |
| Bronchitis | 3.2 | 4.1 | 5.4 | 3.9 | 4.0 |
| Asthma | 1.3 | 1.3 | 2.0 | 2.3 | 0.5 |
| Epistaxis | 1.3 | 0.4 | 1.2 | 0.4 | 0.8 |
| Laryngitis | 1.1 | 0.4 | 0.5 | 0.4 | 0.3 |
| Pneumonia | 0.9 | 1.1 | 0.9 | 1.6 | 0.6 |
| Voice Alteration | 0.1 | 0.1 | 1.3 | 0.0 | 0.3 |
In 3 clinical studies, patients who completed a cough questionnaire reported that the cough tended to occur within seconds to minutes after EXUBERA inhalation, was predominantly mild in severity and was rarely productive in nature. The incidence of this cough decreased with continued EXUBERA use. In controlled clinical studies, 1.2% of patients discontinued EXUBERA treatment due to cough.
Nearly all (>97%) of dyspnea was reported as mild or moderate. A small number of EXUBERA-treated patients (0.4%) discontinued treatment due to dyspnea compared to 0.1% of comparator-treated patients.
The majority of these events were reported as mild or moderate. A small number of EXUBERA-treated patients discontinued treatment due to pharyngitis (0.2%) and sputum increased (0.1%); no patients discontinued treatment due to epistaxis.
The effect of EXUBERA on the respiratory system has been evaluated in over 3800 patients in controlled phase 2 and 3 clinical studies (in which 1977 patients were treated with EXUBERA). In randomized, open-label clinical trials up to two years duration, patients treated with EXUBERA demonstrated a greater decline in pulmonary function, specifically the forced expiratory volume in one second (FEV) and the carbon monoxide diffusing capacity (DL), than comparator treated patients. The mean treatment group differences in FEV and DL, were noted within the first several weeks of treatment with EXUBERA, and did not progress over the two year treatment period. In one completed controlled clinical trial in patients with type 2 diabetes following two years of treatment with EXUBERA, patients showed resolution of the treatment group difference in FEV six weeks after discontinuation of therapy. Resolution of the effect of EXUBERA on pulmonary function in patients with type 1 diabetes has not been studied after long-term treatment.
Figures 3 through 6 display the mean FEV and DL change from baseline versus time from two ongoing randomized, open-label, two year studies in 580 patients with type 1 and 620 patients with type 2 diabetes.
Figure 3: Change from Baseline FEV1 (L) in Patients with Type 1 Diabetes (Mean +/-Standard Deviation)
Figure 4: Change from Baseline FEV1 (L) in Patients with Type 2 Diabetes (Mean +/- Standard Deviation)
Following 2 years of EXUBERA treatment in patients with type 1 and type 2 diabetes, the difference between treatment groups for the mean change from baseline FEV was approximately 40 mL, favoring the comparator.
Figure 5: Change from Baseline DLco (mL/min/mmHg) in Patients with Type 1 Diabetes (Mean +/- Standard Deviation)
Figure 6: Change from Baseline DLco (mL/min/mmHg) in Patients with Type 2 Diabetes (Mean +/- Standard Deviation)
Following 2 years of EXUBERA treatment, the difference between treatment groups for the mean change from baseline DL was approximately 0.5mL/min/mmHg (type 1 diabetes), favoring the comparator, and approximately 0.1mL/min/mmHg (type 2 diabetes), favoring EXUBERA.
During the two-year clinical trials, individual patients experienced notable declines in pulmonary function in both treatment groups. A decline from baseline FEV of ≥ 20% at last observation occurred in 1.5% of EXUBERA-treated and 1.3% of comparator-treated patients. A decline from baseline DL of ≥ 20% at last observation occurred in 5.1% of EXUBERA-treated and 3.6% of comparator treated patients.
What should I look out for while using Exubera?
EXUBERA is contraindicated in patients hypersensitive to EXUBERA or one of its excipients.
EXUBERA is contraindicated in patients who smoke or who have discontinued smoking less than 6 months prior to starting EXUBERA therapy. If a patient starts or resumes smoking, EXUBERA must be discontinued immediately due to the increased risk of hypoglycemia, and an alternative treatment must be utilized (see ). The safety and efficacy of EXUBERA in patients who smoke have not been established.
EXUBERA is contraindicated in patients with unstable or poorly controlled lung disease, because of wide variations in lung function that could affect the absorption of EXUBERA and increase the risk of hypoglycemia or hyperglycemia.
EXUBERA differs from regular human insulin by its rapid onset of action. When used as mealtime insulin, the dose of EXUBERA should be given within 10 minutes before a meal.
Hypoglycemia is the most commonly reported adverse event of insulin therapy, including EXUBERA. The timing of hypoglycemia may differ among various insulin formulations.
Patients with type 1 diabetes also require a longer-acting insulin to maintain adequate glucose control.
Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (e.g., regular, NPH, analogs), or species (animal, human) may result in the need for a change in dosage. Concomitant oral antidiabetic treatment may need to be adjusted.
Glucose monitoring is recommended for all patients with diabetes.
Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function assessed prior to initiating therapy with EXUBERA (see ).
The use of EXUBERA in patients with underlying lung disease, such as asthma or COPD, is not recommended because the safety and efficacy of EXUBERA in this population have not been established (see ).
In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator-treated patients. There has also been 1 postmarketing report of a primary lung malignancy in an Exubera-treated patient. In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years) for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for comparator-treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking.
What might happen if I take too much Exubera?
Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both.
Mild to moderate episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise, may be needed.
Severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery.
How should I store and handle Exubera?
Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArrayEXUBERA (insulin human [rDNA origin]) Inhalation Powder is available in 1 mg and 3 mg unit dose blisters. The blisters are dispensed on perforated cards of six unit dose blisters (PVC/Aluminum). The two strengths are differentiated by color print and tactile marks that can be differentiated by touch. The 1 mg blisters and respective perforated cards are printed with green ink and the cards are marked with one raised bar. The 3 mg blisters and respective perforated cards are printed with blue ink and the cards are marked with three raised bars.Five blister cards are packaged in a clear plastic (PET) thermoformed tray. Each PET tray also contains a desiccant and is covered with a clear plastic (PET) lid. The tray of five blister cards (30 unit dose blisters) is sealed in a foil laminate pouch with a desiccant.EXUBERA (insulin human [rDNA origin]) Inhalation Powder blisters, an EXUBERA Inhaler, and replacement EXUBERA Release Units are required to initiate therapy with EXUBERA and are provided in the EXUBERA Kit. A fully assembled EXUBERA Inhaler consists of the inhaler base, a chamber, and an EXUBERA Release Unit. A fully assembled Inhaler is packaged with a replacement Chamber and is available in the EXUBERA Kit and as a separate unit. The Chamber is also available as an individual component.EXUBERA Release Units are individually packaged in a sealed thermoformed tray. One EXUBERA Release Unit is included in each fully assembled Inhaler. Two additional Release Units are provided in the EXUBERA Kit and in each Combination Pack. EXUBERA Release Units are also available individually. See Tables 9 and 10 for a description of these configurations.EXUBERA (insulin human [rDNA origin]) Inhalation Powder is available in 1 mg and 3 mg unit dose blisters. The blisters are dispensed on perforated cards of six unit dose blisters (PVC/Aluminum). The two strengths are differentiated by color print and tactile marks that can be differentiated by touch. The 1 mg blisters and respective perforated cards are printed with green ink and the cards are marked with one raised bar. The 3 mg blisters and respective perforated cards are printed with blue ink and the cards are marked with three raised bars.Five blister cards are packaged in a clear plastic (PET) thermoformed tray. Each PET tray also contains a desiccant and is covered with a clear plastic (PET) lid. The tray of five blister cards (30 unit dose blisters) is sealed in a foil laminate pouch with a desiccant.EXUBERA (insulin human [rDNA origin]) Inhalation Powder blisters, an EXUBERA Inhaler, and replacement EXUBERA Release Units are required to initiate therapy with EXUBERA and are provided in the EXUBERA Kit. A fully assembled EXUBERA Inhaler consists of the inhaler base, a chamber, and an EXUBERA Release Unit. A fully assembled Inhaler is packaged with a replacement Chamber and is available in the EXUBERA Kit and as a separate unit. The Chamber is also available as an individual component.EXUBERA Release Units are individually packaged in a sealed thermoformed tray. One EXUBERA Release Unit is included in each fully assembled Inhaler. Two additional Release Units are provided in the EXUBERA Kit and in each Combination Pack. EXUBERA Release Units are also available individually. See Tables 9 and 10 for a description of these configurations.EXUBERA (insulin human [rDNA origin]) Inhalation Powder is available in 1 mg and 3 mg unit dose blisters. The blisters are dispensed on perforated cards of six unit dose blisters (PVC/Aluminum). The two strengths are differentiated by color print and tactile marks that can be differentiated by touch. The 1 mg blisters and respective perforated cards are printed with green ink and the cards are marked with one raised bar. The 3 mg blisters and respective perforated cards are printed with blue ink and the cards are marked with three raised bars.Five blister cards are packaged in a clear plastic (PET) thermoformed tray. Each PET tray also contains a desiccant and is covered with a clear plastic (PET) lid. The tray of five blister cards (30 unit dose blisters) is sealed in a foil laminate pouch with a desiccant.EXUBERA (insulin human [rDNA origin]) Inhalation Powder blisters, an EXUBERA Inhaler, and replacement EXUBERA Release Units are required to initiate therapy with EXUBERA and are provided in the EXUBERA Kit. A fully assembled EXUBERA Inhaler consists of the inhaler base, a chamber, and an EXUBERA Release Unit. A fully assembled Inhaler is packaged with a replacement Chamber and is available in the EXUBERA Kit and as a separate unit. The Chamber is also available as an individual component.EXUBERA Release Units are individually packaged in a sealed thermoformed tray. One EXUBERA Release Unit is included in each fully assembled Inhaler. Two additional Release Units are provided in the EXUBERA Kit and in each Combination Pack. EXUBERA Release Units are also available individually. See Tables 9 and 10 for a description of these configurations.EXUBERA (insulin human [rDNA origin]) Inhalation Powder is available in 1 mg and 3 mg unit dose blisters. The blisters are dispensed on perforated cards of six unit dose blisters (PVC/Aluminum). The two strengths are differentiated by color print and tactile marks that can be differentiated by touch. The 1 mg blisters and respective perforated cards are printed with green ink and the cards are marked with one raised bar. The 3 mg blisters and respective perforated cards are printed with blue ink and the cards are marked with three raised bars.Five blister cards are packaged in a clear plastic (PET) thermoformed tray. Each PET tray also contains a desiccant and is covered with a clear plastic (PET) lid. The tray of five blister cards (30 unit dose blisters) is sealed in a foil laminate pouch with a desiccant.EXUBERA (insulin human [rDNA origin]) Inhalation Powder blisters, an EXUBERA Inhaler, and replacement EXUBERA Release Units are required to initiate therapy with EXUBERA and are provided in the EXUBERA Kit. A fully assembled EXUBERA Inhaler consists of the inhaler base, a chamber, and an EXUBERA Release Unit. A fully assembled Inhaler is packaged with a replacement Chamber and is available in the EXUBERA Kit and as a separate unit. The Chamber is also available as an individual component.EXUBERA Release Units are individually packaged in a sealed thermoformed tray. One EXUBERA Release Unit is included in each fully assembled Inhaler. Two additional Release Units are provided in the EXUBERA Kit and in each Combination Pack. EXUBERA Release Units are also available individually. See Tables 9 and 10 for a description of these configurations.EXUBERA (insulin human [rDNA origin]) Inhalation Powder is available in 1 mg and 3 mg unit dose blisters. The blisters are dispensed on perforated cards of six unit dose blisters (PVC/Aluminum). The two strengths are differentiated by color print and tactile marks that can be differentiated by touch. The 1 mg blisters and respective perforated cards are printed with green ink and the cards are marked with one raised bar. The 3 mg blisters and respective perforated cards are printed with blue ink and the cards are marked with three raised bars.Five blister cards are packaged in a clear plastic (PET) thermoformed tray. Each PET tray also contains a desiccant and is covered with a clear plastic (PET) lid. The tray of five blister cards (30 unit dose blisters) is sealed in a foil laminate pouch with a desiccant.EXUBERA (insulin human [rDNA origin]) Inhalation Powder blisters, an EXUBERA Inhaler, and replacement EXUBERA Release Units are required to initiate therapy with EXUBERA and are provided in the EXUBERA Kit. A fully assembled EXUBERA Inhaler consists of the inhaler base, a chamber, and an EXUBERA Release Unit. A fully assembled Inhaler is packaged with a replacement Chamber and is available in the EXUBERA Kit and as a separate unit. The Chamber is also available as an individual component.EXUBERA Release Units are individually packaged in a sealed thermoformed tray. One EXUBERA Release Unit is included in each fully assembled Inhaler. Two additional Release Units are provided in the EXUBERA Kit and in each Combination Pack. EXUBERA Release Units are also available individually. See Tables 9 and 10 for a description of these configurations.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The primary activity of insulin is regulation of glucose metabolism. Insulin lowers blood glucose concentrations by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.
Non-Clinical Toxicology
EXUBERA is contraindicated in patients hypersensitive to EXUBERA or one of its excipients.EXUBERA is contraindicated in patients who smoke or who have discontinued smoking less than 6 months prior to starting EXUBERA therapy. If a patient starts or resumes smoking, EXUBERA must be discontinued immediately due to the increased risk of hypoglycemia, and an alternative treatment must be utilized (see ). The safety and efficacy of EXUBERA in patients who smoke have not been established.
EXUBERA is contraindicated in patients with unstable or poorly controlled lung disease, because of wide variations in lung function that could affect the absorption of EXUBERA and increase the risk of hypoglycemia or hyperglycemia.
EXUBERA differs from regular human insulin by its rapid onset of action. When used as mealtime insulin, the dose of EXUBERA should be given within 10 minutes before a meal.
Hypoglycemia is the most commonly reported adverse event of insulin therapy, including EXUBERA. The timing of hypoglycemia may differ among various insulin formulations.
Patients with type 1 diabetes also require a longer-acting insulin to maintain adequate glucose control.
Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (e.g., regular, NPH, analogs), or species (animal, human) may result in the need for a change in dosage. Concomitant oral antidiabetic treatment may need to be adjusted.
Glucose monitoring is recommended for all patients with diabetes.
Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function assessed prior to initiating therapy with EXUBERA (see ).
The use of EXUBERA in patients with underlying lung disease, such as asthma or COPD, is not recommended because the safety and efficacy of EXUBERA in this population have not been established (see ).
In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator-treated patients. There has also been 1 postmarketing report of a primary lung malignancy in an Exubera-treated patient. In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years) for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for comparator-treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking.
A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.
The following are examples of substances that may reduce the blood glucose-lowering effect of insulin that may result in hyperglycemia: corticosteroids, danazol, diazoxide, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), protease inhibitors, and atypical antipsychotic medications (e.g., olanzapine and clozapine).
The following are examples of substances that may increase the blood glucose-lowering effect of insulin and susceptibility to hypoglycemia: oral antidiabetic products, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, and sulfonamide antibiotics.
Beta-blockers, clonidine, lithium salts, and alcohol may either increase or reduce the blood glucose-lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine, and reserpine, the signs and symptoms of hypoglycemia may be reduced or absent.
Bronchodilators and other inhaled products may alter the absorption of inhaled human insulin (see ). Consistent timing of dosing of bronchodilators relative to EXUBERA administration, close monitoring of blood glucose concentrations and dose titration as appropriate are recommended.
As with all insulin preparations, the time course of EXUBERA action may vary in different individuals or at different times in the same individual. Adjustment of dosage of any insulin may be necessary if patients change their physical activity or their usual meal plan. Insulin requirements may be altered during intercurrent conditions such as illness, emotional disturbances, or stress.
The safety of EXUBERA alone, or in combination with subcutaneous insulin or oral agents, has been evaluated in approximately 2500 adult patients with type 1 or type 2 diabetes who were exposed to EXUBERA. Approximately 2000 patients were exposed to EXUBERA for greater than 6 months and more than 800 patients were exposed for more than 2 years.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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