Insulin human

What is Insulin human?

• Insulin human (AFREZZA) is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.

What are the uses of this medicine?

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.

Limitations of use:

• AFREZZA is not for use in place of long-acting insulin. AFREZZA must be used with long-acting insulin in people who have type 1 diabetes mellitus.
• AFREZZA is not for use to treat diabetic ketoacidosis.
• 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.

How does this medicine work?

• Insulin lowers blood glucose levels by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production.
• Insulin inhibits lipolysis in adipocytes, inhibits proteolysis, and enhances protein synthesis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with the following:

• During episodes of hypoglycemia
• Chronic lung disease, such as asthma or chronic obstructive pulmonary disease (COPD), because of the risk of acute bronchospasm.
• Hypersensitivity to regular human insulin or any of the AFREZZA excipients

What drug interactions can this medicine cause?

• The risk of hypoglycemia associated with AFREZZA use may be increased with antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Dose adjustment and increased frequency of glucose monitoring may be required when AFREZZA is co-administered with these drugs.
• The glucose lowering effect of AFREZZA may be decreased when co-administered with atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline) and thyroid hormones.
• The glucose lowering effect of AFREZZA may be increased or decreased when co-administered with alcohol, beta-blockers, clonidine, and lithium salts.
• The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with AFREZZA.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

• Before initiating, perform a detailed medical history, physical examination, and spirometry (FEV 1) in all patients to identify potential lung disease.

Recommended Dosage:

• Start on 4 units of AFREZZA at each meal.
• 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 (i.e., 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.

Administration

• Take AFREZZA exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much AFREZZA to use and when to use it.
• Know the strength of AFREZZA you use. Do not change the amount of AFREZZA you use unless your healthcare provider tells you to.
• Take AFREZZA at the beginning of your meal.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.
• Keep AFREZZA and all medicines out of the reach of children.
• Your dose of AFREZZA may need to change because of:

• Change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As AFREZZA is available as single-use cartridges of:
• 4 units
• 8 units
• 12 units

This medicine is available in fallowing brand namesː

• AFREZZA

What side effects can this medication cause?

The most common side effects of this medicine include:

• Low blood sugar (hypoglycemia)
• cough
• sore throat

AFREZZA may cause serious side effects that can lead to death, 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)
• Low blood sugar (hypoglycemia)
• Decreased lung function
• Lung cancer
• Diabetic ketoacidosis
• Severe allergic reaction (whole body reaction)
• Low potassium in your blood (hypokalemia)
• Heart failure

What special precautions should I follow?

While using AFREZZA do not:

• Drive or operate heavy machinery, until you know how AFREZZA affects you
• Drink alcohol or use over-the-counter medicines that contain alcohol
• Smoke

• Acute bronchospasm has been observed in patients with asthma and COPD. Before initiating, perform spirometry (FEV 1) in all patients. Do not use in patients with chronic lung disease.
• Glucose monitoring is essential for patients receiving insulin therapy. These changes should be made under close medical supervision and the frequency of blood glucose monitoring should be increased. Concomitant oral antidiabetic treatment may need to be adjusted.
• Hypoglycemia is the most common adverse reaction associated with insulins, including AFREZZA. Patients and caregivers must 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.
• AFREZZA causes a decline in lung function over time as measured by FEV 1. Assess pulmonary function (e.g., spirometry) before initiating, after 6 months of therapy, and annually, even in the absence of pulmonary symptoms.
• AFREZZA should not be used in patients with active lung cancer. In patients with a history of lung cancer or at risk for lung cancer, the benefit of AFREZZA use should outweigh this potential risk.
• More patients using AFREZZA experienced diabetic ketoacidosis in clinical trials. In patients at risk for DKA, monitor and change to alternate route of insulin delivery, if indicated.
• Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including AFREZZA. Discontinue AFREZZA, monitor and treat if indicated.
• Hypokalemia may occur. May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated.
• Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.

What to do in case of emergency/overdose?

• Excess insulin administration may cause hypoglycemia and hypokalemia

Management of overdosage:

• Mild episodes of hypoglycemia can usually 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.
• After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia.
• Hypokalemia must be corrected appropriately.

Can this medicine be used in pregnancy?

• Limited available data with AFREZZA use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes.

Can this medicine be used in children?

• AFREZZA has not been studied in patients younger than 18 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: human insulin
• Inactive ingredients: fumaryl diketopiperazine, polysorbate 80

Who manufactures and distributes this medicine?

• Packager: Mannkind Corporation

What should I know about storage and disposal of this medication?

• Not in Use: Refrigerated Storage 2–8ºC (36–46ºF)
• 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 at 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.

• Dailymed label info on Insulin human
• FDA Insulin human

Insulin human Resources
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