Exubera

DRUG DESCRIPTION

EXUBERA (insulin human rdna origin) consists of blisters containing human insulin inhalation powder, which are administered using the EXUBERA (insulin human rdna origin) Inhaler. EXUBERA (insulin human rdna origin) blisters contain human insulin produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Chemically, human insulin has the empirical formula C257H383N65O77S6 and a molecular weight of 5808. Human insulin has the following primary amino acid sequence:

Exubera (insulin human rdna origin) 
  (insulin human [rdna origin])  Structural Formula Illustration

EXUBERA (insulin human rdna origin) (insulin human [rDNA origin]) Inhalation Powder is a white to off-white powder in a unit dose blister (fill mass, see Table 1). Each unit dose blister of EXUBERA (insulin human rdna origin) contains a 1 mg or 3 mg dose of insulin (see Table 1) in a homogeneous powder formulation containing sodium citrate (dihydrate), mannitol, glycine, and sodium hydroxide. After an EXUBERA (insulin human rdna origin) 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 in vitro test conditions, EXUBERA (insulin human rdna origin) delivers a specific emitted dose of insulin from the mouthpiece of the inhaler (see Table 1). 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.

Table 1: Dose Nomenclature and Information

Fill Mass
(mg powder)
Nominal Dose
(mg insulin)
Emitted Dose*,
(mg insulin)
Fine Particle Dose,
(mg insulin)
1.7 1.0 0.53 0.4
5.1 3.0 2.03 1.0
Flow rate of 30 L/min for 2.5 seconds
Emitted dose and fine particle dose information are not intended to predict actual pharmacodynamic response.
Flow rate of 28.3 L/min for 3 seconds

The actual amount of insulin delivered to the lung will depend on individual patient factors, such as inspiratory flow profile. In vitro, emitted aerosol metrics are unaffected at flow rates above 10 L/min.

What are the possible side effects of insulin inhalation (EXUBERA)?

Hypoglycemia (low blood sugar) is the most common side effect of insulin inhalation. Watch for signs of low blood sugar, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Get emergency medical help if you have any of these signs of an allergic reaction: rash, hives, or itching; wheezing, gasping for breath; fast heartbeat; sweating; feeling light-headed or...

Read All Potential Side Effects and See Pictures of Exubera


Exubera Patient Information Including Side Effects

Brand Names: EXUBERA

Generic Name: insulin inhalation (Pronunciation: IN soo lin in hel AY shun)

  • What is insulin inhalation (Exubera)?
  • What are the possible side effects of insulin inhalation (Exubera)?
  • What is the most important information I should know about insulin inhalation (Exubera)?
  • What should I discuss with my health care provider before taking insulin inhalation (Exubera)?
  • How should I take insulin inhalation (Exubera)?
  • What happens if I miss a dose (Exubera)?
  • What happens if I overdose (Exubera)?
  • What should I avoid while taking insulin inhalation (Exubera)?
  • What other drugs will affect insulin inhalation (Exubera)?
  • Where can I get more information?

What is insulin inhalation (Exubera)?

Insulin inhalation is a rapid-acting form of human insulin that is inhaled through the mouth. It works by lowering levels of glucose (sugar) in the blood.

Insulin inhalation is used to treat type 1 (insulin dependent) or type 2 (non-insulin dependent) diabetes in adults.

Insulin inhalation (Exubera) was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.

Insulin inhalation may also be used for purposes other than those listed here.

What are the possible side effects of insulin inhalation (Exubera)?

Hypoglycemia (low blood sugar) is the most common side effect of insulin inhalation. Watch for signs of low blood sugar, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Get emergency medical help if you have any of these signs of an allergic reaction: rash, hives, or itching; wheezing, gasping for breath; fast heartbeat; sweating; feeling light-headed or fainting.

Other less serious side effects are more likely to occur, such as:

  • cough, sore throat;
  • runny or stuffy nose;
  • dry mouth; or
  • ear pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What is the most important information I should know about insulin inhalation (Exubera)?

Insulin inhalation (Exubera) was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.

Do not use insulin inhalation if you smoke, or if you have recently quit smoking (within the past 6 months). If you start smoking while using insulin inhalation, you will have to stop using this medication and switch to another form of insulin to control your blood sugar.

Before using this medicine, tell your doctor if you have kidney disease, liver disease, or lung disorders such as asthma or COPD (chronic obstructive pulmonary disease).

You should not insulin inhalation if you have a lung disease that is not well controlled with medication or other treatments.

There are many other drugs that can potentially interfere with the glucose-lowering effects of insulin inhalation. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

If you use insulin inhalation as a meal-time insulin, use it no more than 10 minutes before eating the meal.

This medication is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Know the signs and symptoms of hypoglycemia, which include headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and nausea. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

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