insulin inhalation powder

insulin inhalation powder (rDNA origin)

Exubera

Pharmacologic class: Pancreatic hormone

Therapeutic class: Hypoglycemic

Pregnancy risk category C

Action

Rapid-acting inhaled insulin form. Decreases blood glucose level by stimulating peripheral glucose uptake by skeletal muscle and fat and inhibiting hepatic glucose production; inhibits lipolysis in adipocytes, inhibits proteolysis, and enhances protein synthesis.

Availability

Chamber: one replacement chamber

Combination pack 12: 1 mg × 90 blisters, 3 mg × 90 blisters, two release units

Combination pack 15: 1 mg × 180 blisters, 3 mg × 90 blisters, two release units

Inhaler and chamber: one inhaler and one replacement chamber

Kit: one inhaler, one replacement chamber, 1 mg × 180 blisters, 3 mg × 90 blisters, two release units

⊘Indications and dosages

➣ Type 1 diabetes mellitus, given with longer-acting insulin; type 2 diabetes mellitus, given alone or in combination with oral agents or longer-acting insulin

Adults: Initial dosage individualized based on patient's weight, as calculated by this formula: Weight (kg) × 0.05 mg/kg = premeal dosage (mg), rounded down to nearest whole milligram. (See chart below.) Administer by inhalation with Exubera inhaler immediately (no more than 10 minutes) before a meal. Adjust dosage based on patient's need, including blood glucose levels, meal size and nutrient composition, time of day, and recent or anticipated exercise.

Approximate premeal dosage based on weight

Weight (kg)	Initial dose per meal	Number of 1-mg capsules/dose	Number of 3-mg capsules/dose
30-39.9	1 mg	1	-
40-59.9	2 mg	2	-
60-79.9	3 mg	-	1
80-99.9	4 mg	1	1
100-119.9	5 mg	2	1
120-139.9	6 mg	-	2

Dosage adjustment

• Renal or hepatic impairment

Contraindications

• Hypersensitivity to drug or its components
• Unstable or poorly controlled lung disease
• Patients who smoke or who stopped smoking less than 6 months before starting drug

Precautions

Use cautiously in:
• hepatic or renal disease
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Drug is intended only for inhalation with Exubera inhaler.
• Know that 1-mg blister is approximately equivalent to 3 international units of subcutaneously injected regular human insulin; 3-mg blister, to 8 international units.
• When used as meal-time insulin, drug must be taken within 10 minutes before meal.

Route	Onset	Peak	Duration
Inhalation	10-20 min	2 hr	6 hr

Adverse reactions

CV: chest pain

EENT: otitis media, epistaxis, rhinitis, sinusitis, laryngitis, pharyngitis

GI: dry mouth

Metabolic: hypoglycemia

Respiratory: respiratory tract infection, respiratory disorder, increased sputum, bronchitis, asthma, pneumonia, cough, decline in forced expiratory volume and carbon monoxide-diffusing capacity

Other: allergic reaction

Interactions

Drug-drug. Angiotensin-converting enzyme inhibitors, disopyramide, fibric acid derivatives, fluoxetine, monoamine oxidase inhibitors, oral hypoglycemics, pentoxifylline, propoxyphene, salicylates, sulfonamides: increased hypoglycemic effect

Atypical antipsychotics, corticosteroids, danazol, diazoxide, diuretics, estrogens, glucagon, isoniazid, phenothiazine derivatives, progestogens, protease inhibitors, somatropin, sympathomimetics, thyroid hormones: decreased hypoglycemic effect

Beta-adrenergic blockers, clonidine, lithium salts: increased or decreased hypoglycemic effect

Drug-diagnostic tests. Blood glucose: decreased

Drug-food. Caffeine: increased or decreased blood glucose, altered response to insulin

Drug-herbs. Bilberry, eucalyptus, flaxseed, ginseng, stinging nettle: decreased blood glucose

Blue cohosh, devil's claw, melatonin: increased blood glucose

Gingko: increased or decreased blood glucose, altered response to insulin

Drug-behaviors. Alcohol use: increased or decrease hypoglycemic effect

Patient monitoring

• Perform pulmonary function tests before patient starts drug, after first 6 months of therapy, and then annually.
• Monitor blood glucose level frequently.
• Know that as with other insulins, drug may cause rare but potentially serious generalized allergic reaction, which may lead to whole-body rash, shortness of breath, wheezing, blood pressure drop, rapid pulse, and sweating. Severe cases (including anaphylactic reactions) may be life-threatening. If such a reaction occurs, stop drug and expect to administer other therapies.

Patient teaching

• Inform patient that when used as meal-time insulin, drug must be taken within 10 minutes before meal.
☞ Advise patient that capsules are for inhalation only and must be used only with included inhaler.
• Caution patient not to interchange three 1-mg dose blisters for one 3-mg dose blister.
• Instruct patient to take other inhaled medications before drug during respiratory illness.
• Teach patient to clean inhaler mouthpiece and chamber weekly, change release unit in inhaler every 2 weeks, and change inhaler yearly.
• Instruct patient to use unit-dose blisters within 3 months of opening foil overwrap and to return blisters to overwrap to protect from moisture.
• Encourage patient to adhere to prescribed diet.
• Inform patient he'll need to undergo pulmonary function tests before therapy starts, after 6 months, and then annually.
• Advise patient to discuss smoking with prescriber. Caution him not to start smoking during therapy.
• Caution patient not to take other drugs or herbs without consulting prescriber.
• Instruct patient to avoid alcohol during therapy.
• Advise female patient to notify prescriber if she is pregnant or breastfeeding or plans to become pregnant or to breastfeed.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, herbs, and behaviors mentioned above.