insulin, human inhalation

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insulin, human inhalation

(in-soo-lin),

Afrezza

(trade name)

Classification

Therapeutic: antidiabetics
Pharmacologic: hormones
Pregnancy Category: C

Indications

Control of hyperglycemia in patients with diabetes mellitus.

Action

Lowers blood glucose by:
  • stimulating glucose uptake in skeletal muscle and fat,
  • inhibiting hepatic glucose production.
Other actions:
  • inhibition of lypolysis and proteolysis,
  • enhanced protein synthesis.

Therapeutic effects

Control of hyperglycemia in diabetic patients.

Pharmacokinetics

Absorption: Rapidly absorbed from lungs.
Distribution: Widely distributed.
Metabolism and Excretion: Metabolized by liver, spleen, kidney, and muscle.
Half-life: 28–39 min.

Time/action profile (effect on blood glucose)

ROUTEONSETPEAKDURATION
Inhalnwithin 30 min30–60 min160 min

Contraindications/Precautions

Contraindicated in: Hypersensitivity to regular insulin or any other components of the formulation; Hypoglycemia; Smokers or those who have recently stopped smoking; Lung disease, including asthma, COPD and active lung cancer; Lactation: Discontinue breast feeding or inhaled insulin.
Use Cautiously in: Stress and infection (may temporarily ↑ insulin requirements);Renal/hepatic dysfunction (may ↓ insulin requirements);Concomitant use with thiazolidinediones including pioglitazone or rosiglitazone (↑ risk of fluid retention and worsening HF); Obstetric: Pregnancy may temporarily ↑ insulin requirements, should not be used during pregnancy unless potential benefit justifies potential risk to the fetus; Pediatric: Safety not established in children <18 yr.

Adverse Reactions/Side Effects

Central nervous system

  • fatigue

Respiratory

  • bronchospasm (life-threatening)
  • cough (most frequent)
  • ↓ lung function
  • throat pain/irritation

Gastrointestinal

  • diarrhea
  • nausea

Endocrinologic

  • hypoglycemia (life-threatening)

Fluid and Electrolyte

  • hypokalemia (life-threatening)

Metabolic

  • weight gain

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

Concurrent use of other antidiabetics, ACE inhibitors, ARBs, disopyrimide, fibrates, fluoxetine, MAOIs, pentoxifyllin, pramlintide, propoxyphene, salicylates, somastatin analogs including octreotide, and sulfonamide anti-infectives ↑ risk of hypoglycemia, dose modifications may be necessary. Glucose lowering effects may be ↓ by atypical antipsychotics including clozapine, and olanzapine, corticosteroids, danazol, diuretics, estrogens, glucagon, isonazid, niacin, oral (hormonal contraceptives), phenothiazines, progestogens (in hormonal contraceptives), protease inhibitors, somatropin, sympathomimetic agents including albuterol, epinephrine and terbutabline and thyroid hormones.Concurrent use of anti-adrenergics including beta-blockers, clonidine, guanethidine or reserpine may ↓ signs any symptoms of hypoglycemia.Concomitant use with thiazolidinediones including pioglitazone or rosiglitazone (↑ risk of fluid retention and worsening HF)Concurrent use of inhaled albuterol may ↑ absorpion.Glucosamine may worsen blood glucose control.Fenugreek, chromium, and coenzyme Q-10 may produce additive hypoglycemic effects.

Route/Dosage

Inhalation (Adults) 4 or 8 units inhaled at the beginning of a meal; dose depends on a variety of patient factors.

Availability

Single use cartridge for inhalation using Afrezza-specific inhaler: 4 units, 8 units

Nursing implications

Nursing assessment

  • Before starting therapy perform a detailed medical history, physical examination. and spirometry (FEV1 to determine potential lung disease. Assess pulmonary function via spirometry at baseline, after 6 mo and annually thereafter; more frequently if patient has pulmonary symptoms such as wheezing, bronchospasm, breathing difficulties, or persistent, recurring cough. May require discontinuation of inhalation therapy.
  • Assess patient periodically for symptoms of hypoglycemia (anxiety; restlessness; tingling in hands, feet, lips, or tongue; chills; cold sweats; confusion; cool, pale skin; difficulty in concentration; drowsiness; nightmares or trouble sleeping; excessive hunger; headache; irritability; nausea; nervousness; tachycardia; tremor; weakness; unsteady gait) and hyperglycemia (confusion, drowsiness; flushed, dry skin; fruit-like breath odor; rapid, deep breathing, polyuria; loss of appetite; unusual thirst) during therapy.
  • Monitor for bronchospasm. Occurs rarely, but if bronchospasm occurs, discontinue therapy and notify health care professional immediately. Re-administration should be attempted during close monitoring.
  • Assess for respiratory illness. Monitor blood glucose concentrations closely; may require dose adjustments.
  • Monitor body weight periodically. May cause weight gain. Changes in weight may necessitate changes in insulin dose.
  • Lab Test Considerations: Monitor blood glucose every 6 hr during therapy, more frequently in ketoacidosis and times of stress. A1C may be monitored every 3–6 mo to determine effectiveness.
    • Monitor serum potassium in patients at risk for hypokalemia (those using potassium-lowering agents, those receiving IV insulin) periodically during therapy.
  • Overdose is manifested by symptoms of hypoglycemia. Mild hypoglycemia may be treated by ingestion of oral glucose. Severe hypoglycemia is a life-threatening emergency; treatment consists of IV glucose, glucagon, or epinephrine.

Potential Nursing Diagnoses

Noncompliance (Patient/Family Teaching)

Implementation

  • Inhalation insulin must be used in combination with long-acting subcutaneous insulin.
    • Afrezza should only be used with Afrezza inhaler.
  • Inhalation: Administer at beginning of meal. Keep inhaler level; white mouthpiece on top and purple base on the bottom after inserting cartridge. Loss of drug effect occurs if inhaler is upside down, held with mouthpiece pointing down, shaken, or dropped after cartridge is inserted but before dose given. If these occur, replace cartridge before use.
    • Dosing: Insulin nave patients: Start with 4 units before each meal. Patients using subcut mealtime (Prandial) Insulin: Determine appropriate dose for each meal by converting from injected dose using dose conversion. Patients using subcut pre-mixed insulin: Estimate mealtime injected dose by dividing half total daily injected pre-mixed insulin dose equally among three meals. Convert each estimated injected mealtime dose to appropriate inhalation dose using dose conversion. Administer half of total daily injected pre-mixed dose as an injected basal insulin dose.
    • Dose conversion: If injected mealtime insulin dose is up to 4 units: Administer one 4 unit inhalation dose. If injected mealtime insulin dose is 5–8 units: Administer one 8 unit inhalation dose. If injected mealtime insulin dose is 9–12 units: Administer one 4 unit and one 8 unit inhalation dose (12 units). If injected mealtime insulin dose is 13–16 units: Administer two 8 unit inhalation doses (16 units). If injected mealtime insulin dose is 17–20 units: Administer one 4 unit and two 8 unit inhalation doses (20 units). If injected mealtime insulin dose is 21–24 units: Administer three 8 unit inhalation doses (24 units).
    • Adjust dose based on metabolic needs. blood glucose monitoring results, and glycemic control goal. Dose may need to be adjusted with changes in physical activity, meal patterns, renal and hepatic function, or during acute illness.
    • Monitor blood glucose carefully in patients receiving high doses of inhalation insulin. If blood glucose control is not achieved with increased inhalation doses, consider use of subcut mealtime insulin.

Patient/Family Teaching

  • Instruct patient on proper technique for administration. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
  • Advise patient to notify health care professional immediately of signs and symptoms of allergic reaction (rash, trouble breathing, fast heartbeat, sweating) occur.
  • Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long term.
  • Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness and health care professional notified of significant changes.
  • May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Caution patient to avoid smoking while taking inhaled insulin.
  • Emphasize the importance of compliance with nutritional guidelines and regular exercise as directed by health care professional.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products, especially inhaled medications.
  • Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
  • Advise patient to notify health care professional if nausea, vomiting, or fever develops, if unable to eat regular diet, or if blood glucose levels are not controlled.
  • Instruct patient on signs and symptoms of hypoglycemia and hyperglycemia and what to do if they occur.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding or planning to breastfeed.
  • Patients with diabetes mellitus should carry a source of sugar (candy, glucose gel) and identification describing their disease and treatment regimen at all times.
  • Emphasize the importance of regular follow-up, especially during first few weeks of therapy.

Evaluation/Desired Outcomes

  • Control of blood glucose levels in diabetic patients without the appearance of hypoglycemic or hyperglycemic episodes.
References in periodicals archive ?
marketing for Afrezza, said in an interview Tuesday.
Sanofi announced the signing of a worldwide exclusive licensing agreement with MannKind Corporation to develop and commercialize Afrezza (insulin human) Inhalation Powder, a new rapid-acting inhaled insulin therapy for adults with type I and type II diabetes.
I am reminded of this because the FDA recently approved MannKind's inhalable insulin product, Afrezza.
So might something that was in the news last month: the decision by an FDA advisory panel to approve Afrezza, an inhalable insulin produced by MannKind Corporation, for clinical trials.
We recently held a productive End-of-Review meeting with the FDA regarding the path forward for AFREZZA.
The inhaled insulin device, known as Afrezza, has already been turned down once by the FDA, which said in March it would not approve the product until it had received more information.
The insulin, trade name AFREZZA, is orally inhaled for absorption via the lung.
According to its Q2 financial report, AFREZZA became fully accessible in February, but it generate zero revenue.
However, contraindications, side effects, and competition will continue to prevent Afrezza from gaining a sizeable share of the fast-acting insulin market.
The allegations may further delay action by the FDA on MannKind's application to clear the drug, Afrezza, said Simos Simeonidis, an analyst for Rodman & Renshaw in New York.
Afrezza is a dry powder formulation packaged in unit dose cartridges administered to patients using a reusable, breath-powered inhaler that fits into the palm of a patient's hand.
Weil is advising global pharmaceutical and healthcare firm Sanofi on its worldwide exclusive licensing agreement with MannKind Corporation to develop and commercialize Afrezza (insulin human) Inhalation Powder.