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This webinar is FREE
| Event Date: Thursday, June 20, 2019 |
Event Time: 1:00–1:45 p.m. Eastern Time
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Please Note: All times are Eastern. Our webinars
begin at 1:00 pm Eastern / 12:00 noon Central / 11:00 am Mountain / 10:00 am
Pacific.
Program Overview
This webinar is sponsored by MannKind Corporation.
Mealtime glucose control isn’t always easy for today’s patients. AFREZZA, the only inhaled insulin on the market with an ultra-rapid absorption feature, delivers mealtime glucose control in a unique way.
There is no CE credit for this webinar.
Objectives
-- Learn how AFREZZA can help patients with type 1 and type 2 diabetes achieve optimal mealtime glucose control in a unique way
-- Gain an understanding of how to dose & titrate AFREZZA for both type 1 and type 2 patients
-- Learn how to get patients started to help ensure a successful start with AFREZZA
Faculty
Nadia Zaveri, PharmD
Medical and Clinical Affairs Advisor
MannKind
Mark Harmel, MPH, CDE
Clinical Research Coordinator
USC Westside Center for Diabetes
Intended Audience
This LIVE webinar is open to AADE members and non-members.
This webinar will be recorded and posted in DANA (danatech.org), AADE's member-only tech hub. The recorded webinar will be available to AADE members only.
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IMPORTANT SAFETY INFORMATION
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
• Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA.
• AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD.
• Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients.
Indications and Usage
Afrezza (insulin
human) Inhalation Powder is a rapid acting inhaled insulin indicated to improve
glycemic control in adult patients with diabetes mellitus.
Limitations of Use
• AFREZZA is not a substitute for long-acting
insulin. AFREZZA must be used in combination with long-acting insulin in
patients with type 1 diabetes mellitus.
• AFREZZA is not recommended for the treatment of
diabetic ketoacidosis.
• The
safety and efficacy of AFREZZA in patients who smoke have not been established.
The use of AFREZZA is not recommended in patients who smoke or who have
recently stopped smoking (less than 6 months).
Contraindications
AFREZZA is
contraindicated in patients:
• During episodes of hypoglycemia
• With chronic lung disease (such as asthma or
chronic obstructive pulmonary disease [COPD]) because of the risk of acute
bronchospasm
• With hypersensitivity to regular human insulin
or any of the AFREZZA excipients
Warnings and
Precautions
Acute Bronchospasm: Before
initiating therapy, evaluate patients with a medical history, physical
examination and spirometry (FEV1) to
identify potential underlying lung disease. Acute bronchospasm has been
observed following AFREZZA dosing in patients with asthma and patients with
COPD. The long-term safety and efficacy of AFREZZA in patients with chronic
lung disease have not been established.
Changes in Insulin
Regimen: Monitor blood glucose in all patients treated
with insulin. Modify insulin regimen and dose cautiously and only under medical
supervision. Changes in insulin strength, manufacturer, type, or method of
administration may result in the need for a change in insulin dose or an
adjustment in concomitant oral antidiabetic treatment to help mitigate the risk
of hypoglycemia or hyperglycemia.
Hypoglycemia: Hypoglycemia
is the most common adverse reaction of insulin therapy, including AFREZZA, and
may be serious and life-threatening. Educate patients and caregivers on
mitigating the risks associated with hypoglycemia. Increased frequency of blood
glucose monitoring is recommended for patients at higher risk for hypoglycemia
and patients who have reduced symptomatic awareness of hypoglycemia.
Decline in Pulmonary
Function: AFREZZA has been shown to cause a decrease in
lung function as measured by FEV1. In
clinical trials lasting up to 2 years, AFREZZA treated patients experienced a
small (40 mL) but greater FEV1decline
than comparator-treated patients. Assess pulmonary function with spirometry at
baseline, after the initial 6 months of therapy and annually thereafter even in
the absence of pulmonary symptoms. Consider more frequent lung function
assessment in patients with pulmonary symptoms, e.g., wheezing, bronchospasm,
breathing difficulties, or persistent or recurring cough. If symptoms persist,
discontinue AFREZZA.
Lung Cancer: In
clinical trials, 2 cases of lung cancer were reported in patients exposed to
AFREZZA while no cases were reported for the comparators. In both cases, a
prior history of heavy tobacco use was identified as a risk factor for lung
cancer. Two additional cases of lung cancer (squamous cell and lung blastoma)
were reported in non-smokers exposed to AFREZZA after the trial completion.
These data are insufficient to determine whether AFREZZA has an effect on lung
or respiratory tract tumors. In patients with active lung cancer, a prior
history of lung cancer, or in patients at risk of lung cancer, consider whether
the benefits of AFREZZA outweigh the risks.
Diabetic Ketoacidosis
(DKA): Increase the frequency of glucose monitoring
and consider an alternate route of administration of insulin in patients at
risk for DKA.
Hypersensitivity
Reactions: Severe, life-threatening, generalized allergy,
including anaphylaxis, can occur with insulin products, including AFREZZA. If
hypersensitivity reactions occur, discontinue AFREZZA, treat per standard of
care and monitor if indicated.
Hypokalemia: Closely
monitor potassium levels in patients at risk of hypokalemia and treat if
indicated.
Fluid Retention and
Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Fluid
retention, which may lead to or exacerbate heart failure, can occur with
concomitant use of TZDs and insulin. Observe these patients for signs and
symptoms of heart failure. If heart failure occurs, manage according to current
standards and consider TZD dose reduction or discontinuation.
Adverse Reactions
The most common adverse
reactions associated with AFREZZA (2% or greater incidence) are
hypoglycemia, cough, and throat pain or irritation.
Drug Interactions
Certain drugs may
affect glucose metabolism, increasing the risk of hypoglycemia or decreasing
the blood glucose lowering effect of AFREZZA. Dose adjustment and increased
frequency of blood glucose monitoring may be required. Co-administration of
beta-blockers, clonidine, guanethidine, and reserpine with AFREZZA may reduce
the signs and symptoms of hypoglycemia. Full Prescribing Information, including BOXED WARNING, is available on Afrezza.com.
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