MannKind Corp. (MNKD)

[Phaeton]

Look at what I found today on the Internet
Branded by Sanofi
afrezzarems.com/

afrezzarems.com/Documents/US.HUM.14.10.007%20%28Dear%20HCP%20Letter%29.pdf




Prescribing Information Including Boxed Warning Medication Guide
AFREZZA REMS (Risk Evaluation and Mitigation Strategy)
What is the AFREZZA REMS?

A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug product.

The purpose of the AFREZZA REMS is to inform healthcare providers about the following risks of AFREZZA:

Risk of acute bronchospasm in patients with chronic lung disease
Contraindicated in patients with chronic lung disease such as asthma or COPD
Need to evaluate all patients for lung disease before starting AFREZZA
Before initiating AFREZZA, perform

a detailed medical history
physical examination, and
spirometry (FEV1)
A non-promotional factsheet, reviewed by the FDA, with more detailed safety information on these risks is available in the box to the right.
Materials for Healthcare Provider
AFREZZA REMS Safety Information for Providers Factsheet
REMS Letter to Healthcare Providers