Sanofi and MannKind Announce Afrezza®, the Only Inhaled Insulin, Now Available in the U.S.
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"Many people living with diabetes are not able to control their blood sugar on their current medications and may benefit from using insulin. Now they have another option to administer insulin that is not an injection," said Dr.
Afrezza is a drug-device combination product that consists of a dry formulation of human insulin delivered from a small and portable inhaler to help patients achieve blood sugar control. Afrezza is rapidly absorbed and has a short duration of action. It is administered at the beginning of a meal.
Afrezza can help control high blood sugar as part of a diabetes management plan that may include diet, exercise and other diabetes medications. Afrezza should not be used in patients with chronic lung disease such as asthma or COPD. Afrezza cannot be used to treat diabetic ketoacidosis. Afrezza is not recommended in patients who smoke or who have recently stopped smoking.
"Afrezza is an important addition to
"We are extremely proud to see the many years of work that went into developing Afrezza culminate in the day when it is now available to help people manage their diabetes," stated
About Afrezza
Afrezza is a rapid-acting, inhaled insulin used to control high blood sugar in adults with type 1 and type 2 diabetes. The product consists of a dry formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12–15 minutes of administration. Afrezza is available in 4-unit and 8-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 8 units, patients may use a combination of 4 unit and 8 unit cartridges. Other sizes of cartridges are being considered. The disposable inhaler can be used for up to 15 days, should be kept in a clean, dry place with the mouthpiece cover on and may be wiped with a clean, dry cloth if needed.
INDICATION
Prescription Afrezza is a rapid-acting inhaled insulin used to treat adults with type 1 and type 2 diabetes for the control of high blood sugar.
LIMITATIONS OF USE
Do not use Afrezza as a substitute for long-acting insulin; Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes.
Do not use Afrezza to treat diabetic ketoacidosis.
Afrezza is not recommended in patients who smoke or who have recently stopped smoking.
IMPORTANT SAFETY INFORMATION FOR AFREZZA
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE
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Do not use Afrezza if you have problems with your lungs, such as asthma or COPD. Do not use Afrezza during a low blood sugar reaction (hypoglycemia). If you are allergic to any of the ingredients in Afrezza, do not use Afrezza as this may cause a significant and severe allergic reaction.
Before using Afrezza, your doctor will take a medical history, and do a physical exam and a breathing test (called spirometry) to determine if you have lung problems. Patients with lung problems should not use Afrezza. If your doctor finds you have lung problems, use of Afrezza may cause a severe asthma-like breathing problem. Afrezza can reduce lung function, so your doctor will also want to test your breathing 6 months after starting Afrezza, and then each year after that, with more frequent testing done if you have symptoms such as wheezing or coughing. Tell your doctor if you currently have lung cancer or have had it in the past, or if you have an increased risk of developing lung cancer.
You must test your blood sugar levels while using insulin, such as Afrezza. Do not make any changes to your dose or type of insulin without talking to your healthcare provider. Any change of insulin should be made carefully and only under your doctor's care.
The most common side effect of insulin, including Afrezza, is low blood sugar (hypoglycemia), which can be serious and life-threatening. Some people may experience symptoms such as shaking, sweating, fast heartbeat, and blurred vision. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza, and to understand how to lessen the risk of hypoglycemia events.
Tell your doctor about other medicines you take, especially ones commonly called TZDs (thiazolidinediones) and supplements, because they can change the way insulin works. If you have heart failure or other heart problems, it may get worse while you take TZDs with Afrezza. Before starting Afrezza, it is important to tell your doctor about all your medical conditions including if you have a history of lung problems, if you are pregnant or plan to become pregnant, or if you are breast-feeding or planning to breast-feed.
In addition to low blood sugar (hypoglycemia), other possible side effects associated with Afrezza include cough, throat pain or irritation, headache, diarrhea, tiredness, and nausea.
Please see full Prescribing Information for Afrezza, including Boxed WARNING at www.Afrezza.com.
About Sanofi Diabetes
About
About
Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although
Disclosure: After being involved in clinical trials of Afrezza, Dr.
Afrezza® is a registered trademark of
Patented: See http://www.mannkindcorp.com/our-technology-patent-notices.htm
Manufactured by:
Distributed by:
A SANOFI COMPANY
Contacts : |
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Sanofi Media Relations |
Sanofi Investor Relations |
MannKind Investor Relations |
Jack Cox |
Sebastien Martel |
Matthew Pfeffer |
Tel.: + 33 (0) 1 53 77 46 46 |
Tel.: + 33 (0) 1 53 77 45 45 |
+1-661-775-5300 |
Sanofi US Diabetes Communications Susan Brooks +1 908 981 6566 |
Sanofi Global Diabetes Communications Phil McNamara +1 908 981 5497 |
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