RIDGEFIELD, Conn., July 15, 2015 /PRNewswire/ -- Boehringer Ingelheim welcomes the international evidence-based 2015 ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis – An Update of the 2011 Guideline which suggests that clinicians use OFEV® (nintedanib) in patients with IPF.*
The joint guidelines committee consists of representatives from an international group of leading respiratory societies including the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS) and Latin American Thoracic Association (ALAT). The recommendation puts a value on the potential benefit of OFEV on patient-important outcomes such as disease progression as measured by rate of FVC decline and mortality. The recommendation also accounts for the potential significant adverse effects and the expected cost of treatment.
"These guidelines, which update the 2011 iteration, focus on evaluation of clinical trial data in an effort to give healthcare providers an evidence-based set of recommendations for the treatment of IPF," said Imre Noth, M.D., Professor of Medicine and Director of the Interstitial Lung Disease Program at The University of Chicago. "Our priority is to provide quality care for patients living with this devastating disease. These new guidelines help to outline the role of OFEV in the treatment of IPF."
"Until last year, treatment options for patients with IPF were limited. These updated international guidelines mark an important milestone in the care of IPF patients, and we're very pleased that OFEV is included as a recommended treatment option for this devastating disease," said Danny McBryan, M.D., vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc.
The committee continuously analyzes evidence as it becomes available and updates treatment recommendations accordingly. Prior to this update, the last update came in 2011. These updated guidelines include OFEV data from two replicate Phase 3 trials (INPULSIS®-1 and INPULSIS®-2) involving more than 1,000 patients in 24 countries and a Phase II trial (TOMORROW™) involving 432 patients.
*This is a conditional recommendation. This means that clinicians must discuss preferences with their patients to help patients reach treatment decisions consistent with their values and preferences.
About OFEV® (nintedanib) capsules
The U.S. Food and Drug Administration (FDA) approved OFEV for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. OFEV is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease.
The approval was based on findings from the Phase II TOMORROW™ trial (NCT00514683) and the Phase III INPULSIS™ trials (INPULSIS™-1 and INPULSIS™-2; NCT01335464 and NCT01335477) which were all randomized, double-blind, placebo-controlled trials comparing OFEV 150 mg twice daily to placebo for 52 weeks. Both INPULSIS™ trials were identically designed while the TOMORROW™ study design was similar.
About idiopathic pulmonary fibrosis (IPF)
IPF is a rare and serious lung disease that causes permanent scarring of the lungs. It affects as many as 132,000 Americans, most commonly men over the age of 65. Early diagnosis and proper care and treatment are critical to helping people with their condition.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT OFEV?
OFEV can cause birth defects or death to an unborn baby. Women should not become pregnant while taking OFEV. Women who are able to become pregnant should use birth control during treatment and for at least 3 months after treatment. If you become pregnant while taking OFEV, tell your doctor right away.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF OFEV?
OFEV MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
- Liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal or feeling tired. Your doctor will do blood tests regularly to check how well your liver function is working during your treatment with OFEV.
- Diarrhea, nausea, and vomiting. Tell your doctor if you have diarrhea, nausea, or vomiting or if these symptoms do not go away or become worse. Tell your doctor if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements that can cause diarrhea. While you are taking OFEV, your doctor may recommend that you drink fluids or take medicine to treat these side effects.
- Heart attack. Tell your doctor right away if you have symptoms of a heart problem. These symptoms may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
- Stroke. Tell your doctor right away if you have symptoms of a stroke. These symptoms may include numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness.
- Bleeding problems. OFEV may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal. Tell your doctor if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
- Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.
These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
WHAT SHOULD I TELL MY DOCTOR BEFORE USING OFEV?
Before you take OFEV, tell your doctor if you have liver problems, heart problems, a history of blood clots, a bleeding problem or a family history of a bleeding problem, had recent surgery in your stomach (abdominal) area, are a smoker, or have any other medical conditions.
Tell your doctor if you are pregnant or plan to become pregnant. You should avoid becoming pregnant while taking OFEV. OFEV can cause harm, birth defects or death to your unborn baby. Use appropriate birth control methods while taking OFEV and for at least 3 months after your last dose. Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You and your doctor should decide if you will take OFEV or breastfeed. You should not do both.
Tell your doctor if you currently smoke. You should stop smoking prior to taking OFEV and avoid smoking during treatment.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John's wort. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine.
Click here for full Prescribing Information, including Patient Information.
What is OFEV?
OFEV is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). It is not known if OFEV is safe and effective in children.
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