BIPI Statement On The Update To The ATS/ERS/JRS/ALAT Clinical Practice Guidelines For The Treatment Of Idiopathic Pulmonary Fibrosis

Ridgefield, Conn., [May 20, 2015] Boehringer Ingelheim welcomes the update to the ATS/ERS/JRS/ALAT Clinical Practice Guidelines for the treatment of idiopathic pulmonary fibrosis (IPF), which suggests OFEV® (nintedanib) as a treatment for IPF.  The update was presented during a late-breaking session on May 19th at the American Thoracic Society’s International Conference.

Danny McBryan, M.D., vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. commented: “The approval of OFEV was a major milestone for people with IPF and their caregivers who, up until last year, had no FDA-approved drug treatments. As a research-driven pharmaceutical company we take great pride in bringing treatments to people in need. We are pleased that OFEV is being suggested as a treatment option for patients with IPF in the updated treatment guidelines. This is an important step toward improving care for people with IPF.”

BI has a long-standing commitment to addressing the unmet needs of people affected by serious respiratory diseases like IPF. We continue to study the impact of OFEV in IPF and improve the overall understanding of this devastating disease.

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.

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.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about OFEV (nintedanib)?
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 call1-800-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.

Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families.  Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.
 

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