Take on IPF progression with OFEV

Size: px

Start display at page:

Download "Take on IPF progression with OFEV"

Barbra Griffin
5 years ago
Views:

1 Every breath matters Take on IPF progression with OFEV Learn more at IPF=idiopathic pulmonary fibrosis. Please see throughout

Understand how IPF affects you Idiopathic pulmonary fibrosis (IPF) is a serious disease that causes permanent

This scarring causes the lungs to become stiff and difficult to inflate, resulting in impaired lung function

Everyone experiences lung function decline as they age, losing between 30-65 ml per year.

a IPF causes a change from a healthy lung (left) to one with scarring.

2 Understand how IPF affects you Idiopathic pulmonary fibrosis (IPF) is a serious disease that causes permanent and irreversible scarring in the lungs. This scarring causes the lungs to become stiff and difficult to inflate, resulting in impaired lung function that gets worse over time. Everyone experiences lung function decline as they age, losing between ml per year. However, patients with IPF may lose 3 to 4 times more than that per year, or ml. a IPF causes a change from a healthy lung (left) to one with scarring. This scarring may form a honeycomb pattern (right). The cause of IPF is unknown and the course of the disease is often unpredictable. This is because lung function declines at different rates for different people. 2 a Milliliter (ml) is a unit of measurement. In IPF, ml is used to monitor disease progression, as determined by forced vital capacity, or FVC.

Take action with OFEV How OFEV works As of now there is no cure for IPF. However, OFEV (nintedanib) can help slow its progression. The speed at which IPF worsens is different for every person.

OFEV capsules block the effects of some of the substances that are involved in the scarring of the lungs. What is OFEV?

3 Take action with OFEV How OFEV works As of now there is no cure for IPF. However, OFEV (nintedanib) can help slow its progression. The speed at which IPF worsens is different for every person. For some people, IPF gets worse quickly, while others have IPF that does not change for several years. But IPF eventually progresses in everyone. OFEV capsules block the effects of some of the substances that are involved in the scarring of the lungs. 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. 150 mg capsules not shown at actual size. What is the most important information I should know about OFEV (nintedanib)? OFEV can cause harm, birth defects or death to an unborn baby. Women should not become pregnant while taking OFEV. Women who are able to become pregnant should have a pregnancy test before starting treatment and should use birth control during and for at least 3 months after your last dose. If you become pregnant while taking OFEV, tell your doctor right away. While OFEV (nintedanib) can t reverse damage that s already occurred, the sooner you begin treatment with OFEV capsules, the sooner you can start to slow down the decline of lung function. Specifically, OFEV can: 1 Slow down the rate of lung function decline, a measure of IPF progression, by about 50%, a as shown in 3 out of 3 medical studies 2 Reduce the risk of acute exacerbations (sudden and serious attacks of shortness of breath that are diagnosed by your doctor), as shown in 2 out of 3 medical studies 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 any other medical conditions. a This was determined by measuring FVC, one way to measure disease progression. 4 Please see throughout

OFEV can slow IPF progression OFEV (nintedanib) was proven to reduce the rate of lung function decline, a measure of IPF progression, by about 50% in 3 out of 3 medical studies.

4 OFEV can slow IPF progression OFEV (nintedanib) was proven to reduce the rate of lung function decline, a measure of IPF progression, by about 50% in 3 out of 3 medical studies. The studies compared patients taking OFEV capsules for 1 year with those who were not, by measuring their forced vital capacity, or FVC. FVC is the amount of air that you can forcibly exhale after taking the deepest breath possible. FVC is tested OFEV was using a device called a proven to reduce the rate spirometer, and is one of lung function of the ways to measure decline by about 50% IPF progression. What should I tell my doctor before using OFEV? (cont d) Tell your doctor if you: are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You should not breastfeed while taking OFEV. are a smoker. 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, herbal supplements such as St. John s wort. What are the possible side effects of OFEV? OFEV may cause serious side effects. TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including: Liver problems. Unexplained symptoms may include 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 is working during your treatment with OFEV. 6 Please see throughout

OFEV reduces the risk of acute exacerbations Some IPF patients experience acute exacerbations, or severe and sudden attacks of shortness of breath.

5 OFEV reduces the risk of acute exacerbations Some IPF patients experience acute exacerbations, or severe and sudden attacks of shortness of breath. Your doctor will determine if you have had an acute exacerbation. These events cause permanent damage to your lungs and can leave you with less lung function than before the attack. The 2 medical studies showing a benefit had similar results. The remaining study showed no effect of OFEV (nintedanib) on acute exacerbations. In one study, patients taking OFEV capsules were 80% less likely to have an acute exacerbation than those taking placebo (7.3% vs 1.5%, respectively, with an absolute difference of 5.8%). OFEV reduced the chance of having a first acute exacerbation during a 1-year period in 2 out of 3 medical studies vs placebo 80 % (7.3% vs 1.5%, respectively; difference of 5.8%) What are the possible side effects of OFEV? (cont d) TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including: Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have these symptoms, if they do not go away, or get worse and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements. 8 Please see throughout

6 Starting treatment with OFEV OFEV is delivered right to your door Be sure to take OFEV (nintedanib) exactly as your doctor tells you. You will have certain blood tests before and during treatment with OFEV capsules. Additionally, for age-appropriate female patients, your doctor will conduct a pregnancy test prior to starting OFEV. morning evening 150 mg capsules not shown at actual size. Your OFEV (nintedanib) prescription will be filled through a Specialty Pharmacy, which provides medicines for patients with complex diseases. After writing your prescription, your doctor will select a Specialty Pharmacy that is preferred by your insurance company. Take each OFEV capsule with adequate food approximately 12 hours apart 1 in the morning and 1 in the evening. 10 Taking OFEV when you have breakfast and dinner can help you remember to take it on schedule and as your healthcare team recommends. Swallow OFEV capsules whole with a liquid; do not chew or crush them. If you miss a dose, skip it and take your next dose at the regular time. Do not take 2 doses at the same time. If you take too much OFEV (more than 300 mg in 1 day), call your doctor or go to the nearest hospital right away. What are the possible side effects of OFEV? (cont d) TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including: Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath. Stroke. Symptoms of a stroke may include numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness. Please see throughout Each month, your Specialty Pharmacy will call you to arrange the delivery of your OFEV capsules. Their number may come through as blocked or restricted. It s very important that you answer the call or call your Specialty Pharmacy back to schedule the delivery, or you may not receive your OFEV on time. What are the possible side effects of OFEV? (cont d) TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including: 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 and/or 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.

OPEN DOORS : A personalized support program Financial information and assistance The team at the OPEN DOORS Patient Support Program understands the challenges of IPF, and can help manage some of the

7 OPEN DOORS : A personalized support program Financial information and assistance The team at the OPEN DOORS Patient Support Program understands the challenges of IPF, and can help manage some of the details of treatment with OFEV (nintedanib) so you can focus on what s most important your health. OPEN DOORS can help: Answer questions about IPF and OFEV capsules Connect you with nurses on call 24/7 Identify social resources in your area OPEN DOORS can work with you and your caregiver to explore options to help you pay for your prescription. Whether you have commercial insurance, Medicare, or no pharmacy benefits at all, there are programs that may help cover the costs of your OFEV (nintedanib) capsules, including: Copay support for eligible insured patients The BI Cares Patient Assistance Program for eligible patients with limited or no health insurance Patients may pay as little as $ OPENDOOR ( ) or visit Call us now to learn more. 12 Please see throughout

Clinical Educators provide personalized information and support Arrange an appointment to speak with a Clinical Educator Clinical Educators are compassionate, highly trained professionals who

A Clinical Educator helps you learn more about: IPF and what happens as it progresses Getting started on OFEV capsules How OFEV works and what you can expect from treatment Continuing use of OFEV as

8 Clinical Educators provide personalized information and support Arrange an appointment to speak with a Clinical Educator Clinical Educators are compassionate, highly trained professionals who understand IPF. They are available to meet with you to answer your questions and concerns, and share the latest information about IPF and treatment with OFEV (nintedanib). A Clinical Educator helps you learn more about: IPF and what happens as it progresses Getting started on OFEV capsules How OFEV works and what you can expect from treatment Continuing use of OFEV as prescribed A Clinical Educator can meet with you at any point during your treatment journey, and in a variety of formats to meet your needs. Your caregivers and family members are also welcome to attend. 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 or call FDA To set up a time to talk, call OPENDOOR ( ) or ask your doctor to set up a session on your behalf 14 Please see throughout

To enroll in OPEN DOORS, call 1-866-OPENDOOR (1-866-673-6366) or visit www.ofev.

com Talk to your doctor about OFEV today Please see Important Safety Information throughout this

9 To enroll in OPEN DOORS, call OPENDOOR ( ) or visit To learn more about OFEV (nintedanib) capsules, visit Talk to your doctor about OFEV today Please see Important Safety Information throughout this brochure, and accompanying Patient Information Copyright 2016, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved. (12/16) PC-OF-0413-CONS

Tips to Help Treat Diarrhea, Nausea, and Vomiting Side Effects

Tips to Help Treat Diarrhea, Nausea, and Vomiting Side Effects If you have been prescribed OFEV (nintedanib) capsules for the treatment of idiopathic pulmonary fibrosis (IPF) this brochure can help you