Idiopathic pulmonary fibrosis (IPF) is a serious lung condition involving scar tissue inside your lungs that makes it hard to breathe. It is a progressive condition, which means that it gets worse over time. Unfortunately, there is no cure for IPF. Treatment options for IPF are limited, but the goal is to slow down scar tissue growth and reduce breathing problems. Non-medicine treatments may include oxygen therapy and pulmonary rehabilitation (which includes healthy eating, exercise, limiting stress, and breathing exercises). There are also a few medicines available specifically for IPF. Ofev (nintedanib) is one of them. Continue reading to learn more about how Ofev may help with IPF.
How Does Ofev Work for IPF?
Ofev is a kinase inhibitor. It works by blocking the action of several specific proteins, called tyrosine kinases. These proteins play a role in causing scarring (fibrosis) in the lungs. By blocking the action of these proteins, Ofev helps slow down the progression of IPF.
Health care providers use pulmonary function tests to see how well you can move air in and out of your lungs. One of these tests is called forced vital capacity (FVC). It is a measure of the amount of air you can forcefully breathe out after taking a deep breath. FVC can be used to monitor the progression of IPF and to see how well your treatments are working.
How Was It Studied for IPF?
Three studies, each lasting a year, were done to evaluate how well Ofev works for IPF. The first study was a smaller study to see which dose of Ofev worked better than a placebo (containing no medicine). The other two studies (INPULSIS-1 and INPULSIS-2) were larger and compared the best dose from the smaller study to the placebo. In both the studies (INPULSIS-1 and INPULSIS-2), neiher the participants nor the study investigators knew who was taking Ofev or the placebo.
The main goal of these studies was to see how well Ofev works by measuring how much people’s lung function changed over time, based on forced vital capacity (FVC). The study investigators measured FVC at the beginning of each study, at several points during the study, and at the end of the study. This helped them understand if taking Ofev helped limit loss of lung function over time compared to the placebo. Study investigators also looked at how long it took for people in the study to have an acute IPF exacerbation (defined as an episode of significant worsening in lung function not caused by heart failure or extra fluid in the lungs) and how many people had exacerbations.
People were not allowed to enter these studies if they were using certain medicines, had serious liver problems or certain other medical problems, or were likely to need a lung transplant during the study. Everyone in INPULSIS-1 and INPULSIS-2 was at least 40 years old and had been diagnosed with IPF for less than five years. Most of the people in the studies were White (60%) or Asian (30%). Almost 80% were men, and their average age was 67 years. Upon entering the studies:
- Almost 70% of study participants had smoked in the past.
- Less than 25% of study participants were taking a steroid medicine, such as prednisone at a dose of 15 mg per day or less.
- Their average FVC (the amount of air they could blow out) was between about 2600 mL and 2850 mL.
- Their average FVC % of predicted value was about 80% (meaning they had about 80% of what would normally be expected based on age, sex, and other factors).
What Were the Study Results?
Over 52 weeks (one year), people who took Ofev 150 mg twice a day lost less lung function than people who took a placebo. Although FVC dropped for all groups, the average decline in FVC from the start of the study was significantly less among people who took Ofev. The table below shows the average changes in FVC (in milliliters, or mL) from the beginning to the end of the study.
INPULSIS-1 | INPULSIS-2 | |||
|---|---|---|---|---|
Ofev | Placebo | Ofev | Placebo | |
| Average change in FVC in mL | -115 mL | -240 mL | -114 mL | -207 mL |
| Difference from placebo | 125 mL | 94 mL | ||
It is less clear whether Ofev lowers the number of acute exacerbations or delays when they happen. In the INPULSIS-1 study, there was no difference in the time to the first acute IPF exacerbation between Ofev and a placebo. However, in INPULSIS-2, study participants who took Ofev seemed to go longer before having an acute exacerbation compared to those who took the placebo. In addition, fewer people taking Ofev had acute exacerbations (3.6%) compared to those taking the placebo (9.6%).
Your results may differ from what was seen in studies. Talk to your health care provider about what to expect while taking Ofev.
How Can I Prevent and Manage Side Effects?
If you think Ofev is causing a side effect, talk to your health care provider. They may adjust your dose, temporarily pause the medicine, or stop it altogether if needed. Continue reading to learn more about how to address some common side effects of Ofev.
Headaches. Headaches were a frequent side effect in clinical studies. Be sure to get enough sleep, eat healthy foods, drink enough water, and stay physically active. All of these things can be tried to avoid or reduce headaches. If you have headaches that are severe or do not go away, contact your health care provider.
Stomach Problems. Nausea, vomiting, and diarrhea are all possible side effects of Ofev. Sometimes, these can be severe and may even cause dehydration. Here are a few things you can do to try to prevent dehydration:
- Make sure you are drinking fluids all day, whether you are thirsty or not. You should usually drink between six and eight cups of fluids each day.
- Avoid skipping meals. You get a lot of liquid from the foods that you eat, especially fruits and vegetables.
- Limit coffee, alcohol, and caffeinated drinks.
Tell your health care provider right away about any stomach problems you have while taking Ofev, or if your symptoms get worse or do not get better. Your health care provider may recommend that you take medicine to treat or prevent these stomach problems. There are over-the-counter (OTC) and prescription medicines to help reduce diarrhea, nausea, and vomiting. If these do not work, your health care provider may lower your Ofev dose or even stop Ofev altogether.
What Kinds of Interactions May Happen?
Always tell your health care provider about any prescription or OTC medicines, vitamins/minerals, herbal products, and other supplements you are using. In addition, talk to your health care provider if you are a smoker.
Smoking. If you smoke, you should stop smoking before you start taking Ofev. Smoking can affect blood levels of certain medicines, including Ofev. If you smoke while taking Ofev, it may not work as well because smoking can lower the amount of Ofev in your blood.
Blood thinners. Ofev may increase your risk for bleeding all on its own. This risk may get even higher if you take a blood thinner (anticoagulant). If you have concerns, talk to your health care provider. Check out this article for general recommendations on handling bleeding.
Supplements. Supplements are not regulated by the FDA in the same way that medicines are. The FDA does not review these supplements for safety or efficacy before they hit the market. St. John’s wort is a commonly used supplement. It is known to interact with Ofev. Taking both Ofev and St. John’s wort may make Ofev less effective.
This is not a complete list of interactions. Other medicines may alter the blood levels of Ofev. Tell your pharmacist or other health care provider about all the prescription or OTC medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them know if there are any interactions with Ofev.bout your medicine.
What Support Is Available for Me?
Living with a progressive condition like IPF can be scary. The drugmaker of Ofev has a free support program in the form of a care team. It is called the CareConnect4Me Patient Support Program. The care team does not provide medical advice but can help you understand your condition and treatment. To enroll, you can call 866-673-6366, text “START” to 84537, or visit their website.
In addition, there may be cost assistance available for Ofev. The CareConnect4Me Patient Support Program can help you find out if you qualify for any financial assistance. Your eligibility depends on whether you have prescription insurance and what type of insurance you have. You can learn more about possible financial assistance here.
Getting Your Medicine: What to Expect
Ofev is not available at your local pharmacy. Once you and your health care provider decide that Ofev is a good choice for you, the drugmaker will connect you with a specialty pharmacy to help you get your medicine. In fact, the specialty pharmacy will mail Ofev directly to you. They will also keep in touch with you to make sure you get your refills on time and answer questions you have about your medicine.
