Ofev (nintedanib) is a prescription medication used to treat three types of lung disease where scar tissue progressively builds up in the lungs: idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated interstitial lung disease (SSc-ILD), and chronic fibrosing interstitial lung diseases with a progressive phenotype. It doesn’t cure these conditions or reverse existing scarring, but it slows the rate at which lung function declines.
The Three Conditions Ofev Treats
Idiopathic pulmonary fibrosis (IPF) is a chronic disease where the lungs become increasingly scarred for reasons that aren’t fully understood. Over time, the scarring makes the lungs stiff and makes it harder to breathe. IPF was the first condition Ofev was approved to treat, and it remains the most common use.
Systemic sclerosis-associated ILD (SSc-ILD) is lung scarring that develops as a complication of scleroderma, an autoimmune disease that causes hardening of the skin and connective tissues. When scleroderma affects the lungs, it can cause the same kind of progressive fibrosis seen in IPF.
Chronic fibrosing ILDs with a progressive phenotype is a broader category. It covers a range of interstitial lung diseases, beyond IPF and SSc-ILD, where fibrosis is actively getting worse. To qualify, patients typically need to show worsening lung function, worsening symptoms, or increasing fibrosis on imaging within the prior 24 months, with fibrosing disease covering more than 10% of the lungs on a CT scan.
How Ofev Slows Lung Scarring
Lung fibrosis is driven by overactive fibroblasts, the cells responsible for producing scar tissue. Several growth factors fuel this process by signaling fibroblasts to multiply, migrate, and deposit connective tissue in the lungs. Ofev works by blocking the receptors for three of these key growth factors: one involved in blood vessel formation, one that stimulates cell growth, and one that drives fibroblast activity. By occupying the docking site these signals use to enter cells, Ofev reduces fibroblast proliferation, migration, and survival. It also appears to limit abnormal blood vessel growth in the lungs.
The result isn’t a reversal of existing damage. Rather, the scarring process slows down, preserving more of the lung function you still have.
How Much It Slows Lung Function Decline
Lung function in fibrotic lung diseases is measured by forced vital capacity (FVC), the total amount of air you can forcefully exhale. In healthy people, FVC stays relatively stable. In progressive fibrotic disease, it drops steadily year over year.
In three clinical trials of IPF patients, Ofev reduced the annual rate of FVC decline significantly. In one study, patients on placebo lost about 191 mL of lung capacity per year, while those on Ofev lost only 60 mL, a difference of 131 mL per year. The other two IPF trials showed similar results, with treatment differences of 125 mL and 94 mL per year.
In the SSc-ILD trial, patients on Ofev lost 52 mL per year compared to 93 mL per year on placebo. That’s a smaller absolute difference (about 41 mL per year), but SSc-ILD patients in that trial were declining more slowly to begin with. In practical terms, slowing a decline of this size over several years can mean the difference between maintaining independence and needing supplemental oxygen sooner.
Common Side Effects
Diarrhea is by far the most common side effect. In IPF trials, 62% of patients on Ofev experienced it, compared to 18% on placebo. The rates were even higher in SSc-ILD (76%) and progressive fibrosing ILD (67%). For many patients, diarrhea is manageable with over-the-counter antidiarrheal medications and adequate hydration, but it can be significant enough to require a dose change.
Nausea affects roughly a quarter to a third of patients depending on the condition being treated, and vomiting occurs in 12% to 25%. These gastrointestinal effects tend to be most pronounced in the first few months and often improve over time.
Taking Ofev with food is recommended and can help reduce stomach-related side effects.
Managing Side Effects With Dose Changes
If diarrhea or other gastrointestinal symptoms become difficult to tolerate, your doctor has several options before stopping the medication entirely. The standard dose is 150 mg twice daily, but this can be temporarily interrupted to let symptoms settle, then restarted at a reduced dose of 100 mg twice daily. If symptoms resolve at the lower dose, your doctor may try increasing back to 150 mg. If 100 mg twice daily still causes intolerable side effects, the medication is typically discontinued.
The threshold for a dose adjustment is generally diarrhea of four or more extra stools per day above your baseline that persists for two to three days despite antidiarrheal treatment, or seven or more extra stools per day at any point.
Serious Risks to Be Aware Of
Ofev can affect the liver. Regular blood tests to check liver enzymes are part of the monitoring plan, particularly in the first several months of treatment. If liver enzymes rise significantly, a dose reduction or temporary stop may be needed.
Because Ofev blocks a receptor involved in blood vessel maintenance, it carries an increased risk of bleeding. Most bleeding events in clinical practice have been minor, such as nosebleeds or bruising. Patients on full-dose blood thinners or high-dose antiplatelet therapy were excluded from the clinical trials, so the safety profile in those groups isn’t well established.
There is also a potential risk of cardiovascular events, including heart attack and stroke, based on post-marketing surveillance data. These events are uncommon but have been reported. Ofev is not recommended during pregnancy due to the potential for harm to a developing fetus.
What Taking Ofev Looks Like Day to Day
Ofev comes as a capsule taken twice daily, roughly 12 hours apart, with food. It’s available in 150 mg and 100 mg strengths. Treatment is ongoing and typically continues as long as the medication is tolerated and the underlying disease warrants it. There is no defined course length; the goal is sustained slowing of disease progression over years.
Routine monitoring includes periodic blood work to check liver function and ongoing assessment of lung function to track whether the medication is having the expected effect. Your care team will also monitor for any signs of the cardiovascular or bleeding risks described above.