Ofev (nintedanib) for idiopathic pulmonary fibrosis
Fact-checked by What is Ofev for idiopathic pulmonary fibrosis?
Ofev (nintedanib) is an approved oral therapy used to treat people with idiopathic pulmonary fibrosis (IPF) and related lung conditions. It is not a cure for IPF, but it may help slow lung function decline and disease progression.
IPF is a type of pulmonary fibrosis (PF) — a disease in which progressive scarring (fibrosis) in the lungs makes it harder to breathe — that has no clear underlying cause. It belongs to a larger group of lung conditions called interstitial lung diseases (ILDs).
Ofev is an antifibrotic treatment for IPF, meaning it is designed to slow disease progression. It works by blocking a group of enzymes called tyrosine kinases, thereby inhibiting signaling pathways thought to promote fibrosis. This may help slow the loss of lung function over time for people with IPF.
Boehringer Ingelheim markets Ofev, which is also approved for certain other types of ILDs that can progress to pulmonary fibrosis. Generic versions of the medication are available in the U.S.
Therapy snapshot
| Brand name | Ofev |
| Chemical name | Nintedanib |
| Usage | Used to treat idiopathic pulmonary fibrosis and certain other types of interstitial lung disease |
| Administration | Oral capsules |
Who with IPF can take Ofev?
Ofev is approved in the U.S. for adults with IPF. It is also approved for adults with:
- chronic fibrosing ILDs that get worse over time (progressive fibrosing ILDs)
- systemic sclerosis-associated ILD, which is related to systemic sclerosis, an autoimmune condition that can also cause scarring.
Adult approvals are similar in the European Union and Canada. In the EU, Ofev is also approved for certain fibrosing ILDs in children age 6 and older, while Canadian prescribing information says Ofev should not be used in patients younger than 18.
The U.S. prescribing information lists no specific contraindications for Ofev, but it is not recommended for people with moderate or severe liver impairment.
How is Ofev administered in IPF?
Ofev is available as oral capsules. The recommended Ofev dosage is one 150 mg capsule twice daily, for a total dose of 300 mg per day, with the doses spaced about 12 hours apart.
Capsules should be taken with food and should not be opened, crushed, or chewed.
Doctors may prescribe a lower dose if Ofev causes problematic side effects; a lower dose is recommended for people with mild liver impairment.
Ofev in IPF clinical trials
The approval of Ofev for IPF was supported by three clinical trials, which collectively involved more than 1,000 adults ages 40 and older. The studies, each lasting a year, measured changes in forced vital capacity (FVC), an estimate of lung function that measures the amount of air a person can forcefully exhale after taking a deep breath.
- The Phase 2 TOMORROW trial (NCT00514683) showed that Ofev at its now-approved dose slowed declines in FVC by 68.4% relative to a placebo, although the difference did not reach statistical significance in the multiplicity-adjusted analysis. People who received this dose of Ofev experienced fewer acute exacerbations — sudden, clinically significant worsening of respiratory symptoms — than those in the placebo group.
- The Phase 3 INPULSIS-1 (NCT01335464) and INPULSIS-2 (NCT01335477) found that Ofev was associated with significantly slower FVC declines than a placebo. In INPULSIS-2, Ofev-treated participants avoided acute exacerbations for significantly longer than placebo-treated participants.
Other Phase 3 trials evaluated the effects of Ofev on lung function in other types of ILDs:
- INBUILD (NCT02999178) involved people with progressive fibrosing ILD, showing that Ofev lowered the risk of disease progression compared with a placebo.
- SENSCIS (NCT02597933) involved people with systemic sclerosis-associated ILD, showing that Ofev significantly slowed FVC declines compared with a placebo.
Ofev side effects
In clinical trials, the most common side effects of Ofev treatment were:
- diarrhea
- nausea
- abdominal pain
- vomiting
- increased levels of liver enzymes
- decreased appetite
- headache
- weight loss
- high blood pressure
Gastrointestinal side effects can be treated with hydration and medications to manage symptoms. If these problems remain severe despite treatment, doctors may recommend discontinuing Ofev.
The prescribing information also includes warnings about less common, but potentially serious, side effects, including:
- elevated liver enzymes and liver injury, including severe liver injury
- harm to developing fetuses
- blood clots that block arteries
- bleeding complications
- holes in the walls of the stomach or intestines (gastrointestinal perforation)
- very high levels of protein in urine, which can indicate kidney problems
If complications occur, Ofev may need to be paused or discontinued, or the dose adjusted.
Liver function should be checked before starting Ofev, at regular intervals during the first three months of treatment, and periodically afterward, as this is when liver problems are most likely to develop. If Ofev liver monitoring suggests potential liver injury, treatment may be paused or the Ofev dose reduced.
Pregnancy status should be verified before Ofev is started, and people who could become pregnant should use highly effective birth control during treatment and for at least three months after the final dose. Vomiting, diarrhea, or other side effects that could affect drug absorption may make oral birth control less effective. Breastfeeding also isn’t recommended while using Ofev.
Ofev may interact with other medications, so patients should inform their care team about all substances they are using. That includes tobacco products, as smoking can reduce Ofev exposure and may affect how well it works.
Pulmonary Fibrosis News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
