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Idiopathic Pulmonary Fibrosis

Jeremy Feldman, MD

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    • Gastro-Esophageal Reflux (GER) and Idiopathic Pulmonary Fibrosis
    • Interstitial Lung Disease vs. Idiopathic Pulmonary Fibrosis
    • Is Pulmonary Fibrosis Hereditary?
    • Research, Life Expectancy and Prognosis for Idiopathic Pulmonary Fibrosis
  • Diagnosing & Monitoring PF
    • Monitoring Progress of IPF
    • Idiopathic Pulmonary Fibrosis Diagnosis
    • Chest X-rays Used in IPF
    • CPET used in IPF
    • HRCT Scans Used to Evaluate IPF
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    • Esbriet (pirfenidone) Used to Treat IPF
    • OFEV (nintedanib) Used to Treat IPF
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      • Update on Oxygen Use
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    • FAQ: Contagious Cough? Stem Cells, Familial IPF, Flying
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Managing OFEV Side Effects

December 22, 2015 By Dr. Jeremy Feldman

prescription for Ofev (nintedanib)Many medications are accompanied by side effects.  These side effects can range from annoying to life-threatening.  When the FDA considers approving a new medication, there is a careful evaluation of the benefits of the new medication weighed against the side effects.  For life threatening diseases such as pulmonary fibrosis, the FDA is willing to accept substantial side effects.

The most common side effect patients experience with OFEV is diarrhea.

In the clinical studies more than half of patients treated with OFEV had at least some diarrhea.  For most patients this is mild to moderate.  However, for some patients this may be quite severe.  In cases of mild diarrhea, the first strategy is to ensure adequate oral intake of fluids to prevent dehydration.  Over the counter anti-diarrhea medication such as Imodium is often helpful.  For more severe diarrhea, Lomotil (a prescription anti-diarrhea medication) may be effective.

If these interventions are not effective, then I generally stop the medication until the diarrhea has resolved and re-challenge with the lower dose (100mg twice daily).  If severe diarrhea persists at the lower dose then I would stop the medication permanently.  It is important to demonstrate that the diarrhea was caused by OFEV. There are other causes of diarrhea such as antibiotic associated diarrhea.  If the diarrhea does not resolve within a few days of stopping OFEV then I would begin an investigation into other causes.

Many patients find that over time the diarrhea becomes less prominent.  Patients often adjust their diet and find foods that are better tolerated.  OFEV should not be given to patients at increased risk for bowel perforation (a specific type of bowel injury).  We generally withhold OFEV for 4 weeks after major bowel surgery.

Irritation of the Liver

Another potential side effect with OFEV is irritation of the liver manifested as elevated liver function tests.  14% of patients in the pivotal study experienced this side effect.  As a result, monthly liver function testing for the first 3 months then quarterly liver function tests are required.

Bleeding with OFEV

The last significant side-effect encountered in the research studies was a small increased risk of bleeding.  As a result, we monitor blood counts monthly for the first 3 months then quarterly thereafter.

As OFEV is an important treatment for a life-threatening disease, perseverance is important.  It is important to keep your doctor informed of your side-effects.  Open communication maximizes your chances of tolerating this medication.

Filed Under: IPF Treatment

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  • What is Idiopathic Pulmonary Fibrosis?
    • Symptoms of Idiopathic Pulmonary Fibrosis
    • Causes of Idiopathic Pulmonary Fibrosis
    • Who Gets Idiopathic Pulmonary Fibrosis
    • Gastro-Esophageal Reflux (GER) and IPF
    • Interstitial Lung Disease vs. Idiopathic Pulmonary Fibrosis
    • Is Pulmonary Fibrosis Hereditary?
    • Research, Life Expectancy & Prognosis for Pulmonary Fibrosis

Diagnosing IPF

  • Idiopathic Pulmonary Fibrosis Diagnosis
    • Chest X-rays Used in IPF
    • CPET used in IPF
    • HRCT Scans Used to Evaluate IPF
    • Lung Biopsy To Diagnose IPF
    • Pulmonary Function Tests (PFTS)
    • Six Minute Walk Test To Monitor IPF
    • Stages of Idiopathic Pulmonary Fibrosis
    • Complications of Idiopathic Pulmonary Fibrosis

Treating IPF

  • Pulmonary Fibrosis Treatment Options
    • Esbriet (pirfenidone) Used to Treat IPF
    • OFEV (nintedanib) Used to Treat IPF
    • Pulmonary Rehab for IPF Patients
    • Lung Transplantation for Pulmonary Fibrosis
    • Oxygen Used to Treat IPF
    • Clinical Trials in Idiopathic Pulmonary Fibrosis
    • IPF & Leg Swelling
    • Pulmonary Hypertension and Idiopathic Pulmonary Fibrosis
    • IPF Exacerbation

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