Full Answer
What is the survival time for patients treated with Ofev?
Using FVC results from the six clinical trials, the researchers were able to use mathematical models to estimate patients’ survival time. In the models, survival was found to be significantly longer with Ofev treatment than with placebo. Patients treated with Ofev had an estimated average survival time of 11. 6 years from the start of treatment.
How long do Ofev side effects take to go away?
If you would like to notify the FDA about a side effect you’ve had with Ofev, you can do so through MedWatch. Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.
What is the expiration date on Ofev?
When you get Ofev from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication. The expiration date helps guarantee that the medication is effective during this time. The current stance
How often should I take Ofev for lung disease?
For the types of lung disease Ofev is approved to treat, the usual recommended dosage is 150 mg twice per day. Your doses should be taken about 12 hours apart with food. To read about the types of lung disease Ofev is used for, see the “ Ofev uses ” section below.
Does Ofev extend life?
Treatment with Ofev (nintedanib) can significantly extend the survival of patients with idiopathic pulmonary fibrosis (IPF), an analysis of pooled data from six clinical trials shows.
How long should you take Ofev?
Patients were to receive treatment for at least 52 weeks; individual patients were treated for up to 100 weeks. The median duration of exposure was 15 months for patients treated with OFEV and 16 months for patients treated with placebo.
What is the success rate of Ofev?
After they switched to Ofev, treatment successfully prevented respiratory decline in 70% of the patients who had been treated previously with Esbriet.
How long does pulmonary fibrosis last?
The average life expectancy of patients with pulmonary fibrosis is three to five years after diagnosis. However, early detection of the disease is key to slowing progression, and conditions such as chronic obstructive pulmonary disease (COPD) or pulmonary arterial hypertension (PAH) can impact disease prognosis.
Can Ofev reverse fibrosis?
Causes permanent damage to the lungs, impacting how well your lungs function. Once scarring occurs, it cannot be reversed. Scarring may spread throughout the lungs over time.
How long can I take nintedanib for?
New studies indicate that nintedanib effectively slows disease progression up to 3 years, and is efficacious in mild, moderate and severe stages of the disease. Nintedanib is well tolerated and safe up to 3 years, with diarrhoea being the most common adverse event.
Can you live a long life with pulmonary fibrosis?
A diagnosis of PF can be very scary. When you do your research, you may see average survival is between three to five years. This number is an average. There are patients who live less than three years after diagnosis, and others who live much longer.
Does Ofev cure IPF?
OFEV is the only twice-daily pill approved to: treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF). treat adults with a long lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen (progress).
Does Ofev really work?
Results showed that Ofev slowed the loss of pulmonary function by 57 percent (107 mL/year) across a range of patients relative to placebo. In patients with UIP-like fibrotic pattern on HRCT, results showed that treatment with Ofev-versus placebo slowed the loss of pulmonary function by 61 percent (128.2mL/year).
Can you live longer than 5 years with IPF?
Idiopathic pulmonary fibrosis (IPF) portends a poor prognosis. With regard to idiopathic pulmonary fibrosis life expectancy, the estimated mean survival is 2-5 years from the time of diagnosis. Estimated mortality rates are 64.3 deaths per million in men and 58.4 deaths per million in women.
How do you know when pulmonary fibrosis is getting worse?
Symptom: Increased severity of shortness of breath There is a noticeable gradual worsening of breathing. You may feel increasingly out of breath. This is due to a decrease in lung function which makes breathing more difficult. In some people, breathing might get worse more quickly, over weeks or months.
Is Shrinking lung curable?
Shrinking lung syndrome has a good prognosis. Most patients achieve some improvement with appropriate immunosuppressive therapy. Clinical improvement is common, with most patients reporting symptomatic relief. There is stabilization or improvement in lung function testing in most cases.
Before Taking This Medicine
You should not use Ofev if you are allergic to nintedanib, or if you are pregnant.To make sure Ofev is safe for you, tell your doctor if you have e...
What Happens If I Miss A Dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to...
What Happens If I Overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.Do not take more than 300 milligrams of nintedanib in one day.
What Should I Avoid While Taking Ofev?
Smoking can make Ofev less effective. Avoid smoking while taking this medicine, or try to quit before you start this treatment.
What Other Drugs Will Affect Ofev?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Ofev, especially: 1. St. John's wort; 2....
What are the side effects of Ofev?
Ofev side effects. Get emergency medical help if you have signs of an allergic reaction to Ofev: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: severe ongoing nausea, vomiting, or diarrhea; severe stomach pain, bloating, or tenderness; bleeding from your rectum or blood in your ...
Why is Ofev used in lung cancer?
Ofev ( nintedanib) is used in people with diseases that cause scar tissue (fibrosis) to form deep within the lungs. The scar tissue thickens and becomes stiff over time, which can make it harder for your lungs to work. Decreased lung function can make it hard for you to breathe.
What is the FDA's number for liver tests?
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Can you take Ofev with diarrhea?
Drink plenty of liquids and call your doctor at once if you have diarrhea while taking Ofev. You will need frequent medical tests to be sure nintedanib is not causing harmful effects on your liver. Your next few doses may be delayed based on the results.
Can you breastfeed with Ofev?
Ofev may affect fertility (your ability to have children) in women. However, it is important to use birth control to prevent pregnancy because this medicine can harm an unborn baby. You should not breastfeed while using this medicine. Ofev is not approved for use by anyone younger than 18 years old.
Is Ofev safe for you?
To make sure Ofev is safe for you, tell your doctor if you have ever had: liver disease; heart problems; a blood clot; bleeding problems (in you or a family member); surgery on your stomach or intestines; diverticulitis; if you smoke; or. if you take a blood thinner such as warfarin ( Coumadin, Jantoven ).
Can Ofev cause birth defects?
Ofev can cause birth defects or death in an unborn baby. Avoid getting pregnant while you are using this medicine and for at least 3 months after your last dose. Use effective birth control, with an extra barrier method (condom, diaphragm, cervical cap, contraceptive sponge).
How often should I take ofev?
OFEV is taken twice a day, about 12 hours apart, with food. For instance, you can take one capsule of OFEV in the morning and one in the evening. Take OFEV exactly as your doctor tells you to take it. Your doctor will tell you how much OFEV to take and when to take it.
What to know before taking OFEV?
Before you take OFEV, tell your doctor about all of your medical conditions, including if you: Have liver problems. Have heart problems. Have a history of blood clots.
How much OFEV should I take in a day?
Do not take more than 300 mg of OFEV in 1 day. If you take too much OFEV, call your doctor or go to the nearest hospital emergency room right away. Quick Tip: Setting alarms on your phone 12 hours apart is a good way to remember to take your OFEV.
How to keep track of lung disease?
Keep track of your disease by documenting your lung function test results, including your FVC scores , along with any questions you may have. This will help you and your doctor follow your disease progression and determine if any changes should be made to your treatment plan.
Can you breastfeed while taking OFEV?
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.
Is OFEV safe for children?
slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma- associated ILD) It is not known if OFEV is safe and effective in children.
Can OFEV harm a baby?
Have a bleeding problem or a family history of a bleeding problem. Have had recent surgery in your stomach (abdominal) area. Are pregnant or plan to become pregnant. OFEV can harm your unborn baby. OFEV can cause birth defects or death to an unborn baby.
When was OFEV approved?
The U.S. Food and Drug Administration (FDA) approved OFEV for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. OFEV is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease.
What is the most important information about Ofev?
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT OFEV (NINTEDANIB)?#N#OFEV can cause birth defects or death to an unborn baby. Women should not become pregnant while taking OFEV. Women who are able to become pregnant should use birth control during treatment and for at least 3 months after treatment. If you become pregnant while taking OFEV, tell your doctor right away.
What to tell your doctor before taking 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, are a smoker, or have any other medical conditions .
Can you take a stool softener while taking OFEV?
While you are taking OFEV, your doctor may recommend that you drink fluids or take medicine to treat these side effects. Heart attack.
Does OFEV cause stomach pain?
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. The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.
When was Ofev approved?
The U.S. Food and Drug Administration (FDA) approved Ofev for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. Ofev is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease.
How many people have IPF?
IPF is a rare, debilitating and fatal lung disease that affects as many as 132,000 Americans. It causes progressive scarring of the lungs, resulting in continuous and irreversible deterioration in lung function and breathing difficulties. As IPF progresses, lung function gradually and irreversibly deteriorates.
Does Ofev cause stomach pain?
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. The most common side effects of Ofev are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.
In Summary
Common side effects of Ofev include: abdominal pain, abdominal tenderness, abnormal hepatic function tests, diarrhea, gastrointestinal pain, increased gamma-glutamyl transferase, increased liver enzymes, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum transaminases, lower abdominal pain, nausea, upper abdominal pain, vomiting, weight loss, hemorrhage, and decreased appetite.
For the Consumer
Along with its needed effects, nintedanib (the active ingredient contained in Ofev) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
For Healthcare Professionals
The most common side effects included diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, hypertension, and peripheral neuropathy. [ Ref]
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Most voted positive review
I have been diagnosed with IPF, fortunately early in the disease progression. I was on Esbriet, and it caused severe fatigue for me. My pulmonologist switched me to OFEV, and I feel MUCH better. Minimal side effects. Lung functions have been stable for 6 months.
Most voted negative review
Diagnosed Jan 2016. Started OFEV almost 3 months ago. Age 64, at 170, b/p avg 105/64 . Working, I don't know yet. Absolutely no side effect's. I think general health and weight my be causing some side effects for others. I'm trying to stay healthy enough to kick IPF's butt.
Shared reviews and ratings
I have been taking this medication for 5 months after a while it caused severe diarrhoea I was nearly ready to quit however I have found taking one Imodium each morning and eating a banana with both doses as well as taking a broad spectrum Probiotic daily has really helped and the diarrhoea has stopped completely I’m very happy now I would recommend anyone with diarrhoea to try this.
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.
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.
