Ofev (nintedanib) is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF). IPF causes scar tissue to form deep within your 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. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen.
The cause of IPF is often unknown, but this condition is a progressive disease that can be fatal. Ofev is not a cure for IPF, but this medicine may slow the progress of this disease.
Ofev may also be used for purposes not listed in this medication guide.
Important information
Do not use Ofev if you are pregnant. Use effective birth control while you are using this medicine and for at least 3 months after your treatment ends.
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:
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liver disease;
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heart disease, coronary artery disease (hardened arteries);
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history of heart attack or stroke;
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kidney disease;
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a bleeding or blood clotting disorder such as hemophilia;
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recent history of surgery on your stomach or intestines;
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if you smoke; or
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if you take laxatives, stool softeners, or any medicine or supplements that can cause diarrhea.
FDA pregnancy category D. Do not use Ofev if you are pregnant. It could harm the unborn baby. Tell your doctor right away if you become pregnant during treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your treatment ends.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether nintedanib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Ofev.
How should I take Ofev?
Ofev is usually taken 2 times per day, every 12 hours. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Ofev.
Take with food and a full glass of water.
Do not crush or chew a Ofev capsule. Swallow it whole to avoid a bitter taste.
You may be given medication to treat diarrhea or vomiting. Take only the type and amount of medicine your doctor recommends.
Drink plenty of liquids and call your doctor at once if you have diarrhea while taking Ofev.
You may need frequent medical tests to be sure Ofev is not causing harmful effects on your liver. Your next few doses may be delayed based on the results of these tests.
Store at room temperature away from moisture and heat.
Ofev dosing information
Usual Adult Dose for Idiopathic Pulmonary Fibrosis:
150 mg orally every 12 hours with food
Maximum dose: 300 mg/day
Comments:
-Swallow whole with liquid; do not chew or crush due to bitter taste.
-Advise patient to skip missed dose.
Use: Treatment of idiopathic pulmonary fibrosis.
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 make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Ofev?
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Ofev side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Ofev: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Ofev and call your doctor at once if you have:
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severe ongoing nausea, vomiting, or diarrhea;
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chronic cough, chest tightness;
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easy bruising or bleeding (nosebleeds, bleeding gums);
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signs of stomach bleeding - stomach pain or swelling, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
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heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
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liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
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signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.
Common Ofev side effects may include:
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nausea, vomiting, loss of appetite;
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stomach pain;
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diarrhea;
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weight loss;
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high blood pressure; or
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abnormal liver function 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.
See also: Side effects (in more detail)
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:
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St. John"s wort;
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a blood thinner - warfarin, Coumadin, Jantoven; or
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seizure medication - carbamazepine, phenytoin, and others.
This list is not complete. Other drugs may interact with Ofev, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
