nintedanib

What is the most important information I should know about nintedanib?

What is nintedanib?

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. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen.

Nintedanib is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF).

Nintedanib is also used to treat chronic (long lasting) interstitial lung disease in which the scar tissue keeps getting worse.

Nintedanib is also used to slow the decline in lung function in people with a disorder called systemic sclerosis-associated interstitial lung disease (sometimes called scleroderma-associated ILD).

Nintedanib is not a cure for IPF or ILD, but this medicine can slow the effects of these diseases on your lungs.

Nintedanib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking nintedanib?

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).

You may need to have a negative pregnancy test before starting this treatment.

If you use hormonal birth control (birth control pills, injections, implants, skin patches, or vaginal rings), also use a barrier form of birth control to prevent pregnancy while taking nintedanib. Barrier forms include a condom, diaphragm, cervical cap, or contraceptive sponge).

Nintedanib 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.

How should I take nintedanib?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using nintedanib.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take your doses at regular intervals, usually every 12 hours.

Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are taking nintedanib. Take the anti-diarrhea medicine as directed on the label, or as prescribed by your doctor.

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.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Do not take more than 300 milligrams of nintedanib in one day.

What should I avoid while taking nintedanib?

Avoid taking an herbal supplement containing St. John's wort.

What are the possible side effects of nintedanib?

• severe ongoing nausea, vomiting, or diarrhea;
• severe stomach pain, bloating, or tenderness;
• bleeding from your rectum or blood in your stools;
• easy bruising or bleeding, any wound that will not heal;
• fever, chills, cough with mucus, chest pain, feeling short of breath;
• heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems --stomach pain (upper right side), loss of appetite, tiredness, dark urine, jaundice (yellowing of the skin or eyes); or
• signs of a stroke --sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance.

Liver problems may be more likely in women, in people who weigh less than 143 pounds (65 kilograms), and in people of Asian descent.

Your doses may be delayed if you have certain side effects.

Common side effects may include:

• nausea, vomiting, loss of appetite;
• stomach pain;
• diarrhea, weight loss;
• increased blood pressure;
• headache; or
• 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.

What other drugs will affect nintedanib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect nintedanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about nintedanib.