Ofev 150 mg ( Nentedanib ) 60 soft capsules

WHAT IS NINTEDANIB (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. 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 ARE THE POSSIBLE SIDE EFFECTS OF NINTEDANIB (OFEV)?
Get emergency medical help if you have signs of an allergic reaction: 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 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 IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT NINTEDANIB (OFEV)?
Nintedanib can cause birth defects or death in an unborn a 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).

Ofev Patient Information including How Should I Take

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING NINTEDANIB (OFEV)?
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.

Nintedanib can cause birth defects or death in an unborn a baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

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.

You should not breastfeed while using this medicine.

Nintedanib is not approved for use by anyone younger than 18 years old.

HOW SHOULD I TAKE NINTEDANIB (OFEV)?
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 with food and a full glass of water.

Swallow the capsule whole and do not crush, chew, break, or open it.

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

Nintedanib can cause severe diarrhea, which can be life-threatening if it leads to dehydration. You may need to take medication to prevent or quickly treat diarrhea.

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.

Drink plenty of liquids and call your doctor at once if you have diarrhea while taking nintedanib.

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.

Store this medicine in the original container at room temperature, away from moisture and heat.

Ofev Patient Information including If I Miss a Dose

WHAT HAPPENS IF I MISS A DOSE (OFEV)?
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 (OFEV)?
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 NINTEDANIB (OFEV)?
Smoking can make nintedanib less effective. Avoid smoking while taking this medicine, or try to quit before you start this treatment.

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

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with nintedanib may cause you to bruise or bleed easily.

WHAT OTHER DRUGS WILL AFFECT NINTEDANIB (OFEV)?
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 (OFEV)?
Your pharmacist can provide more information about nintedanib.

REMEMBER, KEEP THIS AND ALL OTHER MEDICINES OUT OF THE REACH OF CHILDREN, NEVER SHARE YOUR MEDICINES WITH OTHERS, AND USE THIS MEDICATION ONLY FOR THE INDICATION PRESCRIBED.

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