Nintedanib Esylate

Nintedanib

(nin TED a nib)

Ofev

It is used to treat idiopathic pulmonary fibrosis (IPF) or certain other lung problems. It is used to slow the progress of lung disease in some people.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have liver disease. If you are taking any of these drugs: Carbamazepine, phenytoin, rifampin, or St. John's wort. If you are breast-feeding. Do not breast-feed while you take this drug. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

For all patients taking this drug: Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor. Rarely, some bleeding problems have been deadly. Have blood work checked as you have been told by the doctor. Talk with the doctor. High blood pressure has happened with this drug. Have your blood pressure checked as you have been told by your doctor. This drug may raise the chance of holes or tears in the stomach or bowels. Sometimes, this has been deadly. Call your doctor right away if you have stomach swelling or very bad stomach pain. This drug may cause fertility problems. This may affect being able to have children. Talk with the doctor. Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this drug. This drug may cause harm to an unborn baby. A pregnancy test will be done before you start this drug to show that you are NOT pregnant. Women must use birth control while taking this drug and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away. If you smoke: Stop smoking before starting this drug. Avoid smoking while taking it. Smoking may lower how well this drug works. Talk with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop. Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight. Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain. Very bad and sometimes deadly liver problems have happened with this drug. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. Very bad blood clots like heart attack have happened with this drug. Call your doctor right away if you have signs of heart attack like chest pain or pressure; arm, back, neck, or jaw pain; or shortness of breath. Call your doctor right away if you have signs of stroke like confusion, numbness or weakness on 1 side of your body, very bad dizziness or headache, or change in speech or eyesight.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Headache. Stomach pain. Weight loss. Feeling dizzy, tired, or weak. Back pain. Nose or throat irritation. Signs of a common cold. Diarrhea, throwing up, upset stomach, and feeling less hungry are common with this drug. If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not get better, or get very bad. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take this drug with food. Swallow whole with some water or other drink. Do not chew or crush. Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.

Skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses.

Store at room temperature in a dry place. Do not store in a bathroom. Protect from heat. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.