Nintedanib Oral Capsules

What is this medication?

NINTEDANIB (nin TED a nib) treats idiopathic pulmonary fibrosis, chronic progressive fibrosing interstitial lung diseases, and systemic sclerosis-associated interstitial lung disease. It works by preventing and slowing the scarring of lung tissue.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Ofev

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorders or family history of bleeding disorders
• Heart disease
• History of blood clots
• Liver disease
• Protein in your urine
• Recent surgery
• Smoke tobacco cigarettes
• Stomach or intestinal problems
• An unusual or allergic reaction to nintedanib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label. Do not cut, crush or chew this medicine. Swallow the capsules whole. Take it with food. Keep taking it unless your care team tells you to stop.

If you touch the content of the capsule by accident, wash your hands right away.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

• Aspirin and aspirin-like medicines
• Certain antibiotics like erythromycin or clarithromycin
• Certain medicines for seizures like carbamazepine, phenobarbital, or phenytoin
• Certain medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
• Ketoconazole
• Rifampin
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medication.

Drink plenty of fluids while taking this medication. Check with your care team if you have diarrhea, nausea, and vomiting. The loss of too much body fluid may make it dangerous for you to take this medication.

If you smoke, tell your care team if you notice this medication is not working well for you. Talk to your care team if you decide to stop smoking.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Do not become pregnant while taking this medicine or for 3 months after stopping it. Pregnancy testing must be done before starting treatment with this medication. Women must use a form of birth control while taking this medication and for 3 months after stopping this medication. There is potential for serious harm to an unborn child. Tell your care team right away if you think you might be pregnant. Do not breast-feed an infant while taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Diarrhea
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Protein in your urine—foamy or bubbly urine, swelling of the ankles, hands or feet, sudden weight gain
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Tears in the stomach or intestines—fever, stomach pain, sudden change in bowel habits
• Vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• Headache
• Loss of appetite with weight loss
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Avoid exposure to extreme heat. Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.