What is OFEV?
OFEV is a prescription medicine used:

• to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF).
• to treat adults with a long lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen (progress).
• to slow the rate of decline in lung function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).

It is not known if OFEV is safe and effective in children.

Important Safety Information
What is the most important information I should know about OFEV?

OFEV can cause harm, birth defects, or death to an unborn baby. Women should not become pregnant while taking OFEV. Women who are able to become pregnant should have a pregnancy test before starting treatment and should use highly effective birth control at the start of treatment, during treatment, and for at least 3 months after your last dose. Talk with your doctor about what birth control method is right for you during this time. Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these problems, talk with your doctor about what highly effective birth control method is right for you. If you become pregnant or think you are pregnant while taking OFEV, tell your doctor right away.

What should I tell my doctor before using OFEV?

Before you take OFEV, tell your doctor about all of your medical conditions, including if you have:

• liver problems.
• heart problems.
• a history of blood clots.
• a bleeding problem or a family history of a bleeding problem.
• had recent surgery in your stomach (abdominal) area.

Tell your doctor if you:

• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk.  
• You should not breastfeed while taking OFEV.
• are a smoker. You should stop smoking prior to taking OFEV and avoid smoking during treatment.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort.

What are the possible side effects of OFEV?

OFEV may cause serious side effects.

TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including:

• Liver problems. Unexplained symptoms may include yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea-colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and during your treatment with OFEV.
• Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have these symptoms, if they do not go away, or get worse, and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements.
• Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck, or jaw, or shortness of breath.
• Stroke. Symptoms of a stroke may include numbness or weakness on one side of your body, trouble talking, headache, or dizziness.
• Bleeding problems. OFEV may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, wounds that do not heal, and/or if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
• Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
• Increased protein in your urine (proteinuria). OFEV may increase your chances of having protein in your urine. Tell your doctor if you have any signs and symptoms of protein in the urine such as foamy urine, swelling, including in your hands, arms, legs, or feet, or sudden weight gain.

The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.

These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

CL-OF-100056 01.18.2022

Please click here for full Prescribing Information, including Patient Information.

--Brand Name--
US Brand Name: Ofev

--Description--
Nintedanib is used to treat idiopathic pulmonary fibrosis. It helps prevent changes to the lung tissue. It is also used to treat people with a chronic (long-lasting) interstitial lung disease in which lung fibrosis continues to progress or becomes worse. This medicine is also used to slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease. Nintedanib belongs to the group of drugs called tyrosine kinase inhibitors.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms: Capsule

--Before Using--
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of nintedanib in the pediatric population. Safety and efficacy have not been established.

Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nintedanib in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Acenocoumarol
• Apalutamide
• Apixaban
• Ardeparin
• Argatroban
• Avacopan
• Bemiparin
• Berotralstat
• Bivalirudin
• Capmatinib
• Carbamazepine
• Certoparin
• Clarithromycin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Drotrecogin Alfa
• Enoxaparin
• Fedratinib
• Fexinidazole
• Fondaparinux
• Fosphenytoin
• Heparin
• Itraconazole
• Lepirudin
• Letermovir
• Nadroparin
• Omaveloxolone
• Parnaparin
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenytoin
• Primidone
• Protein C
• Reviparin
• Rifampin
• Rivaroxaban
• St John's Wort
• Tazemetostat
• Tinzaparin
• Vimseltinib
• Voriconazole
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Levothyroxine

Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Green Tea Extract
• Tobacco

Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems, history of or
• Diarrhea or
• Nausea or
• Vomiting—Use with caution. May make these conditions worse.
• Blood clots, history of or
• Coronary artery disease or
• Heart attack, recent or
• Heart disease or
• Stomach or abdominal surgery, recent or
• Stomach or bowel problems (eg, diverticular disease), history of or
• Stroke, history of—Use with caution. May cause side effects to become worse.
• Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
• Liver disease, moderate or severe—Use is not recommended in patients with these conditions.

--Proper Use--
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the capsule whole with liquids. Do not crush, break, or chew it. Take this medicine with food.

Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (capsules):
For idiopathic pulmonary fibrosis, chronic fibrosing interstitial lung disease, or systemic sclerosis-associated interstitial lung disease:

• Adults—150 milligrams (mg) two times a day, taken 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
• Children—Use and dose must be determined by your doctor.

Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

--Precautions--
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Women will receive a pregnancy test before starting this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause stomach or bowel problems, including nausea, vomiting, or diarrhea, and in some cases it can be severe. Do not take any medicines without first checking with your doctor. If mild nausea, vomiting, or diarrhea continues or gets worse, check with your doctor right away.

This medicine may increase your risk of bleeding, or your risk of having a heart attack or stroke. Check with your doctor right away if you have chest pain or discomfort, dizziness, headache, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or unusual bleeding or bruising.

This medicine may cause a tear (perforation) in your stomach or bowels. Check with your doctor right away if you have severe stomach pain that does not go away or blood in the stool.

Check with your doctor right away if you have cloudy urine, swelling in your hands, arms, legs, or feet, or weight gain. These may be symptoms of proteinuria (increased protein in the urine).

This medicine could cause infertility in women. Talk with your doctor before using this medicine if you plan to have children.

Stop smoking before treatment with Ofev® and avoid smoking while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

--Side Effects--
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Dark urine
• diarrhea
• loss of appetite
• nausea
• pain or tenderness in the upper stomach
• pale stools
• severe stomach pain
• vomiting
• yellow eyes or skin

Less common

• Black, tarry stools
• blood in the urine
• blurred vision
• bruising or purple areas on the skin
• chest pain or discomfort
• coughing up blood
• decreased alertness
• dizziness
• headache
• irregular heartbeat
• joint pain or swelling
• nervousness
• nosebleeds
• pain in the chest, groin, or legs, especially calves of the legs
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• severe headaches of sudden onset
• slow or fast heartbeat
• stomach swelling
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• sweating
• trouble breathing

Incidence not known

• Bleeding gums
• bloating
• chills
• cloudy urine
• constipation
• difficult or painful urination
• fast heartbeat
• fever
• indigestion
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• sudden increase or decrease in amount of urine
• swelling of face, feet, or lower legs
• unusual bleeding or bruising
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Weight loss

Less common

• Depression
• dry skin and hair
• feeling cold
• hair loss
• hoarseness or husky voice
• muscle cramps and stiffness
• slow heartbeat
• unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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