Pronunciation:

nin-TED-a-nib

Brand Names:

• Ofev

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Respiratory Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Levoketoconazole

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

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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.