Ofev

Ofev (nintedanib) is a prescription medication used to treat idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs), and systemic sclerosis–associated interstitial lung disease (SSc-ILD) in certain patients.

Ofev is a tyrosine kinase inhibitor that works by slowing the decline in lung function and reducing the buildup of scar tissue, known as pulmonary fibrosis, in the lungs. Ofev plays an important role in helping manage disease progression and preserving lung function over time but it is not a cure and does not reverse existing scar tissue.

Ofev capsules are taken twice daily.

Ofev is a FDA approved treatment for adults with:

• idiopathic pulmonary fibrosis (IPF)
• chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype
• systemic sclerosis-associated interstitial lung disease (SSc-ILD) to slow the rate of decline in pulmonary function.

Ofev FDA approval was first granted on October 15, 2014, for the treatment of idiopathic pulmonary fibrosis (IPF) in adults after its safety and effectiveness were established in three clinical trials of 1,231 patients with IPF. The clinical trials Study 1 (NCT00514683), Study 2 (NCT01335464), and Study 3 (NCT01335477) demonstrated that Ofev patients had a significant decline in forced vital capacity compared to patients receiving placebo. Ofev FDA approval has since been extended to include ILDs with a progressive phenotype and for slowing the rate of decline in pulmonary function in patients with SSc-ILD.

Ofev works by blocking specific enzymes, called tyrosine kinases, that play a key role in the development of lung scarring. By interfering with these signaling pathways, Ofev helps reduce the activity of cells involved in fibrosis and slows the buildup of scar tissue in the lungs. This action helps slow disease progression and the decline in lung function over time.

Ofev mechanism of action is as a small-molecule tyrosine kinase inhibitor (TKI) that targets receptors on the surface of lung cells involved in fibrogenesis, including platelet-derived growth factor (PDGF), fibroblast growth factor (FGF), and vascular endothelial growth factor (VEGF) receptors.

Ofev is usually taken 2 times per day, every 12 hours. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Ofev.

Take with food if you have no liver impairment and apart from food if you have mild hepatic impairment. Take capsules with 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.

Ofev 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 Ofev. 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 Ofev.

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 has warnings and precautions for:

• Hepatic impairment
• Elevated liver enzymes and drug-induced liver injury
• Gastrointestinal disorders
• Embryo-Fetal toxicity: Ofev can cause birth defects or death in an unborn 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). Advise women taking oral hormonal contraceptives experiencing vomiting, diarrhea, or other conditions where the drug absorption may be reduced to use alternative highly effective contraception.
• Arterial thromboembolic events have been reported. Use caution when treating patients at higher cardiovascular risk including known coronary artery disease.
• Bleeding events have been reported.
• Gastrointestinal perforation has been reported. Use OFEV with caution when treating patients with recent abdominal surgery, previous history of diverticular disease or receiving concomitant corticosteroids or NSAIDs.
• Nephrotic range proteinuria has been reported.

To make sure Ofev is safe for you, 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 Ofev. Barrier forms include a condom, diaphragm, cervical cap, or contraceptive sponge).

Ofev 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.

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

Common Ofev side effects

Common Ofev side effects may include:

• nausea, vomiting, loss of appetite;
• stomach pain;
• diarrhea, weight loss;
• increased blood pressure;
• headache; or
• abnormal liver function tests.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction to Ofev with symptoms of hives, difficulty breathing, and 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.

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

Usual Adult Dose (no hepatic impairment)

Recommended Ofev dose: 150 mg orally every 12 hours apart from food. Maximum dose: 300 mg/day.

Usual Adult Dose (mild hepatic impairment)

Recommended dosage in patients with mild hepatic impairment (Child-Pugh A): 100 mg taken orally twice daily, approximately 12 hours taken with food.

Ofev is not recommended for use in patients with moderate or severe hepatic impairment.

General Ofev dosing information

• Do not chew, crush, or open capsules. If you or your caregiver accidentally comes in contact with the content of the capsule, wash your hands well right away.
• Consider temporary dose reduction to 100 mg, treatment interruption, or discontinuation for management of adverse reactions.
• Conduct liver function tests before starting therapy.
• Conduct a pregnancy test in females of reproductive potential before starting therapy.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

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.

Smoking can make Ofev 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.

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 interact with 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.

• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep capsules dry and protect from high heat.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Active ingredient: nintedanib

Inactive ingredients: Fill Material: triglycerides, hard fat, lecithin. Capsule Shell: gelatin, glycerol, titanium dioxide, red ferric oxide, yellow ferric oxide, black ink.