Nintedanib Capsules

OFEV is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Dosage Forms And Strengths

150 mg capsules: brown, opaque, oblong, soft capsules imprinted in black with the Boehringer Ingelheim company symbol and “150”.

100 mg capsules: peach, opaque, oblong, soft capsules imprinted in black with the Boehringer Ingelheim company symbol and “100”.

Storage And Handling

150 mg: brown, opaque, oblong, soft capsules imprinted in black with the Boehringer Ingelheim company symbol and “150”. They are packaged in HDPE bottles with a child-resistant closure, available as follows: Bottles of 60 NDC: 0597-0145-60

100 mg: peach, opaque, oblong, soft capsules imprinted in black with the Boehringer Ingelheim company symbol and “100”. They are packaged in HDPE bottles with a child-resistant closure, available as follows: Bottles of 60 NDC: 0597-0143-60

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from exposure to high humidity and avoid excessive heat. If repackaged, use USP tight container. Keep out of reach of children.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Licensed from: Boehringer Ingelheim International GmbH. Revised: Aug 2017

OFEV®
(OH-fev)
(nintedanib) Capsules

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

OFEV can cause 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 with OFEV. Women who are able to become pregnant should use birth control during treatment and for at least 3 months after treatment. If you become pregnant while taking OFEV, tell your doctor right away.

What is OFEV?

• OFEV is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).
• It is not known if OFEV is safe and effective in children.

What should I tell my doctor before taking OFEV?

Before you take OFEV, tell your doctor if you:

• have liver problems
• have heart problems
• have a history of blood clots
• have a bleeding problem or a family history of a bleeding problem
• have had recent surgery in your stomach (abdominal) area
• are a smoker
• have any other medical conditions
• are pregnant or plan to become pregnant. OFEV can harm your unborn baby. OFEV can cause birth defects or death to an unborn baby. See “What is the most important information I should know about OFEV?”
• are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You should not breastfeed while taking OFEV. 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. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine.

How should I take OFEV?

• Take OFEV exactly as your doctor tells you to take it.
• Your doctor will tell you how much OFEV to take and when to take it.
• Take OFEV with food. Swallow the OFEV capsules whole with a liquid.
• Do not chew or crush OFEV capsules.
• If you miss a dose of OFEV, take your next dose at your regular time. Do not take the missed dose.
• Do not take more than 300 mg of OFEV in 1 day.
• If you take too much OFEV, call your doctor or go to the nearest hospital emergency room right away.
• Your doctor should do certain blood tests before you start taking OFEV.

What are the possible side effects of OFEV?

OFEV may cause serious side effects, including:

• See “What is the most important information I should know about OFEV?”
• liver problems. Call your doctor right away if you have unexplained symptoms such as 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, or feeling tired. Your doctor will do blood tests regularly to check how well your liver function is working during your treatment with OFEV.
• diarrhea, nausea, and vomiting. While you are taking OFEV, your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have diarrhea, nausea, or vomiting or if these symptoms do not go away or become worse. Tell your doctor if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements that can cause diarrhea.
• heart attack. Tell your doctor right away if you have symptoms of a heart problem. These symptoms may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
• stroke. Tell your doctor right away if you have symptoms of a stroke. These symptoms may include numbness or weakness on 1 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, or wounds that do not heal. Tell your doctor 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.

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

These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

How should I store OFEV?

• Store OFEV at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep OFEV dry and protect from high heat.
• Safely throw away any OFEV that is out of date or no longer needed.

Keep OFEV and all medicines out of reach of children.

General information about the safe and effective use of OFEV.

• Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use OFEV for any condition for which it was not prescribed. Do not give OFEV to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about OFEV. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about OFEV that is written for health professionals.
• For more information, go to www.ofev.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800542-6257, or (TTY) 1-800-459-9906, or scan the code below to go to www.ofev.com.

What are the ingredients in OFEV?

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.

This Patient Information has been approved by the U.S. Food and Drug Administration.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Liver Enzyme and Bilirubin Elevations [see WARNINGS AND PRECAUTIONS]
• Gastrointestinal Disorders [see WARNINGS AND PRECAUTIONS]
• Embryo-Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
• Arterial Thromboembolic Events [see WARNINGS AND PRECAUTIONS]
• Risk of Bleeding [see WARNINGS AND PRECAUTIONS]
• Gastrointestinal Perforation [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of OFEV was evaluated in over 1000 IPF patients with over 200 patients exposed to OFEV for more than 2 years in clinical trials.

OFEV was studied in three randomized, double-blind, placebo-controlled, 52-week trials. In the phase 2 (Study 1) and phase 3 (Studies 2 and 3) trials, 723 patients with IPF received OFEV 150 mg twice daily and 508 patients received placebo. The median duration of exposure was 10 months for patients treated with OFEV and 11 months for patients treated with placebo. Subjects ranged in age from 42 to 89 years (median age of 67 years). Most patients were male (79%) and Caucasian (60%).

The most frequent serious adverse reactions reported in patients treated with OFEV, more than placebo, were bronchitis (1.2% vs. 0.8%) and myocardial infarction (1.5% vs. 0.4%). The most common adverse events leading to death in patients treated with OFEV, more than placebo, were pneumonia (0.7% vs. 0.6%), lung neoplasm malignant (0.3% vs. 0%), and myocardial infarction (0.3% vs. 0.2%). In the predefined category of major adverse cardiovascular events (MACE) including MI, fatal events were reported in 0.6% of OFEV-treated patients and 1.8% of placebo-treated patients.

Adverse reactions leading to permanent dose reductions were reported in 16% of OFEV-treated patients and 1% of placebo-treated patients. The most frequent adverse reaction that led to permanent dose reduction in the patients treated with OFEV was diarrhea (11%).

Adverse reactions leading to discontinuation were reported in 21% of OFEV-treated patients and 15% of placebo-treated patients. The most frequent adverse reactions that led to discontinuation in OFEV-treated patients were diarrhea (5%), nausea (2%), and decreased appetite (2%).

The most common adverse reactions with an incidence of ≥5% and more frequent in the OFEV than placebo treatment group are listed in Table 1.

Table 1 : Adverse Reactions Occurring in ≥5% of OFEV-treated Patients and More Commonly Than Placebo in Studies 1, 2, and 3

In addition, hypothyroidism was reported in patients treated with OFEV, more than placebo (1.1% vs. 0.6%).

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of OFEV. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Drug-induced liver injury [see WARNINGS AND PRECAUTIONS]
• Pancreatitis
• Thrombocytopenia

Non-serious and serious bleeding events have been observed in the postmarketing period in line with clinical trial experience [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Ofev (Nintedanib Capsules)

• Esbriet

© Ofev Patient Information is supplied by Cerner Multum, Inc. and Ofev Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.