Brand Name
Ofev
Generic Name
Nintedanib
View Brand Information FDA approval date: October 15, 2014
Classification: Kinase Inhibitor
Form: Capsule
What is Ofev (Nintedanib)?
OFEV is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis .
Approved To Treat
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Randomized Controlled Trial
Summary: Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is associated with a poor prognosis, with a 3-month mortality rate of over 50%. To date, no treatment has been proven to be effective in AI-FPI. The interest of glucocorticoids is controversial and needs to be confirmed. This confirmation is mandatory to validate the improvement of the prognosis of EA-IPF under this treatment but also to...
Non-interventional Prospective Study in Patients With Pulmonary Fibrosis Treated With Nintedanib Participating in a Patient Support Program in Spain, to Describe Patient Satisfaction With the Program and to Monitor Quality of Life - BALANCE Study
Summary: The aim of this study is to describe patients' satisfaction with Patient Support Program (Balance Program), Quality of Life and depression symptoms, dosing pattern, disease symptoms, adverse events and nintedanib discontinuation (both permanent and non-permanent) from study inclusion to 12 months of follow-up.
A Phase II, Multicenter Clinical Study of Sintilimab Combined With Rituximab Followed by R-CHOP Regimen in Patients With Previously Untreated Primary Mediastinal Diffuse Large B-Cell Lymphoma
Summary: The goal of this clinical study is to evaluate the efficacy and safety of sintilimab combined with rituximab followed by R-CHOP regimen in treatment-naïve patients with primary mediastinal diffuse large B-cell lymphoma. The main questions it aims to answer are: 1. Objective response rate of sintilimab combined with rituximab 2. Objective response rate after R-CHOP regimen
Related Latest Advances
Brand Information
Ofev (nintedanib)
1DOSAGE FORMS AND STRENGTHS
Capsules:
- 150 mg, brown, opaque, oblong, soft capsules marked in dark gray with the Boehringer Ingelheim company symbol and "150".
- 100 mg, peach, opaque, oblong, soft capsules marked in dark gray with the Boehringer Ingelheim company symbol and "100".
2CONTRAINDICATIONS
None
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Elevated Liver Enzymes and Drug-Induced Liver Injury
- Gastrointestinal Disorders
- Embryo-Fetal Toxicity
- Arterial Thromboembolic Events
- Risk of Bleeding
- Gastrointestinal Perforation
- Nephrotic Range Proteinuria
3.1Clinical 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, 332 patients with chronic fibrosing ILDs with a progressive phenotype, and over 280 patients with SSc-ILD. Over 200 IPF patients were exposed to OFEV for more than 2 years in clinical trials.
3.2Postmarketing 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.
Blood and Lymphatic System Disorders: Thrombocytopenia
Gastrointestinal Disorders: Pancreatitis
Hepatobiliary Disorders: Drug-induced liver injury
Nervous System Disorders: Posterior reversible encephalopathy syndrome
Renal and Urinary Disorders: Proteinuria
Skin and Subcutaneous Tissue Disorders: Pruritus, rash
Vascular Disorders: Non-serious and serious bleeding events, some of which were fatal
Gastrointestinal Disorders: Pancreatitis
Hepatobiliary Disorders: Drug-induced liver injury
Nervous System Disorders: Posterior reversible encephalopathy syndrome
Renal and Urinary Disorders: Proteinuria
Skin and Subcutaneous Tissue Disorders: Pruritus, rash
Vascular Disorders: Non-serious and serious bleeding events, some of which were fatal
4OVERDOSAGE
In IPF trials, one patient was inadvertently exposed to a dose of 600 mg daily for a total of 21 days. A non-serious adverse event (nasopharyngitis) occurred and resolved during the period of incorrect dosing, with no onset of other reported events. Overdosage was also reported in two patients in oncology studies who were exposed to a maximum of 600 mg twice daily for up to 8 days. Adverse events reported were consistent with the existing safety profile of OFEV. Both patients recovered. In case of overdosage, interrupt treatment and initiate general supportive measures as appropriate.
5DESCRIPTION
OFEV capsules contain nintedanib, a kinase inhibitor
Its structural formula is:
Nintedanib esylate is a bright yellow powder with an empirical formula of C
OFEV capsules for oral administration are available in 2 dose strengths containing 100 mg or 150 mg of nintedanib (equivalent to 120.40 mg or 180.60 mg nintedanib ethanesulfonate, respectively). The inactive ingredients of OFEV are the following: Fill Material: hard fat, lecithin, triglycerides. Capsule Shell: ferric oxide red, ferric oxide yellow, gelatin, glycerol, titanium dioxide.
6HOW SUPPLIED/STORAGE AND HANDLING
150 mg: brown, opaque, oblong, soft capsules marked in dark gray with the Boehringer Ingelheim company symbol and "150". They are packaged in HDPE bottles with a child-resistant closure, available as follows:
100 mg: peach, opaque, oblong, soft capsules marked in dark gray with the Boehringer Ingelheim company symbol and "100". They are packaged in HDPE bottles with a child-resistant closure, available as follows:
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
8PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Carton
NDC 0597-0145-60
Ofev
150 mg*
Rx only
60 capsules
Boehringer
9PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Carton
NDC 0597-0143-60
Ofev
100 mg*
Rx only
60 capsules
Boehringer
