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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
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A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study of the Safety, Tolerability, and Pharmacokinetics of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
Summary: MKC-NI-002 is a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in patients with Idiopathic Pulmonary Fibrosis (IPF). The trial consists of Multiple Ascending Doses (MAD) with the primary objective to evaluate safety, tolerability and pharmacokinetics (PK) of MNKD-201 compared to placebo in patients with IPF.
Multicentre Clinical Trial Evaluating the Safety and Efficacy of the Combination of Nintedanib+Tocilizumab Compared to Standard Treatment in Patients With Systemic Sclerosis and Interstitial Lung Disease. Analysis With Theranostic Approach
Summary: The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks.
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Proof of Concept (POC) Study Evaluating the Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Participants With Idiopathic Pulmonary Fibrosis (IPF) (AURA-IPF)
Summary: This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) as well as assess its safety and tolerability. Adults 40 years of age or older with IPF who meet the inclusion and exclusion criteria can participate in this study if they are not currently on treatment for IPF, a...
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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
