Nintedanib

What is Nintedanib?

• Nintedanib (OFEV) is a kinase inhibitor used for the treatment of idiopathic pulmonary fibrosis and along with other medications for some types of non-small-cell lung cancer.

What are the uses of this medicine?

This medicine is used:

• to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).
• to treat people with a chronic (long lasting) interstitial lung disease in which lung fibrosis continues to worsen (progress).
• to slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).

How does this medicine work?

• Nintedanib (nin ted' a nib) is a small molecular weight tyrosine kinase receptor inhibitor that has potent activity against several growth factor receptors, including vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet derived growth factor receptor (PDGFR).
• The inhibition of these receptors causes modulation of many intracellular pathways including inhibition of activities of pro-fibrotic mediators such as transforming growth factor-beta (TGF-β), and decrease in synthesis of extracellular matrix proteins including collagen and fibronectin.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Coadministration with oral doses of a P-gp and CYP3A4 inducer, rifampicin, decreased exposure to nintedanib by 50%. Concomitant use of P-gp and CYP3A4 inducers (e.g., carbamazepine, phenytoin, and St. John's wort) with OFEV should be avoided as these drugs may decrease exposure to nintedanib.
• Monitor patients on full anticoagulation therapy closely for bleeding and adjust anticoagulation treatment as necessary.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

• Conduct liver function tests in all patients and a pregnancy test in females of reproductive potential prior to initiating treatment with OFEV

Recommended Dosage:

• Recommended dosage: 150 mg twice daily approximately 12 hours apart taken with food.
• Recommended dosage in patients with mild hepatic impairment (Child Pugh A): 100 mg twice daily approximately 12 hours apart taken with food.
• Consider temporary dose reduction to 100 mg, treatment interruption, or discontinuation for management of adverse reactions.

Administration

• 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 dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 150 mg and 100 mg

This medicine is available in fallowing brand namesː

• OFEV

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• nausea
• stomach pain
• vomiting
• liver problems
• decreased appetite
• headache
• weight loss
• high blood pressure

OFEV may cause serious side effects, including:

• liver problems
• diarrhea, nausea, and vomiting
• heart attack
• stroke
• bleeding problems
• tear in your stomach or intestinal wall (perforation)

What special precautions should I follow?

• OFEV is not recommended for use in patients with moderate or severe hepatic impairment. In patients with mild hepatic impairment (Child Pugh A), the recommended dosage is 100 mg twice daily approximately 12 hours apart taken with food. Consider treatment interruption, or discontinuation for management of adverse reactions in these patients.
• ALT, AST, and bilirubin elevations have occurred with OFEV, including cases of drug-induced liver injury. In the postmarketing period, non-serious and serious cases of drug-induced liver injury, including severe liver injury with fatal outcome, have been reported. The majority of hepatic events occur within the first three months of treatment. Liver enzyme and bilirubin increases were reversible with dose modification or interruption in the majority of cases. Monitor ALT, AST, and bilirubin prior to initiation of treatment, at regular intervals during the first three months of treatment, and periodically thereafter or as clinically indicated. Temporary dosage reductions or discontinuations may be required.
• Diarrhea, nausea, and vomiting have occurred with OFEV. Treat patients at first signs with adequate hydration and antidiarrheal medicine (e.g., loperamide) or anti-emetics. Discontinue OFEV if severe diarrhea, nausea, or vomiting persists despite symptomatic treatment.
• OFEV Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use highly effective contraception. 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 with OFEV . Use caution when treating patients at higher cardiovascular risk including known coronary artery disease.
• Bleeding events have been reported with OFEV. Use OFEV in patients with known bleeding risk only if anticipated benefit outweighs the potential risk.
• Gastrointestinal perforation has been reported with OFEV. Use OFEV with caution when treating patients with recent abdominal surgery, previous history of diverticular disease or receiving concomitant corticosteroids or NSAIDs. Discontinue OFEV in patients who develop gastrointestinal perforation. Only use OFEV in patients with known risk of gastrointestinal perforation if the anticipated benefit outweighs the potential risk.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nasopharyngitis

Management of overdosage:

• In case of overdose, interrupt treatment and initiate general supportive measures as appropriate.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action , OFEV can cause fetal harm when administered to a pregnant woman.
• There are no data on the use of OFEV during pregnancy.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• 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

Who manufactures and distributes this medicine?

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

OFEV is a registered trademark of and used under license from Boehringer Ingelheim International GmbH.

What should I know about storage and disposal of this medication?

• Store OFEV at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep OFEV dry and protect from high heat.
• Keep OFEV and all medicines out of the reach of children.

• Dailymed label info on Nintedanib
• FDA Nintedanib

Nintedanib Resources
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Pulmonary Disease Agents

• Chronic Obstructive Pulmonary Disease (COPD) Agents
  • Anticholinergic Agents
    • Ipratropium, Tiotropium, Aclidinium
  • Beta-2 Adrenergic Agonists
    • Albuterol, Formoterol, Salmeterol, Terbutaline
  • Corticosteroids
    • Budesonide, Fluticasone
  • Miscellaneous
    • Roflumilast, Theophylline

• Pulmonary Arterial Hypertension Agents
  

• • Endothelin Receptor Antagonists
    • • Ambrisentan, Bosentan, Macitentan
  • Phosphodiesterase Type 5 (PDE5) Inhibitors
    • Avanafil, Sildenafil, Tadalafil, Vardenafil
  •  Prostacyclin Analogs
    • Epoprostenol, Iloprost, Treprostinil
  •  Miscellaneous
    • Riociguat, Selexipag

• Pulmonary Fibrosis Agents
  • Nintedanib, Pirfenidone