Highlights of prescribing information these highlights do not include all the information needed to use injectafer safely and effectively. Ofev nintedanib capsules is an fdaapproved prescription medicine used. The prescriber will collect liver function tests on the schedule recommended in the package insert 4. Please see full prescribing information, including patient information and important safety information. Martinez, md chief, division of pulmonary and critical care bruce webster professor of medicine joan and sandford weill department of medicine weill cornell medical college new yorkpresbyterian hospitalweill cornell medical center new york, ny.
Nintedanib is a substrate of the transporter pglycoprotein which moves the absorbed substance back into the guts lumen. Highlights of prescribing information these highlights do. Pradaxa dabigatran etexilate mesylate capsules, for oral use. If you have any further questions, ask your doctor or pharmacist. After intravenous infusion, a high volume of distribution v ss. Coadministration with oral doses of a pgp and cyp3a4 inducer, rifampicin, decreased exposure to nintedanib by 50%.
Nintedanib, a tyrosine kinase inhibitor, is one of two drugs approved for the treatment of ipf. Keep fighting to inspire your loved ones by taking ofev nintedanib. Diarrhoea should be treated atfirst signs with adequate hydration and antidiarrhoeal medicinal products, for exampleloperamide,and may require interruption, dose reduction or discontinuation of therapy with vargatefsee section4. Cases of druginduced liver injury dili have been observed with esbriet. In clinical trials, nintedanib slowed disease progression by reducing the rate. Starting treatment may help slow down the loss of lung function. Data from trials with pirfenidone and nintedanib have shown these drugs to be generally well tolerated and reasonably safe, but significant side effects can occur table 3. As the impact of nintedanib on the effectiveness of hormonal contraception is unknown, advise women using hormonal contraceptives to add a barrier method. Treatmentemergent adverse events are defined as all events that occurred from the first dose of pirfenidone through 28 days after the last dose in the longterm, openlabel, phase 3 extension study. Contains nonbinding recommendations draft guidance on nintedanib esylate recommended sept 2015 this draft guidance, when finalized, will represent the.
Oncology teams should also consult the nintedanib prescribing information and package insert carefully prior to initiating treatment. Esbriet has been used in more than 42,000 patients worldwide. Mar 05, 2020 nintedanib was negative for genotoxicity in the in vitro bacterial reverse mutation assay, the mouse lymphoma cell forward mutation assay, and the in vivo rat micronucleus assay. These highlights do not include all the information needed to use ofev safely and effectively. Why choose ofev nintedanib capsules an ipf treatment option. Coadministration of nintedanib with ketoconazole, a pgp and cyp3a4 inhibitor, increases expo. See full prescribing information for complete boxed warning. Serious infections and malignancies 1 indications and usage 1. Dailymed esbriet pirfenidone capsule esbriet pirfenidone.
Esbriet pirfenidone capsules and filmcoated tablets, for oral use initial u. It is important to note that, although patients with nsclc of all histologies were included in the lumelung 1 study, the data discussed here are for patients with adenocarcinoma nsclc, in line with the approved. Ipf has a variable clinical course but a poor prognosis. Use effective birth control to prevent pregnancy while you are using nintedanib and for at least 3 months after your last dose.
In a drug interaction study, the use of nintedanib with oral doses of rifampin decreased the nintedanib auc to 50. Management of idiopathic pulmonary fibrosis in the elderly. Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis ipf. Hepatotoxicity severe and sometimes fatal hepatotoxicity has occurred in clinical trials see warnings and precautions 5. Nintedanib with addon pirfenidone in idiopathic pulmonary.
Ninetedanib ofev national drug monograph march 2015. The pglycoprotein inhibitor ketoconazole is known to increase blood plasma levels of nintedanib by a factor of 1. Please see important safety information and full prescribing information. Use caution when treating patients at higher cardiovascular risk including known coronary. Highlights of prescribing information these highlights do not include all the information needed to use esbriet safely and effectively.
Nintedanib, sold under the brand names ofev and vargatef, is an oral medication used for the treatment of idiopathic pulmonary fibrosis and along with other medications for some types of nonsmallcell lung cancer in march 2020, it was approved for use in the united states to treat chronic fibrosing scarring interstitial lung diseases ild with a progressive phenotype trait. Nintedanib, at the same dose, was also investigated in combination with pemetrexed 500 mgm 2 and compared with pemetrexed 500 mgm 2 plus placebo in the lumelung 2 phase iii controlled randomized trial hanna et al. Lenvima lenvatinib capsules, for oral use initial u. Boehringer ingelheim pharmaceuticals, inc march 2020. Adverse drug reactions are defined as adverse events judged by the investigator as possibly or probably related to pirfenidone. Ofev nintedanib capsules is prescription medicine used. Side effects and safety data esbriet pirfenidone hcp. Ofev nintedanib capsules, for oral use drug information pdf dosing. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext.
Nintedanib esylate pharmacokinetics absorption bioavailability. In the postmarketing period, nonserious and serious cases of dili, including severe liver injury with fatal outcome, have been reported. Information for the patient ofev 150 mg soft capsules nintedanib read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Highlights of prescribing information these highlights do not include all the information needed to use angiomax safely and effectively. Contains nonbinding recommendations draft guidance on nintedanib esylate recommended sept 2015 this draft guidance, when finalized, will represent the current thinking of the food and drug. Nintedanib with addon pirfenidone in idiopathic pulmonary fibrosis results of the injourney trial carlo vancheri1, michael kreuter2, luca richeldi3, christopher j. Arterial occlusion has occurred in at least 35% of iclusig treated patients including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain. Highlights of prescribing information platinumresistant. Efficacy and safety of nintedanib in idiopathic pulmonary.
Monitor hepatic function prior to and during treatment see warnings and precautions 5. Nintedanib supplemental oxygen, pulmonary rehabilitation, and other supportive. Clinical use of nintedanib in patients with idiopathic. Hepatotoxicity see full prescribing information for complete boxed warning. Nintedanib was negative for genotoxicity in the in vitro bacterial reverse mutation assay, the mouse lymphoma cell forward mutation assay, and the in vivo rat micronucleus assay. All patients including new patients requesting authoriz ation for continuation of therapy may be granted an. Nintedanib is a small molecule that inhibits multiple receptor tyrosine kinases rtks and nonreceptor tyrosine kinases nrtks. Supporting documents older than three years profilnine sd factor ix complex.
Follow applicable special handling and disposal procedures. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for dilantin phenytoin. Esbriet is proven to help preserve lung function for some people with ipf. Important things to keep in mind with ipf treatment. Serum albumin is considered to be the major binding protein. Cases of druginduced liver injury have been observed with nintedanib treatment, including severe liver injury with fatal outcome. Gleevec imatinib mesylate tablets, for oral use initial u.
Ipf is progressive, so slowing its decline can be an important goal of treatment. A drug interaction assessment needs to be performed before. Ninlaro 4 mg capsules contain 4 mg of ixazomib equivalent to 5. Qt prolongation andsudden deaths 1 indications and usage 1. Johns wort with ofev should be avoided as these drugs may decrease exposure to nintedanib. In rats, nintedanib reduced female fertility at exposure levels approximately 3 times the mrhd on an auc basis at an oral dose of 100 mgkgday.
Grutters6,7, sabrina wiebe8, wibke stansen9, manuel quaresma2,9, susanne stowasser9, and wim a. Entereg is available only through a restricted program for shortterm use 15 doses called the entereg access support and education e. This draft guidance, when finalized, will represent the. The most frequent adverse event in the nintedanib groups was diarrhea, with rates of 61. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. Vargatef, innnintedanib european medicines agency europa eu. Other therapeutic options nonformulary alternative other considerations. Clinical pharmacokinetics and pharmacodynamics of nintedanib.
Moderate dual inhibitors of pglycoprotein pgp and cyp3a4, such as ritonavir, are expected to increase the exposure and clinical effect of. Interrupt and then reduce or discontinue stivarga for hepatotoxicity as manifested by elevated liver. Ofev nintedanib rationale for inclusion in pa program. Richeldi l, du bois rm, raghu g, azuma a, inpulsis trial investigators. Ninlaro ixazomib capsules, for oral use hepatotoxicity. Highlights of prescribing information these highlights. Dose increase or reduction is recommended based on individual safety and tolerability. Ofev nintedanib dose, indications, adverse effects. An official atsersjrsalat clinical practice guideline. Pirfenidone esbriet national drug monograph february 2015. See full prescribing information for complete boxed. Severe and sometimes fatal hepatotoxicity has occurred in clinical trials.
Ofev can cause fetal harm when administered to a pregnant woman. Nintedanib follows at least biphasic disposition kinetics. Commonly reported side effects of nintedanib include. A premature discontinuation of pradaxa increases the risk of thrombotic events, and b spinalepidural hematoma see full prescribing information for complete boxed warning procedures when possible, then restart promptly 2. Highlights of prescribing information these highlights do not. Ofev is the only twicedaily pill for ipf that helps slow progression in 2 waysby reducing the rate of lung function decline and reducing the risk of an acute exacerbation. Injectafer ferric carboxymaltose injection, for intravenous use initial u.
Leucovorin calcium for injection rx only description leucovorin is one of several active, chemically reduced derivatives of folic acid. Exhibits doseproportional pharmacokinetics following oral administration of 50450 mg once daily and 150300 mg twice daily. 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. Nintedanib was teratogenic and embryofetocidal in rats and rabbits at less than and approximately 5 times the maximum recommended human dose mrhd in adults on an auc basis at oral doses of 2. Over the course of treatment, patients who tolerate inlyta for at least two consecutive weeks with no adverse reactions grade 2 according to the common toxicity criteria for adverse events ctcae, are normotensive, and are not receiving anti. The medication must be prescribed by, or in conjunction with, a pulmonologist. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Idiopathic pulmonary fibrosis ipf is a rare lung disease characterised by progressive loss of lung function, dyspnoea and cough. If ofev is used during pregnancy, or if the patient becomes pregnant while taking ofev, the.
Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. Light orange gelatin capsule imprinted with takeda on the cap and 4 mg on the body in black ink. Mar 05, 2018 package insert profilnine sd pdf 280kb supporting documents. Arterial occlusion has occurred in at least 35% of iclusig treated patients including fatal myocardial infarction.
442 723 619 640 622 1154 576 670 1356 310 581 397 1115 636 136 689 1311 854 1231 396 1273 222 1405 453 984 802 933 295 667 39 1050 430 805 130 665 342 607 1154 895