animal data, may reduce fertility in females of reproductive potential Lactation There is no information on the presence of nintedanib in human milk, the effects on the breast-fed infant or the effects on milk production Nintedanib and/or its metabolites are present in the milk of lactating rats Because of the potential for serious adverse effects in breastfed infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the motherPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Tyrosine kinase inhibitor; targets growth factors, which have been shown to be potentially involved in pulmonary fibrosis (eg, vascular endothelial growth factor receptor [VEGFR], fibroblast growth factor receptor [FGFR], platelet-derived growth factor receptor [PDGF]) Binds competitively to the adenosine triphosphate (ATP)-binding pocket of these receptors and blocks the intracellular signaling, which is crucial for the proliferation, migration, and transformation of fibroblasts, representing essential mechanisms of the IPF pathology Absorption Bioavailability: 4.7%; undergoes substantial first-pass metabolism Peak plasma concentration: 2-4 hr Food increases systemic exposure by ~20% and delays peak level to ~4 hr Distribution Protein bound: 97.8% Vd: 1050 L Metabolism Hydrolytic cleavage by esterases resulting in the free acid moiety BIBF 1202 is the prevalent metabolic pathway (~25%); BIBF 1202 is subsequently glucuronidated by UGT enzymes, namely UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10 to BIBF 1202 glucuronide Only a minor extent of the biotransformation consists of CYP pathways (~5%), with CYP3A4 being the predominant enzyme involved Elimination Excretion: 93.4% feces/biliary; 0.65% urine Oral Administration Take with food Swallow capsule whole with liquid; do not chew or crush (bitter taste); effect of crushing on the pharmacokinetics is unknown Missed dose: Take next dose at next scheduled time; advise patient to not make up for a missed dose Storage Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) Protect from exposure to high humidity and avoid excessive heat If repackaged, use USP tight container Keep out of reach of children BRAND FORM. UNIT PRICE PILL IMAGE Ofev oral- 150 mg capsuleOfev oral- 100 mg capsuleCopyright © 2010 First DataBank, Inc.Print Patient Educationnintedanib oral NINTEDANIB - ORAL (nin-TED-a-nib) COMMON BRAND NAME(S): Ofev USES: This medication is used to treat certain types of lung disease (idiopathic pulmonary fibrosis- IPF, interstitial lung disease). Both types of lung disease scar and stiffen your lungs, making it hard to breathe. Nintedanib may help slow down the worsening of your lung disease. HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking nintedanib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with food as directed by your doctor, usually twice daily (about 12 hours apart). The dosage is based on your medical condition and response to treatment. Follow your doctor's instructions carefully.Swallow the capsule whole. Do not crush or chew because the drug has a bitter taste. Do not open the capsules. Wash your hands well right away if your skin comes in contact with the content inside the capsules.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition worsens. SIDE EFFECTS: Diarrhea, nausea, vomiting, abdominal pain, decreased appetite, and weight loss may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Diarrhea, nausea, and vomiting can be severe. Your doctor may have you drink more fluids if these symptoms occur and prescribe medications to treat the diarrhea, nausea, and vomiting.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.Tell your doctor right away if you have any serious side effects, including: unusual bruising/bleeding, cough/stuffy chest, foamy urine, swelling ankles/feet/hands, symptoms of liver problems (such as dark urine, yellowing eyes/skin).Get medical help right away if you have any very serious side effects, including: symptoms of a heart attack (such as chest/jaw/left arm pain, unusual sweating), symptoms of a stroke (such as weakness on one side of body, sudden vision problems, trouble speaking), sudden/severe back pain or headache, severe stomach/abdominal pain, abdominal swelling.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking nintedanib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, heart disease (such as chest pain, heart attack), high blood pressure, blood clots, bleeding problems, blood vessel problems (such as an aneurysm or a tear/break in the aorta or other blood vessels), recent abdominal surgery, stomach/intestinal problems (such as ulcers, diverticular disease).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using nintedanib. Nintedanib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control (such as condoms) while using this medication and for at least 3 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if nintedanib passes into breast milk. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran).Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.Other medications can affect the removal of nintedanib from your body, which may affect how nintedanib works. Examples include rifamycins (such as rifampicin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.Cigarette smoking decreases blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking. OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood pressure, liver function tests) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. MISSED DOSE: If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised April 2022. Copyright(c) 2023 First Databank, Inc. IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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