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Frequently asked questions about OFEV

Clinical Trial Patient Population

What are the clinical characteristics of the patients who enrolled in INPULSIS® and TOMORROW?+

The study populations for INPULSIS®-1, INPULSIS®-2, and TOMORROW included a range of patients with IPF who had FVC ≥50% predicted value (no upper limit for FVC) and DLCO 30%-79% of predicted value at baseline.1 Across all 3 clinical trials, the patient populations were similar.1-4

Learn more about the patient population

Were patients required to have a surgical lung biopsy confirm the IPF diagnosis for enrollment into OFEV clinical trials?+

No, surgical lung biopsy was not required. If surgical lung biopsy was not available, HRCT pattern had to be consistent with a diagnosis of IPF. Patients with definite UIP and possible UIP on HRCT were enrolled.1-3

Learn more about HRCT inclusion criteria

What percentage of patients had emphysema on HRCT in clinical trials with OFEV?+

The percentage of patients with IPF who had emphysema on HRCT in the TOMORROW, INPULSIS®-1, and INPULSIS®-2 trials were as follows: 27.1% in the OFEV arm vs 22.4% in the placebo arm, 38.2% in the OFEV arm vs 38.2% in the placebo arm, and 41.3% in the OFEV arm vs 40.2% in the placebo arm, respectively.4

Learn more about the patient population

What was the range of FVC and DLCO among patients included in the 3 clinical trials?+

The study populations included a range of patients with IPF with FVC ≥50% predicted value (no upper limit) and DLCO 30%-79% of predicted value.1

Learn more about inclusion and exclusion criteria

Were patients with PAH excluded from clinical trials with OFEV?+

No, patients with PAH were not excluded from clinical trials.1-3

Learn more about inclusion and exclusion criteria

Can OFEV be used in patients who are taking anticoagulants?+

OFEV may increase the risk of bleeding. In clinical trials, bleeding events were reported in 10% of patients treated with OFEV and in 7% of patients treated with placebo. Use OFEV in patients with known risk of bleeding only if the anticipated benefit outweighs the potential risk. Monitor patients on full anticoagulation therapy closely for bleeding and adjust anticoagulation treatment as necessary.

Use caution when treating patients at higher cardiovascular risk including known coronary artery disease. Consider treatment interruption in patients who develop signs or symptoms of acute myocardial ischemia.1

Should OFEV be used in patients with cardiovascular risk?+

Use caution when treating patients at higher cardiovascular risk including known coronary artery disease. Consider treatment interruption in patients who develop signs or symptoms of acute myocardial ischemia.1

Can I use OFEV in patients with advanced liver disease?+

No. Treatment with OFEV is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) 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.1

Are there any contraindications for OFEV?+

No, there are no contraindications for OFEV.1

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Efficacy

Does OFEV slow IPF progression?+

Yes. The totality of the evidence demonstrates that OFEV slows IPF progression.1,5-8 OFEV demonstrated reproducible reductions in the annual rate of FVC decline in 3 clinical trials and reduced the risk of first acute IPF exacerbation over 52 weeks compared with placebo in 2 out of 3 clinical trials.1

See clinical efficacy results

Do the 2015 ATS/ERS/JRS/ALAT guidelines recommend OFEV for the treatment of IPF?+

Yes. Guidelines published by ATS/ERS/JRS/ALAT in 2015 recommend OFEV for the treatment of IPF. This is a conditional recommendation. This means that different choices will be appropriate for each patient based on individual preferences.9

Download the guidelines to learn more

Copyright ©2016, American Thoracic Society. Raghu G, et al. Am J Resp Crit Care Med. 2015;192(2):e3-e19. The American Journal of Respiratory and Critical Care Medicine is an official journal of the American Thoracic Society.

Why was the annual rate of FVC decline selected as the primary endpoint? +

The annual rate of FVC decline was selected as the primary endpoint for clinical trials with OFEV because FVC has been shown to be a robust and reliable measure of IPF progression.2,5-7

See primary endpoint results

Do the results of the INPULSIS® trials confirm results seen in the phase 2 TOMORROW trial?+

Yes. OFEV demonstrated reproducible reductions in the annual rate of FVC decline in all 3 clinical trials.1

See primary endpoint results

Did the effect of OFEV differ in patients with lower or higher percent-predicted FVC at baseline? +

In a prespecified analysis of the primary endpoint of the INPULSIS® trials, there was a consistent treatment effect on the reduction of the annual rate of FVC decline between patients with >70% FVC predicted at baseline and those with ≤70% FVC predicted at baseline.4 Patients with <50% FVC at baseline were excluded from clinical trials.2,3

See primary endpoint results

How did the efficacy of OFEV look in patients who had dose reductions in the INPULSIS® trials? +

In a prespecified analysis of the primary endpoint of the INPULSIS® trials, there was a consistent treatment effect on the reduction of the annual rate of FVC decline between patients on >90% of the maximum dose and ≤90% of the maximum dose (as measured by dose intensity). Dose intensity is defined as the amount of drug administered over the study divided by the amount of drug that would have been received had the 150-mg bid dose been administered throughout the 52-week study or until discontinuation in patients who discontinued prematurely.4

See primary endpoint results

How were acute IPF exacerbations adjudicated in the INPULSIS® trials? +

Acute IPF exacerbations were adjudicated using the following criteria1,2:

  • Unexplained worsening or development of dyspnea within 30 days
  • New diffuse pulmonary infiltrates on chest X-ray and/or HRCT
  • Parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities)
  • Exclusion of alternative causes of the acute worsening (including infection, left heart failure, pulmonary embolism, etc)

See acute IPF exacerbation results

Did OFEV have an effect on overall mortality in the INPULSIS® trials? +

OFEV achieved a numerical difference in mortality at 52 weeks in INPULSIS®-1 and -2, however, it was nonsignificant (HR=0.70, 95% CI=0.43, 1.12). Survival was evaluated for OFEV compared with placebo in INPULSIS®-1 and -2 as an exploratory analysis to support the primary endpoint (FVC). All-cause mortality was assessed over the study duration and available follow-up period, irrespective of cause of death and whether patients continued treatment.1

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Safety data and adverse reaction management

What were the frequency, severity, and duration of diarrhea events in clinical trials?+

Diarrhea was experienced by 62% of patients treated with OFEV 150 mg bid vs 18% placebo. The majority of diarrhea events were mild or moderate in intensity and occurred within the first 3 months of treatment.1,2

Learn about diarrhea management

How should GI-related adverse reactions be managed?+

Below is a top-level overview of an approach to managing GI adverse reactions for patients receiving OFEV.

  • advise your patients before initiating OFEV. They should know about the possibility of experiencing GI adverse reactions and when to notify you if symptoms occur1
  • initiate symptomatic treatment at the first signs of symptoms1
  • dose modification, including discontinuation, may be required if GI adverse reactions are persistent or severe despite symptomatic treatment1

Get more details about the management of GI-related adverse reactions

How often should liver enzymes be monitored?+

Liver function tests, including ALT, AST, and bilirubin, should be conducted prior to initiation of treatment with OFEV, at regular intervals during the first three months of treatment, and periodically thereafter or as clinically indicated.1

Dosage modifications or interruption may be necessary for liver enzyme elevations. Measure liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.1

Learn more about liver enzyme monitoring

How should liver enzyme elevations be managed?+

For AST or ALT elevations greater than 3x to less than 5x ULN without signs of liver damage, interrupt treatment or reduce OFEV to 100 mg twice daily. Once liver enzymes have returned to baseline values, OFEV may be reintroduced at the reduced dosage (100 mg twice daily). OFEV may subsequently be increased to the full dosage (150 mg twice daily). For AST or ALT greater than 3x ULN with signs or symptoms of liver injury and for AST or ALT elevations greater than 5x ULN, discontinue OFEV.1

Learn more about liver enzyme management

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Dosing

What is the recommended dosage for OFEV?+

OFEV offers twice-daily oral dosing. The recommended dosage of OFEV is 150 mg twice daily administered approximately 12 hours apart, with food, and should be swallowed with a glass of water.1

For patients with mild hepatic impairment (Child Pugh A), the recommended dosage is 100 mg twice daily with food.1

See more additional dosing details

Is OFEV still effective at the reduced dose (100 mg twice daily) when managing adverse events?+

Yes. In a prespecified analysis of the primary endpoint of the INPULSIS® trials, there was a consistent treatment effect on the reduction of the annual rate of FVC decline between patients on >90% of the maximum dose and ≤90% of the maximum dose (as measured by dose intensity). Dose intensity is defined as the amount of drug administered over the study divided by the amount of drug that would have been received had the 150-mg bid dose been administered throughout the 52-week study or until discontinuation in patients who discontinued prematurely.4

See primary endpoint results

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Access

How can I start my appropriate patients with IPF on OFEV?+

Just complete the OFEV Prescription Form and fax it to one of the specialty pharmacies in our distribution network listed on the Prescription Form.

Download the Prescription Form

How are prescriptions for OFEV filled?+

OFEV prescriptions are filled through our participating specialty pharmacies. Just complete the OFEV Prescription Form and fax it to one of the specialty pharmacies in our distribution network listed on the Prescription Form.

Download the Prescription Form

How are prior authorizations handled if they are required?+

If the prescription requires a prior authorization or an appeal, the specialty pharmacy will notify you to discuss the steps necessary to complete the claim. Common prior authorizations for OFEV coverage are confirmed diagnosis and additional lab/test results.

How is fulfillment accomplished?+

Once the Prescription Form is submitted to a participating specialty pharmacy, the specialty pharmacy will begin benefit investigation and communicate with both you and your patients. To ensure timely fulfillment of OFEV, make sure to complete all forms required by the specialty pharmacy, payor, and financial programs.

Is financial assistance available for patients who are prescribed OFEV?+

Patients have different financial assistance options available to them, depending on their insurance coverage and financial situation.

*There is no copay card as the program is managed by the specialty pharmacy. If a patient becomes ineligible at any time, the patient's ID number will be terminated.

†Only required for Medicare Part D patients.

‡Some Medicare-eligible patients who have difficulty meeting their Part D drug costs and who do not qualify for other assistance may be eligible as long as there is no other prescription drug coverage and they meet the rest of the eligibility criteria.

How does Boehringer Ingelheim ensure that patients receive OFEV in a timely manner through the specialty pharmacy?+

Once the Prescription Form is faxed to the specialty pharmacy, they will verify the form for completeness and accuracy. If this process is delayed for ≥7 days due to investigation, prior authorization, or appeal, the patient may be eligible for the OFEV Bridge Program. This service provides a 15-day supply of OFEV and up to 3 additional 15-day refills to the patient at no cost.

What happens if a prescription is sent to the wrong specialty pharmacy?+

If this happens, the specialty pharmacy will refer the prescription to a different specialty pharmacy that is part of the patient's prescription coverage network.

If a patient starts on 150 mg of OFEV capsules and requires a dose modification to 100 mg, will there be a gap in coverage?+

The OFEV Bridge Program can provide complimentary 15-day or 30-day supplies of OFEV for patients who have had their dose of OFEV changed more than once within the same month and whose plan will not cover the cost of the second prescription.

We have a dose-modification program to cover patients if their prescription plan doesn't cover 2 prescriptions in a 30-day period.

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Resources

What resources are available for patients?+

The OPEN DOORS™ Patient Support Program is available to provide personal support and advice for patients who have been prescribed OFEV.

There are also several materials available to help your patients with IPF and their caregivers, such as brochures, journals, and medication reminders.

Learn more about OPEN DOORS™

How does OPEN DOORS™ support the patient experience?+

OPEN DOORS™ patient support network is a resource that specializes in providing personal support and advice for patients who have been prescribed OFEV.

OPEN DOORS™ provides the following to patients and their caregivers:

  • Specially trained nurses ready to assist–24 hours a day, 7 days a week
  • Explanation of insurance benefits
  • Financial assistance
  • Access to social resources that can help identify additional community services

Learn more about OPEN DOORS™

Is financial assistance available for patients who are prescribed OFEV?+

Patients have different financial assistance options available to them, depending on their insurance coverage and financial situation.

*There is no copay card as the program is managed by the specialty pharmacy. If a patient becomes ineligible at any time, the patient's ID number will be terminated.

†Only required for Medicare Part D patients.

‡Some Medicare-eligible patients who have difficulty meeting their Part D drug costs and who do not qualify for other assistance may be eligible as long as there is no other prescription drug coverage and they meet the rest of the eligibility criteria.

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Clinical Educators

How can clinical educators help my patients and my practice?+

IPF Clinical Educators bring expert background and knowledge of the IPF disease state and treatment to your office, offering education to clinical staff and patients alike.

For your practice, Clinical Educators can provide in-office educational discussions about IPF or about the use of OFEV as well as company-approved information, tools, and resources. And, your patients with IPF who have been prescribed OFEV can benefit from their one-on-one patient education and assistance for starting treatment and learning what to expect during treatment.

Learn more about clinical educators

How can I initiate patient education in my practice?+

OFEV Clinical Educators are highly trained specialists who offer education to clinical staff and patients alike.

Programs with OFEV Clinical Educators can be initiated by calling OPEN DOORS™ Patient Support Program at 866-OPENDOOR (673-6366) or by contacting your local OFEV Sales Representative.

Learn more about clinical educators

How can I initiate education about IPF and OFEV for my practice?+

OFEV Clinical Educators are highly trained specialists who offer education to clinical staff and patients alike.

Programs with OFEV Clinical Educators can be initiated by calling OPEN DOORS™ Patient Support Program at 866-OPENDOOR (673-6366) or by contacting your local OFEV Sales Representative.

Learn more about clinical educators

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IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

Hepatic Impairment

  • OFEV is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Patients with mild hepatic impairment (Child Pugh A) can be treated with a reduced dosage (100 mg twice daily). Consider treatment interruption or discontinuation for management of adverse reactions.

Elevated Liver Enzymes and Drug-Induced Liver Injury

  • Cases of drug-induced liver injury (DILI) have been observed with OFEV treatment. In the post-marketing period, non-serious and serious cases of DILI, including severe liver injury with fatal outcome, have been reported. The majority of hepatic events occur within the first three months of treatment. OFEV was associated with elevations of liver enzymes (ALT, AST, ALKP, and GGT) and bilirubin. Liver enzyme and bilirubin increases were reversible with dose modification or interruption in the majority of cases. The majority (94%) of patients with ALT and/or AST elevations had elevations less than 5 times ULN. The majority (95%) of patients with bilirubin elevations had elevations less than 2 times ULN.
  • Patients with a low body weight (less than 65 kg), Asian, and female patients may have a higher risk of elevations in liver enzymes. Nintedanib exposure increased with patient age, which may result in increased liver enzymes.
  • Conduct liver function tests prior to initiation of treatment, at regular intervals during the first three months of treatment, and periodically thereafter or as clinically indicated. Measure liver function tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. Dosage modifications, interruption, or discontinuation may be necessary for liver enzyme elevations.

Gastrointestinal Disorders

Diarrhea

  • Diarrhea was the most frequent gastrointestinal event reported in 62% versus 18% of patients treated with OFEV and placebo, respectively. Events were primarily mild to moderate intensity and occurred within the first 3 months. Diarrhea led to permanent dose reduction in 11% and discontinuation in 5% of OFEV patients versus 0 and less than 1% in placebo patients, respectively.
  • Dosage modifications or treatment interruptions may be necessary in patients with diarrhea. Treat diarrhea at first signs with adequate hydration and antidiarrheal medication (e.g., loperamide), and consider treatment interruption if diarrhea continues. OFEV treatment may be resumed at the full dosage (150 mg twice daily), or at the reduced dosage (100 mg twice daily), which subsequently may be increased to the full dosage. If severe diarrhea persists, discontinue treatment.

Nausea and Vomiting

  • Nausea was reported in 24% versus 7% and vomiting was reported in 12% versus 3% of patients treated with OFEV and placebo, respectively. Events were primarily of mild to moderate intensity. Nausea and vomiting led to discontinuation of OFEV in 2% and 1% of patients, respectively.
  • If nausea or vomiting persists despite appropriate supportive care including anti-emetic therapy, consider dose reduction or treatment interruption. OFEV treatment may be resumed at full dosage or at reduced dosage, which subsequently may be increased to full dosage. If severe nausea or vomiting does not resolve, discontinue treatment.

Embryofetal Toxicity: OFEV can cause fetal harm when administered to a pregnant woman and patients should be advised of the potential risk to a fetus. Women should be advised to avoid becoming pregnant while receiving OFEV and to use effective contraception during treatment and at least 3 months after the last dose of OFEV. Verify pregnancy status prior to starting OFEV.

Arterial Thromboembolic Events: Arterial thromboembolic events were reported in 2.5% of OFEV and 0.8% of placebo patients, respectively. Myocardial infarction was the most common arterial thromboembolic event, occurring in 1.5% of OFEV and 0.4% of placebo patients. Use caution when treating patients at higher cardiovascular risk including known coronary artery disease. Consider treatment interruption in patients who develop signs or symptoms of acute myocardial ischemia.

Risk of Bleeding: OFEV may increase the risk of bleeding. Bleeding events were reported in 10% of OFEV versus 7% of placebo patients. Use OFEV in patients with known risk of bleeding only if the anticipated benefit outweighs the potential risk. In the post-marketing period, non-serious and serious bleeding events, some of which were fatal, have been observed.

Gastrointestinal Perforation: OFEV may increase the risk of gastrointestinal perforation. Gastrointestinal perforation was reported in 0.3% of OFEV versus in 0% placebo patients. In the post-marketing period, cases of gastrointestinal perforations have been reported, some of which were fatal. Use caution when treating patients who have had recent abdominal surgery, previous history of diverticular disease or receiving concomitant corticosteroids or NSAIDs. Discontinue therapy with 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.

ADVERSE REACTIONS

  • Adverse reactions reported in greater than or equal to 5% of OFEV patients included diarrhea, nausea, abdominal pain, liver enzyme elevation, vomiting, decreased appetite, weight decreased, headache, and hypertension.
  • The most frequent serious adverse reactions reported in OFEV patients were bronchitis and myocardial infarction. The most common adverse events leading to death in OFEV patients versus placebo were pneumonia (0.7% vs. 0.6%), lung neoplasm malignant (0.3% vs. 0%), and myocardial infarction (0.3% vs. 0.2%). In the predefined category of major adverse cardiovascular events (MACE) including MI, fatal events were reported in 0.6% of OFEV versus 1.8% in placebo patients.

DRUG INTERACTIONS

  • P-glycoprotein (P-gp) and CYP3A4 Inhibitors and Inducers: Coadministration with oral doses of a P-gp and CYP3A4 inhibitor, ketoconazole, increased exposure to nintedanib by 60%. Concomitant use of potent P-gp and CYP3A4 inhibitors (e.g., erythromycin) with OFEV may increase exposure to nintedanib. In such cases, patients should be monitored closely for tolerability of OFEV. Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with OFEV. 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.
  • Anticoagulants: Nintedanib may increase the risk of bleeding. Monitor patients on full anticoagulation therapy closely for bleeding and adjust anticoagulation treatment as necessary.

USE IN SPECIFIC POPULATIONS

  • Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from OFEV, advise women that breastfeeding is not recommended during treatment.
  • Reproductive Potential: OFEV may reduce fertility in females of reproductive potential.
  • Smokers: Smoking was associated with decreased exposure to OFEV, which may affect the efficacy of OFEV. Encourage patients to stop smoking prior to and during treatment.
CL-OF-100007 01.29.18

Indication

OFEV (nintedanib) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Click here for full Prescribing Information, including Patient Information.

References

1. OFEV® (nintedanib) Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2018. 2. Richeldi L, du Bois RM, Raghu G, et al; for the INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;370(22):2071-2082. 3. Richeldi L, Costabel U, Selman M, et al. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011;365(12):1079-1087. 4. Data on file. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 5. Zappala CJ, Latsi PI, Nicholson AG, et al. Marginal decline in forced vital capacity is associated with a poor outcome in idiopathic pulmonary fibrosis. Eur Respir J. 2010;35(4):830-836. 6. Schmidt SL, Tayob N, Han MK, et al. Predicting pulmonary fibrosis disease course from past trends in pulmonary function. Chest. 2014;145(3):579-585. 7. du Bois RM, Weycker D, Albera C, et al. Forced vital capacity in patients with idiopathic pulmonary fibrosis: test properties and minimal clinically important difference. Am J Respir Crit Care Med. 2011;184(12):1382-1389. 8. Song JW, Hong S-B, Lim C-M, Koh Y, Kim DS. Acute exacerbation of idiopathic pulmonary fibrosis: incidence, risk factors and outcome. Eur Respir J. 2011;37(2):356-363. 9. Raghu G, Rochwerg B, Zhang Y, et al; on behalf of the ATS, ERS, JRS, and ALAT. An official ATS/ERS/JRS/ALAT clinical practice guideline: treatment of idiopathic pulmonary fibrosis: an executive summary. An update of the 2011 clinical practice guideline. Am J Respir Crit Care Med. 2015;192(2):e3-e19.

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

Hepatic Impairment

  • OFEV is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment. Patients with mild hepatic impairment (Child Pugh A) can be treated with a reduced dosage (100 mg twice daily). Consider treatment interruption or discontinuation for management of adverse reactions.

Elevated Liver Enzymes and Drug-Induced Liver Injury

  • Cases of drug-induced liver injury (DILI) have been observed with OFEV treatment. In the post-marketing period, non-serious and serious cases of DILI, including severe liver injury with fatal outcome, have been reported. The majority of hepatic events occur within the first three months of treatment. OFEV was associated with elevations of liver enzymes (ALT, AST, ALKP, and GGT) and bilirubin. Liver enzyme and bilirubin increases were reversible with dose modification or interruption in the majority of cases. The majority (94%) of patients with ALT and/or AST elevations had elevations less than 5 times ULN. The majority (95%) of patients with bilirubin elevations had elevations less than 2 times ULN.
  • Patients with a low body weight (less than 65 kg), Asian, and female patients may have a higher risk of elevations in liver enzymes. Nintedanib exposure increased with patient age, which may result in increased liver enzymes.
  • Conduct liver function tests prior to initiation of treatment, at regular intervals during the first three months of treatment, and periodically thereafter or as clinically indicated. Measure liver function tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. Dosage modifications, interruption, or discontinuation may be necessary for liver enzyme elevations.

Gastrointestinal Disorders

Diarrhea

  • Diarrhea was the most frequent gastrointestinal event reported in 62% versus 18% of patients treated with OFEV and placebo, respectively. Events were primarily mild to moderate intensity and occurred within the first 3 months. Diarrhea led to permanent dose reduction in 11% and discontinuation in 5% of OFEV patients versus 0 and less than 1% in placebo patients, respectively.
  • Dosage modifications or treatment interruptions may be necessary in patients with diarrhea. Treat diarrhea at first signs with adequate hydration and antidiarrheal medication (e.g., loperamide), and consider treatment interruption if diarrhea continues. OFEV treatment may be resumed at the full dosage (150 mg twice daily), or at the reduced dosage (100 mg twice daily), which subsequently may be increased to the full dosage. If severe diarrhea persists, discontinue treatment.

Nausea and Vomiting

  • Nausea was reported in 24% versus 7% and vomiting was reported in 12% versus 3% of patients treated with OFEV and placebo, respectively. Events were primarily of mild to moderate intensity. Nausea and vomiting led to discontinuation of OFEV in 2% and 1% of patients, respectively.
  • If nausea or vomiting persists despite appropriate supportive care including anti-emetic therapy, consider dose reduction or treatment interruption. OFEV treatment may be resumed at full dosage or at reduced dosage, which subsequently may be increased to full dosage. If severe nausea or vomiting does not resolve, discontinue treatment.

Embryofetal Toxicity: OFEV can cause fetal harm when administered to a pregnant woman and patients should be advised of the potential risk to a fetus. Women should be advised to avoid becoming pregnant while receiving OFEV and to use effective contraception during treatment and at least 3 months after the last dose of OFEV. Verify pregnancy status prior to starting OFEV.

Arterial Thromboembolic Events: Arterial thromboembolic events were reported in 2.5% of OFEV and 0.8% of placebo patients, respectively. Myocardial infarction was the most common arterial thromboembolic event, occurring in 1.5% of OFEV and 0.4% of placebo patients. Use caution when treating patients at higher cardiovascular risk including known coronary artery disease. Consider treatment interruption in patients who develop signs or symptoms of acute myocardial ischemia.

Risk of Bleeding: OFEV may increase the risk of bleeding. Bleeding events were reported in 10% of OFEV versus 7% of placebo patients. Use OFEV in patients with known risk of bleeding only if the anticipated benefit outweighs the potential risk. In the post-marketing period, non-serious and serious bleeding events, some of which were fatal, have been observed.

Gastrointestinal Perforation: OFEV may increase the risk of gastrointestinal perforation. Gastrointestinal perforation was reported in 0.3% of OFEV versus in 0% placebo patients. In the post-marketing period, cases of gastrointestinal perforations have been reported, some of which were fatal. Use caution when treating patients who have had recent abdominal surgery, previous history of diverticular disease or receiving concomitant corticosteroids or NSAIDs. Discontinue therapy with 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.

ADVERSE REACTIONS

  • Adverse reactions reported in greater than or equal to 5% of OFEV patients included diarrhea, nausea, abdominal pain, liver enzyme elevation, vomiting, decreased appetite, weight decreased, headache, and hypertension.
  • The most frequent serious adverse reactions reported in OFEV patients were bronchitis and myocardial infarction. The most common adverse events leading to death in OFEV patients versus placebo were pneumonia (0.7% vs. 0.6%), lung neoplasm malignant (0.3% vs. 0%), and myocardial infarction (0.3% vs. 0.2%). In the predefined category of major adverse cardiovascular events (MACE) including MI, fatal events were reported in 0.6% of OFEV versus 1.8% in placebo patients.

DRUG INTERACTIONS

  • P-glycoprotein (P-gp) and CYP3A4 Inhibitors and Inducers: Coadministration with oral doses of a P-gp and CYP3A4 inhibitor, ketoconazole, increased exposure to nintedanib by 60%. Concomitant use of potent P-gp and CYP3A4 inhibitors (e.g., erythromycin) with OFEV may increase exposure to nintedanib. In such cases, patients should be monitored closely for tolerability of OFEV. Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with OFEV. 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.
  • Anticoagulants: Nintedanib may increase the risk of bleeding. Monitor patients on full anticoagulation therapy closely for bleeding and adjust anticoagulation treatment as necessary.

USE IN SPECIFIC POPULATIONS

  • Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from OFEV, advise women that breastfeeding is not recommended during treatment.
  • Reproductive Potential: OFEV may reduce fertility in females of reproductive potential.
  • Smokers: Smoking was associated with decreased exposure to OFEV, which may affect the efficacy of OFEV. Encourage patients to stop smoking prior to and during treatment.
CL-OF-100007 01.29.18

Indication

OFEV (nintedanib) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Click here for full Prescribing Information, including Patient Information.
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