Experience matters

Courage to face IPF head on,
Confidence to treat with OFEV®

OFEV® has a demonstrated treatment effect in reducing FVC decline from treatment initiation, and a safety profile that is sustained over time1-6

OFEV® - A consistent treatment effect over 52 weeks in multiple large, Phase III trials2,3,6

IPF: Idiopathic pulmonary fibrosis; SSc-ILD: Systemic Sclerosis associated interstitial lung disease

The treatment effect on slowing FVC decline was consistent across trials studying patients with IPF, other chronic fibrosing ILDs with a progressive phenotype, and SSc-ILD2,3,6,7

 

Think OFEV® for a demonstrated treatment effect in slowing FVC decline in patients with IPF, other chronic fibrosing ILDs with a progressive phenotype, and SSc-ILD7-13

An Effect consistent over time….

The INPULSIS®-ON trial confirmed that the efficacy of OFEV® in patients with IPF persists over 4 years1

The effect of OFEV® on reducing disease progression in the INPULSIS® trials was consistent over long-term treatment in the INPULSIS®-ON open-label extension trial*†1

 

*Per protocol, the off-treatment period between INPULSIS® and INPULSIS®-ON could be between 4 and 12 weeks1
†The differences in FVC decline in INPULSIS®-ON between patients who received OFEV® and placebo in the preceding INPULSIS® trials were not considered to be clinically meaningful, particularly when put into perspective with the FVC decline observed in placebo-treated patients in INPULSIS® (-223.5 mL/year) and the minimal clinically important difference in FVC, which is believed to be 2–6% predicted (a difference of at least 75–80 mL)1,14

Additionally, long-term OFEV® treatment (up to 68.3 months) had a manageable safety and tolerability profile, with no new safety signals identified1

 

Consider OFEV® for sustained efficacy and safety in patients with IPF over 4 years1,6,10

Manage your patients, so they can remain on treatment:

In clinical trials across all of OFEV®’s indications, AE management helped patients to remain on therapy3,15,16

Across the INPULSIS®, SENSCIS®, and INBUILD® trials, AEs resulted in OFEV® discontinuation in 16.0–19.6% of patients,2,3,15 suggesting that OFEV® treatment can be effectively managed in most patients

 

Most patients were able to remain on treatment in each trial2,3,15

 

Management of common Side effects

GI Side effects

Supportive medications7

Antidiarrheals, such as loperamide
Antiemetic therapy

Dose adjustment7

Temporary treatment interruption or dose reduction (100 mg twice daily) if symptomatic treatment is ineffective If a patient does not tolerate 100 mg twice daily, treatment with OFEV® should be discontinued

Dietary changes7,17

Adequate hydration at first sign of diarrhea Avoidance of dried fruits with high pectin content Use of the BRAT (bananas, rice, applesauce, toast) diet

 
 

DECREASED APPETITE AND WEIGHT LOSS

  • Decreased appetite can be managed using quality food/protein intake, high-protein nutritional drinks and more frequent meals. Weight loss can be managed using increased calorie intake, a dietary schedule of three meals per day with snacks in between, and high-protein nutritional drinks17
  • Dose modification (reduction or interruption) should be initiated if a patient with decreased appetite loses >4.5 kg (>10 lbs)17
  • Dose modification (reduction or interruption) should be considered in patients with persistent weight loss17

LIVER ENZYMES

  • Liver enzyme elevations have been reported with OFEV® treatment; in most cases, these were reversible on dose reduction or treatment interruption*7
  • Dose reduction or interruption of OFEV® treatment plus close monitoring is recommended if AST/ALT >3 x ULN occurs7
  • OFEV® treatment should be permanently discontinued if liver enzyme elevations occur in association with clinical signs and symptoms of liver injury7
 

Consider OFEV® for patients with IPF, chronic fibrosing ILDs with a progressive phenotype or SSc ILD, for a treatment with a manageable safety profile3,7-10,12,13,15,16

Courage to face IPF head on,
Confidence to treat with OFEV®

References:

1. Crestani B, Huggins JT, Kaye M et al. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med 2019;7:60–8. 2. Distler O, Highland KB, Gahlemann M et al. Nintedanib for systemic sclerosis-associated interstitial lung disease. N Engl J Med 2019;380:2518–28. 3. Flaherty KR, Wells AU, Cottin V et al. Nintedanib in progressive fibrosing interstitial lung diseases. N Engl J Med 2019;381:1718–27. 4. Highland KB, Vonk MC, Azuma A et al. Continued treatment with nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD): Data from the SENSCIS-ON Trial. Am J Respir Crit Care Med 2021a;203:abstract A1806. 5. Maher TM, Wuyts W. Management of Fibrosing Interstitial Lung Diseases. Adv Ther 2019;36:1518–31. 6. 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;380:2071–82. 7. OFEV® Professional information leaflet; Ingelheim Pharmaceuticals (Pty) Ltd 31 July 2021. 8. George PM, Spagnolo P, Kreuter M et al. Progressive fibrosing interstitial lung disease: Clinical uncertainties, consensus recommendations, and research priorities. Lancet Respir Med 2020;8:925–34. 9. Hoffmann-Vold A-M, Allanore Y, Bendstrup E et al. The need for a holistic approach for SSc-ILD – achievements and ambiguity in a devastating disease. Respir Res 2020b;21:197. 10. Raghu G, Rochwerg B, Zhang Y et al. An official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of idiopathic pulmonary fibrosis. An update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med 2015;192:e3–e19. 11. Roofeh D, Lescoat A, Khanna D. Treatment for systemic sclerosis-associated interstitial lung disease. Curr Opin Rheumatol 2021;33:240–8. 12. Varone F, Sgalla G, Iovene B et al. Progressive fibrosing interstitial lung disease. A proposed integrated algorithm for management. Ann Am Thor Soc 2020;17:1199–203. 13. Wongkarnjana A, Scallan C, Kolb MRJ. Progressive fibrosing interstitial lung disease: Treatable traits and therapeutic strategies. Curr Opin Pulm Med 2020;26:436–42. 14. du Bois RM, Weycker D, Albera C et al. Forced vital capacity in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2011;184:1382–9. 15. Corte T, Bonella F, Crestani B et al. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res 2015;16:116. 16. Seibold JR, Maher TM, Highland KB et al. Safety and tolerability of nintedanib in patients with systemic sclerosis-associated interstitial lung disease: Data from the SENSCIS trial. Ann Rheum Dis 2020;79:1478–84. 17. Rahaghi F, Belperio JA, Fitzgerald J et al. Delphi Consensus Recommendations on Management of Dosing, Adverse Events, and Comorbidities in the Treatment of Idiopathic Pulmonary Fibrosis with Nintedanib. Clin Med Insights Circ Respir Pulm Med 2021;15:11795484211006050.

  • S4OFEV® 100 mg contains 100 mg nintedanib base (as esilate salt) Reg. No./Nr.: A 52/26/0153.
  • S4OFEV® 150 mg contains 150 mg nintedanib base (as esilate salt) Reg. No./Nr.: A 52/26/0154.
  • For full prescribing information refer to the professional information approved by the Regulatory Authority.
    Applicant details: Ingelheim Pharmaceuticals (PTY) LTD. Building 4, 2nd Floor, Waterfall Corporate Campus, 74 Waterfall Drive, Midrand, South Africa. Tel: +27 (011) 348-2400. Cpy. Reg. No. 1966/008618/07. BI Ref. No. PC-ZA-101566. Expiry date: November 2023.