What laboratory tests are recommended when starting patients on Ofev (nintedanib)?

Laboratory Testing Recommendations When Starting Patients on Ofev (Nintedanib)

When initiating Ofev (nintedanib) therapy, liver function tests should be monitored monthly for the first 3 months, then every 3 months thereafter, as hepatotoxicity is a significant concern with this medication. 1

Initial Laboratory Tests Before Starting Ofev

• Complete blood count (CBC) to establish baseline hematologic parameters 1
• Comprehensive metabolic panel including:
  • Liver function tests (ALT, AST, alkaline phosphatase, bilirubin) to screen for pre-existing liver disease 1
  • Renal function tests (BUN, creatinine, eGFR) to assess kidney function 1
  • Electrolytes (sodium, potassium, calcium, magnesium) 1
• Coagulation studies (INR) to assess bleeding risk, as nintedanib may increase bleeding risk 1, 2
• Pregnancy test for women of childbearing potential 1

Monitoring Schedule During Treatment

First 3 Months

• Liver function tests (ALT, AST, bilirubin) every month 1
• Monitor for diarrhea and weight loss at each visit 1
• Blood pressure monitoring due to potential cardiovascular effects 1, 2

After 3 Months

• Liver function tests every 3 months 1
• Continue monitoring for:
  • Gastrointestinal symptoms (particularly diarrhea) 1, 2
  • Weight loss 1
  • Signs of bleeding 2
  • Cardiovascular adverse events 2

Special Considerations

Hepatic Impairment

• For patients with mild hepatic impairment (Child Pugh A):
  • More frequent liver function monitoring may be needed 3
  • Dose adjustment may be required based on tolerability 3
• Nintedanib is not recommended for patients with moderate or severe hepatic impairment 3

Bleeding Risk

• Patients on anticoagulants or with known bleeding disorders require careful monitoring 2
• Consider more frequent CBC monitoring in these patients 2

Management of Adverse Events

• For liver enzyme elevations:
  • If AST or ALT >3× ULN with signs of liver injury, discontinue treatment 1
  • For AST or ALT >3× to <5× ULN without signs of liver injury, interrupt treatment until values return to baseline 1
• For diarrhea:
  • Implement dose reduction or treatment interruption as needed 2
  • Consider anti-diarrheal medications 2

Pitfalls to Avoid

• Failure to obtain baseline liver function tests may lead to difficulty interpreting subsequent abnormalities 1, 3
• Inadequate monitoring during the first 3 months when risk of hepatotoxicity is highest 1
• Overlooking drug-drug interactions, particularly with P-glycoprotein inhibitors or inducers 3
• Not adjusting monitoring frequency in patients with mild hepatic impairment or other risk factors 3

By adhering to these laboratory monitoring recommendations, clinicians can optimize the safety profile of nintedanib therapy while managing potential adverse events promptly.