NINTEDANIB CAP,ORAL NEW
Clinical Criteria Summary
Exclusion Criteria
- Current smoker
- Child Pugh B or C hepatic impairment
- For IPF diagnosis: currently on pirfenidone (ESBRIET)
- Documented ongoing nonadherence to prior medications or medical treatment
- Pregnant or has not received contraceptive counseling regarding potential risk vs. benefit of taking nintedanib if pregnancy occurs
Inclusion Criteria by Diagnosis
- Idiopathic Pulmonary Fibrosis (IPF)
- Treatment initiated and followed by VA/VA Community Care Pulmonologist experienced in diagnosis and management of interstitial lung disease
- Diagnosis confirmed preferably through multidisciplinary evaluation (e.g., pulmonologist, radiologist, pathologist)
- Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
- Treatment initiated and followed by VA/VA Community Care Pulmonologist or Rheumatologist experienced in diagnosis and management of SSc-ILD
- Diagnosis confirmed preferably through multidisciplinary discussion (e.g., pulmonologist, rheumatologist, radiologist, pathologist)
- Demonstrates disease progression: absolute decline in FVC% predicted >10% from baseline OR DLCO levels >15% from baseline while on mycophenolate or cyclophosphamide, OR patient is unable to take mycophenolate or cyclophosphamide
- Chronic Fibrosing Interstitial Lung Disease – Progressive Phenotype (CFILD)
- Treatment initiated and followed by VA/VA Community Care Pulmonologist experienced in diagnosis and management of CFILD
- Diagnosis confirmed preferably through multidisciplinary discussion (e.g., pulmonologist, rheumatologist, radiologist, pathologist)
- Meets criteria for disease progression within a 24-month period: worsening symptoms with relative decline >10% in FVC; OR worsening symptoms with relative decline >15% in DLCO; OR worsening symptoms with radiological appearance accompanied by >5–<10% relative decrease in FVC
Dose Modifications for Liver Chemistry Abnormalities
- AST or ALT >3 but ≤5x upper limit of normal (ULN), without symptoms or hyperbilirubinemia after starting therapy: Discontinue confounding medications, exclude other causes, monitor closely; reduce to 100mg twice daily or place on temporary hold; repeat liver chemistry tests as clinically indicated; resume at 100mg twice daily or full dosage when normalized
- Permanently discontinue nintedanib if AST or ALT >3 but ≤5x ULN accompanied by symptoms or hyperbilirubinemia, OR if AST/ALT >5x ULN regardless of symptoms or hyperbilirubinemia