Nintedanib
OFEV
What it isOral triple tyrosine-kinase inhibitor (VEGFR, FGFR, PDGFR) for idiopathic pulmonary fibrosis.
Why this oneUnlike pirfenidone, it also treats systemic-sclerosis ILD and other progressive fibrosing lung disease.
What limits itDiarrhea often limits treatment; monitor liver tests and bleeding risk, and avoid use in pregnancy.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Idiopathic pulmonary fibrosis (IPF) | Adults | 150 mg BID (~12 h apart) with food | 150 mg BID | 300 mg/day |
| Chronic fibrosing ILDs with progressive phenotype | Adults | 150 mg BID (~12 h apart) with food | 150 mg BID | 300 mg/day |
Renal Mild–moderate: no starting-dose adjustment; not studied in severe (CrCl <30 mL/min) or ESRD
Hepatic Child-Pugh A: 100 mg BID; Child-Pugh B or C: not recommended
Instructions
- Take with food; swallow capsule whole with liquid — do not chew, crush, or open (bitter taste; wash hands if contents contacted)
- Before starting: liver function tests (all patients) and pregnancy test (females of reproductive potential)
- Missed dose: skip; do not exceed 300 mg/day
- For adverse reactions: reduce to 100 mg BID or interrupt; may re-escalate to 150 mg BID after resolution; discontinue if 100 mg BID not tolerated
- LFT-based rules: AST/ALT >3–<5× ULN without liver-injury signs → interrupt or reduce to 100 mg BID; >3× ULN with signs, or >5× ULN → discontinue
Cautions
- Elevated liver enzymes and drug-induced liver injury (incl. fatal) — LFTs at baseline, regularly ×3 mo, then periodically; most events within first 3 mo
- GI disorders: diarrhea, nausea, vomiting — treat early with hydration and antidiarrheals/antiemetics; discontinue if severe and persistent
- Embryo-fetal toxicity — highly effective contraception; if on oral hormonal contraceptives with vomiting/diarrhea, add alternative method
- Arterial thromboembolic events (incl. MI) — caution with higher cardiovascular risk/known CAD
- Bleeding events — use only if benefit outweighs risk in patients with known bleeding risk
- GI perforation — caution after recent abdominal surgery, diverticular disease, or concomitant corticosteroids/NSAIDs; discontinue if perforation occurs
- Nephrotic-range proteinuria — consider interruption for new/worsening proteinuria
- Smoking decreases exposure — encourage cessation before and during treatment
Adverse reactions
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
- Liver enzyme elevation
- Decreased appetite
- Headache
- Weight decreased
- Hypertension (all >=5%)
Pregnancy Can cause fetal harm (animal embryo-fetal death and structural abnormalities at <=~5× MRHD); no human data; verify pregnancy status before starting.
Lactation Breastfeeding is not recommended.
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Nintedanib ballicule
