Nintedanib

FDA label

Read the full label on DailyMed ↗

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

Available strengths

• cap 100, 150 mg

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.