Fruquintinib

FDA label

Read the full label on DailyMed ↗

Renal Undefined

Hepatic Mild: no adjustment. Moderate: not sufficiently studied. Severe: not recommended

Dose reductions for toxicity: 4 mg QD, then 3 mg QD; permanently discontinue if 3 mg QD not tolerated

Instructions

• Swallow capsule whole; with or without food, same time each day
• Missed dose: take if <12 h late; never double up; if vomiting after dose, do not re-dose - continue with next scheduled dose
• Withhold >=2 weeks before major surgery; do not give for >=2 weeks after and until adequate wound healing

Available strengths

• cap 1, 5 mg

Cautions

• Hypertension (49%; Grade 3-4 19%) - control BP before starting; monitor weekly first month then monthly
• Hemorrhagic events, may be fatal - monitor at-risk patients and INR on anticoagulants
• Infections incl. fatal - do not start during active infection; withhold for Grade 3-4
• GI perforation/fistula (1.3%) - permanently discontinue
• Hepatotoxicity - monitor LFTs at baseline and periodically
• Proteinuria - monitor urine protein; discontinue for nephrotic syndrome
• Palmar-plantar erythrodysesthesia
• Posterior reversible encephalopathy syndrome (PRES) - discontinue immediately if confirmed
• Impaired wound healing
• Arterial thromboembolic events - discontinue if occur; caution with recent history
• Contains FD&C Yellow No. 5 (tartrazine) and No. 6 - possible allergic reactions incl. bronchial asthma
• Embryo-fetal toxicity - contraception during treatment and 2 weeks after (F and M)

Adverse reactions

• Hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, asthenia (>=20%)

Pregnancy Can cause fetal harm (rat teratogenicity/embryolethality below clinical exposure); verify pregnancy status before starting; no human data

Lactation Do not breastfeed during treatment and for 2 weeks after last dose