Turalio = pexidartinib (CSF-1R inhibitor) used for tenosynovial giant cell tumor (TGCT). Its safety profile centers on a key risk and several common adverse effects.
Key safety points
- Boxed warning: Hepatotoxicity. Severe and potentially fatal liver injury has occurred. Liver tests must be monitored closely.
- REMS program: Turalio is available only through a risk-management program to ensure appropriate liver monitoring and patient selection.
- Monitoring plan: Baseline liver tests (ALT/AST, bilirubin, etc.), then liver tests every 2 weeks for the first 8 weeks, and periodically thereafter (often monthly). Report symptoms suggestive of liver injury promptly (see below).
- If liver injury is suspected or lab values elevate significantly (e.g., ALT/AST elevations with bilirubin or signs of liver failure), treatment is stopped or discontinued as advised by the prescriber.
Other important safety considerations
- Pregnancy and contraception: Pexidartinib can harm a fetus. Not recommended in pregnancy; use effective contraception during treatment and for a period after stopping. If pregnancy occurs, inform your clinician immediately.
- Hepatic impairment: Exposure to the drug increases with hepatic impairment. The drug is generally avoided or used with caution in patients with moderate to severe hepatic impairment; dose adjustments may be required or the drug may be avoided depending on the level of impairment.
- Drug interactions: Avoid concomitant use with strong CYP3A4 inhibitors or inducers if possible, and adjust therapy if necessary. Your clinician will review other medicines (including over-the-counter and herbal products) that affect liver enzymes.
- Common adverse effects (experienced by many patients; incidence varies): Alopecia (hair loss), fatigue, nausea, diarrhea, constipation, decreased appetite, altered taste (dysgeusia), abdominal pain, rash, headache, dizziness.
- Other potential but less common effects: swelling (edema), elevated liver enzymes, bilirubin elevations, and other signs of liver or blood abnormalities. Rare but serious events can occur; abrupt symptoms should prompt medical attention.
What to watch for and report
- Signs of liver injury: fatigue, loss of appetite, right upper abdominal tenderness, dark urine, pale stools, nausea/vomiting, jaundice (yellowing of skin or eyes).
- Other symptoms: new or worsening numbness/tingling, severe headaches, severe dizziness, swelling, or unusual bleeding/bruising.
If you’d like, I can tailor this to your situation (e.g., age, liver test results, other medications) or pull up the exact monitoring schedule and thresholds from the current label. Always consult your prescriber or pharmacist for instructions specific to your case.