Label Changes for:
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Effect of CYP3A4 Inducers on CAPRELSA
- Rifampicin, a strong CYP3A4 inducer, decreased vandetanib plasma concentrations. Avoid concomitant use of known strong CYP3A4 inducers during CAPRELSA therapy. Avoid concomitant use of St. John’s Wort because it can decrease vandetanib exposure unpredictably [Effect of CAPRELSA on OCT2 Transporter
- CAPRELSA increased plasma concentrations of metforman that is transported by the organic cation transporter type 2 (OCT2). Use caution and closely monitor for toxicities when administering CAPRELSA with drugs that are transported by OCT2
Effect of CAPRELSA on Digoxin
- CAPRELSA increased plasma concentrations of digoxin. Use caution and closely monitor for toxicities when administering CAPRELSA with digoxin
Drugs that Prolong the QT Interval
- Avoid concomitant use of CAPRELSA with agents that may prolong the QT interval
- Intestinal perforation occurred in 0.4% of CAPRELSA treated patients versus 0% of placebo treated
Clinical Studies Experience
- Table 1 - Adverse Reactions With a ≥ 5% Increased Incidence in Patients on Caprelsa Compared to Placebo During Randomized Treatment: Updated and additions made.