Label Changes for:
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Severe Skin Reactions (previously Skin Reactions and Stevens-Johnson Syndrome)
- Severe and sometimes fatal skin reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome, have occurred in patients treated with CAPRELSA. Permanently discontinue CAPRELSA for severe skin reactions and refer the patient for urgent medical evaluation. Systemic therapies such as corticosteroids may be required.
- The following serious adverse reactions are discussed elsewhere in the label:
- Serious Skin Reactions replace Skin Reactions and Stevens-Johnson Syndrome
PATIENT COUNSELING INFORMATION
Serious Skin Reactions replace Skin Reactions and Stevens-Johnson Syndrome
- CAPRELSA may cause serious side effects, including:
- Serious skin reactions. CAPRELSA can cause serious skin reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome …
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.