Safety

Caprelsa (vandetanib) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

July 2016

Summary View

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.

ADVERSE REACTIONS

  • 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 …

 

March 2014

Summary View

ADVERSE REACTIONS

DRUG INTERACTIONS
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

 

July 2013

Summary View

ADVERSE REACTIONS

  • Intestinal perforation occurred in 0.4% of CAPRELSA treated patients versus 0% of placebo treated

 

October 2012

Summary View

ADVERSE REACTIONS

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.

 

Page Last Updated: 08/15/2016
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