s with impaired renal function. The starting dose should be reduced to 200 mg in patients with moderate to severe renal impairment and QT interval should be monitored closely. There is no information available for patients with end-stage renal disease requiring dialysis. [see Boxed Warning, Dosage and Administration (2.4) and Use in Specific Populations (8.6)]
5.13 Hepatic Impairment
CAPRELSA is not recommended for use in patients with moderate and severe hepatic impairment, as safety and efficacy have not been established. [see Dosage and Administration (2.5)]
5.14 Use in Pregnancy
CAPRELSA can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women using CAPRELSA. In nonclinical studies in rats, vandetanib was embryotoxic, fetotoxic, and teratogenic, at exposures equivalent to or lower than those expected at the recommended human dose of 300 mg/day. As expected from its pharmacological actions, vandetanib has shown significant effects on all stages of female reproduction in rats.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during treatment with CAPRELSA. Women should be advised that they must use effective contraception to prevent pregnancy during treatment and for at least four months following the last dose of CAPRELSA [see Use in Specific Populations (8.1)].
5.15 CAPRELSA REMS (Risk eva luation and Mitigation Strategy) Program
Because of the risk of QT prolongation, Torsades de pointes, and sudden death, CAPRELSA is available only through the restricted distribution program called CAPRELSA REMS Program. Only prescribers and pharmacies certified with the program are able to prescribe and dispense CAPRELSA.
An overview of the requirements for prescribers and pharmacies is included below.
To be certified, prescribers must review the educational materials, agree to comply with the REMS requirements, and enroll in the program.
To be certified, pharmacies that dispense CAPRELSA must enroll in the program, train their pharmacy staff to verify that each prescription is written by a certified prescriber before dispensing to a patient, and agree to comply with the REMS requirements.
To learn about the specific REMS requirements and to enroll in the CAPRELSA REMS Program, call 1-800-236-9933 or visit www.caprelsarems.com.
6. ADVERSE REACTIONS
The most commonly reported adverse drug reactions (>20%) have been diarrhea, rash, acne, nausea, hypertension, headache, fatigue, decreased appetite, and abdominal pain. The most common laboratory abnormalities (>20%) were decreased calcium, increased ALT, and decreased glucose [see Dosage and Administration (2.1)and Warnings and Precautions (5.2, 5.3and 5.9)].
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
6.1. Clinical Studies Experience
Patients with unresectable locally advanced or metastatic medullary thyroid cancer were treated with CAPRELSA 300 mg (n=231) or Placebo (n= 99). Patients with investigator-determined progression or patients who continued treatment after the data cut |
