Photos courtesy of Elizabeth Manchen, RN, MS, OCN. Reproduced with patients' permission.
Hand-foot skin reaction (HFSR) and rash are the most common adverse reactions attributed to NEXAVAR1
Management may include topical therapies for symptomatic relief
In cases of any severe or persistent adverse reactions, temporary treatment interruption, dosage modification, or permanent discontinuation of NEXAVAR should be considered
There have been reports of severe dermatologic toxicities, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These cases may be life-threatening. Discontinue NEXAVAR if SJS or TEN are suspected1
Patient counseling considerations for HFSR
Advise patients to:
In the hepatocellular carcinoma (HCC) study, hypertension was reported in approximately 9.4% of NEXAVAR-treated patients and 4.3% of patients receiving placebo
In the renal cell carcinoma (RCC) study, hypertension was reported in approximately 16.9% of NEXAVAR-treated patients and 1.8% of patients receiving placebo
In the differentiated thyroid carcinoma (DTC) study, hypertension was reported in 40.6% of NEXAVAR-treated patients and 12.4% of patients receiving placebo
Hypertension was usually mild to moderate, occurred early in the course of treatment, and was managed with standard antihypertensive therapy. Permanent discontinuation due to hypertension occurred in 1 of 297 NEXAVAR-treated patients in the SHARP (HCC) study, 1 of 451 NEXAVAR-treated patients in the TARGET (RCC) study, and 1 of 207 NEXAVAR-treated patients in the DECISION (DTC) study
Monitor blood pressure weekly during the first 6 weeks of therapy with NEXAVAR. Thereafter, monitor blood pressure and treat hypertension, if required, in accordance with standard medical practice
In cases of severe or persistent hypertension despite institution of antihypertensive therapy, consider temporary or permanent discontinuation of NEXAVAR
To report suspected adverse reactions, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.