Monitor patients and intervene early

PREPARATION

Some adverse reactions may occur early in treatment. Educate your patients about possible adverse reactions, contacting their healthcare team immediately in the case of emerging symptoms, and self-management interventions, when appropriate1-3

OBSERVATION

Maintain regular follow-up with patients to monitor for adverse reactions, especially early in treatment1,2

INTERVENTION

In the instance of adverse reactions, dose reduction, interruption, or, in severe or persistent cases, permanent discontinuation may be necessary. Patients should be instructed to contact their healthcare provider's office immediately if they experience any adverse reactions1,2

Guidance on HFSR Management
Grade 1: Mild
Mild adverse reaction
Grade 2: Moderate
Moderate adverse reaction
Grade 3: Severe
Severe adverse reaction

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:

  • Use creams or lotions on their hands or feet4

  • Soak skin in an Epsom salt bath with warm water5

  • See a skin or foot doctor about sores or other problems with their feet3

  • Wear cotton socks and use shoe pads3

  • Wear loose clothes and shoes4

Maintain frequent communication with patients during weeks 2 to 4 of treatment to ensure that symptoms are detected early. Continue to maintain communication throughout the course of treatment3

Guidance on hypertension1

  • 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.