IMPORTANT SAFETY INFORMATION:
NEXAVAR is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of NEXAVAR. Continue reading below

Prescribing Nexavar

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

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 reactions1-3

Nexavar (sorafenib) Efficacy and Safety button

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 NEXAVAR1,3
    • Management may include topical therapies for symptomatic relief3
    • In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of NEXAVAR should be considered1
  • 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 suspected

Patient counseling considerations for HFSR

Advise patients to3,4:

  • Use creams or lotions on their hands or feet
  • Soak skin in an Epsom salt bath with warm water
  • See a skin or foot doctor about sores or other problems with their feet
  • Wear cotton socks and use shoe pads
  • Wear loose clothes and shoes

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 treatment

Guidance on hypertension

  • In the hepatocellular carcinoma (HCC) study, hypertension was reported in approximately 9.4% of NEXAVAR-treated patients and 4.3% of patients in the placebo-treated group
  • In the renal cell carcinoma (RCC) study, hypertension was reported in approximately 16.9% of NEXAVAR-treated patients and 1.8% of patients in the placebo-treated group
  • In the differentiated thyroid carcinoma (DTC) study, hypertension was reported in 40.6% of NEXAVAR-treated patients and 12.4% of the placebo-treated patients
  • Hypertension was usually mild to moderate, occurred early in the course of treatment, and was managed with standard antihypertensive therapy
  • Monitor blood pressure weekly during the first 6 weeks of therapy with NEXAVAR and periodically thereafter, treating as required1
  • 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.

Indications

NEXAVAR is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC).

NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

NEXAVAR is indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.

Important Safety Information

For important risk and use information about NEXAVAR, please see the full Prescribing Information.

INDICATION and IMPORTANT SAFETY INFORMATION for STIVARGA® (regorafenib)

For important risk and use information about STIVARGA, please see the full Prescribing Information including the Boxed Warning.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

REFERENCES:

1. NEXAVAR Prescribing Information. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc. 2. Wood LS. Managing the side effects of sorafenib and sunitinib. Community Oncol. 2006;3:558-562. 3. Lacouture ME, Wu S, Robert C, et al. Evolving strategies for the management of hand-foot skin reaction associated with the multitargeted kinase inhibitors sorafenib and sunitinib. Oncologist. 2008;13(9):1001-1011. 4. Cancer.net. Hand-foot syndrome or palmar-plantar erythrodysesthesia. http://www.cancer.net/navigating-cancer-care/side-effects/hand-foot-syndrome-or-palmar-plantar-erythrodysesthesia. Accessed February 1, 2017.