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2.2 Dose Modifications (Due to Toxicity)
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hepatoxicity
5.2 Hemorrhage
5.3 Dermatological Toxicity
5.4 Hypertension
5.5 Cardiac Ischemia and Infarction
5.6 Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
5.7 Gastrointestinal Perforation or Fistula
5.8 Wound Healing Complications
5.9 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Effect of Strong CYP3A4 Inducers on Regorafenib
7.2 Effect of Strong CYP3A4 Inhibitors on Regorafenib
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
8.8 Females and Males of Reproductive Potential
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
Patient Package Insert
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Stivarga® is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
The recommended dose is 160 mg regorafenib (four 40 mg tablets) taken orally once daily for the first 21 days of each 28-day cycle. Continue treatment until disease progression or unacceptable toxicity.
Take Stivarga at the same time each day. Swallow tablet whole with a low-fat breakfast that contains less than 30% fat [see Clinical Pharmacology (12.3)]. Examples of a low-fat breakfast include 2 slices of white toast with 1 tablespoon of low-fat margarine and 1 tablespoon of jelly, and 8 ounces of skim milk (319 calories and 8.2 g fat); or 1 cup of cereal, 8 ounces of skim milk, 1 slice of toast with jam, apple juice, and 1 cup of coffee or tea (520 calories and 2 g fat). Do not take two doses of Stivarga on the same day to make up for a missed dose from the previous day.)].
2.2 Dose Modifications (Due to Toxicity)
Interrupt Stivarga for the following:
• NCI CTCAE Version 3.0 (v3.0) Grade 2 hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia (PPE)] that is recurrent or does not improve within 7 days despite dose reduction; interrupt therapy for a minimum of 7 days for Grade 3 HFSR • Symptomatic Grade 2 hypertension • Any NCI CTCAE v3.0 Grade 3 or 4 adverse reaction
Reduce the dose of Stivarga to 120 mg:
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