STIVARGA(regorafenib) tablet, film coated
[Bayer HealthCare Pharmaceuticals Inc.]
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Stivarga safely and effectively.
See full prescribing information for Stivarga.
Stivarga (regorafenib) tablets, oral
Initial U.S. Approval: 2012
适应症和用途
Stivarga是一种激酶抑制剂适用于既往曾用基于氟嘧啶fluoropyrimidine]-，奥沙利铂[oxaliplatin]-和伊立替康[irinotecan]-化疗，一种抗-VEGF治疗，和，如KRAS野生型，一种抗-EGFR治疗过的转移结肠直肠癌(CRC)患者的治疗。
剂量和给药方法
（1） 推荐剂量：160 mg口服，每天1次每28天疗程的头21天。
（2）与食物服用Stivarga(一种低脂肪早餐)。
剂型和规格
40 mg薄膜包衣片。禁忌症
INDICATIONS AND USAGE
Stivarga is a kinase inhibitor 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. (1)
DOSAGE AND ADMINISTRATION
• Recommended Dose: 160 mg orally, once daily for the first 21 days of each 28-day cycle. (2.1)
• Take Stivarga with food (a low-fat breakfast). (2.1, 12.3))
DOSAGE FORMS AND STRENGTHS
40 mg film-coated tablets (3)
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
• Hemorrhage: Permanently discontinue Stivarga for severe or life-threatening hemorrhage. (5.2) • Dermatological toxicity: Interrupt and then reduce or discontinue Stivarga depending on severity and persistence of dermatologic toxicity. (5.3) • Hypertension: Temporarily or permanently discontinue Stivarga for severe or uncontrolled hypertension. (5.4) • Cardiac ischemia and infarction: Withhold Stivarga for new or acute cardiac ischemia/infarction and resume only after resolution of acute ischemic events. (5.5) • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue Stivarga. (5.6) • Gastrointestinal perforation or fistulae: Discontinue Stivarga. (5.7) • Wound healing complications: Stop Stivarga before surgery. Discontinue in patients with wound dehiscence. (5.8) • Embryofetal toxicity: Can cause fetal harm. Advise women of potential risk to a fetus. (5.9, 8.1)
ADVERSE REACTIONS
The most common adverse reactions (≥30%) are asthenia/fatigue, decreased appetite and food intake, hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia (PPE)], diarrhea, mucositis, weight loss, infection, hypertension, and dysphonia. (6)
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
DRUG INTERACTIONS
• Strong CYP3A4 inducers: Avoid strong CYP3A4 inducers. (7.1)
• Strong CYP3A4 inhibitors: Avoid strong CYP3A4 inhibitors. (7.2)
USE IN SPECIFIC POPULATIONS
Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of the drug to the mother. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 09/2012
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
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