2.0

1.7

  95% CI

(1.9, 2.3)

(1.7, 1.8)
  HR (95% CI)

0.49 (0.42, 0.58)

  Stratified Log-Rank Test P-value a

<0.0001

Overall Response Rate

   Overall response, n (%)

5 (1%)
1 (0.4%)
  95% CI

0.3%, 2.3%

0%, 2.2%

Figure : Kaplan-Meier Curves of Overall Survival

16 HOW SUPPLIED/STORAGE AND HANDLING
 
16.1 How Supplied
 
Stivarga tablets are supplied in packages containing three bottles, with each bottle containing 28 tablets, for a total of 84 tablets per package (NDC 50419-171-03).
 
16.2 Storage and Handling
 
Store Stivarga at 25°C (77°F); excursions are permitted from 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature].
 
Store tablets in the original bottle and do not remove the desiccant. Keep the bottle tightly closed after first opening.
 
Discard any unused tablets 28 days after opening the bottle. Dispose of unused tablets in accordance with local requirements.
 
17 PATIENT COUNSELING INFORMATION
 
See FDA-Approved Patient Labeling (Patient Information).
   Inform your patients of the following: • Stivarga may cause severe or life-threatening liver damage. Inform patients that they will need to undergo monitoring for liver damage and to immediately report any signs or symptoms of severe liver damage to their health care provider. • Stivarga can cause severe bleeding. Advise patients to contact their health care provider for any episode of bleeding. • Stivarga can cause hand-foot skin reactions or rash elsewhere. Advise patients to contact their health care provider if they experience skin changes associated with redness, pain, blisters, bleeding, or swelling. • Stivarga can cause or exacerbate existing hypertension. Advise patients they will need to undergo blood pressure monitoring and to contact their health care provider if blood pressure is elevated or if symptoms from hypertension occur including severe headache, lightheadedness, or neurologic symptoms. • Stivarga increased the risk for myocardial ischemia and infarction. Advise patients to seek immediate emergency help if they experience chest pain, shortness of breath, or feel dizzy or like passing out. • Contact a healthcare provider immediately if they experience severe pains in their abdomen, persistent swelling of the abdomen, high fever, chills, nausea, vomiting, severe diarrhea (frequent or loose bowel movements), or dehydration. • Stivarga may complicate wound healing. Advise patients to inform their health care provider if they plan to undergo a surgical procedure or had recent surgery. • Inform patients that regorafenib can cause fetal harm. Advise women of reproductive potential and men of the need for effective contraception during Stivarga treatment and for up to 2 months after completion of treatment. Instruct women of reproductive potential to immediately contact her health care provider if pregnancy is suspected or confirmed during or within 2 months of completing treatment with Stivarga. • Advise nursing mothers that it is not known whether regorafenib is present in breast milk and discuss whether to discontinue nursing or to discontinue regorafenib. • Inform patients to take any missed dose on the same day, as soon as they remember, and that they m