| Medication Name | Stivarga |
| Generic Name | Regorafenib |
| Boxed/Label Warning | Severe liver problems. Stivarga can cause severe and sometimes fatal liver problems. Your doctor should do blood tests to check your liver function before you start taking Stivarga and during your treatment. Tell your doctor right away if you develop any of the following signs or symptoms of liver problems: yellowing of your skin or the whites of your eyes (jaundice), dark urine, light-colored stools (bowel movements), nausea, vomiting, loss of appetite, pain on the right side of your stomach area, tiredness, feel weak, bleeding or bruising more easily than normal. Increased risk of bleeding. Stivarga can increase your risk of bleeding. Tell your doctor if you develop any signs of bleeding during treatment with Stivarga, including black, tarry stools, blood in your stools, or vomit that looks like coffee grounds. Skin problems, including hand-foot skin reaction. Stivarga can cause skin problems, including hand-foot skin reaction (HFSR) and severe skin rashes. Tell your doctor right away if you develop any skin problems during treatment with Stivarga, including: pain, redness, swelling, blisters, or peeling skin on your hands and feet. HFSR can be severe and may require treatment with other medicines, dose reductions or stopping Stivarga. |
| Purpose | Tyrosine kinase inhibitor used to treat certain types of cancer, including metastatic colorectal cancer, gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma (liver cancer). |
| Mechanism of Action | Inhibits several protein kinases involved in tumor angiogenesis, oncogenesis, and the tumor microenvironment. |
| Dosage Forms | Oral tablets |
| Available Strengths | 40 mg |
| Dosage Frequency | Once daily for the first 21 days of each 28-day cycle, or as directed by a healthcare provider. |
| Common Side Effects | Weakness or fatigue, decreased appetite, hand-foot skin reaction, diarrhea, mucositis, weight loss, infection, hypertension, dysphonia. |
| Serious Side Effects | Liver damage, severe bleeding, gastrointestinal perforation, wound healing complications, hypertension, cardiac ischemia and infarction, reversible posterior leukoencephalopathy syndrome (RPLS). |
| Drug Interactions | Strong CYP3A4 inducers (e.g., rifampin, phenytoin), strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin), drugs metabolized by UGT1A1 (e.g., irinotecan). |
| Important Notes | Take after a low-fat meal; swallow tablets whole with water; monitor liver function, blood pressure, and signs of bleeding or infection; avoid grapefruit and grapefruit juice. |
| Storage | Store at room temperature away from moisture and light. |
| Missed Dose | If a dose is missed, take it as soon as you remember unless it is close to the time of the next dose. Do not double the dose. |
| Alternatives | Lenvatinib (Lenvima), Sorafenib (Nexavar), Cabozantinib (Cabometyx) |