Medicine Overview
Adult Dose
| Clinical Information | Administration Information |
|---|---|
|
Indication: Metastatic colorectal cancer, Unresectable, metastatic malignant gastrointestinal stromal tumours, hepatocellular Carcinoma Age: Adult Condition: Patients who have been previously treated with or are not candidates for available therapies |
Dose: Oral – 160 mg Frequency: once daily Duration: 21 days of each 28-day cycle Note: Continue treatment until disease progression or if unacceptable toxicity occurs. |
|
Indication: Metastatic colorectal cancer, Unresectable, metastatic malignant gastrointestinal stromal tumours, hepatocellular Carcinoma Age: Adult Condition: Hepatic Impairment Mild (total bilirubin less than or equal to upper limit of normal and AST greater than upper limit of normal, or total bilirubin greater than upper limit of normal to less than or equal to 1.5x upper limit of normal) or moderate (total bilirubin greater than 1.5 to less than or equal to 3x upper limit of normal and any AST) |
Dose: Oral – 160 mg Frequency: once daily Note: No dosage adjustment necessary. |
Child Dose
| Clinical Information | Administration Information |
|---|---|
|
Age: Pediatric |
Dose: No approved pediatric dosage available Note: Not recommended |
Renal Dose
| Clinical Information | Administration Information |
|---|---|
|
Condition: Renal Impairment Mild-to-severe |
Dose: Renal Dose – No dosage adjustment necessary Note: Patients on dialysis: Not studied |
Administration
- Take with low-fat meal
- Take at same time each day
Side Effect
- Anemia (79%)
- Increased AST (65%)
- Asthenia (64%)
- Proteinuria (60%)
- Hypocalcemia (59%)
- Hypophosphatemia (57%)
- Lymphopenia (54%)
- Decreased appetite and food intake (47%)
- Increased lipase (46%)
- HFSR/PPES (45%)
- Hyperbilirubinemia (45%)
- Increased ALT (45%)
- Diarrhea (43%)
- Thrombocytopenia (41%)
- Mucositis (33%)
- Weight loss (32%)
- Infection (31%)
- Hypophosphatemia, Grade 3 or 4 (31%)
- Hypertension (30%)
- Dysphonia (30%)
- Hyponatremia (30%)
- Pain (29%)
- Fever (28%)
- Rash (26%)
- Hypokalemia (26%)
- Increased amylase (26%)
- Increased INR (24%)
- Hemorrhage (21%)
- Nausea (20%)
- HFSR/PPES, Grade 3 or 4 (17%)
- Asthenia/fatigue, Grade 3 or 4 (15%)
- HFSR/PPES (67%)
- Pain (60%)
- Hypertension (59%)
- Proteinuria (59%)
- Increased AST (58%)
- Hypophosphatemia (55%)
- Asthenia (52%)
- Diarrhea (47%)
- Mucositis (40%)
- Dysphonia (39%)
- Increased ALT (39%)
- Hyperbilirubinemia (33%)
- Infection (32%)
- Decreased appetite and food intake (31%)
- Rash (30%)
- Lymphopenia (30%)
- Alopecia (24%)
- ever (21%)
- HFSR/PPES, Grade 3 or 4 (22%)
- Hypokalemia (21%)
- Nausea (20%)
- Hypophosphatemia, Grade 3 or 4 (20%)
- Hypothyroidism (18%)
- Vomiting (17%)
- Hypocalcemia (17%)
- Headache (16%)
- Neutropenia (16%)
- Weight loss (14%)
- Increased lipase (14%)
- Muscle spasms (14%)
- Thrombocytopenia (13%)
- Hemorrhage (11%)
- Increased AST (93%)
- Hyperbilirubinemia (78%)
- Hypophosphatemia (70%)
- Increased ALT (70%)
- Lymphopenia (68%)
- Thrombocytopenia (63%)
- Pain (55%)
- Proteinuria (51%)
- HFSR/PPES (51%)
- Increased INR (44%)
- Asthenia/fatigue (42%)
- Diarrhea (41%)
- Increased lipase (41%)
- Hypophosphatemia, Grade 3 or 4 (31%)
- Hypertension (31%)
- Infection (31%)
- Hypokalemia (31%)
- Decreased appetite and food intake (31%)
- Hypocalcemia (23%)
- Increased amylase (23%)
- Fever (20%)
- Hypothyroidism (18%)
- Hemorrhage (18%)
- Dysphonia (18%)
- Nausea (17%)
- Hypocalcemia (17%)
- Proteinuria, Grade 3 or 4 (17%)
- Headache (16%)
- Hypertension, Grade 3 or 4 (15%)
- Neutropenia (14%)
- Mucositis (13%)
- Vomiting (13%)
- Weight loss (13%)
- Hyperbilirubinemia, Grade 3 or 4 (13%)
- HFSR/PPES, Grade 3 or 4 (12%)
- Increased lipase, Grade 3 or 4 (11%)
- Headache (10%)
- Hyperbilirubinemia, Grade 3 or 4 (10%)
- Pain, Grade 3 or 4 (9%)
- Infection, Grade 3 or 4 (9%)
- Increased lipase, Grade 3 or 4 (9%)
- Lymphopenia, Grade 3 or 4 (9%)
- Hypertension, Grade 3 or 4 (8%)
- Diarrhea, Grade 3 or 4 (8%)
- Hypokalemia, Grade 3 or 4 (7%)
- Musculoskeletal stiffness (6%)
- Rash, Grade 3 or 4 (6%)
- Decreased appetite and food intake, Grade 3 or 4 (5%)
- Anemia, Grade 3 or 4 (5%)
- Increased AST/ALT, Grade 3 or 4 (6%)
- Mucositis, Grade 3 or 4 (4%)
- Hypokalemia, Grade 3 or 4 (4%)
- Neutropenia (3%)
- Tremor (2%)
- Hemorrhage, Grade 3 or 4 (2%)
- Fever, Grade 3 or 4 (2%)
- Proteinuria, Grade 3 or 4 (2%)
- Increased amylase, Grade 3 or 4 (2%)
- Neutropenia, Grade 3 or 4 (1%)
- Hypocalcemia, Grade 3 or 4 (1%)
- Lymphopenia, Grade 3 or 4 (8%)
- Pain, Grade 3 or 4 (8%)
- Diarrhea, Grade 3 or 4 (8%)
- Rash, Grade 3 or 4 (8%)
- Infection, Grade 3 or 4 (5%)
- Asthenia/fatigue, Grade 3 or 4 (4%)
- Hemorrhage, Grade 3 or 4 (4%)
- Increased AST/ALT, Grade 3 or 4 (3-4%)
- Hyperbilirubinemia, Grade 3 or 4 (3%)
- Proteinuria, Grade 3 or 4 (3%)
- Hypokalemia, Grade 3 or 4 (3%)
- Neutropenia, Grade 3 or 4 (2%)
- Mucositis, Grade 3 or 4 (2%)
- Nausea, Grade 3 or 4 (2%)
- Hypocalcemia, Grade 3 or 4 (2%)
- Thrombocytopenia, Grade 3 or 4 (1%)
- (HCC) Muscle spasms (10%)
- Asthenia/fatigue, Grade 3 or 4 (10%)
- Infection, Grade 3 or 4 (8%)
- Increased ALT, Grade 3 or 4 (6%)
- Hemorrhage, Grade 3 or 4 (5%)
- Thrombocytopenia, Grade 3 or 4 (5%)
- Neutropenia, Grade 3 or 4 (4%)
- Diarrhea, Grade 3 or 4 (3%)
- Diarrhea, Grade 3 or 4 (3%)
- Decreased appetite or food intake (3%)
- Weight loss (2%)
- Mucositis, Grade 3 or 4 (1%)
- Hepatotoxicity
- haemorrhage
- GI perforation or fistula
Drug Interaction
Drug Interaction
| Drug Name | Risk Factors |
|---|---|
|
Strong CYP3A4 inhibitors (eg, clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, voriconazole)
|
Increased regorafenib plasma concentrations, decreased active metabolite concentrations, may increase toxicity
|
|
BCRP Substrates (Breast Cancer Resistance Protein substrates) (eg, methotrexate, fluvastatin, atorvastatin)
|
Increases plasma concentrations of BCRP substrates
|
Disease Interaction
Disease Interaction
| Disease Name | Risk Factors |
|---|---|
|
No specific contraindications listed
|
Monitor for general drug reactions
|
Pregnancy
Pregnancy
Lactation
Special Use
Precaution
Overdose
Pharmacology
Storage
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Data Sources
Clinical & regulatory information on this page is compiled from the following government sources:
DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.