Medicine Overview
Adult Dose
| Clinical Information | Administration Information |
|---|---|
|
Indication: Advanced renal cell carcinoma Age: Adult |
Dose: Oral – 5 mg Frequency: twice daily (given approximately 12 hours apart) Note: Initially 5 mg twice daily; may be increased further to 7 mg twice daily, then 10 mg twice daily, if the initial dose is tolerated (patients with no adverse reactions above grade 2, with normal blood pressure, and are not receiving antihypertensive therapy) for at least 2 consecutive weeks. |
|
Indication: First-line treatment of advanced renal cell carcinoma Age: Adult Condition: Combination therapy with avelumab |
Dose: Oral – 5 mg Frequency: twice daily Note: Administered in combination with avelumab 800 mg intravenous every 2 weeks. |
Child Dose
| Clinical Information | Administration Information |
|---|---|
|
Age: less than 18 years |
Dose: Not established Note: Safety and efficacy not established |
Renal Dose
| Clinical Information | Administration Information |
|---|---|
|
Condition: Pre-existing mild-to-severe renal impairment |
Dose: Not specified Note: No dedicated renal impairment trial has been conducted. Based on population pharmacokinetic analyses, no significant difference in clearance was observed in patients with pre-existing mild-to-severe renal impairment. |
Administration
- May be taken with or without food
- Take exactly 12 hours apart
Side Effect
- Diarrhea (55%)
- Hypertension (40%)
- Fatigue (39%)
- Decreased appetite (34%)
- Nausea (32%)
- Dysphonia (31%)
- Palmar-plantar erythrodysesthesia syndrome (27%)
- Weight decreased (25%)
- Vomiting (24%)
- Asthenia (21%)
- Constipation (20%)
- Hypothyroidism (19%)
- Cough (15%)
- Mucosal inflammation (15%)
- Arthralgia (15%)
- Stomatitis (15%)
- Dyspnea (15%)
- Abdominal pain (14%)
- Headache (14%)
- Extremity pain (13%)
- Rash (13%)
- Proteinuria (11%)
- Dysgeusia (11%)
- Dry skin (10%)
- Dyspepsia (10%)
- Dizziness (9%)
- Upper abdominal pain (8%)
- Myalgia (7%)
- Pruritus (7%)
- Dehydration (6%)
- Epistaxis (6%)
- Hypercalcemia (6%)
- Anemia (4%)
- Alopecia (4%)
- Hemorrhoids (4%)
- Hematuria (3%)
- Tinnitus (3%)
- Increased lipase (3%)
- Glossodynia (3%)
- Pulmonary embolism (2%)
- Rectal hemorrhage (2%)
- Hemoptysis (2%)
- Erythema (2%)
- DVT (1%)
- Retinal vein occlusion/thrombosis (1%)
- Polycythemia (1%)
- TIA (1%)
- Reversible posterior leukoencephalopathy syndrome
- Cardiac failure
- arterial thrombotic events (eg MI, TIA, CVA, retinal artery exclusion)
- venous thrombotic events (eg DVT, pulmonary embolism, retinal vein occlusion or thrombosis)
- hypertensive crisis
- haemorrhagic events (eg GI or cerebral haemorrhage, haemoptysis, haematuria, melaena)
- GI perforation and fistula formation
Drug Interaction
Drug Interaction
| Drug Name | Risk Factors |
|---|---|
|
Strong CYP3A4/5 inhibitors (e.g. ketoconazole, ritonavir, clarithromycin)
|
Increased plasma concentration
|
|
Strong CYP3A4/5 inducers (e.g. rifampicin, phenytoin, carbamazepine)
|
Decreased plasma concentration
|
Disease Interaction
Disease Interaction
| Disease Name | Risk Factors |
|---|---|
|
Recent Active GI Bleeding
|
Risk of bleeding complications
|
|
Untreated Brain Metastases
|
Risk of cerebral hemorrhage
|
Pregnancy
Pregnancy
Lactation
Special Use
Precaution
Overdose
Pharmacology
Storage
Store at 20°C to 25°C
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.