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Medicine Overview
Adult Dose
| Clinical Information | Administration Information |
|---|---|
|
Indication: advanced unresectable or metastatic human epidermal growth factor (HER2)-positive, breast cancer (including brain metastases) Age: Adult |
Dose: Oral – 300 mg Frequency: twice daily Note: In combination with trastuzumab and capecitabine for patients who have received greater than 1 anti-HER2-based regimens in the metastatic setting. Continue until disease progression or unacceptable toxicity. |
|
Indication: RAS wild-type HER 2-positive unresectable or metastatic colorectal cancer Age: Adult Condition: progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy |
Dose: Oral – 300 mg Frequency: twice daily Note: In combination with trastuzumab. Continue until disease progression or unacceptable toxicity. |
Child Dose
| Clinical Information | Administration Information |
|---|---|
|
Age: Pediatric |
Dose: No approved pediatric dosage available Note: No approved pediatric dosage available |
Renal Dose
| Clinical Information | Administration Information |
|---|---|
|
Condition: Renal impairment Mild-to-moderate (Creatinine Clearance 30-89 mL/minute) |
Dose: Not specified Note: No dosage adjustment necessary |
|
Condition: Renal impairment Severe (Creatinine Clearance less than 30 mL/minute) |
Dose: Not specified Note: Use in combination with trastuzumab and capecitabine is not recommended; capecitabine is contraindicated in patients with severe renal impairment |
Administration
Administer tucatinib orally as a 300 mg dose twice daily, approximately 12 hours apart, with or without food. Tablets must be swallowed whole and should not be chewed, crushed, or split; do not ingest if the tablet is broken or damaged. If a dose is missed or vomiting occurs, the next dose should be taken at the regularly scheduled time. For patients with severe hepatic impairment, the dosage should be reduced to 200 mg twice daily. Avoid concomitant use with strong CYP2C8 inhibitors; if unavoidable, reduce the tucatinib dose to 100 mg twice daily. Patients should be monitored for hepatotoxicity and diarrhea, requiring potential dose interruptions or reductions. Use in pediatric populations has not been established, and effective contraception is required due to embryo-fetal toxicity risks.
Side Effect
- Diarrhea (81%)
- Palmoplantar erythrodysesthesia syndrome (63%)
- Decreased hemoglobin (59%)
- Nausea (58%)
- Decreased phosphate (57%)
- Increased bilirubin (47%)
- Increased ALT (46%)
- Increased AST (43%)
- Hepatotoxicity (42%)
- Decreased magnesium (40%)
- Vomiting (36%)
- Decreased potassium (36%)
- Increased creatinine (33%)
- Stomatitis (32%)
- Decreased sodium (28%)
- Increased alkaline phosphatase (26%)
- Decreased appetite (25%)
- Anemia (21%)
- Rash (20%)
- Arthralgia (15%)
- Increased creatinine (14%)
- Decreased weight (13%)
- Peripheral neuropathy (13%)
- Epistaxis (12%)
- Diarrhea (64%)
- Increased creatinine (58%)
- Increased glucose (56%)
- Decreased hemoglobin (46%)
- Increased ALT (46%)
- Fatigue (44%)
- Decreased lymphocytes (39%)
- Rash (37%)
- Nausea (35%)
- Increased AST (33%)
- Increased bilirubin (28%)
- Increased alkaline phosphatase (25%)
- Decreased albumin 24%)
- Decreased leukocytes (22%)
- Abdominal pain (21%)
- Infusion-related reaction (21%)
- Pyrexia (20%)
- Decreased sodium (20%)
- Chills (19%)
- Decreased appetite (19%)
- Back pain (17%)
- Vomiting (16%)
- Arthralgia (16%)
- Cough (16%)
- Decreased potassium (16%)
- Decreased platelets (15%)
- Constipation (14%)
- Dyspnea (14%)
- Myalgia (13%)
- Palmoplantar erythrodysesthesia syndrome (13%)
- Diarrhea (0.5-12%)
- Decreased lymphocytes (12%)
- Hepatoxicity (0.2-9%)
- Increased ALT (8%)
- Decreased phosphate (8%)
- Increased AST (6%)
- Decreased potassium (6%)
- Anemia (3.7%)
- Nausea (3.7%)
- Decreased hemoglobin (3.3%)
- Vomiting (3%)
- Stomatitis (2.5%)
- Decreased sodium (2.5%)
- Increased bilirubin (1.5%)
- Decreased weight (1%)
- Anemia (10%)
- Anxiety (10%)
- Hypertension (7%)
- Decreased sodium (6%)
- Diarrhea (3.5%)
- Decreased hemoglobin (3.5%)
- Increased AST (2.4-3.5%)
- Increased bilirubin (2.4-3.5%)
- Increased glucose (2.4%)
- Increased ALT (2.4%)
- Abdominal pain (2.3%)
- Fatigue (2.3%)
- Back pain (2.3%)
- Constipation (1.2%)
- Chills (1.2%)
- Arthralgia (1.2%)
- Increased alkaline phosphatase (1.2%)
- Decreased bilirubin (1.2%)
- Decreased potassium (1.2%)
Drug Interaction
Drug Interaction
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Disease Interaction
Disease Interaction
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Pregnancy
Pregnancy
Lactation
Special Use
Precaution
Overdose
Pharmacology
Storage
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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.