Tucatinib Dosage
Medically reviewed by Drugs.com. Last updated on May 4, 2023.
Applies to the following strengths: 50 mg; 150 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Breast Cancer
300 mg orally 2 times a day in combination with trastuzumab and capecitabine until disease progression or unacceptable toxicity
Comments:
- When given in combination with this drug, the recommended dose of capecitabine is 1000 mg/m2 orally 2 times daily taken within 30 minutes after a meal.
Use: This drug, in combination with trastuzumab and capecitabine, is indicated for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting
Usual Adult Dose for Colorectal Cancer
300 mg orally 2 times a day in combination with trastuzumab until disease progression or unacceptable toxicity
Comments:
- Confirm the presence of HER2 protein overexpression and RAS wild-type in tumor specimens prior to initiation of therapy.
Use: In combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy.
Renal Dose Adjustments
Mild to moderate renal impairment (CrCl 30 to 89 mL/min): No adjustment recommended.
Severe renal impairment (CrCl less than 30 mL/min): Use of this drug in combination with capecitabine and trastuzumab is not recommended.
Liver Dose Adjustments
Mild (Child-Pugh A) or moderate (Child-Pugh B) liver dysfunction: No adjustment recommended.
Severe (Child-Pugh C) liver dysfunction: Reduce dose to 200 mg orally 2 times daily.
Dose Adjustments
Refer to the full prescribing information for trastuzumab and capecitabine for information about dose modifications.
RECOMMENDED DOSE REDUCTION STEPS FOR ADVERSE REACTIONS:
- First dose reduction: 250 mg orally 2 times daily
- Second dose reduction: 200 mg orally 2 times daily
- Third dose reduction: 150 mg orally 2 times daily
- Permanently discontinue this drug in patients unable to tolerate 150 mg orally 2 times daily.
DOSE MODIFICATIONS FOR ADVERSE REACTIONS:
DIARRHEA:
- Grade 3 without antidiarrheal treatment: Initiate or intensify medical management; withhold this drug until recovery to Grade 1 or less; resume at the same dose level.
- Grade 3 with antidiarrheal treatment: Initiate or intensify medical management; withhold this drug until recovery to Grade 1 or less; resume at the next lower dose level.
- Grade 4: Permanently discontinue therapy.
- Grade 2 bilirubin (greater than 1.5 to 3 times upper limit of normal [ULN]): Withhold therapy until recovery to Grade 1 or less; resume at the same dose level.
- Grade 3 ALT or AST (greater than 5 to 20 x ULN) OR Grade 3 bilirubin (greater than 3 to 10 x ULN): Withhold therapy until recovery to Grade 1 or less; resume at the next lower dose level.
- Grade 4 ALT or AST (greater than 20 x ULN) OR Grade 4 bilirubin (greater than `10 x ULN): Permanently discontinue therapy.
- ALT or AST greater than 3 x ULN AND Bilirubin greater than 2 x ULN: Permanently discontinue therapy.
- Grade 3: Withhold therapy until recovery to Grade 1 or less; resume at the next lower dose level.
- Grade 4: Permanently discontinue therapy.
DOSE MODIFICATIONS FOR CONCOMITANT USE WITH STRONG CYP450 2C8 INHIBITORS:
- Avoid concomitant use of strong CYP450 2C8 inhibitors with this drug.
- If concomitant use with a strong CYP450 2C8 inhibitor cannot be avoided, reduce the dose of this drug to 100 mg orally 2 times daily.
- After discontinuation of the strong CYP450 2C8 inhibitor for 3 elimination half-lives, resume the dose of this drug that was taken prior to initiating the inhibitor.
Precautions
CONTRAINDICATIONS:
- None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Swallow tablets whole; do not chew, crush, or split prior to swallowing.
- Do not ingest tablet if it is broken, cracked, or not otherwise intact.
- Take this drug approximately 12 hours apart and at the same time each day with or without a meal.
- If the patient vomits or misses a dose, take the next dose at its usual scheduled time.
Storage requirements:
- Store at controlled room temperature, 20C to 25C (68F to 77F); excursions permitted from 15C to 30C (59F to 86F).
General:
- Dispense to patient in original container only; store in original container to protect from moisture.
- Replace cap securely each time after opening.
- Do not discard desiccant.
- Discard any unused tablets 3 months after opening the bottle.
Monitoring:
- Liver function: ALT, AST and bilirubin prior to treatment, and then every 3 weeks during treatment and as clinically indicated.
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
Frequently asked questions
- How effective is tucatinib (Tukysa) for breast cancer?
- What’s the difference between tucatinib and neratinib?
- What's the mechanism of action for tucatinib?
More about tucatinib
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