TUKYSA® Drug Interactions

(tucatinib)

7 DRUG INTERACTIONS

     

7.1 Effects of Other Drugs on TUKYSA

Table 7 summarizes the effect of other drugs on TUKYSA.

Table 7: Drug Interactions that Affect TUKYSA

Strong CYP3A Inducers or Moderate CYP2C8 Inducers

Clinical Impact

Concomitant use of TUKYSA with a strong CYP3A or moderate CYP2C8 inducer decreased tucatinib plasma concentrations [see Clinical Pharmacology (12.3)], which may reduce TUKYSA activity.

Management

Avoid concomitant use of TUKYSA with a strong CYP3A inducer or a moderate CYP2C8 inducer.

Strong or Moderate CYP2C8 Inhibitors

Clinical Impact

Concomitant use of TUKYSA with a strong CYP2C8 inhibitor increased tucatinib plasma concentrations [see Clinical Pharmacology (12.3)], which may increase the risk of TUKYSA toxicity.

Management

Avoid concomitant use of TUKYSA with a strong CYP2C8 inhibitor. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.

7.2 Effects of TUKYSA on Other Drugs

Table 8 summarizes the effect of TUKYSA on other drugs.

Table 8: TUKYSA Drug Interactions that Affect Other Drugs

CYP3A Substrates

Clinical Impact

Concomitant use of TUKYSA with a CYP3A substrate increased the plasma concentrations of CYP3A substrate [see Clinical Pharmacology (12.3)], which may increase the toxicity associated with a CYP3A substrate.

Management

Avoid concomitant use of TUKYSA with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage in accordance with approved product labeling.

P-glycoprotein (P-gp) Substrates

Clinical Impact

Concomitant use of TUKYSA with a P-gp substrate increased the plasma concentrations of P-gp substrate [see Clinical Pharmacology (12.3)], which may increase the toxicity associated with a P-gp substrate.

Management

Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

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Drug Interactions

7 DRUG INTERACTIONS

     

7.1 Effects of Other Drugs on TUKYSA

Table 7 summarizes the effect of other drugs on TUKYSA.

Table 7: Drug Interactions that Affect TUKYSA

Strong CYP3A Inducers or Moderate CYP2C8 Inducers

Clinical Impact

Concomitant use of TUKYSA with a strong CYP3A or moderate CYP2C8 inducer decreased tucatinib plasma concentrations [see Clinical Pharmacology (12.3)], which may reduce TUKYSA activity.

Management

Avoid concomitant use of TUKYSA with a strong CYP3A inducer or a moderate CYP2C8 inducer.

Strong or Moderate CYP2C8 Inhibitors

Clinical Impact

Concomitant use of TUKYSA with a strong CYP2C8 inhibitor increased tucatinib plasma concentrations [see Clinical Pharmacology (12.3)], which may increase the risk of TUKYSA toxicity.

Management

Avoid concomitant use of TUKYSA with a strong CYP2C8 inhibitor. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.

7.2 Effects of TUKYSA on Other Drugs

Table 8 summarizes the effect of TUKYSA on other drugs.

Table 8: TUKYSA Drug Interactions that Affect Other Drugs

CYP3A Substrates

Clinical Impact

Concomitant use of TUKYSA with a CYP3A substrate increased the plasma concentrations of CYP3A substrate [see Clinical Pharmacology (12.3)], which may increase the toxicity associated with a CYP3A substrate.

Management

Avoid concomitant use of TUKYSA with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage in accordance with approved product labeling.

P-glycoprotein (P-gp) Substrates

Clinical Impact

Concomitant use of TUKYSA with a P-gp substrate increased the plasma concentrations of P-gp substrate [see Clinical Pharmacology (12.3)], which may increase the toxicity associated with a P-gp substrate.

Management

Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.
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