Select therapeutic use:

Bone and connective tissue cancer:

Indications for VITRAKVI:

Treatment of patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

Adults and Children:

Confirm presence of a NTRK gene fusion in tumor. Caps and oral soln are interchangeable. Swallow caps whole. Body surface area (BSA) <1.0m2: 100mg/m2 twice daily; BSA ≥1.0m2: 100mg twice daily. Both: give until disease progression or unacceptable toxicity. Avoid concomitant strong CYP3A4 inhibitors, if unavoidable, reduce Vitrakvi dose by 50%. Avoid concomitant strong CYP3A4 inducers; if unavoidable, double Vitrakvi dose. Moderate-to-severe hepatic impairment: reduce initial dose by 50%. Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Risk of neurotoxicity, hepatotoxicity; withhold or permanently discontinue based on severity; adjust dose when resumed. Monitor liver tests (including ALT/AST) every 2 weeks during the first month, then monthly thereafter, and as clinically indicated. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after final dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by strong CYP3A4 inhibitors (eg, itraconazole, grapefruit, or grapefruit juice); adjust dose (see Adults and Children). Antagonized by strong CYP3A4 inducers (eg, rifampin, St. John's wort); adjust dose (see Adults and Children). Potentiates sensitive CYP3A4 substrates (eg, midazolam); if unavoidable, monitor for adverse reactions.

Adverse Reactions:

Fatigue, nausea, dizziness, vomiting, anemia, increased AST/ALT, cough, constipation, diarrhea.

Generic Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL

Breast cancer:

Indications for VITRAKVI:

Treatment of patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

Adults and Children:

Confirm presence of a NTRK gene fusion in tumor. Caps and oral soln are interchangeable. Swallow caps whole. Body surface area (BSA) <1.0m2: 100mg/m2 twice daily; BSA ≥1.0m2: 100mg twice daily. Both: give until disease progression or unacceptable toxicity. Avoid concomitant strong CYP3A4 inhibitors, if unavoidable, reduce Vitrakvi dose by 50%. Avoid concomitant strong CYP3A4 inducers; if unavoidable, double Vitrakvi dose. Moderate-to-severe hepatic impairment: reduce initial dose by 50%. Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Risk of neurotoxicity, hepatotoxicity; withhold or permanently discontinue based on severity; adjust dose when resumed. Monitor liver tests (including ALT/AST) every 2 weeks during the first month, then monthly thereafter, and as clinically indicated. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after final dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by strong CYP3A4 inhibitors (eg, itraconazole, grapefruit, or grapefruit juice); adjust dose (see Adults and Children). Antagonized by strong CYP3A4 inducers (eg, rifampin, St. John's wort); adjust dose (see Adults and Children). Potentiates sensitive CYP3A4 substrates (eg, midazolam); if unavoidable, monitor for adverse reactions.

Adverse Reactions:

Fatigue, nausea, dizziness, vomiting, anemia, increased AST/ALT, cough, constipation, diarrhea.

Generic Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL

Colorectal and other GI cancers:

Indications for VITRAKVI:

Treatment of patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

Adults and Children:

Confirm presence of a NTRK gene fusion in tumor. Caps and oral soln are interchangeable. Swallow caps whole. Body surface area (BSA) <1.0m2: 100mg/m2 twice daily; BSA ≥1.0m2: 100mg twice daily. Both: give until disease progression or unacceptable toxicity. Avoid concomitant strong CYP3A4 inhibitors, if unavoidable, reduce Vitrakvi dose by 50%. Avoid concomitant strong CYP3A4 inducers; if unavoidable, double Vitrakvi dose. Moderate-to-severe hepatic impairment: reduce initial dose by 50%. Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Risk of neurotoxicity, hepatotoxicity; withhold or permanently discontinue based on severity; adjust dose when resumed. Monitor liver tests (including ALT/AST) every 2 weeks during the first month, then monthly thereafter, and as clinically indicated. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after final dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by strong CYP3A4 inhibitors (eg, itraconazole, grapefruit, or grapefruit juice); adjust dose (see Adults and Children). Antagonized by strong CYP3A4 inducers (eg, rifampin, St. John's wort); adjust dose (see Adults and Children). Potentiates sensitive CYP3A4 substrates (eg, midazolam); if unavoidable, monitor for adverse reactions.

Adverse Reactions:

Fatigue, nausea, dizziness, vomiting, anemia, increased AST/ALT, cough, constipation, diarrhea.

Generic Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL

Melanoma and other skin cancers:

Indications for VITRAKVI:

Treatment of patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

Adults and Children:

Confirm presence of a NTRK gene fusion in tumor. Caps and oral soln are interchangeable. Swallow caps whole. Body surface area (BSA) <1.0m2: 100mg/m2 twice daily; BSA ≥1.0m2: 100mg twice daily. Both: give until disease progression or unacceptable toxicity. Avoid concomitant strong CYP3A4 inhibitors, if unavoidable, reduce Vitrakvi dose by 50%. Avoid concomitant strong CYP3A4 inducers; if unavoidable, double Vitrakvi dose. Moderate-to-severe hepatic impairment: reduce initial dose by 50%. Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Risk of neurotoxicity, hepatotoxicity; withhold or permanently discontinue based on severity; adjust dose when resumed. Monitor liver tests (including ALT/AST) every 2 weeks during the first month, then monthly thereafter, and as clinically indicated. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after final dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by strong CYP3A4 inhibitors (eg, itraconazole, grapefruit, or grapefruit juice); adjust dose (see Adults and Children). Antagonized by strong CYP3A4 inducers (eg, rifampin, St. John's wort); adjust dose (see Adults and Children). Potentiates sensitive CYP3A4 substrates (eg, midazolam); if unavoidable, monitor for adverse reactions.

Adverse Reactions:

Fatigue, nausea, dizziness, vomiting, anemia, increased AST/ALT, cough, constipation, diarrhea.

Generic Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL

Pancreatic, thyroid, and other endocrine cancers:

Indications for VITRAKVI:

Treatment of patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

Adults and Children:

Confirm presence of a NTRK gene fusion in tumor. Caps and oral soln are interchangeable. Swallow caps whole. Body surface area (BSA) <1.0m2: 100mg/m2 twice daily; BSA ≥1.0m2: 100mg twice daily. Both: give until disease progression or unacceptable toxicity. Avoid concomitant strong CYP3A4 inhibitors, if unavoidable, reduce Vitrakvi dose by 50%. Avoid concomitant strong CYP3A4 inducers; if unavoidable, double Vitrakvi dose. Moderate-to-severe hepatic impairment: reduce initial dose by 50%. Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Risk of neurotoxicity, hepatotoxicity; withhold or permanently discontinue based on severity; adjust dose when resumed. Monitor liver tests (including ALT/AST) every 2 weeks during the first month, then monthly thereafter, and as clinically indicated. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after final dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by strong CYP3A4 inhibitors (eg, itraconazole, grapefruit, or grapefruit juice); adjust dose (see Adults and Children). Antagonized by strong CYP3A4 inducers (eg, rifampin, St. John's wort); adjust dose (see Adults and Children). Potentiates sensitive CYP3A4 substrates (eg, midazolam); if unavoidable, monitor for adverse reactions.

Adverse Reactions:

Fatigue, nausea, dizziness, vomiting, anemia, increased AST/ALT, cough, constipation, diarrhea.

Generic Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL

Respiratory and thoracic cancers:

Indications for VITRAKVI:

Treatment of patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

Adults and Children:

Confirm presence of a NTRK gene fusion in tumor. Caps and oral soln are interchangeable. Swallow caps whole. Body surface area (BSA) <1.0m2: 100mg/m2 twice daily; BSA ≥1.0m2: 100mg twice daily. Both: give until disease progression or unacceptable toxicity. Avoid concomitant strong CYP3A4 inhibitors, if unavoidable, reduce Vitrakvi dose by 50%. Avoid concomitant strong CYP3A4 inducers; if unavoidable, double Vitrakvi dose. Moderate-to-severe hepatic impairment: reduce initial dose by 50%. Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Risk of neurotoxicity, hepatotoxicity; withhold or permanently discontinue based on severity; adjust dose when resumed. Monitor liver tests (including ALT/AST) every 2 weeks during the first month, then monthly thereafter, and as clinically indicated. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after final dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by strong CYP3A4 inhibitors (eg, itraconazole, grapefruit, or grapefruit juice); adjust dose (see Adults and Children). Antagonized by strong CYP3A4 inducers (eg, rifampin, St. John's wort); adjust dose (see Adults and Children). Potentiates sensitive CYP3A4 substrates (eg, midazolam); if unavoidable, monitor for adverse reactions.

Adverse Reactions:

Fatigue, nausea, dizziness, vomiting, anemia, increased AST/ALT, cough, constipation, diarrhea.

Generic Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL