Select therapeutic use:

Bone and connective tissue cancer:

Indications for VITRAKVI ORAL SOLUTION:

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 specimens. 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: continue 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.

VITRAKVI ORAL SOLUTION Warnings/Precautions:

Risk of CNS effects (including cognitive impairment, mood disorders, dizziness, sleep disturbances), 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. Evaluate if signs of potential skeletal fractures occur. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

See Also:

VITRAKVI ORAL SOLUTION Classification:

Kinase inhibitor.

VITRAKVI ORAL SOLUTION 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 Drug Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL

Breast cancer:

Indications for VITRAKVI ORAL SOLUTION:

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 specimens. 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: continue 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.

VITRAKVI ORAL SOLUTION Warnings/Precautions:

Risk of CNS effects (including cognitive impairment, mood disorders, dizziness, sleep disturbances), 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. Evaluate if signs of potential skeletal fractures occur. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

See Also:

VITRAKVI ORAL SOLUTION Classification:

Kinase inhibitor.

VITRAKVI ORAL SOLUTION 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 Drug Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL

Colorectal and other GI cancers:

Indications for VITRAKVI ORAL SOLUTION:

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 specimens. 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: continue 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.

VITRAKVI ORAL SOLUTION Warnings/Precautions:

Risk of CNS effects (including cognitive impairment, mood disorders, dizziness, sleep disturbances), 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. Evaluate if signs of potential skeletal fractures occur. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

See Also:

VITRAKVI ORAL SOLUTION Classification:

Kinase inhibitor.

VITRAKVI ORAL SOLUTION 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 Drug Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL

Melanoma and other skin cancers:

Indications for VITRAKVI ORAL SOLUTION:

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 specimens. 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: continue 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.

VITRAKVI ORAL SOLUTION Warnings/Precautions:

Risk of CNS effects (including cognitive impairment, mood disorders, dizziness, sleep disturbances), 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. Evaluate if signs of potential skeletal fractures occur. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

See Also:

VITRAKVI ORAL SOLUTION Classification:

Kinase inhibitor.

VITRAKVI ORAL SOLUTION 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 Drug Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL

Pancreatic, thyroid, and other endocrine cancers:

Indications for VITRAKVI ORAL SOLUTION:

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 specimens. 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: continue 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.

VITRAKVI ORAL SOLUTION Warnings/Precautions:

Risk of CNS effects (including cognitive impairment, mood disorders, dizziness, sleep disturbances), 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. Evaluate if signs of potential skeletal fractures occur. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

See Also:

VITRAKVI ORAL SOLUTION Classification:

Kinase inhibitor.

VITRAKVI ORAL SOLUTION 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 Drug Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL

Respiratory and thoracic cancers:

Indications for VITRAKVI ORAL SOLUTION:

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 specimens. 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: continue 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.

VITRAKVI ORAL SOLUTION Warnings/Precautions:

Risk of CNS effects (including cognitive impairment, mood disorders, dizziness, sleep disturbances), 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. Evaluate if signs of potential skeletal fractures occur. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

See Also:

VITRAKVI ORAL SOLUTION Classification:

Kinase inhibitor.

VITRAKVI ORAL SOLUTION 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 Drug Availability:

NO

How Supplied:

Caps—60; Oral soln—100mL