Select therapeutic use:

Bone and connective tissue cancer:

Indications for ROZLYTREK:

Treatment of patients with solid tumors that have a neurotrophic tyrosine receptor 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 either progressed following treatment or have no satisfactory alternative therapy.

Adult:

Confirm presence of a NTRK gene fusion. Swallow whole. 600mg once daily. Give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable, reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Children:

<12yrs: not established. Confirm presence of a NTRK gene fusion. Swallow whole. Base dose on body surface area (BSA). ≥12yrs (BSA >1.50m2): 600mg once daily; (BSA 1.11–1.50m2): 500mg once daily; (BSA 0.91–1.10m2): 400mg once daily. Give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable and ≥12yrs (w. BSA >1.50m2), reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Assess LVEF prior to initiation in those with risk factors for CHF. Withhold, reduce dose or permanently discontinue based on severity if CHF or CNS effects occur. Increased risk for fractures. Monitor LFTs (including AST/ALT) every 2 weeks during the 1st month, then monthly thereafter, and as clinically indicated; withhold and resume (at same or reduced dose) or permanently discontinue based on severity. Known long QT syndrome. Bradyarrhythmias. Uncontrolled heart failure. Electrolyte abnormalities. Assess QT interval, electrolytes, and serum uric acid levels prior to initiation then periodically; withhold and resume (at same or reduced dose) based on severity; monitor. Withhold dose if vision disorders or new changes occur until improvement or stabilization; conduct an ophthalmological exam as clinically appropriate. Embryo-fetal toxicity. Advise use of effective contraception during and for 5 weeks (females of reproductive potential) or for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 days after the last dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by moderate or strong CYP3A inhibitors; avoid; if unavoidable, reduce dose (see Adults and Children). Avoid grapefruit products. Antagonized by moderate or strong CYP3A inducers; avoid use. Avoid concomitant other drugs known to prolong QTc interval.

Adverse Reactions:

Fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, vision disorders; CHF, CNS effects, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation.

Generic Availability:

NO

How Supplied:

Caps 100mg—30; 200mg—90

Pricing for ROZLYTREK

200mg capsule (Qty: 30)
Appx. price $5548
GoodRx

Breast cancer:

Indications for ROZLYTREK:

Treatment of patients with solid tumors that have a neurotrophic tyrosine receptor 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 either progressed following treatment or have no satisfactory alternative therapy.

Adult:

Confirm presence of a NTRK gene fusion. Swallow whole. 600mg once daily. Give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable, reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Children:

<12yrs: not established. Confirm presence of a NTRK gene fusion. Swallow whole. Base dose on body surface area (BSA). ≥12yrs (BSA >1.50m2): 600mg once daily; (BSA 1.11–1.50m2): 500mg once daily; (BSA 0.91–1.10m2): 400mg once daily. Give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable and ≥12yrs (w. BSA >1.50m2), reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Assess LVEF prior to initiation in those with risk factors for CHF. Withhold, reduce dose or permanently discontinue based on severity if CHF or CNS effects occur. Increased risk for fractures. Monitor LFTs (including AST/ALT) every 2 weeks during the 1st month, then monthly thereafter, and as clinically indicated; withhold and resume (at same or reduced dose) or permanently discontinue based on severity. Known long QT syndrome. Bradyarrhythmias. Uncontrolled heart failure. Electrolyte abnormalities. Assess QT interval, electrolytes, and serum uric acid levels prior to initiation then periodically; withhold and resume (at same or reduced dose) based on severity; monitor. Withhold dose if vision disorders or new changes occur until improvement or stabilization; conduct an ophthalmological exam as clinically appropriate. Embryo-fetal toxicity. Advise use of effective contraception during and for 5 weeks (females of reproductive potential) or for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 days after the last dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by moderate or strong CYP3A inhibitors; avoid; if unavoidable, reduce dose (see Adults and Children). Avoid grapefruit products. Antagonized by moderate or strong CYP3A inducers; avoid use. Avoid concomitant other drugs known to prolong QTc interval.

Adverse Reactions:

Fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, vision disorders; CHF, CNS effects, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation.

Generic Availability:

NO

How Supplied:

Caps 100mg—30; 200mg—90

Pricing for ROZLYTREK

200mg capsule (Qty: 30)
Appx. price $5548
GoodRx

Colorectal and other GI cancers:

Indications for ROZLYTREK:

Treatment of patients with solid tumors that have a neurotrophic tyrosine receptor 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 either progressed following treatment or have no satisfactory alternative therapy.

Adult:

Confirm presence of a NTRK gene fusion. Swallow whole. 600mg once daily. Give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable, reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Children:

<12yrs: not established. Confirm presence of a NTRK gene fusion. Swallow whole. Base dose on body surface area (BSA). ≥12yrs (BSA >1.50m2): 600mg once daily; (BSA 1.11–1.50m2): 500mg once daily; (BSA 0.91–1.10m2): 400mg once daily. Give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable and ≥12yrs (w. BSA >1.50m2), reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Assess LVEF prior to initiation in those with risk factors for CHF. Withhold, reduce dose or permanently discontinue based on severity if CHF or CNS effects occur. Increased risk for fractures. Monitor LFTs (including AST/ALT) every 2 weeks during the 1st month, then monthly thereafter, and as clinically indicated; withhold and resume (at same or reduced dose) or permanently discontinue based on severity. Known long QT syndrome. Bradyarrhythmias. Uncontrolled heart failure. Electrolyte abnormalities. Assess QT interval, electrolytes, and serum uric acid levels prior to initiation then periodically; withhold and resume (at same or reduced dose) based on severity; monitor. Withhold dose if vision disorders or new changes occur until improvement or stabilization; conduct an ophthalmological exam as clinically appropriate. Embryo-fetal toxicity. Advise use of effective contraception during and for 5 weeks (females of reproductive potential) or for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 days after the last dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by moderate or strong CYP3A inhibitors; avoid; if unavoidable, reduce dose (see Adults and Children). Avoid grapefruit products. Antagonized by moderate or strong CYP3A inducers; avoid use. Avoid concomitant other drugs known to prolong QTc interval.

Adverse Reactions:

Fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, vision disorders; CHF, CNS effects, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation.

Generic Availability:

NO

How Supplied:

Caps 100mg—30; 200mg—90

Pricing for ROZLYTREK

200mg capsule (Qty: 30)
Appx. price $5548
GoodRx

Melanoma and other skin cancers:

Indications for ROZLYTREK:

Treatment of patients with solid tumors that have a neurotrophic tyrosine receptor 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 either progressed following treatment or have no satisfactory alternative therapy.

Adult:

Confirm presence of a NTRK gene fusion. Swallow whole. 600mg once daily. Give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable, reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Children:

<12yrs: not established. Confirm presence of a NTRK gene fusion. Swallow whole. Base dose on body surface area (BSA). ≥12yrs (BSA >1.50m2): 600mg once daily; (BSA 1.11–1.50m2): 500mg once daily; (BSA 0.91–1.10m2): 400mg once daily. Give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable and ≥12yrs (w. BSA >1.50m2), reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Assess LVEF prior to initiation in those with risk factors for CHF. Withhold, reduce dose or permanently discontinue based on severity if CHF or CNS effects occur. Increased risk for fractures. Monitor LFTs (including AST/ALT) every 2 weeks during the 1st month, then monthly thereafter, and as clinically indicated; withhold and resume (at same or reduced dose) or permanently discontinue based on severity. Known long QT syndrome. Bradyarrhythmias. Uncontrolled heart failure. Electrolyte abnormalities. Assess QT interval, electrolytes, and serum uric acid levels prior to initiation then periodically; withhold and resume (at same or reduced dose) based on severity; monitor. Withhold dose if vision disorders or new changes occur until improvement or stabilization; conduct an ophthalmological exam as clinically appropriate. Embryo-fetal toxicity. Advise use of effective contraception during and for 5 weeks (females of reproductive potential) or for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 days after the last dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by moderate or strong CYP3A inhibitors; avoid; if unavoidable, reduce dose (see Adults and Children). Avoid grapefruit products. Antagonized by moderate or strong CYP3A inducers; avoid use. Avoid concomitant other drugs known to prolong QTc interval.

Adverse Reactions:

Fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, vision disorders; CHF, CNS effects, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation.

Generic Availability:

NO

How Supplied:

Caps 100mg—30; 200mg—90

Pricing for ROZLYTREK

200mg capsule (Qty: 30)
Appx. price $5548
GoodRx

Pancreatic, thyroid, and other endocrine cancers:

Indications for ROZLYTREK:

Treatment of patients with solid tumors that have a neurotrophic tyrosine receptor 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 either progressed following treatment or have no satisfactory alternative therapy.

Adult:

Confirm presence of a NTRK gene fusion. Swallow whole. 600mg once daily. Give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable, reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Children:

<12yrs: not established. Confirm presence of a NTRK gene fusion. Swallow whole. Base dose on body surface area (BSA). ≥12yrs (BSA >1.50m2): 600mg once daily; (BSA 1.11–1.50m2): 500mg once daily; (BSA 0.91–1.10m2): 400mg once daily. Give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable and ≥12yrs (w. BSA >1.50m2), reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Assess LVEF prior to initiation in those with risk factors for CHF. Withhold, reduce dose or permanently discontinue based on severity if CHF or CNS effects occur. Increased risk for fractures. Monitor LFTs (including AST/ALT) every 2 weeks during the 1st month, then monthly thereafter, and as clinically indicated; withhold and resume (at same or reduced dose) or permanently discontinue based on severity. Known long QT syndrome. Bradyarrhythmias. Uncontrolled heart failure. Electrolyte abnormalities. Assess QT interval, electrolytes, and serum uric acid levels prior to initiation then periodically; withhold and resume (at same or reduced dose) based on severity; monitor. Withhold dose if vision disorders or new changes occur until improvement or stabilization; conduct an ophthalmological exam as clinically appropriate. Embryo-fetal toxicity. Advise use of effective contraception during and for 5 weeks (females of reproductive potential) or for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 days after the last dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by moderate or strong CYP3A inhibitors; avoid; if unavoidable, reduce dose (see Adults and Children). Avoid grapefruit products. Antagonized by moderate or strong CYP3A inducers; avoid use. Avoid concomitant other drugs known to prolong QTc interval.

Adverse Reactions:

Fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, vision disorders; CHF, CNS effects, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation.

Generic Availability:

NO

How Supplied:

Caps 100mg—30; 200mg—90

Pricing for ROZLYTREK

200mg capsule (Qty: 30)
Appx. price $5548
GoodRx

Respiratory and thoracic cancers:

Indications for ROZLYTREK:

Treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Treatment of patients with solid tumors that have a neurotrophic tyrosine receptor 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 either progressed following treatment or have no satisfactory alternative therapy.

Adult:

Confirm presence of ROS1 rearrangement(s) or a NTRK gene fusion. Swallow whole. NSCLC or solid tumors: 600mg once daily. Both: give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable, reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Children:

NSCLC: not established. Solid tumors: <12yrs: not established. Confirm presence of a NTRK gene fusion. Swallow whole. Base dose on body surface area (BSA). ≥12yrs (BSA >1.50m2): 600mg once daily; (BSA 1.11–1.50m2): 500mg once daily; (BSA 0.91–1.10m2): 400mg once daily. Give until disease progression or unacceptable toxicity. Avoid moderate or strong CYP3A inhibitors; if unavoidable and ≥12yrs (w. BSA >1.50m2), reduce to 200mg once daily (moderate CYP3A inhibitors); and 100mg once daily (strong CYP3A inhibitors). Dose modifications for adverse reactions: see full labeling.

Warnings/Precautions:

Assess LVEF prior to initiation in those with risk factors for CHF. Withhold, reduce dose or permanently discontinue based on severity if CHF or CNS effects occur. Increased risk for fractures. Monitor LFTs (including AST/ALT) every 2 weeks during the 1st month, then monthly thereafter, and as clinically indicated; withhold and resume (at same or reduced dose) or permanently discontinue based on severity. Known long QT syndrome. Bradyarrhythmias. Uncontrolled heart failure. Electrolyte abnormalities. Assess QT interval, electrolytes, and serum uric acid levels prior to initiation then periodically; withhold and resume (at same or reduced dose) based on severity; monitor. Withhold dose if vision disorders or new changes occur until improvement or stabilization; conduct an ophthalmological exam as clinically appropriate. Embryo-fetal toxicity. Advise use of effective contraception during and for 5 weeks (females of reproductive potential) or for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 days after the last dose).

Pharmacologic Class:

Kinase inhibitor.

Interactions:

Potentiated by moderate or strong CYP3A inhibitors; avoid; if unavoidable, reduce dose (see Adults and Children). Avoid grapefruit products. Antagonized by moderate or strong CYP3A inducers; avoid use. Avoid concomitant other drugs known to prolong QTc interval.

Adverse Reactions:

Fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, dysesthesia, dyspnea, myalgia, cognitive impairment, increased weight, cough, vomiting, pyrexia, arthralgia, vision disorders; CHF, CNS effects, skeletal fractures, hepatotoxicity, hyperuricemia, QT prolongation.

Generic Availability:

NO

How Supplied:

Caps 100mg—30; 200mg—90

Pricing for ROZLYTREK

200mg capsule (Qty: 30)
Appx. price $5548
GoodRx