- Bone and connective tissue cancer
- Breast cancer
- Colorectal and other GI cancers
- Melanoma and other skin cancers
- Pancreatic, thyroid, and other endocrine cancers
- Respiratory and thoracic cancers
- Solid tumors
Bone and connective tissue cancer:
Breast cancer:
Colorectal and other GI cancers:
Melanoma and other skin cancers:
Pancreatic, thyroid, and other endocrine cancers:
Respiratory and thoracic cancers:
Indications for: ROZLYTREK
In adults with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
Adult Dosage:
Confirm presence of ROS1 rearrangement(s) in tumor specimens. Swallow whole. 600mg once daily, 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 Dosage:
Not established.
ROZLYTREK 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 eye 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).
ROZLYTREK Classification:
Kinase inhibitor.
ROZLYTREK 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 Drug Availability:
NO
How Supplied:
Caps 100mg—30; 200mg—90
Solid tumors:
Indications for: ROZLYTREK
Treatment of patients with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test 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 Dosage:
Confirm presence of a NTRK gene fusion. Swallow whole. 600mg once daily, 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 Dosage:
<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.
ROZLYTREK 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 eye 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).
ROZLYTREK Classification:
Kinase inhibitor.
ROZLYTREK 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 Drug Availability:
NO
How Supplied:
Caps 100mg—30; 200mg—90
