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Rozlytrek Generic Name & Formulations
Legal Class
Rx
General Description
Entrectinib 100mg, 200mg; caps.
Pharmacological Class
Kinase inhibitor.
How Supplied
Caps 100mg—30; 200mg—90
Manufacturer
Generic Availability
NO
Rozlytrek Indications
Indications
In adults with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
Rozlytrek Dosage and Administration
Adult
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
Not established.
Rozlytrek Contraindications
Not Applicable
Rozlytrek Boxed Warnings
Not Applicable
Rozlytrek Warnings/Precautions
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 Pharmacokinetics
See Literature
Rozlytrek Interactions
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.
Rozlytrek Adverse Reactions
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.
Rozlytrek Clinical Trials
See Literature
Rozlytrek Note
Not Applicable
Rozlytrek Patient Counseling
See Literature
Rozlytrek Generic Name & Formulations
Legal Class
Rx
General Description
Entrectinib 100mg, 200mg; caps.
Pharmacological Class
Kinase inhibitor.
How Supplied
Caps 100mg—30; 200mg—90
Manufacturer
Generic Availability
NO
Rozlytrek Indications
Indications
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.
Rozlytrek Dosage and Administration
Adult
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
<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 Contraindications
Not Applicable
Rozlytrek Boxed Warnings
Not Applicable
Rozlytrek Warnings/Precautions
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 Pharmacokinetics
See Literature
Rozlytrek Interactions
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.
Rozlytrek Adverse Reactions
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.
Rozlytrek Clinical Trials
See Literature
Rozlytrek Note
Not Applicable
Rozlytrek Patient Counseling
See Literature
