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Rozlytrek Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Caps 100mg—30; 200mg—90; Pellets—42
Manufacturer
Generic Availability
Mechanism of Action
Rozlytrek Indications
Indications
Rozlytrek Dosage and Administration
Adult
Confirm presence of ROS1 rearrangement(s) in tumor or plasma specimens. Swallow caps whole; if unable to swallow or requires enteral administration (eg, gastric or nasogastric tube), prepare as oral susp by pouring contents of cap(s) into water or milk; see full labeling. Pellets (not for enteral administration or for oral susp prep): sprinkle contents of packet on ≥1 spoonfuls of soft food (eg, applesauce, yogurt, or pudding). 600mg once daily, until disease progression or unacceptable toxicity. Dose modifications for adverse reactions, concomitant moderate or strong CYP3A inhibitors: see full labeling.
Children
Rozlytrek Contraindications
Not Applicable
Rozlytrek Boxed Warnings
Not Applicable
Rozlytrek Warnings/Precautions
Warnings/Precautions
Assess LVEF prior to initiation. 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. Severe renal impairment (CrCl <30mL/min): not studied. Moderate (total bilirubin >1.5–3.0×ULN with any AST) or severe (total bilirubin >3.0×ULN with any AST) hepatic impairment: consider risk/benefit profile prior to administration; monitor frequently for adverse reactions. 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
Absorption
Maximum plasma concentration: 4–6 hours after administration of a 600mg dose.
Distribution
Plasma protein bound: >99% (in vitro). Estimated apparent volume of distribution: 551 L.
Elimination
Fecal (83%), renal (3%). Estimated apparent clearance: 19.6 L/h. Estimated half-life: 20 hours.
Rozlytrek Interactions
Interactions
Potentiated by moderate or strong CYP3A inhibitors; avoid; if unavoidable, reduce dose. 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
Rozlytrek Clinical Trials
See Literature
Rozlytrek Note
Not Applicable
Rozlytrek Patient Counseling
See Literature
Rozlytrek Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Caps 100mg—30; 200mg—90; Pellets—42
Manufacturer
Generic Availability
Mechanism of Action
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 in tumor or plasma specimens. Swallow caps whole; if unable to swallow or requires enteral administration (eg, gastric or nasogastric tube), prepare as oral susp by pouring contents of cap(s) into water or milk; see full labeling. Pellets (not for enteral administration or for oral susp prep): sprinkle contents of packet on ≥1 spoonfuls of soft food (eg, applesauce, yogurt, or pudding). 600mg once daily, until disease progression or unacceptable toxicity. Dose modifications for adverse reactions, concomitant moderate or strong CYP3A inhibitors: see full labeling.
Children
<1mos: not established. Confirm presence of a NTRK gene fusion in tumor or plasma specimens. Swallow caps whole; if unable to swallow or requires enteral administration (eg, gastric or nasogastric tube), prepare as oral susp by pouring contents of cap(s) into water or milk; see full labeling. Pellets (not for enteral administration or for oral susp prep): sprinkle contents of packet on ≥1 spoonfuls of soft food (eg, applesauce, yogurt, or pudding). Base dose on body surface area (BSA). 1–≤6mos: 250mg/m2 once daily (caps prepared as an oral susp). >6mos (BSA ≤0.50m2): 300mg/m2 once daily (caps prepared as an oral susp); (BSA 0.51–0.80m2): 200mg once daily; (BSA 0.81–1.10m2): 300mg once daily; (BSA 1.11–1.50m2): 400mg once daily; (BSA ≥1.51m2): 600mg once daily. Give until disease progression or unacceptable toxicity. Dose modifications for adverse reactions, concomitant moderate or strong CYP3A inhibitors: see full labeling.
Rozlytrek Contraindications
Not Applicable
Rozlytrek Boxed Warnings
Not Applicable
Rozlytrek Warnings/Precautions
Warnings/Precautions
Assess LVEF prior to initiation. 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. Severe renal impairment (CrCl <30mL/min): not studied. Moderate (total bilirubin >1.5–3.0×ULN with any AST) or severe (total bilirubin >3.0×ULN with any AST) hepatic impairment: consider risk/benefit profile prior to administration; monitor frequently for adverse reactions. 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
Absorption
Maximum plasma concentration: 4–6 hours after administration of a 600mg dose.
Distribution
Plasma protein bound: >99% (in vitro). Estimated apparent volume of distribution: 551 L.
Elimination
Fecal (83%), renal (3%). Estimated apparent clearance: 19.6 L/h. Estimated half-life: 20 hours.
Rozlytrek Interactions
Interactions
Potentiated by moderate or strong CYP3A inhibitors; avoid; if unavoidable, reduce dose. 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
Rozlytrek Clinical Trials
See Literature
Rozlytrek Note
Not Applicable
Rozlytrek Patient Counseling
See Literature
