Rozlytrek Dosage & Drug Information

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Core Prescribing Info

Contents

Entrectinib

Indications/Uses

Adult & ped patients ≥12 yr w/ neurotrophic tyrosine receptor kinase fusion +ve solid tumors w/o a known acquired resistance mutation & who have progressed following prior therapies or have no satisfactory alternative treatments. Adult patients w/ ROS1 +ve locally advanced or metastatic NSCLC.

Dosage/Direction for Use

Adult 600 mg once daily. Concomitant use w/ strong CYP3A inhibitor Reduce dose to 100 mg once daily. Concomitant use w/ moderate CYP3A inhibitor Reduce dose to 200 mg once daily. Ped ≥12 yr who have ability to swallow cap 300 mg/m² once daily. Max daily dose: 600 mg. Ped ≥12 yr w/ BSA ≥1.51 m² 600 mg once daily, 1.11-1.5 m² 400 mg once daily, 0.81-1.1 m² 300 mg once daily.

Administration

May be taken with or without food: Swallow whole, do not open/dissolve.

Contraindications

Hypersensitivity.

MIMS Class

Targeted Cancer Therapy

ATC Classification

L01EX14 - entrectinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.

Regulatory Classification

POM

Presentation/Packing

Form

Rozlytrek hard cap 100 mg

Packing/Price

1's

Form

Rozlytrek hard cap 200 mg

Packing/Price

1's

Rozlytrek

entrectinib

Manufacturer:

Catalent Greenville Inc