Bitrackbeak (Larotrectinib Sulfate)

Adult dose

(Adults) The recommended adult dose of this drug is 100 mg orally twice daily until there is no longer clinical benefit from treatment or unacceptable toxicity occurs. Table 1. Recommended dose modifications for adverse reactions Adults First dose reduction: 75 mg twice daily Second dose reduction: 50 mg twice daily Third dose reduction: 100 mg once daily Patients with hepatic impairment Reduce the starting dose of this drug by 50% in patients with moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment. No dose adjustment is required in patients with mild (Child-Pugh A) hepatic impairment. Concomitant use with strong CYP3A4 inhibitors: Avoid concomitant use of this drug with strong CYP3A4 inhibitors. If concomitant use with a strong CYP3A4 inhibitor is unavoidable, reduce the dose of this drug by 50%. After discontinuing the inhibitor for a period equivalent to 3~5 times its elimination half-life, resume this drug at the dose used before concomitant administration of the CYP3A4 inhibitor (see Precautions for Use, 5. Interactions). Concomitant use with strong or moderate CYP3A4 inducers: Avoid concomitant use of this drug with strong CYP3A4 inducers. If concomitant use with a strong CYP3A4 inducer is unavoidable, double the dose of this drug. Also, double the dose of this drug when used concomitantly with a moderate CYP3A4 inducer. After discontinuing the inducer for a period equivalent to 3~5 times its elimination half-life, resume this drug at the dose used before concomitant administration of the CYP3A4 inducer (see Precautions for Use, 5. Interactions).

Child dose

(Pediatric patients) 100 mg/m2 orally twice daily; maximum dose per administration is 100 mg Table 1. Recommended dose modifications for adverse reactions Pediatric patients with a body surface area of 1.0 m2 or greater — First dose reduction: 75 mg twice daily Pediatric patients with a body surface area of 1.0 m2 or greater — Second dose reduction: 50 mg twice daily Pediatric patients with a body surface area of 1.0 m2 or greater — Third dose reduction: 100 mg once daily Pediatric patients with a body surface area of less than 1.0 m2 — First dose reduction: 75 mg/m2 twice daily Pediatric patients with a body surface area of less than 1.0 m2 — Second dose reduction: 50 mg/m2 twice daily Pediatric patients with a body surface area of less than 1.0 m2 — Third dose reduction: 25 mg/m2 twice dailya a Pediatric patients receiving 25 mg/m2 twice daily should continue this dose during treatment even if their body surface area increases to more than 1.0 m2. At the third dose reduction, the maximum dose should be 25 mg/m2 twice daily.

This drug may affect the nervous system, potentially causing symptoms such as dizziness, gait disturbances, and sensory disturbances. If these symptoms occur, it may be necessary to temporarily stop the medication or reduce the dosage. It may also affect liver function, leading to elevated liver enzyme levels; therefore, regular liver function tests should be conducted before and during treatment. If liver function abnormalities are detected, dosage adjustment or discontinuation of the medication may be necessary. Patients with allergies to the active ingredients or excipients of this medication should not receive it. Common side effects such as vomiting, constipation, diarrhea, fatigue, dizziness, and anemia may occur during treatment; caution is advised. In particular, side effects associated with liver enzyme elevation are frequent in the first three months of treatment, so increased vigilance is necessary during this period. This medication may interact with other drugs, so if you are taking other medications, it is essential to inform your healthcare provider. Dose adjustments may be needed when taken in conjunction with drugs that inhibit or activate enzymes involved in drug metabolism in the liver. It is advisable to avoid using this medication during pregnancy, and women of childbearing potential should have a pregnancy test prior to treatment and employ effective contraception during and for a period after treatment. In breastfeeding mothers, as this medication may be excreted into breast milk, breastfeeding should be halted during treatment and for three days after the last dose. It can also be used in children and the elderly, but caution should be exercised as side effects may occur more frequently. Patients with impaired kidney function may also use it without dosage adjustment, but consultation with healthcare providers is recommended depending on their condition. In case of overdose, there is no specific antidote, so standard emergency measures are necessary, and dizziness and fatigue may occur, making it safer to avoid driving or operating machinery during the first three months of treatment.

• Increased ALT
• increased AST
• vomiting
• anemia
• constipation
• diarrhea
• nausea
• fatigue
• dizziness
• decreased neutrophil count

This medication is sensitive to light, so it should be stored in a tightly closed container that protects it from light. Furthermore, it is crucial to keep it at a refrigerated temperature between 2 to 8 degrees Celsius to maintain its effectiveness.

Appearance

A clear solution without foreign substances that is colorless, yellow, orange, red, or brown, contained in a brown glass bottle as an oral solution.

Package unit

1 box - 50 milliliters/bottle [X 2 bottles]