100mg Entrectinib PHOENTR 60 Capsules Gastrointestinal Cancer Treatment

 inherit;">Generic Name:Entrectinib Capsules

Product Name:Rozlytrek®, Product Name Rozlytrek® in English

English name: Entrectinib Capsules

Chinese Pinyin: Enqutini Jiaonan

[Indications]
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This product is indicated for adults and children 12 years of age and older with solid tumors who meet the following criteria.

Diagnosis of neurotrophic tyrosine receptor kinase (NTRK) fusion genes by a well-validated test that does not include known acquired resistance mutations, and

Patients with locally advanced, metastatic disease or in whom surgical resection may result in serious complications and in whom there is no satisfactory alternative treatment or in whom previous treatment has failed.

This indication has been conditionally approved for marketing based on surrogate endpoints. Clinical endpoint data are not yet available, and efficacy and safety will need to be further demonstrated post-marketing.

Non-Small Cell Lung Cancer (NSCLC)

This product is indicated for adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

[Usage and dosage]
[Usage and dosage]
Patient's choice

solid tumor

Treatment with this product should be initiated by a physician experienced in anti-cancer therapy.

Patient tumor samples must be confirmed to carry the NTRK fusion gene prior to treatment with this product. A validated assay should be used to determine the patient's NTRK fusion gene status. Patients carrying an NTRK fusion gene may be eligible for treatment with this product based on hospital or laboratory test results, which must be reviewed by an independent third party designated by Roche to confirm that the patient has an NTRK fusion gene and can continue taking the drug.

Non-Small Cell Lung Cancer (NSCLC)

Validated assays are needed to select patients with locally advanced or metastatic NSCLC who are ROS1 positive. ROS1-positive status should be determined prior to initiating treatment with entrectinib.

recommended dose

This product is suitable for oral administration. Hard capsules should be swallowed whole. Because of the bitter taste of the contents, the capsules should not be opened or dissolved before taking the medicine. This product may be taken with food or alone, but should not be taken with grapefruit or grapefruit juice.

Adults: The recommended dose for adults is 600 mg PO once daily.

Pediatric patients: The recommended dose for pediatric patients 12 years of age and older is 300 mg/m2 PO once daily.

Duration of treatment

It is recommended that patients receive this product until disease progression or intolerable toxicity occurs.

Delayed or missed doses

If a patient misses a dose, he or she may miss a dose unless the next dose is less than 12 hours away.

If a patient vomits immediately after taking entrectinib, the patient can take the drug again.

Dose Adjustment in Adult Patients

Adult entrectinib doses may be reduced by up to a factor of two, depending on tolerability. Table 2 provides general dose adjustment recommendations for adult patients. If the patient cannot tolerate a once-daily dose of 200 mg, therapy with entrectinib should be permanently discontinued.

Co-administration of strong or moderate CYP3A inhibitors

Adults: In adult patients, co-administration with potent or moderate CYP3A inhibitors should be avoided or limited to no more than 14 days. If coadministration is unavoidable, the dose of entrectinib should be reduced to 100 mg once daily in combination with a potent CYP3A inhibitor and to 100 mg once daily in combination with a moderate CYP3A inhibitor. to 200 mg once daily. After discontinuation of a potent or moderate CYP3A inhibitor combination, entrectinib can be resumed at the pre-combination dose. CYP3A4 inhibitors with long half-lives may require an elution period.

Pediatric Patients:Concomitant administration of potent or moderate CYP3A inhibitors should be avoided in pediatric patients 12 years of age and older.

Concomitant use of CYP3A inducers

Concomitant use of CYP3A inducers should be avoided in adult and pediatric patients.

Dosage instructions for special populations

Children: The safety and efficacy of entrectinib in children under 12 years of age have not been established.

Elderly patients:No dose adjustment of entrectinib is required in patients ≥65 years of age.

Renal Impairment:No dose adjustment is necessary in patients with mild or moderate renal impairment. The safety and efficacy of entrectinib have not been studied in patients with severe renal insufficiency. However, since renal elimination of entrectinib is negligible, no dose adjustment is necessary in patients with severe renal insufficiency.

Hepatic Impairment:No dose adjustment is recommended in patients with mild hepatic impairment. The safety and efficacy of entrectinib have not been studied in patients with moderate to severe hepatic impairment.

[Adverse Reaction]

The most common adverse reactions (≥20%) were fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, hypesthesia, dyspnea, anemia, weight gain, elevated serum creatinine, pain, cognitive impairment, vomiting, cough, and fever.

The most common serious adverse reactions (≥2%) were pulmonary infection (5.2%), dyspnea (4.6%), cognitive impairment (3.8%), pleural effusion (3.0%), and fracture (2.4%). Treatment was permanently discontinued in 4.6% of patients due to adverse effects.

[Storage]
Store in a sealed container at a temperature not exceeding 30℃.