90 Pills Entrectinib Rozlytrek 200mg Gastrointestinal Cancer Treatment

【Drug Name】
Generic name: entrectinib capsules

Product name: Rozlytrek®, English product name Rozlytrek®

English name: Entrectinib Capsules

Chinese Pinyin: Enqutini Jiaonan

【Indications】
solid tumors

This product is suitable for adults and children aged 12 and above with solid tumors who meet the following conditions:

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

Patients with locally advanced, metastatic disease or in whom surgical resection may result in serious complications, and patients with no satisfactory alternative treatments or in whom previous treatments have failed.

This indication has been conditionally approved for marketing based on surrogate endpoints. No clinical endpoint data have been obtained yet, and the effectiveness and safety need to be further confirmed after marketing.

Non-small cell lung cancer (NSCLC)

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

【Dosage】
patient choice

solid tumors

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

Before treatment with this product, it must be confirmed that the patient's tumor sample carries the NTRK fusion gene. A validated assay should be used to determine a patient's NTRK fusion gene status. Patients who are judged to carry the NTRK fusion gene according to the test results of the hospital or laboratory can receive treatment with this product, and an independent third party designated by Roche must conduct an audit to confirm that the patient indeed has the NTRK fusion gene and can continue to take the drug.

Non-small cell lung cancer (NSCLC)

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

Recommended dosage

This product is suitable for oral administration. Hard capsules should be swallowed whole. Because the contents are bitter, they should not be opened or dissolved before taking the medicine. This product may be taken with or without food, 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

treatment duration

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

Delayed or missed dose

If the patient misses a dose, he or she may take a missed dose unless it is less than 12 hours before the next dose.

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

Dosage Adjustment for Adult Patients

The entrectinib dose in adults may be reduced up to two times based on tolerability. Table 2 provides general dose adjustment recommendations for adult patients. If a patient cannot tolerate the 200 mg once daily dose, entrectinib therapy should be permanently discontinued.

Coadministration of strong or moderate CYP3A inhibitors

Adults: In adult patients, coadministration with strong or moderate CYP3A inhibitors should be avoided or should be limited to no more than 14 days. If coadministration is unavoidable, the entrectinib dose should be reduced to 100 mg once daily when coadministered with a strong CYP3A inhibitor and reduced to 100 mg once daily when coadministered with a moderate CYP3A inhibitor. to 200 mg once daily. After discontinuation of a coadministered strong or moderate CYP3A inhibitor, entrectinib may be resumed at the preconcomitant dose. CYP3A4 inhibitors with long half-lives may require a washout period.

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

Concomitant use of CYP3A inducers

In adult and pediatric patients, coadministration of CYP3A inducers should be avoided.

Dosage Instructions for Special Populations

Children: The safety and effectiveness of entrectinib in children younger than 12 years of age have not been established.

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

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

Hepatic Impairment: No dosage adjustments are 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 reactions】

The most common adverse reactions (≥20%) are fatigue, constipation, dysgeusia, edema, dizziness, diarrhea, nausea, hypoesthesia, dyspnea, anemia, weight gain, increased 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%). 4.6% of patients permanently discontinued treatment due to adverse reactions.

【Storage】
Sealed and stored no more than 30℃.