Entrectinib
Composition: Reknib-100: Each capsule contains Entrectinib INN 100 mg.
Indications:
•ROS1-Positive Non-Small Cell Lung Cancer: Entrectinib is indicated for the treatment of adult patients with metastatic non- small cell lung cancer (NSCLC) whose tumors are ROS1- positive.
•NTRK Gene Fusion- Positive Solid Tumors: Entrectinib is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:
• have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion 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.
Dosage and
Administration:
•Recommended Dosage for ROS1-Positive Non- Small Cell Lung Cancer: The recommended dosage of Entrectinib is 600 mg orally once daily with or without food until disease progression or unacceptable toxicity.
•Recommended Dosage for NTRK Gene Fusion- Positive Solid Tumors: Adults: The recommended dosage of Entrectinib in adults is 600 mg orally once daily with or without food until disease progression or unacceptable toxicity. Or, as directed by the registered physician.
Dosing in Pediatric Patients 12 Years and Older (Adolescents):
|
Body Surface Area (BSA) |
Recommended Dosage (Orally Once Daily) |
|
Greater than 1.50 m2 |
600 mg |
|
1.11 to 1.50 m2 |
500 mg |
|
0.91 to 1.10 m2 |
400 mg |
Recommended
Dose Reductions for Entrectinib Adverse Reactions:
|
Action |
Adults and Pediatric Patients 12 Years and Older with BSA Greater than 1.50 m2 (Orally once daily) |
Pediatric Patients 12 Years and Older with BSA of 1.11 to 1.50 m2 (Orally once daily) |
Pediatric Patients 12 Years and Older with BSA of 0.91 to 1.10 m2 (Orally once daily) |
|
First dose reduction |
400 mg |
400 mg |
300 mg |
|
Second dose reduction |
200 mg |
200 mg |
200 mg |
Use in Pregnancy and Lactation: Entrectinib can cause fetal harm when administered to a pregnant
woman. There are no available data on Entrectinib use in pregnant women. Advise pregnant women of the potential risk to a
fetus.
The
pregnancy status should be verified of females of reproductive potential prior
to initiating Entrectinib. Female patients of
reproductive potential are advised to use effective contraception during
treatment with Entrectinib and for at least 5
weeks following the final dose. Male patients with female partners of
reproductive potential are advised to use effective contraception during
treatment with Entrectinib and for 3 months
following the final dose.
Lactation: There are no data on the presence of Entrectinib or its
metabolites in human milk or their effects on either the breastfed child or on
milk production. Because of the potential adverse reactions in breastfed
children from Entrectinib, lactating woman should be advised to discontinue
breastfeeding during treatment with Entrectinib and for 7 days after the final
dose.
Packaging: Reknib-100: Each box contains 30 capsules in a container.
