Rozlytrek Dosage
Generic name: ENTRECTINIB 100mg
Dosage form: capsule
Drug class: Multikinase inhibitors
Medically reviewed by Drugs.com. Last updated on Nov 20, 2024.
Patient Selection
- Select patients for the treatment of metastatic NSCLC with ROZLYTREK based on the presence of ROS1 rearrangement(s) in tumor or plasma specimens. Testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing.
Information on FDA-approved tests for the detection of ROS1 rearrangement(s) in NSCLC is available at http://www.fda.gov/CompanionDiagnostics. - Select patients for treatment of locally advanced or metastatic solid tumors with ROZLYTREK based on the presence of a NTRK gene fusion in tumor or plasma specimens. Testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing.
Information on FDA-approved tests for the detection of NTRK gene fusion(s) in solid tumors is available at http://www.fda.gov/CompanionDiagnostics.
Recommended Evaluation and Testing Before Initiating ROZLYTREK
Before initiating ROZLYTREK, evaluate:
- left ventricular ejection fraction (LVEF)
- serum uric acid levels
- QT interval and electrolytes
ROZLYTREK Dosage Form Overview
The physician should prescribe the most appropriate dosage form of ROZLYTREK according to the dose required and patient needs.
ROZLYTREK is available in two dosage forms, and can be administered either as capsules swallowed whole, capsules made into an oral suspension (or for enteral tube administration) and as oral pellets swallowed with soft food.
ROZLYTREK Capsules 100 mg and 200 mg
- Whole capsules: For patients who can swallow whole capsules and whose doses are multiples of 100 mg.
- Capsules prepared as an oral suspension:
- For patients who have difficulty or are unable to swallow capsules or who require enteral administration (e.g., gastric or nasogastric tube)..
- For dose increments of 10 mg, only use capsules prepared as a suspension.
ROZLYTREK Oral Pellets 50 mg per packet
- Pellets sprinkled on one or more spoonfuls of soft food:
- For patients who have difficulty or are unable to swallow capsules but can swallow soft food and whose doses are multiples of 50 mg..
- Do not use pellets for preparation of suspension.
- Do not attempt to use partial quantities of pellets from 50 mg pellet packets to prepare a dose.
- Do not use the pellet formulation for enteral tube administration as the pellets may clog the tube.
ROZLYTREK Administration Overview
- Administer ROZLYTREK capsules, capsules prepared as a suspension, or pellets once daily, with or without food.
- If a dose of ROZYTREK is missed, make up that dose unless the next dose is due within 12 hours.
- If vomiting occurs immediately after taking a dose of ROZLYTREK, repeat that dose.
ROZLYTREK Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer
The recommended dosage of ROZLYTREK is 600 mg orally once daily with or without food until disease progression or unacceptable toxicity.
ROZLYTREK Recommended Dosage for NTRK Gene Fusion-Positive Solid Tumors
The recommended dosages of ROZLYTREK for the treatment of adult and pediatric patients with NTRK Gene Fusion-Positive Solid Tumors are provided in Table 1.
Administer the recommended dosage of ROZLYTREK capsules and oral pellets with or without food until disease progression or unacceptable toxicity.
Sprinkle ROZLYTREK oral pellets on one or more spoonfuls of soft food as a vehicle.
Patient Population | Recommended Dosage of ROZLYTREK | Duration of Treatment |
---|---|---|
|
||
Adults Pediatric patients with BSA ≥ 1.51 m2: |
600 mg orally once daily | Until disease progression or unacceptable toxicity. |
Pediatric patients > 6 months: | see Table 2 | |
Pediatric patients > 1 month to ≤ 6 months: | 250 mg/m2 orally once daily* |
The recommended dosages of ROZLYTREK for the treatment of pediatric patients older than 6 months with NTRK Gene Fusion-Positive Solid Tumors is provided in Table 2.
Body Surface Area (BSA)* | Recommended Dosage Orally Once Daily |
---|---|
≤0.50 m2 | 300 mg/m2† |
0.51 to 0.80 m2 | 200 mg |
0.81 to 1.10 m2 | 300 mg |
1.11 to 1.50 m2 | 400 mg |
≥ 1.51 m2 | 600 mg |
ROZLYTREK Dosage Modifications for Adverse Reactions
The recommended dosage reductions of ROZLYTREK for the management of adverse reactions for adults and pediatric patients are provided in Table 3.
Starting Dose once daily | First dose reduction | Second dose reduction | |
---|---|---|---|
|
|||
250 mg/m2 or 300 mg/m2 | Reduce the once daily dose to two thirds of the starting dose* | Reduce the once daily dose to one third of the starting dose* | Permanently discontinue ROZLYTREK in patients who are unable to tolerate ROZLYTREK after two dose reductions. |
200 mg | 150 mg once daily | 100 mg once daily | |
300 mg | 200 mg once daily | 100 mg once daily | |
400 mg | 300 mg once daily | 200 mg once daily | |
600 mg | 400 mg once daily | 200 mg once daily |
Table 4 provides the ROZLYTREK recommended dosage modifications for the management of adverse reactions.
Adverse Reaction | Severity* | Dosage Modification |
---|---|---|
|
||
Congestive Heart Failure |
Grade 2 or 3 |
|
Grade 4 |
|
|
Central Nervous System Effects |
Intolerable Grade 2 |
|
Grade 3 |
|
|
Grade 4 |
|
|
Hepatotoxicity |
Grade 3 |
|
Grade 4 |
|
|
ALT or AST greater than 3 times ULN with concurrent total bilirubin greater than 1.5 times ULN (in the absence of cholestasis or hemolysis). |
|
|
Hyperuricemia |
Symptomatic or Grade 4 |
|
QT Interval Prolongation |
QTc greater than 500 ms |
|
Torsade de pointes; polymorphic ventricular tachycardia; signs/symptoms of serious arrhythmia |
|
|
Vision Disorders |
Grade 2 or above |
|
Anemia or Neutropenia | Grade 3 or 4 |
|
Other Adverse Reactions | Grade 3 or 4 |
|
ROZLYTREK Dosage Modifications for Drug Interactions
Moderate and Strong CYP3A Inhibitors
Adults and Pediatric Patients 2 Years and Older
Avoid coadministration of ROZLYTREK with moderate or strong CYP3A inhibitors. If coadministration cannot be avoided, reduce the ROZLYTREK dose as shown in Table 5 and limit coadministration to 14 days or less.
Starting dose* | Moderate CYP3A inhibitor | Strong CYP3A inhibitor |
---|---|---|
|
||
200 mg | 50 mg once daily | 50 mg on alternate days |
300 mg | 100 mg once daily | 50 mg once daily |
400 mg | 200 mg once daily | 50 mg once daily |
600 mg | 200 mg once daily | 100 mg once daily |
After discontinuation of a strong or moderate CYP3A inhibitor for 3 to 5 elimination half-lives, resume the ROZLYTREK dose that was taken prior to initiating the CYP3A inhibitor.
ROZLYTREK Preparation and Administration Instructions
ROZLYTREK Capsules Prepared as a Suspension for Oral or Enteral Tube Administration
It is recommended that a healthcare provider discuss with the patient or caregiver, the volume of water or milk to be added and oral suspension to withdraw, prior to administration of the first dose (see Table 6).
Table 6 provides the ROZLYTREK dose and volume of room temperature drinking water or milk required to prepare an oral suspension. Instruct patients or caregivers to carefully open capsule(s) and pour the contents into room temperature drinking water or milk to prepare an oral suspension. Let sit for 15 minutes.
Dose of ROZLYTREK to be administered | Dose needed for suspension (using 100 mg or 200 mg capsules, as appropriate) | Volume of water or milk to be added | Volume of oral suspension to withdraw and administer |
---|---|---|---|
20 mg | 100 mg | 5 mL | 1 mL |
30 mg | 100 mg | 5 mL | 1.5 mL |
40 mg | 100 mg | 5 mL | 2 mL |
50 mg | 100 mg | 5 mL | 2.5 mL |
60 mg | 100 mg | 5 mL | 3 mL |
70 mg | 100 mg | 5 mL | 3.5 mL |
80 mg | 100 mg | 5 mL | 4 mL |
90 mg | 100 mg | 5 mL | 4.5 mL |
100 mg | 100 mg | 5 mL | 5 mL |
110 mg | 200 mg | 10 mL | 5.5 mL |
120 mg | 200 mg | 10 mL | 6 mL |
130 mg | 200 mg | 10 mL | 6.5 mL |
140 mg | 200 mg | 10 mL | 7 mL |
150 mg | 200 mg | 10 mL | 7.5 mL |
200 mg | 200 mg | 10 mL | 10 mL |
300 mg | 300 mg | 15 mL | 15 mL |
400 mg | 400 mg | 20 mL | 20 mL |
600 mg | 600 mg | 30 mL | 30 mL |
Administer ROZLYTREK oral suspension immediately after preparation.
Discard any unused suspension if not used within 2 hours.
Instruct patients to drink water after taking the oral suspension to ensure ROZLYTREK has been completely swallowed.
Enteral Tube Administration
If enteral administration (e.g., gastric or nasogastric tube) is required, administer the oral suspension via the tube. Use an enteral tube that is 8 FR or higher to administer dosing volumes of 3 mL or higher. Instruct patients to divide dosing volumes of 3 mL or higher into at least two aliquots and flush the tube after each administration. Flush the tube with a volume of water or milk that is equal to the aliquot administered. For a dose volume of 30 mL, divide into at least three (10 mL) aliquots. The tube should be flushed with water or milk after delivering each aliquot of ROZLYTREK.
Refer to the Instructions for Use for detailed instructions on preparation and administration of ROZLYTREK capsules as an oral suspension via an enteral tube.
ROZLYTREK Oral Pellets
Sprinkle pellets on one or more spoonfuls of a soft food (e.g., applesauce, yogurt, or pudding) and take within 20 minutes of preparation. Do not crush or chew to avoid a bitter taste.
The patient should drink water after taking the pellets to ensure the drug has been completely swallowed.
Do not attempt to use partial quantities of pellets from 50 mg pellet packets to prepare a dose.
Do not use the pellet formulation for enteral tube administration as the pellets may clog the tube.
Refer to the Instructions for Use for detailed instructions on preparation and administration of ROZLYTREK oral pellets.
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