Augtyro Dosage
Generic name: REPOTRECTINIB 40mg
Dosage form: capsule
Drug class: Multikinase inhibitors
Medically reviewed by Drugs.com. Last updated on Nov 15, 2023.
Patient Selection
Select patients for the treatment of locally advanced or metastatic NSCLC with AUGTYRO based on the presence of ROS1 rearrangement(s) in tumor specimens [see Clinical Studies (14.1)]. An FDA-approved test to detect ROS1 rearrangements for selecting patients for treatment with AUGTYRO is not currently available.
Important Information Prior to Initiating AUGTYRO
Prior to initiating AUGTYRO, discontinue strong and moderate CYP3A inhibitors for 3 to 5 elimination half-lives of the CYP3A inhibitor [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Recommended Evaluation and Testing Before Initiating AUGTYRO
Prior to initiation of AUGTYRO, evaluate:
- •
- liver function tests including bilirubin [see Warnings and Precautions (5.3)]
- •
- uric acid level [see Warnings and Precautions (5.5)]
Recommended Dosage
The recommended dosage of AUGTYRO is 160 mg taken orally once daily with or without food [see Clinical Pharmacology (12.3)] for 14 days, then increase to 160 mg twice daily and continue until disease progression or unacceptable toxicity.
Dosage Modifications for Adverse Reactions
The recommended dosage reductions of AUGTYRO for the management of adverse reactions are provided in Table 1.
Dose |
Dose Reduction |
|
First |
Second |
|
160 mg Once Daily |
120 mg Once Daily |
80 mg Once Daily |
160 mg Twice Daily |
120 mg Twice Daily |
80 mg Twice Daily |
Recommended dosage modifications of AUGTYRO for the management of adverse reactions are provided in Table 2.
*Graded per Common Terminology Criteria for Adverse Events v4.03 | ||
Adverse Reaction |
Severity* |
Dosage Modification |
Central Nervous System Effects |
Intolerable Grade 2 |
|
Grade 3 |
|
|
Grade 4 |
|
|
Interstitial Lung Disease (ILD)/Pneumonitis |
Any Grade |
|
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) |
|
|
Creatine Phosphokinase (CPK) Elevation [see Warnings and Precautions (5.4)] |
CPK elevation greater than 5 times ULN |
|
CPK elevation greater than 10 times ULN or second occurrence of CPK elevation of greater than 5 times ULN |
|
|
Hyperuricemia [see Warnings and Precautions (5.5)] |
Grade 3 or Grade 4 |
|
Other Clinically Relevant Adverse Reactions [see Adverse Reactions (6.1)] |
Intolerable Grade 2 or Grade 3 or Grade 4 |
|
Administration
Take AUGTYRO at approximately the same time each day with or without food [see Pharmacokinetics (12.3)].
Swallow AUGTYRO capsules whole. Do not open, chew, crush, or dissolve the capsule prior to swallowing. Do not take any AUGTYRO capsules that are broken, cracked, or damaged.
If a dose of AUGTYRO is missed or if vomiting occurs at any time after taking a dose, skip the dose and resume AUGTYRO at its regularly scheduled time.
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