Source: FDA, National Drug Code (US) Revision Year: 2023
FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.
The recommended dose of FRUZAQLA is 5 mg orally once daily for the first 21 days of each 28-day cycle until disease progression or unacceptable toxicity. Take FRUZAQLA with or without food [see Clinical Pharmacology (12.3)] at approximately the same time each day.
Swallow the FRUZAQLA capsule whole.
Take a missed dose if less than 12 hours have passed since the missed scheduled dose. Do not take two doses on the same day to make up for a missed dose.
Do not take an additional dose if vomiting occurs after taking FRUZAQLA but continue with the next scheduled dose.
The recommended dose reductions for adverse reactions are provided in Table 1.
Table 1. Recommended Dose Reductions for FRUZAQLA:
| Dose Level | [FRUZAQLA DOSE] |
|---|---|
| First dose reduction | 4 mg orally once daily |
| Second dose reduction | 3 mg orally once daily |
Permanently discontinue FRUZAQLA in patients unable to tolerate 3 mg orally once daily.
The recommended dosage modifications for adverse reactions are provided in Table 2.
Table 2. Recommended Dosage Modifications for FRUZAQLA:
| Adverse Reaction | Severity* | FRUZAQLA Dosage Modification |
|---|---|---|
| Hypertension [see Warnings and Precautions (5.1)] | Grade 3 | • Withhold FRUZAQLA for Grade 3 hypertension that persists despite optimal anti-hypertensive therapy. • If hypertension fully resolves or recovers to Grade 1, resume at the next lower dose level. |
| Grade 4 | Permanently discontinue FRUZAQLA. | |
| Hemorrhagic Events [see Warnings and Precautions (5.2)] | Grade 2 | • Withhold FRUZAQLA until bleeding fully resolves or recovers to Grade 1. • Resume at the next lower dose level. |
| Grade 3 or Grade 4 | Permanently discontinue FRUZAQLA. | |
| Hepatotoxicity [see Warnings and Precautions (5.5)] | Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times upper limit of normal (ULN) with total bilirubin less than or equal to 2 times ULN | • Withhold FRUZAQLA and monitor AST/ALT and total bilirubin until resolution to Grade 1 or baseline. • Resume at the next lower dose level. |
| ALT or AST greater than 3 times ULN with concurrent total bilirubin greater than 2 times ULN (in the absence of cholestasis or hemolysis) | Permanently discontinue FRUZAQLA. | |
| AST or ALT greater than 20 times ULN or bilirubin greater than 10 times ULN | Permanently discontinue FRUZAQLA. | |
| Proteinuria [see Warnings and Precautions (5.6)] | 2 grams or greater proteinuria in 24 hours | • Withhold FRUZAQLA until proteinuria fully resolves or is <1 gram/24 hours. • Upon recovery, resume at the next lower dose level.Permanently discontinue FRUZAQLA for nephrotic syndrome or if proteinuria does not recover to <1 gram/24 hours. |
| Palmar-plantar erythrodysesthesia (PPE) [see Warnings and Precautions (5.7)] | Grade 2 | • Withhold FRUZAQLA and initiate supportive treatment. • If toxicity fully resolves or recovers to Grade 1, resume at the same dose level. |
| Grade 3 | • Withhold FRUZAQLA and initiate supportive treatment. • If toxicity fully resolves or recovers to Grade 1, resume at the next lower dose level. | |
| Other Adverse Reactions [see Adverse Reactions (6.1)] | Grade 3 | • Withhold FRUZAQLA. • If toxicity fully resolves or recovers to Grade 1, resume at the next lower dose level. |
| Grade 4 | Discontinue FRUZAQLA. Consider resuming FRUZAQLA at the next lower dose level only if the toxicity is non-life threatening and fully resolves or recovers to Grade 1 and the potential benefit outweighs the risks. |
* Severity as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Store at 20°C to 25°C (68°F to 77°F). Brief exposure to 15°C and 30°C (59°F to 86°F) permitted (see USP Controlled Room Temperature).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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