Source: FDA, National Drug Code (US) Revision Year: 2023
OGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment.
The recommended dosage of OGSIVEO is 150 mg administered orally twice daily until disease progression or unacceptable toxicity. Each 150 mg dose of OGSIVEO consists of three 50 mg tablets. OGSIVEO may be taken with or without food.
Instruct patients to swallow OGSIVEO tablets whole and not to break, crush, or chew prior to swallowing.
If a patient vomits or misses a dose, instruct the patient to take the next dose at its scheduled time.
The recommended dose modifications for OGSIVEO for selected severe adverse reactions are summarized in Table 1 [see Warnings and Precautions (5), Adverse Reactions (6)]. For other severe adverse reactions, life-threatening adverse reactions, or persistent intolerable Grade 2 adverse events, withhold drug until resolved to Grade ≤ 1 or baseline. Only restart at a dose of 100 mg twice daily after considering the potential benefit and likelihood of recurrence of the adverse reaction. Permanently discontinue OGSIVEO for recurrence of severe or life-threatening adverse reaction upon rechallenge at the reduced dose.
Table 1. Recommended Dose Modifications for Adverse Reactions:
| Adverse Reaction | Severity | OGSIVEO Dosage Modifications |
|---|---|---|
| Diarrhea persisting for ≥ 3 days despite maximal medical therapy [see Warnings and Precautions (5.1)] | Grades 3 or 4 | Withhold OGSIVEO until resolved to Grade ≤ 1 or baseline, then restart at a dose of 100 mg twice daily. |
| ALT or AST increased [see Warnings and Precautions (5.3)] | Grade 2 (≥ 3 to 5 × ULN) | Withhold OGSIVEO until ALT, AST, or both are resolved to < 3 × ULN or baseline, then restart at a dose of 100 mg twice daily. |
| Grades 3 or 4 (> 5 × ULN) | Permanently discontinue. | |
| Hypophosphatemia persisting for ≥ 3 days despite maximal replacement therapy [see Warnings and Precautions (5.5)] | Grades 3 or 4 | Withhold OGSIVEO until resolved to Grade ≤ 1 or baseline, then restart at a dose of 100 mg twice daily. |
| Hypokalemia despite maximal replacement therapy [see Warnings and Precautions (5.5)] | Grades 3 or 4 | Withhold OGSIVEO until resolved to Grade ≤ 1 or baseline, then restart at a dose of 100 mg twice daily. |
Due to the high level of protein binding, OGSIVEO is not expected to be dialyzable [see Clinical Pharmacology (12.3)].
Store at 20°C-25°C (68°F-77°F). Excursions permitted between 15°C-30°C (59°F-86°F). See USP Controlled Room Temperature.
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