Source: FDA, National Drug Code (US) Revision Year: 2026
LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies (14)].
Follow LIFYORLI dosing instructions provided on the blister card.
Take LIFYORLI with food.
Swallow capsules whole. Do not crush, chew, dissolve, or split the capsules.
If a dose of LIFYORLI is missed by less than 12 hours, take the missed dose. If a dose of LIFYORLI is missed by 12 hours or more, skip the missed dose and take the next dose at the regularly scheduled time. Do not take 2 doses at the same time to make up for a missed dose.
If vomiting occurs after taking LIFYORLI, do not take an additional dose.
The recommended dosage and dosage modifications for nab-paclitaxel when administered in combination with LIFYORLI differ from those for other nab-paclitaxel indications [see Dosage and Administration (2.2 and 2.3) and Clinical Studies (14)].
Do not substitute with other paclitaxel formulations.
The recommended dosage of LIFYORLI is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion until disease progression or unacceptable toxicity.
The recommended dosage for nab-paclitaxel is 80 mg/m 2 administered as an intravenous infusion on Days 1, 8 and 15 of each 28-day cycle until disease progression or unacceptable toxicity [see Clinical Pharmacology (12.3), Clinical Studies (14)]. Refer to the Prescribing Information for nab-paclitaxel for administration.
Dose reduction levels are summarized in Table 1 and Table 2.
Table 1. Recommended Dosage Reductions for Adverse Reactions for Nab-Paclitaxel:
| Dose Reduction | Nab-Paclitaxel |
| First | 60 mg/m2 on Days 1, 8 and 15 of each 28-day cycle |
| Second | 60 mg/m2 on Days 1 and 15 of each 28-day cycle |
| Third | Permanently discontinue nab-paclitaxel if unable to <brtolerate after two dose reductions. |
Table 2. Recommended Dosage Reductions for Adverse Reactions for LIFYORLI:
| Dose Reduction | LIFYORLI |
| First | 125 mg once the day before, the day of and the day<br after the nab-paclitaxel infusion |
| Second | Permanently discontinue LIFYORLI in patients unable to<br tolerate after one dose reduction. |
The recommended dosage modifications for adverse reactions are provided in Tables 3 and 4. Interrupt or discontinue LIFYORLI whenever nab-paclitaxel is interrupted or discontinued.
Table 3. Dosage Modifications for Hematologic Adverse Reactions:
| Adverse Reaction | Severitya | Dosage Modification |
| Neutropenia Day 1 [see Warnings and Precautions (5.1)] | ANC 1,000 to < 1,500/mm³ | Nab-paclitaxel: Withhold until ≥ 1,500/mm³; resume at same dose LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes |
ANC < 1,000/mm³ | Nab-paclitaxel: Withhold until ≥ 1,500/mm³; resume at reduced dose LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes | |
| Neutropenia Day 8 or 15 [see Warnings and Precautions (5.1)] | ANC < 1,000/mm³ | Nab-paclitaxel: Omit dose; resume at reduced dose or continue at the same dose with short acting G-CSFb,c LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes |
| Febrile neutropenia [see Warnings and Precautions (5.1)] | Grade 3 or 4 | Nab-paclitaxel: Withhold until fever resolves and ANC ≥ 1,500/mm³; resume at reduced dosec LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes |
| Thrombocytopenia Day 1 [see Adverse Reactions (6.1)] | Platelets < 100,000/mm3 | Nab-paclitaxel: Withhold until ≥ 100,000/mm³; resume at the same dose LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes |
| Thrombocytopenia Day 8 or 15 [see Adverse Reactions (6.1)] | Platelets < 50,000/mm³ | Nab-paclitaxel: Omit dose; resume at reduced dose LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes |
| Other hematologic adverse reaction (excluding laboratory abnormalities that are not clinically relevant) [see Adverse Reactions (6.1)] | Grade 3 or 4 | Nab-paclitaxel: Withhold until Grade ≤ 1; resume at reduced dosec LIFYORLI: Withhold until Grade ≤ 1; resume at reduced dose |
a Unless otherwise specified, Grade per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
b Supportive short acting G-CSF administered 24 hours after nab-paclitaxel for 2 days in accordance with clinical practice.
c If the delay in nab-paclitaxel dosing exceeds 7 days, omit the nab-paclitaxel dose.
Table 4. Dosage Modifications for non-Hematologic Adverse Reactions:
| Adverse Reaction | Severitya | Dosage Modification |
|---|---|---|
| Peripheral neuropathy [see Adverse Reactions (6.1)] | Intolerable Grade 2 | Nab-paclitaxel: Reduce dose LIFYORLI: No change |
| Grade 3 | Nab-paclitaxel: Withhold until Grade ≤ 2; resume at reduced doseb LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes | |
| Grade 4 | Nab-paclitaxel: Permanently discontinue LIFYORLI: Permanently discontinue | |
| Cutaneous toxicity [see Adverse Reactions (6.1)] | Grade 3 | Nab-paclitaxel: Withhold until Grade ≤ 1; resume at reduced doseb LIFYORLI: Resume at the same dose once nab-paclitaxel resumes |
| Grade 4 | Nab-paclitaxel: Permanently discontinue LIFYORLI: Permanently discontinue | |
| Mucositis or Diarrhea [see Adverse Reactions (6.1)] | Grade 3 or 4 | Nab-paclitaxel: Withhold until Grade ≤ 1; resume at reduced doseb LIFYORLI: Resume at the same dose once nab-paclitaxel resumes. |
| Other non-hematologic adverse reactions (excluding laboratory abnormalities that are not clinically relevant) [see Adverse Reactions (6.1)] | Grade 3 | Nab-paclitaxel: Withhold until Grade ≤ 1; resume at reduced doseb LIFYORLI: Withhold until Grade ≤ 1; resume at reduced dose |
| Grade 4 | Nab-paclitaxel: Permanently discontinue LIFYORLI: Permanently discontinue |
a Unless otherwise specified, Grade per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
b If the delay in nab-paclitaxel dosing exceeds 7 days, omit the nab-paclitaxel dose.
Store and dispense LIFYORLI in their original carton. Store LIFYORLI at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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