Lifyorli

2 DOSAGE AND ADMINISTRATION 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. ( 2 ) 2.1 Important Dosage and Administration Information LIFYORLI 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. Nab-Paclitaxel 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. 2.2 Recommended Dosage and Administration 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. 2.3 Dosage Modifications for Adverse Reactions 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/m 2 on Days 1, 8 and 15 of each 28-day cycle Second 60 mg/m 2 on Days 1 and 15 of each 28-day cycle Third Permanently discontinue nab-paclitaxel if unable to tolerate 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 after the nab-paclitaxel infusion Second Permanently discontinue LIFYORLI in patients unable to 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 Severity a Dosage Modification 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. Neutropenia Day 1 [see Warnings and Precautions ( 5.1 )] ANC 1,000 to < 1,500/mm 3 Nab-paclitaxel: Withhold until ≥ 1,500/mm 3 ; resume at same dose LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes ANC < 1,000/mm 3 Nab-paclitaxel: Withhold until ≥ 1,500/mm 3 ; 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/mm 3 Nab-paclitaxel: Omit dose; resume at reduced dose or continue at the same dose with short acting G-CSF b,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/mm 3 ; resume at reduced dose c LIFYORLI: Withhold; resume at the same dose once nab-paclitaxel resumes Thrombocytopenia Day 1 [see Adverse Reactions ( 6.1 )] Platelets < 100,000/mm 3 Nab-paclitaxel: Withhold until ≥ 100,000/mm 3 ; 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/mm 3 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 dose c LIFYORLI: Withhold until Grade ≤ 1; resume at reduced dose Table 4: Dosage Modifications for non-Hematologic Adverse Reactions Adverse Reaction Severity a Dosage Modification 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. 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 dose b 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 dose b 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 dose b 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 dose b LIFYORLI: Withhold until Grade ≤ 1; resume at reduced dose Grade 4 Nab-paclitaxel: Permanently discontinue LIFYORLI: Permanently discontinue

See official label

1 INDICATIONS AND USAGE 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 )] .