Yulareb

Abemaciclib

In combination w/ endocrine therapy for the adjuvant treatment of adults w/ hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve, node +ve early breast cancer at high risk of recurrence. In combination w/ an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women, & men, w/ HR +ve, HER2 -ve advanced or metastatic breast cancer. In combination w/ fulvestrant for adults w/ HR +ve, HER2 -ve advanced or metastatic breast cancer w/ disease progression following endocrine therapy. As monotherapy for adults w/ HR +ve, HER2 -ve advanced or metastatic breast cancer w/ disease progression following endocrine therapy & prior chemotherapy in the metastatic setting.

In combination w/ fulvestrant, tamoxifen or an aromatase inhibitor 150 mg bid. Dose modification for AR: Initially 150 mg bid; 1st dose reduction: 100 mg bid; 2nd dose reduction: 50 mg bid. Discontinue if patient is unable to tolerate 50 mg bid. Monotherapy 200 mg bid. Dose modification for AR: Initially 200 mg bid; 1st dose reduction: 150 mg bid; 2nd dose reduction: 100 mg bid; 3rd dose reduction: 50 mg bid. Discontinue if patient is unable to tolerate 50 mg bid. Early breast cancer Take continuously for 2 yr, or until disease recurrence or unacceptable toxicity occurs. Advanced or metastatic breast cancer Continue treatment until disease progression or unacceptable toxicity. Concomitant use of strong CYP3A4 inhibitors other than ketoconazole Reduce dose to 100 mg bid in patient w/ 200 or 150 mg bid starting dose. Further reduce to 50 mg bid in patient w/ dose reduction of 100 mg daily due to AR. Concomitant use of moderate CYP3A4 inhibitors Reduce dose in 50 mg decrements. Severe hepatic impairment (Child Pugh-C) Reduce dosing frequency to once daily.

May be taken with or without food: Take at the same time each day. Swallow whole, do not chew/crush/split. Avoid grapefruit or grapefruit juice.

Start antidiarrheal therapy (eg, loperamide) at the 1st sign of loose stools & increase oral fluids. Discontinue therapy for grade 3 or 4 diarrhea, or diarrhea that requires hospitalization until toxicity resolves to ≤ grade 1, & then resume therapy at the next lower dose. Neutropenia, including febrile neutropenia & fatal neutropenic sepsis; any episodes of fever should be reported. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis; signs & symptoms of venous thrombosis & pulmonary embolism. Dose interruption/reduction is recommended for patients who develop persistent or recurrent Grade 2 ILD or pneumonitis; permanently discontinue in all patients w/ Grade 3 or 4 ILD or pneumonitis. VTE including DVT, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian & axillary vein thrombosis, & inferior vena cava thrombosis. Dose interruption for early breast cancer patients w/ any grade venous thromboembolic event & for advanced or metastatic breast cancer patients w/ grade 3 or 4 venous thromboembolic event. Monitor CBC & LFTs prior to the start of therapy, every 2 wk for the 1st 2 mth, mthly for the next 2 mth, & as clinically indicated. Severe hepatic impairment (Child-Pugh C). Severe renal impairment (CrCl <30 mL/min, C-G), ESRD, or patients on dialysis. Females of reproductive potential should use effective contraception during treatment & for 3 wk after the last dose. May impair fertility in males of reproductive potential. Pregnancy (verify pregnancy status prior to initiating treatment; may cause fetal harm). Lactating women should not breastfeed during treatment & for at least 3 wk after the last dose. Childn.

Diarrhea, neutropenia, fatigue, infections, nausea, abdominal pain, anemia, vomiting, alopecia, decreased appetite, leukopenia. ILD/pneumonitis, hepatotoxicity, VTE. Monotherapy: Thrombocytopenia. Monotherapy & in combination w/ fulvestrant: Headache.

Increased exposure & toxicity w/ strong & moderate CYP3A4 inhibitors. Increased AUC w/ ketoconazole. Avoid grapefruit products. Decreased plasma conc & reduced activity w/ strong & moderate CYP3A4 inducers.

Targeted Cancer Therapy

L01EF03 - abemaciclib ; Belongs to the class of cyclin-dependent kinase (CDK) inhibitors. Used in the treatment of cancer.

Rx