Yulareb

Abemaciclib

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

Monotherapy: 200 mg bid. Dose modifications for adverse reactions: 1st dose reduction: 150 mg bid; 2nd dose reduction: 100 mg bid; 3rd dose reduction: 50 mg bid. Combination therapy w/ fulvestrant, tamoxifen or aromatase inhibitor: 150 mg bid. Dose modifications for adverse reactions: 1st dose reduction: 100 mg bid; 2nd dose reduction: 50 mg bid. Early breast cancer Take continuously for 2 yr, or until disease recurrence or unacceptable toxicity. Concomitant use w/ strong CYP3A inhibitors other than ketoconazole in patient w/ recommended starting dose of 200 mg or 150 mg bid Reduce dose to 100 mg bid, patient who had dose reduction to 100 mg bid May further reduce dose to 50 mg bid. Severe hepatic impairment (Child Pugh-C) Reduce frequency to once daily.

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

Hypersensitivity.

Discontinue treatment if Grade 3 or 4 diarrhea or diarrhea requiring hospitalization; Grade 3 or 4 ILD or pneumonitis occur. Neutropenia including febrile neutropenia & fatal neutropenic sepsis; VTE including DVT, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian & axillary vein thrombosis, & inferior vena cava thrombosis. Patients who develop Grade 3 or 4 neutropenia; Grade 2 ILD or pneumonitis; persistent or recurrent Grade 2, 3 or 4 hepatic transaminase elevation; w/ early breast cancer who had history of VTE or advanced or metastatic breast cancer w/ Grade 3 or 4 VTE event. Initiate antidiarrheal therapy (eg, loperamide) & increase oral fluids at 1st sign of loose stools. Monitor CBC & LFTs prior to start of therapy, every 2 wk for 1st 2 mth & mthly for next 2 mth; for pulmonary symptoms indicative of ILD/pneumonitis; signs & symptoms of venous thrombosis & pulmonary embolism. Severe renal impairment (CrCl <30 mL/min), ESRD & patients on dialysis. Severe hepatic impairment (Child-Pugh C). Females of reproductive potential should use effective contraception during treatment & for at least 3 wk after last dose, & perform pregnancy testing prior to treatment. Pregnancy (potential risk to fetus). Not to breastfeed during treatment & for at least 3 wk after last dose. Ped.

Infections; neutropenia, leukopenia, anaemia, thrombocytopenia, lymphopenia; decreased appetite; headache, dysgeusia, dizziness; diarrhoea, vomiting, nausea, stomatitis; alopecia, pruritus, rash; pyrexia, fatigue; increased ALT & AST. Increased lacrimation; VTE; ILD/pneumonitis; dyspepsia; nail disorder, dry skin; muscular weakness.

Increased exposure w/ strong & moderate CYP3A4 inhibitors. Increased AUC w/ ketoconazole. Avoid grapefruit products. Decreased plasma conc w/ strong or moderate CYP3A inducers.

Targeted Cancer Therapy

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

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