Eli Lilly


Zuellig Pharma


Zuellig Pharma
Concise Prescribing Info
Monotherapy in adults w/ hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative 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 w/ HR-positive, HER2-negative advanced or metastatic breast cancer; w/ fulvestrant for women w/ HR-positive, HER2-negative advanced or metastatic breast cancer w/ disease progression following endocrine therapy.
Dosage/Direction for Use
Monotherapy 200 mg bid. Combination therapy 150 mg bid w/ aromatase inhibitor, or 500 mg fulvestrant given on Days 1, 15, 29 & once mthly thereafter. Dose modifications for adverse reactions Reduce dose to 50 mg bid from current dosing. Concomitant use w/ strong CYP3A inhibitors other than ketoconazole Initially 200 mg or 150 mg bid, then reduce dose to 100 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.
Special Precautions
Discontinue if Grade 3 or 4 diarrhea or diarrhea requiring hospitalization; Grade 3 or 4 ILD or pneumonitis occur. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis; signs & symptoms of venous thrombosis & pulmonary embolism. Patients who develop Grade 3 or 4 neutropenia; persistent or recurrent Grade 2, 3 or 4 hepatic transaminase elevation. VTE eg, DVT, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian & axillary vein thrombosis, & inferior vena cava thrombosis. Initiate antidiarrheal therapy (eg, loperamide) & increase oral fluids at the 1st sign of loose stools. Monitor CBC, liver function tests prior to start of therapy, every 2 wk for 1st 2 mth & mthly for next 2 mth. 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. Not to breastfeed during treatment & for at least 3 wk after last dose. Ped patients.
Adverse Reactions
Diarrhea, neutropenia, fatigue, infections, nausea, abdominal pain, anemia, vomiting, alopecia, decreased appetite, leukopenia. ILD/pneumonitis. VTE. Monotherapy: Thrombocytopenia. Monotherapy & in combination w/ fulvestrant: Headache.
Drug Interactions
Increased exposure w/ strong & moderate CYP3A4 inhibitors. Increased AUC w/ ketoconazole. Avoid grapefruit products. Concomitant use w/ moderate CYP3A inhibitors. Decreased plasma conc w/ strong or moderate CYP3A inducers.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EF03 - abemaciclib ; Belongs to the class of cyclin-dependent kinase (CDK) inhibitors. Used in the treatment of cancer.
Yulareb film-coated tab 100 mg
2 × 7's
Yulareb film-coated tab 150 mg
2 × 7's
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