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Yulareb

Yulareb

Manufacturer:

Eli Lilly

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Abemaciclib
Indications/Uses
In combination w/ aromatase inhibitor as initial endocrine-based therapy for postmenopausal women w/ hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer; in combination w/ fulvestrant for women w/ HR-positive, HER2-negative advanced or metastatic breast cancer w/ disease progression following endocrine therapy.
Dosage/Direction for Use
150 mg bd w/ aromatase inhibitor or fulvestrant 500 mg on days 1, 15, 29 & once mthly thereafter. Severe hepatic impairment (Child-Pugh C) Reduce frequency to once daily.
Administration
May be taken with or without food: Take approx at the same time each day. Swallow whole, do not chew/crush/split.
Contraindications
Special Precautions
Start antidiarrheal therapy & increase fluid intake at 1st sign of loose stools. Suspend until toxicity resolves to ≤grade 1 then resume at next lower dose for persistent or recurrent grade 2 diarrhea/grade 3 or 4, or diarrhea that requires hospitalization. Monitor complete blood counts & liver function tests prior to therapy, every 2 wk for 1st 2 mth, then mthly for next 2 mth; pulmonary symptoms indicative of interstitial lung disease (ILD)/pneumonitis; signs & symptoms of venous thrombosis & pulmonary embolism. Avoid concomitant use w/ ketoconazole, grapefruit products. Severe renal impairment (CrCl <30 mL/min), end-stage renal disease or patients on dialysis; severe hepatic impairment (Child-Pugh C). May impair male fertility. Women of childbearing potential should use effective contraception during & at least 3 wk after last dose. Pregnancy. Not to be used during lactation. Ped patients.
Adverse Reactions
Diarrhea, nausea, abdominal pain, vomiting, constipation, stomatitis; infections; neutropenia, anemia, leukopenia, thrombocytopenia; fatigue, flu-like illness; peripheral edema, pyrexia; alopecia, rash, pruritus; decreased appetite, dehydration; increased blood creatinine, AST & ALT, decreased wt, WBC, neutrophil, lymphocyte & platelet count; anemia; cough, dyspnea; dizziness, headache, dysgeusia. ILD/pneumonitis.
Drug Interactions
Increased exposure w/ strong & moderate CYP3A4 inhibitors. Increased AUC w/ ketoconazole. Decreased plasma conc w/ strong or moderate CYP3A inducers. Avoid grapefruit products.
ATC Classification
L01EF03 - abemaciclib ; Belongs to the class of cyclin-dependent kinase (CDK) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Yulareb tab 50 mg
Packing/Price
2 × 7's
Form
Yulareb tab 150 mg
Packing/Price
2 × 7's
Form
Yulareb tab 100 mg
Packing/Price
2 × 7's
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