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Yulareb

Yulareb

abemaciclib

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) +ve, human epidermal growth factor receptor 2 (HER2) -ve advanced or metastatic breast cancer; in combination w/ fulvestrant for women w/ HR +ve, HER2 -ve advanced or metastatic breast cancer w/ disease progression following endocrine therapy.
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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.
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Overdosage
View Yulareb overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Take approx at the same time each day. Swallow whole, do not chew/crush/split.
Contraindications
Hypersensitivity.
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Special Precautions
Start antidiarrheal therapy & increase fluid intake at 1st sign of loose stools. Discontinue use until toxicity resolves to ≤grade 1 then resume at next lower dose for grade 3 or 4, or diarrhea that requires hospitalization. Monitor CBC & LFTs prior to therapy, every 2 wk for 1st 2 mth, then mthly for next 2 mth; pulmonary symptoms indicative of ILD/pneumonitis; signs & symptoms of venous thrombosis & pulmonary embolism. Avoid concomitant use w/ ketoconazole, grapefruit products. Severe renal impairment (CrCl <30 mL/min), ESRD 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.
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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; increased blood creatinine, AST & ALT, decreased wt, WBC, neutrophil, lymphocyte & platelet count; anemia; cough, dyspnea; dizziness, headache, dysgeusia. ILD/pneumonitis.
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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.
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Storage
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Description
View Yulareb description for details of the chemical structure and excipients (inactive components).
Action
View Yulareb mechanism of action for pharmacodynamics and pharmacokinetics details.
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.
Patient Counseling Information
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Presentation/Packing
Form
Yulareb tab 100 mg
Packing/Price
2 × 7's
Form
Yulareb tab 150 mg
Packing/Price
2 × 7's
Form
Yulareb tab 50 mg
Packing/Price
2 × 7's
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