Verzenio

Verzenio

abemaciclib

Manufacturer:

Eli Lilly

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma
Concise Prescribing Info
Contents
Abemaciclib
Indications/Uses
Post-menopausal women w/ hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination w/ an aromatase inhibitor as initial endocrine-based therapy; women w/ HR-positive, HER2-negative advanced or metastatic breast cancer w/ disease progression following endocrine therapy in combination w/ fulvestrant. As monotherapy in adults w/ HR-positive, HER2-negative advanced or metastatic breast cancer w/ disease progression following endocrine therapy & prior chemotherapy in the metastatic setting.
Dosage/Direction for Use
Combination therapy: 150 mg bid w/ aromatase inhibitor, or 500 mg fulvestrant given on day 1, 15, 29 & once mthly thereafter. Dose modification: 1st dose reduction: 100 mg bid; 2nd dose reduction: 50 mg bid. Monotherapy: 200 mg bid. Dose modification: 1st dose reduction: 150 mg bid; 2nd dose reduction: 100 mg bid; 3rd dose reduction: 50 mg bid. Patient w/ severe hepatic impairment (Child Pugh-C) Reduce frequency to once daily.
Administration
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.
Contraindications
Special Precautions
Start antidiarrheal therapy (eg, loperamide) at the 1st sign of loose tools & increase oral fluids. Discontinue treatment for Grade 3 or 4 diarrhea that requires hospitalization, then resume at the next lower dose when toxicity resolves to ≤Grade 1. Monitor complete blood count, liver function tests prior to start of therapy, every 2 wk for the 1st 2 mth & mthly for the next 2 mth; pulmonary symptoms indicative of interstitial lung disease (ILD)/pneumonitis; signs & symptoms of venous thrombosis & pulmonary embolism. Recommend dose interruption, reduction or delay in starting treatment in patients who develop Grade 3 or 4 neutropenia; dose interruption or reduction in persistent or recurrent Grade 2 ILD/pneumonitis; dose interruption, reduction, discontinuation, or delay in starting treatment cycles in persistent or recurrent Grade 2, 3 or 4 hepatic transaminase elevation. Permanently discontinue in patients w/ Grade 3 or 4 ILD or pneumonitis. Patients on dialysis. Severe renal impairment (CrCl <30 mL/min) & end stage renal disease. Severe hepatic impairment (Child-Pugh C). Females of reproductive potential should use effective contraception during treatment & for at least 3 wk after the last dose. Pregnancy. Lactating women should not breastfeed during treatment & for at least 3 wk after the last dose. Pregnancy testing for females of reproductive potential prior to initiating treatment. Ped patients.
Adverse Reactions
Diarrhea, nausea, abdominal pain, vomiting, constipation, stomatitis, dry mouth; infections; neutropenia, anemia, leukopenia, thrombocytopenia; fatigue, influenza-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. Avoid grapefruit products. 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.
Presentation/Packing
Form
Verzenio FC tab 100 mg
Packing/Price
2 × 7's
Form
Verzenio FC tab 150 mg
Packing/Price
2 × 7's
Form
Verzenio FC tab 200 mg
Packing/Price
2 × 7's
Form
Verzenio FC tab 50 mg
Packing/Price
2 × 7's
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