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Verzenio

Verzenio

abemaciclib

Manufacturer:

Eli Lilly

Distributor:

Zuellig
Concise Prescribing Info
Contents
Abemaciclib
Indications/Uses
In combination w/ endocrine therapy for adjuvant treatment of adult patients w/ hormone receptor (HR) +ve, human epidermal growth factor receptor 2 (HER2) -ve, node +ve early breast cancer at high risk of recurrence. Treatment of women w/ HR +ve, HER2 -ve locally advanced or metastatic breast cancer in combination w/ an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Dosage/Direction for Use
150 mg bd, in combination w/ endocrine therapy. Patient w/ severe hepatic impairment Decrease dosing frequency to once daily. Patient concomitantly taking a strong CYP3A4 inhibitor 100 mg bd. Early breast cancer Take Verzenio continuously for 2 yr, or until disease recurrence or unacceptable toxicity. Advanced or metastatic breast cancer Take continuously as long as the patient is deriving clinical benefit from therapy or until unacceptable toxicity occurs.
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
Risk of neutropenia; infections; VTE; increases in ALT & AST; diarrhoea; ILD/pneumonitis. Monitor CBC prior to treatment initiation, every 2 wk for the 1st 2 mth, mthly for the next 2 mth, & as clinically indicated. Avoid concomitant use w/ CYP3A4 inducers. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Minor influence on the ability to drive & use machines. Caution in patients w/ severe renal or hepatic impairment. Women of childbearing potential should use highly effective contraception methods (eg, double-barrier contraception) during treatment & for at least 3 wk after completing therapy. Not recommended during pregnancy & in women of child-bearing potential not using contraception. Patients receiving abemaciclib should not breastfeed. Safety & efficacy have not been established in childn & adolescents <18 yr. No data on efficacy & safety in patients w/ visceral crisis.
Adverse Reactions
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.
Drug Interactions
Increased plasma conc w/ strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, ketoconazole, lopinavir/ritonavir, posaconazole or voriconazole). Avoid grapefruit or grapefruit juice. Decreased plasma conc w/ strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampicin, St. John's wort). Interactions w/ substrates of OCT2, MATE1, MATE2-K (eg, metformin) may occur. Interactions w/ P-gp substrates w/ narrow therapeutic index (eg, digoxin or dabigatran etexilate) may occur.
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
56's
Form
Verzenio FC tab 150 mg
Packing/Price
56's
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