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Verzenio
abemaciclib
Adult Dosing .
Dosage forms: TAB: 50 mg, 100 mg, 150 mg, 200 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
hormone receptor-positive HER2-negative breast CA, early
- [adjuvant tx, combo with tamoxifen or aromatase inhibitor]
- Dose: 150 mg PO bid x2y; Info: for patients with node-positive early disease at high risk of recurrence; give with LHRH agonist in pre/perimenopausal patients or male patients if used in combo with aromatase inhibitor; do not cut/crush/chew tab
hormone receptor-positive HER2-negative breast CA, advanced or metastatic
- [first-line tx, combo with aromatase inhibitor]
- Dose: 150 mg PO bid; Info: give with LHRH agonist in pre/perimenopausal patients or male patients; do not cut/crush/chew tab
- [progressive disease, combo with fulvestrant]
- Dose: 150 mg PO bid; Info: give with LHRH agonist in pre/perimenopausal patients or male patients; do not cut/crush/chew tab
- [progressive disease, monotherapy]
- Dose: 200 mg PO bid; Info: do not cut/crush/chew tab
ER-positive HER2-negative, ESR1-mutated breast CA, advanced or metastatic
- [progressive disease, combo with imlunestrant]
- Dose: 150 mg PO bid; Info: give with LHRH agonist in pre/perimenopausal patients or male patients; do not cut/crush/chew tab
- [first-line tx, combo with camizestrant (off-label)]
- Dose: 150 mg PO bid; Info: for patients with emerging ESR1 mutation before radiographic disease progression; give with LHRH agonist in pre/perimenopausal patients or male patients; do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [adjust dose frequency]
- Child-Pugh Class C: give usual dose qd
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and for at least 3wk after D/C
- caution: patients of childbearing potential
- caution: hepatic impairment, Child-Pugh Class C
- caution: thromboembolism history
Drug Interactions .
Overview
abemaciclib
kinase inhibitor
- CYP3A4 substrate
- MATE1 inhibitor
- MATE2-K inhibitor
- OCT2 inhibitor
- immunomodulatory effects
- myelosuppressive oncologic agent
- thrombogenic effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- diarrhea, severe
- neutropenia
- febrile neutropenia
- sepsis
- pneumonia
- interstitial lung disease
- pneumonitis, non-infectious
- hepatotoxicity
- acute kidney injury
- renal failure
- venous thromboembolism
- cerebral infarction
- MI
- cardiac arrest
- cardiac failure
- ventricular fibrillation
- arrhythmia
- cerebral hemorrhage
Common Reactions
- diarrhea
- infection
- neutropenia
- fatigue
- nausea
- vomiting
- headache
- musculoskeletal pain
- appetite decr.
- alopecia
- stomatitis
- dizziness
- rash
- peripheral edema
- fever
- pruritus
- abdominal pain
- dysgeusia
- dyspepsia
- hepatotoxicity
- nail disorder
- lacrimation incr.
- cough
- pneumonitis
- interstitial lung disease
- weight decr.
- hot flashes
- insomnia
- arrhythmia
- back pain
- venous thromboembolism
- constipation
- Cr incr.
- anemia
- lymphocytes decr.
- platelets decr.
- ALT or AST incr.
- hypokalemia
- triglycerides incr.
- cholesterol incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; CBC with diff, LFTs at baseline, then q2wk x2mo, then qmo x2mo and as clinically indicated; BUN, cystatin C, calculated GFR during tx; signs/symptoms of interstitial lung disease, thromboembolism
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of teratogenicity and decr. fetal wt based on animal data at 1x or greater systemic exposure and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x3wk after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and for at least 3wk after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for abemaciclib: liver primarily; CYP450: 3A4 substrate; Info: active metabolites
Excretion: for abemaciclib: feces 81%, urine 3%; Half-life: 18.3h
Subclass: Kinase Inhibitors, CDK Inhibitors
Mechanism of Action
for abemaciclib: inhibits cyclin-dependent kinase (CDK) 4 and 6, leading to decr. malignant cellular proliferation
Formulary .
No Formulary Selected
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