Oral Hormone receptor positive, HER2-negative locally advanced carcinoma of breast, Hormone receptor positive, HER2-negative metastatic carcinoma of breast
Adult: In combination with aromatase inhibitor as initial endocrine-based therapy: 150 mg bid. In combination with fulvestrant in patients with disease progression following endocrine therapy: 150 mg bid. As monotherapy in patients with disease progression following prior endocrine therapy and chemotherapy: 200 mg bid. Continue therapy until disease progression or unacceptable toxicity. Dose reduction, interruption, or discontinuation may be required according to individual safety or tolerability occurs. In pre- or perimenopausal women or men, endocrine therapy must be combined with a gonadotropin-releasing hormone/luteinising hormone-releasing hormone agonist according to current clinical practice standards. Treatment recommendations may vary among countries and between individual products (refer to specific or detailed product guidelines).
Oral Hormone receptor positive, HER2-negative, node-positive early carcinoma of breast
Adult: As adjuvant treatment in combination with endocrine therapy (e.g. tamoxifen or an aromatase inhibitor) in patients at high risk of recurrence: 150 mg bid. Continue therapy for 2 years, or until disease recurrence or unacceptable toxicity occurs. Dose reduction, interruption, or discontinuation may be required according to individual safety or tolerability. In pre- or perimenopausal women or men, endocrine therapy must be combined with a gonadotropin-releasing hormone/luteinising hormone-releasing hormone agonist according to current clinical practice standards. Treatment recommendations may vary among countries and between individual products (refer to specific or detailed product guidelines).
What are the brands available for Abemaciclib in Hong Kong?
Patients taking strong CYP3A4 inhibitors (other than ketoconazole): Reduce to 100 mg bid, further reduce to 50 mg bid according to individual safety and tolerability. If the strong CYP3A inhibitor is discontinued, increase the dose (after 3-5 half-lives of the CYP3A inhibitor) to the dose that was used before starting the strong inhibitor. Dosage recommendations may vary among countries and between individual products (refer to specific or detailed product guidelines).
Hepatic Impairment
Severe (Child-Pugh class C): Reduce dosing frequency to once daily.
Administration
Abemaciclib tab: May be taken with or without food. Swallow whole, do not chew/crush/split.
Special Precautions
Patients taking strong CYP3A4 inhibitors. Severe hepatic and renal impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Infections or infestations; severe diarrhoea associated with infection and dehydration; increased ALT and AST (grade 3 or higher); increased risk for serious arterial thromboembolic events (ATEs), including MI and ischaemic stroke (especially when given in combination with endocrine therapies). Blood and lymphatic system disorders: Anaemia, leucopenia, thrombocytopenia, lymphopenia. Eye disorders: Increased lacrimation. Gastrointestinal disorders: Nausea, vomiting, abdominal pain, constipation, stomatitis. General disorders and administration site conditions: Fatigue, pyrexia. Metabolism and nutrition disorders: Decreased appetite, dehydration. Musculoskeletal and connective tissue disorders: Arthralgia, muscular weakness. Nervous system disorders: Dysgeusia, headache, dizziness. Respiratory, thoracic and mediastinal disorders: Cough. Skin and subcutaneous tissue disorders: Alopecia, pruritus, rash, dry skin. Potentially Fatal: Neutropenia (including febrile neutropenia and fatal neutropenic sepsis); severe interstitial lung disease or pneumonitis; venous thromboembolic events, including pulmonary embolism, DVT, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis.
Patient Counseling Information
This drug may cause dizziness or fatigue, if affected, do not drive or operate machinery. Women of childbearing potential must use proven birth control methods during therapy and for 3 weeks after stopping the treatment. Do not breastfeed during therapy and for 3 weeks after the last dose.
Monitoring Parameters
Verify pregnancy status prior to initiation of therapy. Hepatitis B virus screening with HBsAg, hepatitis B core antibody, total Ig or IgG, and antibody to HBsAg is recommended before or at the beginning of systemic chemotherapy. Monitor CBC with differential and platelets at baseline, every 2 weeks for the 1st 2 months, monthly for the next 2 months, then as clinically indicated; ALT, AST, and serum bilirubin at baseline, every 2 weeks for the 1st 2 months, monthly for the next 2 months, then as clinically indicated. Monitor for signs and symptoms of diarrhoea, dehydration, interstitial lung disease, pneumonitis, venous thrombosis and pulmonary embolism.
Overdosage
Symptoms: Fatigue, diarrhoea.
Management: Supportive treatment.
Drug Interactions
Increased plasma concentrations with strong CYP3A4 inhibitors (e.g. clarithromycin, itraconazole, ketoconazole, lopinavir/ritonavir, posaconazole, voriconazole). Decreased plasma concentrations with the strong CYP3A4 inducer (e.g. carbamazepine, phenytoin, rifampicin).
Food Interaction
Decreased plasma concentrations with St. John's wort. Increased plasma concentrations with grapefruit.
Action
Description: Mechanism of Action: Abemaciclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK 4 and CDK 6). It blocks retinoblastoma tumour suppressor protein phosphorylation and prevents progression through the cell cycle, resulting in arrest at the G1 phase. Pharmacokinetics: Absorption: Bioavailability: 45% (following 200 mg single oral dose). Time to peak plasma concentration: 8 hours (range: 4.1-24 hours). Distribution: Volume of distribution: Approx 690.3 L. Plasma protein binding: Approx 96%. Metabolism: Metabolised in the liver primarily by CYP3A4 and forms primary metabolite N-desethylabemaciclib (M2); hydroxyabemaciclib (M20), and hydroxy-N-desethylabemaciclib (M18) active metabolites; and oxidative metabolite (M1). Excretion: Via faeces (approx 81%, as metabolites); urine (approx 3%). Elimination half-life: 18.3 hours.
Chemical Structure
Abemaciclib Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 46220502, Abemaciclib. https://pubchem.ncbi.nlm.nih.gov/compound/Abemaciclib. Accessed Feb. 27, 2026.
Storage
Store between 15-30°C. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
L01EF03 - abemaciclib ; Belongs to the class of cyclin-dependent kinase (CDK) inhibitors. Used in the treatment of cancer.
References
Abemaciclib. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/02/2026.Abemaciclib. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/02/2026.Brayfield A, Cadart C (eds). Abemaciclib. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/02/2026.Eli Lilly and Company (NZ) Limited. Verzenio 50 mg, 100 mg and 150 mg Film-coated Tablets data sheet 30 September 2025. Medsafe. http://www.medsafe.govt.nz. Accessed 06/02/2026.Joint Formulary Committee. Abemaciclib. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/02/2026.Verzenio Tablet (Eli Lilly and Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/02/2026.Verzenios 50 mg Film-coated Tablets (Eli Lilly Nederland B.V.). MHRA. https://products.mhra.gov.uk. Accessed 06/02/2026.Yulareb 50 mg, 100 mg and 150 mg Film-coated Tablet (Zuellig Pharma Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/02/2026.
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