Description
Abemaciclib 50mg
Each film-coated tablet contains Abemaciclib……………………50mg.
INDICATION
LuciAbe is a kinase inhibitor indicated: • In combination with endocrine ther apy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR) -positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. • In combination with an aromatase inhibitor as initial endocrinebased therapy for the treatment of adult patients with hormone receptor (HR) -positive, human epid ermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. • In combination with fulvestrant for t he treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative advanced or metastatic breast cancer with disease progression following endocrine theray. • As monotherapy for the treatment of adult patients with HRpositive, HER2 -negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
DOSAGE AND USE
LuciAbe tablets are taken orally with or without food. • Recommended starting dose i n combination with fulvestrant, tamoxifen, or an aromatase inhibitor: 150 mg twice daily. • Recommended starting dose as monotherapy: 200 mg twice daily.
• Dosing interruption and/or dose reductions may be required based on individual safety and tolerability.
SIDE EFFECT
Most common adverse reactions (incidence ≥20%) were diarrhea, neutropenia, nausea, abdominal pain , infections, fatigue, anemia, leukopenia, decreased appetite, vom iting, headache, alopecia, and thrombocytopenia.
WARNING
• Diarrhea: LuciAbe can cause severe cases of diarrhea, associated with dehydration and infection. Instruct patients at the first sign of loose stools to initiate an tidiarrheal therapy, increase oral fluids, and notify their healthcare provider. • Neutropenia: Monitor complete bloo d counts prior to the start of LuciAbe therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. • Interstitial Lung Disease (ILD)/Pneum onitis: Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for clinical symptoms or radiological changes indicative of ILD/pneumonitis. Permanently discontinue LuciAbe in all patients with Grade 3 or 4 ILD or pneumonitis. • Hepatotoxicity: Increases in serum transaminase levels have been observed. Perform liver function tests (LFTs) before initiating treatment with LuciAbe. Monitor LFTs every two we eks for the first two months, monthly for the ne xt 2 months, and as clinically indicated. • Venous Thromboembolism: Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. • Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
STORAGE
Store at 20℃to 25℃, in a dry place.
PRESENTATION
Each film-coated tablet contains Abemaciclib 50mg, 28 tablets/bottle. Keep out of reach of Children and in a dry place.
MANUFACTURED AND MARKETED BY
LUCIUS PHARMACEUTICALS(LAO) CO., LTD Thongmang village, Xaythany district, Vientiane Capital, Laos
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