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Abemaciclib is mainly used for patients with hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer. It can be combined with endocrine therapy or used as a single drug to significantly reduce the risk of disease recurrence or delay disease progression.
1. Generic name: Abemaciclib
2. Trade name: VERZENIO™
< h2>2. Indications1. Combined with fulvestrant for the treatment of female patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced or metastatic breast cancer whose disease has progressed after previous endocrine therapy.
2. As monotherapy for adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer who have previously received endocrine therapy and chemotherapy in the metastatic setting.
Abeciclib tablet specifications: 50mg
1. Each tablet contains 50mg of abeciclib.
2. Excipients include: microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, and silicon dioxide.
3. Coating ingredients include: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.
1. Combined treatment with fulvestrant: The recommended starting dose is 150 mg, taken orally twice a day.
2. Monotherapy: The recommended starting dose is 200mg, taken orally twice a day.
3. The medication time is not affected by food. It is recommended to take the medication at a fixed time every day.
4. If you miss a dose or vomit, you should not take the next dose as scheduled.
5. The tablet should be swallowed whole and should not be chewed, crushed or broken.
Dose adjustment or suspension of medication is required according to the severity of adverse reactions:
1. Hematological toxicity (such as neutropenia): suspension or reduction according to CTCAE classification.
2. Diarrhea: Anti-diarrhea treatment should be started and drinking water should be increased as soon as loose stools appear for the first time. In severe cases, the dosage should be suspended or reduced.
3. Hepatotoxicity: Monitor liver function. If sustained or severe elevation of transaminases occurs, dosage adjustment is required.
4. Other toxicities (such as fatigue, nausea, etc.): Adjust the dose according to the severity.
5. The dosage should be reduced when used in combination with strong CYP3A inhibitors and avoid combined use with strong CYP3A inducers.
6. Patients with severe hepatic insufficiency (Child-Pugh C grade) should reduce the frequency of medication to once a day.
1. Medication time: Take it at a fixed time every day, with food or on an empty stomach.
2. Treatment of missed doses: Do not take the next dose as planned.
3. Treatment of vomiting: If you vomit after taking the medicine, you should not take a supplementary dose and continue taking the medicine as originally planned.
4. Swallowing requirements: Swallow the whole tablet without damaging the tablet structure.
5. It is necessary to avoid combination with strong CYP3A inhibitors such as ketoconazole and avoid eating grapefruit products.
6. Blood routine, liver function and thrombosis symptoms need to be monitored regularly during treatment.
1. Pregnant women: It has embryo-fetal toxicity and needs to take effective contraceptive measures.
2. Breastfeeding women: Breastfeeding is prohibited during treatment and for at least 3 weeks after the last dose.
3. Elderly people: No dose adjustment is required.
4. Hepatic insufficiency: No adjustment is needed for mild to moderate symptoms, and medication needs to be taken at a reduced frequency for severe symptoms.
5. Renal insufficiency: No adjustment is needed for mild to moderate, and insufficient data for severe.
6. Children: Safety and effectiveness have not been established.
1. Common adverse reactions (incidence ≥20%) include: Diarrhea, neutropenia, nausea, abdominal pain, infection, fatigue, anemia, leukopenia, decreased appetite, vomiting Vomiting, headache, thrombocytopenia;
2. Serious adverse reactions include:Severe diarrhea may lead to dehydration or infection, neutropenia may lead to infection or even death, hepatotoxicity, venous thromboembolism, and embryo-fetal toxicity.
No clear contraindications.
1. Avoid combination with strong CYP3A inhibitors (such as ketoconazole), and reduce the dosage if necessary.
2. Avoid combined use with strong CYP3A inducers (such as rifampicin).
3. Pay attention to possible interactions when used in combination with loperamide, metformin and other drugs.
4. Avoid using grapefruit products at the same time.
1. Store at 20°C to 25°C (68°F to 77°F). Short-term storage is allowed at 15°C to 30°C (59°F to 86°F).
2. Keep the medicine intact and avoid moisture, high temperature and light.