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On August 6, 2018, China's National Medical Products Administration (NMPA) approved the marketing of Pfizer's palbociclib in China. This is the first CDK4/6 inhibitor approved for marketing in China. It will be included in the national medical insurance directory in October 2021.
1. Generic name: Palbociclib
2. Trade name: IBRANCE®
U200c is used in combination with letrozole to treat estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women as initial endocrine therapy for metastatic disease.
1. 125mg capsule : Opaque hard capsule.
2. 100mg capsule : Opaque hard capsule.
Active ingredient: Palbociclib (chemical name: 6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one).
1. Standard dose : 125mg once a day, taken for 21 consecutive days, followed by 7 days of discontinuation, forming a 28-day cycle. Need to be taken with food.
2. Combined use of : Letrozole 2.5 mg needs to be taken simultaneously once a day.
1. Hematological toxicity : When grade 3 neutropenia (accompanied by fever/infection) or grade 4 neutropenia occurs, suspend administration until recovery to grade ≤ 2, and then reduce the subsequent dose to 100 mg or 75 mg.
2. Non-hematological toxicity : For grade 3 and above toxicity, administration should be suspended and the dose should be reduced after recovery.
3. Combined use of strong CYP3A inhibitor : The dose needs to be reduced to 75 mg once a day.
1. Medication time : Take with food. Swallow the capsule whole. Do not chew or open the capsule.
2. Missed dose/vomiting : There is no need to take a supplementary dose on the same day, just take the next dose as originally planned.
3. Dietary taboos : Avoid grapefruit and its products.
1. Pregnancy/breastfeeding : It may cause fetal injury. Contraception is required during treatment and within 2 weeks of stopping the drug; it is contraindicated during breastfeeding.
2. Hepatic/renal insufficiency : No adjustment is required for mild to moderate liver dysfunction, and tablets are prohibited for severe liver damage.
3. Elderly : No special adjustment is required, but individualized monitoring is required.
1. Common reactions (≥10%): Neutropenia (75%), leukopenia, fatigue, anemia, upper respiratory tract infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia.
2. Severe reactions :Pulmonary embolism (5%), infection (5%), QT interval prolongation.
There are no absolute contraindications, but it is prohibited for those allergic to pleuromutilins.
1. Strong CYP3A inhibitor (such as ketoconazole): Avoid combined use, and reduce the dose to 75 mg if necessary.
2. Strong CYP3A inducer (such as rifampicin): Avoid combined use, which may reduce the efficacy of the drug.
3. Sensitive CYP3A substrate (such as midazolam): The dose needs to be reduced.
Save at room temperature 20°C-25°C, avoid moisture and direct sunlight.