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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
3. English name: Palbociclib
< h2>II. IndicationsThis product, in combination with letrozole, is suitable for the treatment of estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in postmenopausal women as the initial endocrine therapy for metastatic disease.
125 mg capsule: opaque hard gelatin capsule.
1. Active ingredient: Palbociclib.
2. Excipients: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate and hard gelatin capsule shell. The capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide; the printing ink contains shellac, titanium dioxide, ammonium hydroxide, propylene glycol and simethicone.
1. Recommended starting dose: 125 mg, once a day, with food.
2. Dosing schedule: 21 days of continuous use, followed by 7 days of discontinuation, forming a complete 28-day treatment cycle. This product needs to be used in conjunction with letrozole (2.5 mg once daily for a 28-day cycle).
3. How to take: Swallow the capsule whole. Do not chew, crush or open the capsule. Do not take if capsule is broken, cracked or incomplete.
1. Dose adjustment is based on individual safety and tolerability.
2. Recommended dose levels: starting dose 125 mg/day; first dose reduced to 100 mg/day; second dose reduced to 75 mg/day. If it is necessary to drop below 75 mg/day, treatment should be discontinued.
3. Hematological toxicity adjustment: Based on indicators such as neutrophil count, it may be necessary to suspend administration, delay the start of the next cycle, and/or reduce the dose.
4. Adjustment of non-hematological toxicity: For persistent grade 3 or above non-hematological toxicity, the administration needs to be suspended until symptoms are relieved, and then treatment is resumed at a reduced dose.
5. Combination with strong CYP3A inhibitors: Combination use should be avoided. If combined use is necessary, the dose of this product should be reduced to 75 mg once a day; after stopping the strong inhibitor, the dose can be restored to the original dose.
1. Medication time: Take it with meals at about the same time every day to increase absorption and reduce blood concentration fluctuations.
2. Missed dose or vomiting: If the patient vomits or misses a dose, he should not take it again on the same day. The next prescribed dose should be taken at your regular time.
1. Pregnant women: Based on animal research and mechanism of action, this product can cause fetal harm and is contraindicated in pregnant women. Women of childbearing potential should use effective contraceptive measures during treatment and for at least two weeks after the last dose.
2. Lactating women: It is recommended that lactating women stop breastfeeding during treatment.
3. Men of childbearing age: Based on animal findings, treatment may damage male fertility.
4. Children: Safety and effectiveness have not been determined.
5. Elderly people: No overall difference with young patients was observed, but higher sensitivity of some elderly individuals cannot be ruled out.
6. Hepatic/renal insufficiency: Patients with mild liver damage or mild to moderate renal impairment do not need to adjust the dose. Data are lacking in patients with moderate or severe hepatic impairment and severe renal impairment.
1. The most common adverse reactions (incidence ≥10%) include: neutropenia, leukopenia, fatigue, anemia, upper respiratory tract infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, weakness, peripheral neuropathy, and epistaxis.
2. Serious adverse reactions that require vigilance: neutropenia (need to be closely monitored for blood routine), infection, and pulmonary embolism.
There are no obvious contraindications, but patients should be careful not to be allergic to drug ingredients.
1. Strong CYP3A inhibitors: Avoid simultaneous use. If it cannot be avoided, the dose of this product needs to be reduced.
2. Strong and moderate CYP3A inducers: Avoid simultaneous use.
3. Sensitive CYP3A4 substrates with narrow therapeutic windows: the dosage of these drugs may need to be reduced when combined with this product.
4. Grapefruit products: They may increase the blood concentration of this product and should be avoided during treatment.
Storage at 20℃ to 25℃ (68℉ to 77℉); short-distance transportation allowed between 15℃ to 30℃ (59℉ to 86℉).