Lanslip Tablet 125 mg (Palbociclib)

Adult dose

The recommended dose of this medicine is 125 mg orally once daily for 21 consecutive days, followed by 7 days off treatment, in a complete 28-day cycle. This medicine may be taken with or without food. When this medicine is administered with an aromatase inhibitor, administer the recommended dose of the aromatase inhibitor (refer to the prescribing information for the aromatase inhibitor to be administered). When this medicine is administered with fulvestrant, the recommended dose of fulvestrant is 500 mg on day 1, day 15, and day 29, and then once monthly (refer to the prescribing information for fulvestrant). Patients should be encouraged to take this medicine at the same time every day. If a patient vomits after taking this medicine or misses a dose, an additional dose of this medicine should not be taken. The next dose should be taken at the scheduled time. This medicine should be swallowed whole (do not chew or crush it, and do not split the tablet before swallowing). Do not take the tablet if it is broken, cracked, or otherwise not intact. Premenopausal and perimenopausal women receiving this medicine in combination with endocrine therapy should also receive a luteinizing hormone-releasing hormone (LHRH) agonist in accordance with local clinical practice guidelines. The recommended dose modifications for adverse reactions are shown in Tables 1, 2, and 3 below. Dose level Recommended starting dose: 125 mg/day First dose reduction: 100 mg/day Second dose reduction: 75 mg/day* * Discontinue treatment if a further dose reduction below 75 mg/day is required. Monitor complete blood counts before starting this medicine, at the beginning of each treatment cycle, on day 15 of each of the first two cycles, and as clinically indicated. In patients who experience a maximum of Grade 1 or Grade 2 neutropenia during the first 6 cycles, monitor complete blood counts before the start of a treatment cycle and every 3 months thereafter, as clinically indicated. Grade 1 or 2: No dose adjustment required Grade 3 Day 1 of the cycle: · Temporarily withhold this medicine and repeat complete blood count monitoring after 1 week. · If recovery to Grade 2 or lower occurs, start the next cycle at the same dose. Day 15 of each of the first two cycles: · If the patient has Grade 3 neutropenia on day 15, continue this medicine at the current dose through the end of the cycle and repeat complete blood count measurement on day 22. · If the patient has Grade 4 neutropenia on day 22, refer to the dose modification for Grade 4 below. Consider dose reduction if recovery from Grade 3 neutropenia is delayed (>1 week) by day 1 of the next cycle or if Grade 3 neutropenia recurs. Grade 3 neutropenia with fever of 38.5 °C or higherb and/or infection At any time: Temporarily withhold this medicine until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grade 4 At any time: Temporarily withhold this medicine until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grade 1 or 2: No dose adjustment required Grade 3 or higher nonhematologic toxicity (if persistent despite medical treatment) Temporarily withhold treatment until the symptoms resolve to: · Grade 1 or lower · Grade 2 or lower (if not considered a risk to patient safety) Resume treatment at the next lower dose level. Avoid concomitant use with strong CYP3A inhibitors and consider alternative concomitant medications with no or minimal CYP3A inhibitory effects. If concomitant administration with a strong CYP3A inhibitor is necessary, reduce the dose of this medicine to 75 mg once daily. If the strong inhibitor is discontinued, increase the dose of this medicine to the dose used before starting the strong CYP3A inhibitor after 3-5 half-lives of the inhibitor. No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh A and B). For patients with severe hepatic impairment (Child-Pugh C), the recommended dose of this medicine is 75 mg once daily, administered for 3 weeks followed by 1 week off treatment (refer to 11. Other, (3) Pharmacokinetics). Permanently discontinue this medicine in patients with severe interstitial lung disease or pneumonitis.

This medication can reduce the number of neutrophils in the blood, weakening the immune system; therefore, it is essential to check the neutrophil count through blood tests before and during treatment. During pregnancy, this medication may be harmful to the fetus, so women of childbearing potential should use effective contraception during and for at least 3 weeks after treatment. This medication can cause inflammation in the lungs or serious respiratory issues such as interstitial lung disease; if symptoms like shortness of breath or coughing occur, medical consultation should be sought immediately. Patients with a history of interstitial lung disease or at risk for lung disease should be particularly cautious when using this medication. While taking this medication, there may be an increased risk of infection, so if symptoms of infection such as fever appear, medical personnel should be notified immediately. Patients with severely impaired liver or kidney function may need dosage adjustments; consultations with healthcare professionals are required. There may be interactions when taken with other medications; caution is especially needed when used in conjunction with certain antifungals, antibiotics, or drugs affecting liver metabolism. It is considered safe for women who are pregnant or breastfeeding to discontinue breastfeeding while taking this medication. This medication has not been proven to be safe or effective for children, so it should not be used in pediatric patients. Elderly patients may use this medication without special dosage adjustments, though medical judgment may be necessary based on their condition. In case of overdose, there is no specific antidote; standard treatment and supportive care should be utilized.

Neutropenia, infection, leukopenia, fatigue, nausea, alopecia, stomatitis, diarrhea, anemia, rash, asthenia, thrombocytopenia, vomiting, decreased appetite, dry skin, fever, taste disturbance, increase in alanine aminotransferase, increase in aspartate aminotransferase, epistaxis, increased tearing, dry eyes, blurred vision, febrile neutropenia, interstitial lung disease, pneumonia, hand-foot syndrome of erythematous sensory changes, cutaneous lupus erythematosus, venous thromboembolism, pulmonary embolism, embolism, deep vein thrombosis, peripheral embolism, thrombosis, increased serum creatinine, various gastrointestinal disorders, abdominal pain, constipation, dyspepsia, arthralgia, insomnia, pruritus, lung inflammation, cough, pulmonary embolism, febrile neutropenia, neutropenia, pancytopenia, asthenia, nausea, abdominal pain, gastroesophageal reflux disease, gastric ulcer, gingival swelling, hepatitis, decreased appetite, myalgia, lower back pain, flank pain, plantar fasciitis, headache, dizziness, sensory impairment, peripheral neuropathy, peripheral sensory neuropathy, hyperhidrosis, increased C-reactive protein, blood calcium abnormalities, vasculitis, tinnitus

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it should be kept in a location that is not too hot or too cold, ideally at room temperatures between 1°C and 30°C.

Appearance

Bright purple oval film-coated tablet

Package unit

Box - 21 tablets/box [(7 tablets/PTP) x 3]