Lanceclip 100 mg (Palbociclib)

Adult dose

The recommended dose of this medicine is one 125 mg tablet 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 (see 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 once daily on Days 1, 15, and 29, and once monthly thereafter (see the prescribing information for fulvestrant). Patients should be encouraged to take this medicine at the same time each day. If a patient vomits after taking this medicine or misses a dose, an additional dose 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; do not split the tablet before swallowing). Do not take the tablet if it is damaged, such as being broken or cracked. 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. Recommended starting dose: 125 mg/day First dose reduction: 100 mg/day Second dose reduction: 75 mg/day* * Discontinue treatment if further dose reduction below 75 mg/day is required. Monitor complete blood counts before starting treatment with this medicine, at the beginning of each treatment cycle, on Day 15 of each of the first two cycles, and as clinically indicated. For 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 necessary. Grade 1 or 2: No dose adjustment required Grade 3, Day 1 of a 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. Grade 3, Day 15 of either of the first two cycles: If Grade 3 on Day 15, continue this medicine at the current dose until the end of the cycle and repeat complete blood count measurement on Day 22. If Grade 4 on Day 22, refer to the Grade 4 dose adjustment below. Consider reducing the dose if recovery from Grade 3 neutropenia is delayed (>1 week) on Day 1 of the next cycle or if Grade 3 neutropenia recurs. Grade 3 neutropenia accompanied by fever of 38.5 °C or higher and/or infection, any duration: Temporarily withhold this medicine until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grade 4, any duration: Temporarily withhold this medicine until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grade 3 or higher nonhematologic toxicity (if persistent despite medical treatment): Temporarily withhold treatment until symptoms recover to the following: 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 medicines with no or minimal CYP3A inhibitory effects. If concomitant administration with a strong CYP3A inhibitor is unavoidable, reduce this medicine to 75 mg once daily. If the strong inhibitor is discontinued, increase 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 in patients with mild or moderate hepatic impairment (Child-Pugh A and B). In patients with severe hepatic impairment (Child-Pugh C), the recommended dose of this medicine is 75 mg once daily, with 3 weeks on treatment/1 week off treatment (see 11. Other, (3) Pharmacokinetics). Permanently discontinue this medicine in patients with severe interstitial lung disease or pneumonitis.

This medication may cause a side effect known as neutropenia, which is a reduction in a specific type of white blood cell in the blood; therefore, regular blood tests to monitor white blood cell counts should be performed before and during treatment. If a pregnant woman takes this medication, it may be harmful to the fetus, so women who are pregnant or may become pregnant should not use this medication and must utilize effective contraception for at least 3 weeks during and after treatment. This drug can potentially cause severe lung diseases such as interstitial lung disease or pneumonia, so if symptoms such as difficulty in breathing, cough, or fever occur, it is important to inform healthcare personnel immediately, and in severe cases, discontinuation of the drug should be considered. Patients with a history of interstitial lung disease or at high risk for lung disease should use this drug cautiously and periodically monitor their lung function. During treatment with this drug, the risk of infection may increase, so any symptoms of infection should be reported to medical professionals immediately for appropriate treatment. Patients with severely impaired liver function should have their drug dosage adjusted, while those with renal function impairment may not generally need dose adjustments; however, data in dialysis patients is insufficient. This medication can interact with several drugs, so caution is needed when used with medications metabolized by the liver, as the blood concentrations of this drug or the concurrent drug may change, necessitating dose adjustments. Both pregnant and breastfeeding women should discontinue breastfeeding while taking this medication, and male patients should use contraception during and for a certain period after treatment. Safety and efficacy have not been established in pediatric patients, so use in this population is not recommended. Elderly patients can be treated without special dose adjustments, but it is advisable to consult with healthcare professionals considering other health conditions. In cases of overdose, as there is no specific antidote, general supportive measures should be taken; keep the medication out of reach of children and store it in its original container.

Neutropenia, infection, leukopenia, fatigue, nausea, alopecia, stomatitis, diarrhea, anemia, rash, asthenia, thrombocytopenia, vomiting, decreased appetite, dry skin, fever, dysgeusia, interstitial lung disease, pneumonia, hand-foot syndrome with red palms and soles, erythematous lupus, venous thromboembolism, pulmonary embolism, embolism, deep vein thrombosis, peripheral embolism, thrombosis, increased serum creatinine, upper abdominal pain, constipation, dyspepsia, arthralgia, insomnia, pruritus, lung inflammation, cough, pulmonary embolism, febrile neutropenia, pancytopenia, asthenia, nausea, abdominal pain, gastroesophageal reflux disease, gastric ulcer, gingival swelling, hepatitis, decreased appetite, myalgia, back pain, flank pain, plantar fasciitis, headache, dizziness, sensory loss, peripheral neuropathy, peripheral sensory neuropathy, diaphoresis, increased C-reactive protein, blood calcium abnormalities, vasculitis, tinnitus

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain room temperature between 1 degree and 30 degrees.

Appearance

Green oval film-coated tablet

Package unit

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