Lanklip 75 mg (Palbociclib)

Adult dose

The recommended dose of this drug is 125 mg orally once daily for 21 consecutive days, followed by 7 days off treatment, in a complete 28-day cycle. This drug should be taken with food. When this drug 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 drug 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 drug at the same time each day. If a patient vomits after taking this drug or misses a dose, an additional dose of this drug should not be taken. The next dose should be taken at the scheduled time. This drug must be swallowed whole (do not chew or crush; do not open the capsule before swallowing). Do not take the drug if the capsule is broken, cracked, or otherwise not intact. Premenopausal and perimenopausal women receiving this drug in combination with endocrine therapy should also receive a luteinizing hormone-releasing hormone (LHRH) agonist in accordance with local clinical practice. Recommended dose modifications for adverse reactions are shown in Tables 1, 2, and 3 below. [Table 1] Recommended dose modifications for adverse reactions 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. [Table 2] Dose modification and management - Hematologic toxicitya Monitor complete blood counts before starting treatment with this drug, at the start 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 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 modification required Grade 3 Day 1 of the cycle: • Temporarily withhold this drug 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 Grade 3 occurs on Day 15, continue this drug at the current dose until the end of the cycle and repeat complete blood count measurement on Day 22. • If Grade 4 occurs 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) on Day 1 of the next cycle or if Grade 3 neutropenia recurs. Grade 3 neutropenia accompanied by fever of 38.5 °C or higherb and/or infection At any time: Temporarily withhold this drug until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grade 4 At any time: Temporarily withhold this drug until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. [Table 3] Dose modification and management - Nonhematologic toxicity Grade 1 or 2: No dose modification required Grade 3 or higher nonhematologic toxicity (if it persists despite medical treatment) Temporarily withhold treatment until symptoms recover 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. For information related to the concomitantly administered endocrine therapy drug, refer to the prescribing information for that drug (dose modification guidance for toxicity, other relevant safety information, or contraindications). Avoid concomitant use with strong CYP3A inhibitors and consider alternative concomitant medications with no or minimal CYP3A inhibitory effects. If a patient must receive concomitant treatment with a strong CYP3A inhibitor, reduce the dose of this drug to 75 mg once daily. When treatment with the strong inhibitor is discontinued, increase the dose of this drug to the dose used before starting the strong CYP3A inhibitor after 3-5 half-lives of the inhibitor. No dose modification is required for 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 drug is 75 mg once daily for 3 weeks on treatment/1 week off treatment (see 11. Other, (3) Pharmacokinetics). Permanently discontinue this drug in patients with severe interstitial lung disease or pneumonitis.

This medication can reduce the number of neutrophils among white blood cells, so blood tests should be conducted regularly to monitor neutrophil levels before and during treatment. This medication can be harmful to the fetus if administered to pregnant women, so women who are pregnant or planning to become pregnant should not use this medication and should employ effective contraception for the duration of treatment and for at least 3 weeks afterwards. Serious pulmonary conditions such as interstitial lung disease or pneumonia may occur with this medication, so if symptoms like shortness of breath, cough, or fever appear, consult a doctor immediately. Patients with lactose intolerance or specific genetic metabolic disorders should not take this medication. Patients with a history of interstitial lung disease should use this medication with caution and monitor lung function closely. This medication can increase the risk of infection, so report any signs of infection to healthcare providers immediately and consider regular infection monitoring. There may be interactions with other medications taken concurrently, so if currently taking any other medications, be sure to inform your doctor or pharmacist. Pregnant or breastfeeding women should preferably avoid using this medication, and if breastfeeding, should suspend nursing for the duration of treatment and for 3 weeks afterwards. The safety of this medication for children has not been established, so it should not be administered to pediatric patients. Elderly patients can use this medication without special dosage adjustments, but they should be monitored for side effects. There is no specific antidote for overdose, and symptomatic treatment should be provided. This medication should be kept out of the reach of children, and should be stored in its original container to maintain quality.

• Neutropenia
• infection
• leukopenia
• fatigue
• nausea
• alopecia
• stomatitis
• diarrhea
• anemia
• rash

This medication should be stored in a sealed container to protect it from air and humidity. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Bright purple round film-coated tablet

Package unit

Box - 21 tablets/PTP[((7 tablets/PTP)X3)]