Alensi Capsule 75 mg (Palbociclib)

Adult dose

1. Recommended Dose and Administration Schedule The recommended dose of this drug is one 125 mg capsule taken orally once daily for 21 consecutive days, followed by 7 days off treatment, in a complete 28-day cycle. This drug must be taken with food. When this drug 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 drug is administered with fulvestrant, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, and 29, and once monthly thereafter (refer to the prescribing information for fulvestrant). Patients should be encouraged to take this drug at the same time every day. If a patient vomits after taking this drug or misses a dose, an additional dose of this drug should not be administered. 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). If the capsule is damaged, such as being broken or cracked, it should not be taken. 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 guidelines. 2. Dose Modifications The recommended dose modifications for adverse reactions are shown in Tables 1, 2, and 3 below. [Table 1] Recommended Dose Modifications for Adverse Reactions Dose level Dose 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 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 indicated. CTCAE Grade Dose Modification Grade 1 or 2 No dose modification required Grade 3 Day 1 of the cycle: • 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 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 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 with fever of 38.5 °C or higherb and/or infection At any time: Withhold this drug until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grade 4 At any time: Withhold this drug until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grades are assigned according to CTCAE 4.0 CTCAE= Common Terminology Criteria for Adverse Events, LLN= lower limit of normal. a The table above applies to all hematologic adverse reactions except lymphopenia (unless associated with clinical events such as opportunistic infections). b ANC= absolute neutrophil count: Grade 1: ANC <LLN - 1500/mm 3, Grade 2: ANC 1000-<1500/mm 3, Grade 3:ANC 500-<1000/mm 3, Grade 4: ANC<500/mm 3 [Table 3] Dose Modification and Management - Nonhematologic Toxicity CTCAE Grade Dose Modification Grade 1 or 2 No dose modification required Grade 3 or higher nonhematologic toxicity (if persistent despite medical treatment) 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. Grades according to CTCAE 4.0 CTCAE= Common Terminology Criteria for Adverse Events For the coadministered endocrine therapy drug, refer to its prescribing information (dose modification guidance for toxicity, other relevant safety information, or contraindications). 3. Dose Modification When Coadministered with Strong CYP3A Inhibitors Avoid concomitant use with strong CYP3A inhibitors and consider alternative concomitant medications with no or minimal CYP3A inhibitory effects. If a patient must be coadministered a strong CYP3A inhibitor, reduce the dose of this drug to 75 mg once daily. When the strong inhibitor is discontinued, increase the dose of this drug to the dose used before initiation of the strong CYP3A inhibitor after 3-5 half-lives of the inhibitor. 4. Dose Modification for Patients with Hepatic Impairment No dose modification 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 drug is 75 mg once daily, with 3 weeks of treatment followed by 1 week off treatment (refer to 11. Other Information, (3) Pharmacokinetics). 5. Permanently discontinue this drug in patients with severe interstitial lung disease or pneumonitis.

This medication may reduce the number of neutrophils in the blood, making patients more susceptible to infections. Therefore, regular blood tests should be conducted during the course of treatment, and any signs of fever or infection should be reported to medical personnel immediately. During pregnancy, it may harm the fetus; therefore, pregnant women or those who may become pregnant should not take this medication and must use effective contraception during treatment. Serious lung diseases such as interstitial lung disease or pneumonia may occur; thus, immediate medical attention should be sought if symptoms such as difficulty breathing, cough, or fever arise. Patients with genetic lactose intolerance should not take this medication, and caution is required for patients allergic to Yellow 5. Patients with liver or kidney dysfunction should consult healthcare professionals before taking this medication, and those with a history of interstitial lung disease should take extra care. This medication may interact with various other drugs; thus, patients taking other medications should inform their physician or pharmacist. Women who are breastfeeding should discontinue breastfeeding while taking this medication, and in cases of overdose, general treatment according to symptoms should be administered, as there are no specific antidotes available. Lastly, this medication should be stored out of the reach of children and kept in its original container.

Neutropenia, infection, leukopenia, fatigue, nausea, alopecia, stomatitis, diarrhea, anemia, rash, asthenia, thrombocytopenia, vomiting, appetite loss, dry skin, fever, taste disorders, interstitial lung disease, pneumonia, hand-foot syndrome with erythema and sensory abnormalities, lupus erythematosus, venous thromboembolism, increased serum creatinine, pulmonary inflammation, cough, pulmonary embolism, febrile neutropenia, pancytopenia, pneumonia, asthenia, nausea, abdominal pain, gastroesophageal reflux disease, gastric ulcer, gingival swelling, hepatitis, decreased appetite, myalgia, 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 should be stored in a tightly sealed container to prevent exposure to air and moisture, at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's efficacy for a longer period.

Appearance

An opaque capsule with bright orange upper and lower parts filled with a whitish to yellowish powder.

Package unit

21 capsules/box [7 capsules/PTP×3]