Ibrance Capsule 100 mg (Palbociclib)

Adult dose

1. Recommended Dose and Dosing Schedule The recommended dose of this drug is 125 mg once daily, administered orally for 21 consecutive days followed by 7 days off treatment, in a 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 (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 once daily 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 each 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 should be swallowed whole (do not chew or crush, and do not open the capsule before swallowing). If the capsule is damaged, such as 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 according to local clinical practice. 2. Dose Modification 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 a 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 a 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 through 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) 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 Any time: Withhold this drug until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grade 4 Any time: Withhold this drug until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grade 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 (persisting despite medical treatment) Withhold treatment until symptoms recover to: • Grade 1 or lower • Grade 2 or lower (if not considered to pose a risk to patient safety) Resume treatment at the next lower dose level. Grade according to CTCAE 4.0 CTCAE= Common Terminology Criteria for Adverse Events For information regarding drugs used in combination as endocrine therapy, refer to the prescribing information for the relevant drug (dose modification guidance for toxicities, other relevant safety information, or contraindications). 3. Dose Modification for Concomitant Use with Strong CYP3A Inhibitors 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 unavoidable, 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 starting 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 on treatment/1 week off treatment (see 11. Other, (3) Pharmacokinetics). 5. Permanently discontinue this drug in patients with severe interstitial lung disease or pneumonitis.

This drug may lower absolute neutrophil count leading to increased risk of infections. Therefore, routine blood tests must be conducted to check neutrophil counts before and during treatment. During pregnancy, this drug may be harmful to the fetus, so women who are pregnant or planning to become pregnant should not use this medication and must employ effective contraception during and for a certain period after treatment. This drug can cause serious pulmonary conditions such as interstitial lung disease or pneumonia; if symptoms such as difficulty breathing, cough, or fever occur, medical personnel must be informed immediately. Patients with lactose intolerance or certain inherited metabolic disorders should not take this medication. Patients with a history of interstitial lung disease should use this drug cautiously and their lung conditions should be closely monitored. This medication may cause various side effects, with common side effects including neutropenia, infection, fatigue, nausea, hair loss, stomatitis, diarrhea, and anemia, and in severe cases, dosage adjustment or discontinuation may be necessary. Patients with severely impaired liver function require dosage adjustments, while patients with reduced kidney function may be administered without special dosage adjustments; however, data for patients on dialysis is insufficient. This drug is metabolized by certain enzymes in the liver, so interactions with other medications may occur, and patients should consult medical personnel regarding other medications they are taking. Pregnant and nursing mothers may face risks to the fetus and newborn when taking this medication, so breastfeeding should be discontinued during the treatment period and for a certain period afterward. The safety and effectiveness of this drug in pediatric patients have not been established, and it can generally be used safely in elderly patients; however, caution is required. In the event of overdose, there are no specific antidotes, and general treatment should be performed according to symptoms. The drug should be kept out of the reach of children.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained between 1 and 30 degrees Celsius. This will help preserve the drug's effectiveness and ensure safe usage.

Appearance

A caramel-colored capsule containing a white to yellow powder; upper part is caramel color, lower part is bright orange.

Package unit

Blister: 21 capsules, Bottle: 21 capsules