Ibrance Capsule 75 mg (Palbociclib)

Adult dose

1. Recommended dose and administration schedule 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 (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 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 capsule if it 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. 2. Dose modification 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 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 2 neutropenia during the first 6 cycles, monitor complete blood counts before the beginning 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 the condition recovers to Grade 2 or lower, 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) 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: 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 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 Nonhematologic toxicity of Grade 3 or higher (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. Grades according to CTCAE 4.0 CTCAE= Common Terminology Criteria for Adverse Events For the concomitant endocrine therapy drug, refer to its prescribing information (dose modification guidance for toxicity, 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 a patient must receive this drug concomitantly with a strong CYP3A inhibitor, reduce the dose of this drug to 75 mg once daily. If 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 for 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 have side effects such as neutropenia, so regular blood tests to check neutrophil counts should be performed before starting treatment and during treatment. Additionally, it may be harmful to the fetus in pregnant women, thus women of childbearing potential must take effective contraception during and for at least 3 weeks after taking this drug. Severe pulmonary side effects such as interstitial lung disease or pneumonia may occur, therefore if symptoms such as shortness of breath, cough, or fever develop, medical facilities must be visited immediately. Patients with lactose intolerance or specific genetic metabolic issues should not take this drug. Patients with severely impaired liver function will require dose adjustments, and caution is warranted in patients with reduced kidney function. Because this drug may cause vulnerability to infections, immediate consultation with a doctor is required if any signs of infection occur. This drug may interact with other medications, so it is essential to inform the doctor or pharmacist if other medications are being taken. Particularly, caution is needed when used in combination with drugs that affect the CYP3A enzyme, and grapefruit or grapefruit juice should be avoided. Pregnant or nursing women should not use this drug, and it is recommended to discontinue breast feeding during taking and for 3 weeks after the medication. Due to insufficient safety and efficacy evidence in children and the elderly, special caution is necessary. In case of overdose, there is no specific antidote; general treatment according to symptoms should be administered. Finally, this drug should be kept out of reach of children, stored in its original container, and the container should not be changed arbitrarily.

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

This drug may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature. This helps maintain the drug's effectiveness for a longer period.

Appearance

An opaque capsule with a light orange upper and lower part containing a whitish to yellowish powder.

Package unit

Blister: 21 capsules, Bottle: 21 capsules