Ibrance Tablets 75 mg (Palbociclib)

Adult dose

1. Recommended dose and administration schedule The recommended dose of this drug is one 125 mg tablet taken orally once daily for 21 consecutive days, followed by 7 days off treatment, in a complete 28-day cycle. This drug may be taken with or without 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 Day 1, Day 15, and Day 29, and then 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 the 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 split the tablet before swallowing). If a tablet is broken, cracked, or otherwise not intact, 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 adjustment The recommended dose adjustments for adverse reactions are shown in Tables 1, 2, and 3 below. [Table 1] Recommended dose adjustments for adverse reactions Dose level / Dose Recommended starting dose / 125 mg/day 1st dose reduction / 100 mg/day 2nd dose reduction / 75 mg/day* * Discontinue treatment if further dose reduction below 75 mg/day is required. [Table 2] Dose adjustment 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. In 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. CTCAE Grade / Dose adjustment Grade 1 or 2 / No dose adjustment 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 on Day 15, continue this drug at the current dose through the end of the cycle and repeat the complete blood count on Day 22. · If Grade 4 on Day 22, refer to the Grade 4 dose adjustment 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 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. Grading 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/mm3, Grade 2: ANC 1000-<1500/mm3, Grade 3:ANC 500-<1000/mm3, Grade 4: ANC<500/mm3 [Table 3] Dose adjustment and management - Nonhematologic toxicity CTCAE Grade / Dose adjustment Grade 1 or 2 / No dose adjustment required Grade 3 or higher nonhematologic toxicity (persisting 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. Grading according to CTCAE 4.0 CTCAE= Common Terminology Criteria for Adverse Events For information related to the drug used in combination as endocrine therapy, refer to that drug's prescribing information (dose adjustment guidance in the event of toxicity, other relevant safety information, or contraindications). 3. Dose adjustment 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 the 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 adjustment in patients with hepatic impairment 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 drug is 75 mg once daily for 3 weeks on treatment/1 week off treatment (refer to 11. Other, (3) Pharmacokinetics). 5. Permanently discontinue this drug in patients with severe interstitial lung disease or pneumonitis.

This medication may cause neutropenia, leading to a reduction in the number of neutrophils, a type of white blood cell, so regular blood tests should be conducted before and during treatment to monitor neutrophil counts. This medication may be harmful to the fetus if administered to pregnant women, so fertile women should employ effective contraception during the treatment period and for at least 3 weeks after cessation. This medication carries a risk of serious pulmonary conditions such as interstitial lung disease or pneumonia; therefore, patients should immediately inform healthcare professionals if they experience respiratory symptoms like shortness of breath, cough, or fever. Patients with a history of interstitial lung disease should be particularly cautious when using this medication, as there is a possibility of exacerbation of lung conditions, requiring close observation by healthcare professionals. Using this medication may increase susceptibility to infections; hence, any signs of infection should prompt immediate consultation with healthcare providers for appropriate treatment. Dose adjustments are necessary for patients with severely impaired liver function, and caution is advised for those with reduced kidney function. This medication can interact with other drugs, particularly those that inhibit or induce CYP3A enzymes, and grapefruit or grapefruit juice should be avoided. During treatment, the potential for side effects such as interstitial lung disease, infections, hematological abnormalities, and liver dysfunction must be continuously monitored, along with any symptoms that may arise. Breastfeeding women are advised to discontinue breastfeeding during and for a certain period after using this medication. The safety and efficacy of this medication have not been established for pediatric patients, while elderly patients can use it without special dose adjustments but should be monitored for adverse effects.

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

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1°C and 30°C. This will help preserve the efficacy of the medication and prevent degradation.

Appearance

Light purple round film-coated tablets

Package unit

21 tablets/box [(7 tablets/blister X 3)]