Ibrance 125 mg (Palbociclib) Tablets

Adult dose

The recommended dose of this medicine is one 125 mg tablet once daily by mouth for 21 consecutive days, followed by 7 days off treatment, in a 28-day cycle. This medicine may be taken with or without food. When this medicine is administered with an aromatase inhibitor, administer the recommended dose of the aromatase inhibitor (see the prescribing information for the aromatase inhibitor being administered). When this medicine is administered with fulvestrant, the recommended dose of fulvestrant is 500 mg on Days 1, 15, and 29, and then once monthly thereafter (see the prescribing information for fulvestrant). Patients should be encouraged to take this medicine at the same time each day. If the patient vomits after taking this medicine or misses a dose, an additional dose should not be taken. The next dose should be taken at the scheduled time. The 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 this medicine, 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 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 a cycle: · Withhold this medicine 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 the condition is Grade 3 on Day 15, continue this medicine at the current dose until the end of the cycle and repeat the complete blood count on Day 22. · If the condition is 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 accompanied by fever of 38.5 °C or higherb and/or infection At any time: Withhold this medicine until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grade 4 At any time: Withhold this medicine 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 Nonhematologic toxicity of Grade 3 or higher (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. Avoid concomitant use with strong CYP3A inhibitors and consider alternative concomitant medications with no or minimal CYP3A inhibitory effects. If the patient must receive a strong CYP3A inhibitor concomitantly, reduce this medicine to 75 mg once daily. If the strong inhibitor is discontinued, increase this medicine to the dose used before initiation of the strong CYP3A inhibitor after 3-5 half-lives of the inhibitor. 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 medicine is 75 mg once daily for 3 weeks on treatment/1 week off treatment (see 11. Other, (3) Pharmacokinetics). Permanently discontinue this medicine in patients with severe interstitial lung disease or pneumonitis.

This drug may decrease the number of important white blood cells in the blood, known as neutropenia, so regular blood tests should be conducted before administration and during treatment to monitor white blood cell counts. This drug can harm the fetus if used during pregnancy, therefore, women who are pregnant or of childbearing potential must implement effective contraception during and for some time after taking this medication. This drug can cause serious lung diseases such as interstitial lung disease or pneumonia, so if symptoms like difficulty breathing, cough, or fever occur, it is crucial to inform medical personnel immediately and discontinue administration if necessary. Patients with a history of interstitial lung disease or current lung disease should be particularly cautious when using this drug and require strict medical supervision to prevent worsening of their condition. This drug can lower the levels of immune cells in the blood, increasing the risk of infections, so if infection symptoms appear, it is essential to visit a medical institution promptly for appropriate treatment. During the use of this medication, if there are issues with liver or kidney function, special dosage adjustments may be necessary, so consulting with medical personnel is advised. This drug can interact with certain enzymes (CYP3A) to alter the effects of other medications, thus it is important to inform your physician or pharmacist of any other medications being taken. This drug is not recommended for nursing women, and it is safest to discontinue breastfeeding while taking it. It can also be used in elderly patients; however, although specific side effect risks do not significantly differ from other age groups, careful observation is required. In case of overdose, there is no specific antidote, so general emergency treatment should be followed as directed by medical personnel. This drug should be kept out of reach of children and it is important to store it securely in its original container.

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

This drug must be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. This will help maintain the efficacy and safety of the drug longer.

Appearance

Bright purple oval film-coated tablets

Package unit

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