Allensy Capsule 125 mg (Palbociclib)

Adult dose

1. Recommended Dose and Administration Schedule The recommended dose of this drug is 125 mg once daily as a capsule, taken orally 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 on Days 1, 15, and 29, and once monthly thereafter (refer to the fulvestrant prescribing information). 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 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 capsules that are 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 guidelines. 2. Dose Modification [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 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. 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 occurs on Day 15, continue treatment with this drug at the current dose until the end of the cycle, and repeat complete blood count measurement on Day 22. • If Grade 4 occurs 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 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. [Table 3] Dose Modification and Management - Nonhematologic Toxicity Grade 1 or 2: No dose modification required Grade 3 or higher nonhematologic toxicity (persisting despite medical treatment) Withhold treatment until symptoms recover as follows: • Grade 1 or lower • Grade 2 or lower (if not considered a risk to patient safety) Resume treatment at the next lower dose level. For the coadministered endocrine therapy drug, refer to its prescribing information (dose modification guidance for toxicities, other relevant safety information, or contraindications). 3. Dose Modification When Coadministered with Strong CYP3A Inhibitors Avoid coadministration 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. 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 in Patients with Hepatic Impairment No dose modification is required for 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/1 week off (see 11. Other Information, (3) Pharmacokinetics). 5. Permanently discontinue treatment with this drug in patients with severe interstitial lung disease or pneumonitis.

This drug may cause side effects such as neutropenia, which is a decrease in blood cell count, so blood tests should be periodically monitored before and during administration. Pregnant women should be cautious as this drug may be harmful to the fetus, and effective contraception should be used during and for a certain period after receiving this medication if they are pregnant or of childbearing potential. This drug may cause serious lung diseases such as interstitial lung disease or pneumonia, so if respiratory symptoms like cough or breathing difficulties occur, the doctor should be informed immediately, and administration should be discontinued if necessary. Patients with lactose intolerance or certain genetic metabolic disorders should not take this medication. Patients with severely impaired liver function may need a dosage adjustment, while those with impaired kidney function can take it without specific dosage adjustments. This medication may increase susceptibility to infections; hence, if infection symptoms occur, consult healthcare professionals immediately for appropriate treatment. Due to the risk of venous thromboembolism, if symptoms such as leg pain or swelling or sudden shortness of breath arise, patients should visit the hospital immediately. This drug may interact with other medications, so especially when taking certain antifungals, antibiotics, anticonvulsants, grapefruit juice, etc., patients should consult their doctor or pharmacist. Nursing women should discontinue breastfeeding while taking this medication and use effective contraception. Safety has not been established for children or adolescents, and caution is also needed for the elderly. In the case of overdose, there are no specific antidotes, so symptomatic treatment should be given. Store this medication out of reach of children and in its original container to maintain its quality and safety.

Neutropenia, infection, leukopenia, fatigue, nausea, alopecia, stomatitis, diarrhea, anemia, rash, asthenia, thrombocytopenia, vomiting, decreased appetite, dry skin, fever, dysgeusia, interstitial lung disease, pneumonia, hand-foot syndrome with erythema and sensory abnormalities, skin erythematous lupus, venous thromboembolism, increased serum creatinine, abdominal pain, constipation, dyspepsia, arthralgia, insomnia, pruritus, 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 loss, peripheral neuropathy, peripheral sensory neuropathy, hyperhidrosis, increased C-reactive protein, blood calcium abnormalities, vasculitis, tinnitus

This drug can be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius. This will help maintain the drug's efficacy for a long time.

Appearance

An opaque capsule with light brown top and bottom filled with a white to yellow powder.

Package unit

21 capsules/box [(7 capsules/PTP × 3)]