Alensicap 100 mg (Palbociclib)

Adult dose

The recommended dose of this medication is 125 mg orally once daily for 21 consecutive days, followed by 7 days off treatment, in a 28-day cycle. This medication should be taken with food. When this medication 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 medication is administered with fulvestrant, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, and 29, and once monthly thereafter (see the prescribing information for fulvestrant). Patients should be encouraged to take this medication at the same time each day. If a patient vomits after taking this medication or misses a dose, an additional dose should not be taken. The next dose should be taken at the scheduled time. This medication must be swallowed whole (do not chew or crush; do not open the capsule before swallowing). Do not take the medication if the capsule is broken, cracked, or otherwise not intact. Premenopausal and perimenopausal women receiving this medication in combination with endocrine therapy should also receive a luteinizing hormone-releasing hormone (LHRH) agonist in accordance with local clinical practice guidelines. Dose levels 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. Monitor complete blood counts before starting treatment with this medication, 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 no more than 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 adjustment required Grade 3 Day 1 of a cycle: • Temporarily interrupt treatment with this medication 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 the patient has Grade 3 neutropenia on Day 15, continue this medication at the current dose through the end of the cycle and repeat the complete blood count on Day 22. • If Grade 4 neutropenia is present 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: Temporarily interrupt treatment with this medication until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grade 4 At any time: Temporarily interrupt treatment with this medication until recovery to Grade 2 or lower. Resume treatment at the next lower dose level. Grade 1 or 2: No dose adjustment required Grade 3 or higher nonhematologic toxicity (if it persists despite medical treatment) Temporarily interrupt 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 concomitant use with a strong CYP3A inhibitor is unavoidable, reduce the dose of this medication to 75 mg once daily. If the strong inhibitor is discontinued, increase the dose of this medication to the dose used before starting the strong CYP3A inhibitor after 3-5 half-lives of the inhibitor. No dose adjustment is necessary 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 medication is 75 mg once daily, with 3 weeks on treatment/1 week off treatment (see 11. Other information, (3) Pharmacokinetics). Permanently discontinue this medication in patients with severe interstitial lung disease or pneumonitis.

This medication may reduce the number of neutrophils in the blood, which can increase the risk of infection. Therefore, regular blood tests should be conducted before and during treatment with this medication. Particularly, closer monitoring is necessary during the first few weeks. Women who are pregnant or may become pregnant should not take this medication and should ensure effective contraception during and for some time after treatment. Serious lung conditions such as interstitial lung disease or pneumonia may occur, so if symptoms such as difficulty breathing, cough, or fever appear, medical personnel should be notified immediately. Patients with lactose intolerance or specific genetic metabolic disorders should not take this medication. Patients with impaired liver or kidney function should be cautious when using this medication; however, patients with mild to moderate liver impairment may use it without dose adjustment. This medication can interact with other drugs, so if other medications are being taken, it is essential to inform medical personnel. Special caution is required when taken with specific antifungal agents, antibiotics, or antiviral drugs. This medication may cause side effects such as hair loss, nausea, diarrhea, fatigue, fever, and skin rash. If abnormal symptoms are severe, consultation with medical personnel is advised. Nursing women are recommended to discontinue breastfeeding for a certain period during and after taking this medication as it may affect the baby through breast milk. Safety for children or elderly patients has not been sufficiently confirmed, so consultation with a specialist is necessary before use of this medication. In case of overdose, since there is no specific antidote, seek appropriate treatment immediately at a medical institution. This medication should be stored out of reach of children and kept in its original container to maintain its quality.

Neutropenia, infection, leukopenia, fatigue, nausea, alopecia, stomatitis, diarrhea, anemia, rash, asthenia, thrombocytopenia, vomiting, decreased appetite, dry skin, fever, taste disturbance, interstitial lung disease, pneumonia, hand-foot syndrome with erythematous sensory abnormalities, erythematous lupus, venous thromboembolism, febrile neutropenia, pulmonary inflammation, cough, pulmonary embolism, febrile neutropenia, nausea, abdominal pain, gastroesophageal reflux disease, gastric ulcer, gingival swelling, hepatitis, myalgia, back pain, flank pain, plantar fasciitis, headache, dizziness, sensory impairment, peripheral neuropathy, peripheral sensory neuropathy, hyperhidrosis, increased C-reactive protein, abnormal blood calcium, vasculitis, tinnitus

This medication should be stored in a closed container to protect it from air and moisture, and it is safe to store at a temperature between 1°C and 30°C. Therefore, to maintain the medication's efficacy, it is important to avoid direct sunlight and not store it in excessively hot or cold places.

Appearance

Opaque capsule filled with a whitish to yellowish powder, light brown upper part and bright orange lower part

Package unit

21 capsules/box [7 capsules/PTP×3]