Lucius LuciPalbo Palbociclib 125mg

Product Information

• Product name: LuciPalbo Palbociclib 125mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Palbociclib
• Current strength: 125mg
• SKU: LU-ITEM-85
• Site category: CDK4/6 target, other cancer

Product Summary

LuciPalbo Palbociclib 125mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Palbociclib is the active ingredient used for this product page. Public prescribing information for Palbociclib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Palbociclib is an inhibitor of cyclin-dependent kinases (CDK) 4 and 6. Cyclin D1 and CDK4/6 are downstream of signaling pathways which lead to cellular proliferation. Treatment of breast cancer cell lines with the combination of palbociclib and antiestrogens leads to decreased retinoblastoma (Rb) protein phosphorylation resulting in reduced E2F expression and signaling, and increased growth arrest compared to treatment with each drug alone.

Reference Indications

Palbociclib is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant in patients with disease progression following endocrine therapy. Palbociclib is indicated in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

Reference Dosage and Administration

Recommended Dose and Schedule The recommended dose of Palbociclib is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. taken orally with food in combination with an aromatase inhibitor, fulvestrant, or inavolisib and fulvestrant.

With this 125mg product, that corresponds to 1 x 125mg tablet when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Neutropenia: Monitor complete blood count prior to start of Palbociclib therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. ( 2.2 , 5.1 ) Interstitial Lung Disease (ILD)/Pneumonitis: Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for pulmonary symptoms of ILD/pneumonitis. Interrupt Palbociclib immediately in patients with suspected ILD/pneumonitis. Permanently discontinue Palbociclib if severe ILD/pneumonitis occurs. Embryo-Fetal Toxicity: Palbociclib can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) 5.1 Neutropenia Neutropenia was the most frequently reported adverse reaction in PALOMA-2 with an incidence of 80% and PALOMA-3 with an incidence of 83%.

Common Adverse Reactions and Monitoring

Experience PALOMA-2: Palbociclib plus Letrozole Patients with estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine-based therapy The safety of Palbociclib (125 mg/day) plus letrozole (2.5 mg/day) versus placebo plus letrozole was evaluated in PALOMA-2. The data described below reflect exposure to Palbociclib in 444 out of 666 patients with ER-positive, HER2-negative advanced breast cancer who received at least 1 dose of Palbociclib plus letrozole in PALOMA-2. The median duration of treatment for Palbociclib plus letrozole was 19.8 months while the median duration of treatment for placebo plus letrozole arm was 13.8 months.

Drug Interactions and Special Populations

Palbociclib is primarily metabolized by CYP3A and sulfotransferase (SULT) enzyme SULT2A1. CYP3A Inhibitors: Avoid concurrent use of Palbociclib with strong CYP3A inhibitors. If the strong inhibitor cannot be avoided, reduce the Palbociclib dose. ( 2.2 , 7.1 ) CYP3A Inducers: Avoid concurrent use of Palbociclib with strong CYP3A inducers. CYP3A Substrates: The dose of sensitive CYP3A4 substrates with narrow therapeutic indices may need to be reduced when given concurrently with Palbociclib. Avoid concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole). Avoid grapefruit or grapefruit juice during Palbociclib treatment.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Ibrance public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.