Big Bear BESIDX Abemaciclib 150mg

Product Information

• Product name: BESIDX Abemaciclib 150mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Abemaciclib
• Current strength: 150mg
• SKU: BB-ITEM-31
• Site category: breast cancer, other cancer

Product Summary

BESIDX Abemaciclib 150mg is an AISTIKA-listed product supplied by Laos BigBear 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

Abemaciclib is the active ingredient used for this product page. Public prescribing information for Abemaciclib 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

Abemaciclib is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). These kinases are activated upon binding to D-cyclins.

Reference Indications

Abemaciclib ® is a kinase inhibitor indicated: in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. ( 1.1 , 14.1 ) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

Reference Dosage and Administration

Recommended Dose and Schedule When used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor, the recommended dose of Abemaciclib is 150 mg taken orally twice daily. taken orally with or without food.

With this 150mg product, that corresponds to 1 x 150mg 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

Diarrhea: Abemaciclib can cause severe cases of diarrhea, associated with dehydration and infection. Instruct patients at the first sign of loose stools to initiate antidiarrheal therapy, increase oral fluids, and notify their healthcare provider. ( 2.2 , 5.1 ) Neutropenia: Monitor complete blood counts prior to the start of Abemaciclib therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. ( 2.2 , 5.2 ) Interstitial Lung Disease (ILD)/Pneumonitis: Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for clinical symptoms or radiological changes indicative of ILD/pneumonitis. Permanently discontinue Abemaciclib in all patients with Grade 3 or 4 ILD or pneumonitis. ( 2.2 , 5.3 ) Hepatotoxicity: Increases in serum transaminase levels have been observed.

Common Adverse Reactions and Monitoring

Interstitial Lung Disease (ILD) or Pneumonitis . The safety population includes exposure to Abemaciclib as a single agent at 200 mg twice daily in 132 patients in MONARCH 1 and to Abemaciclib at 150 mg twice daily in 3559 patients administered in combination with fulvestrant, tamoxifen, or an aromatase inhibitor in monarchE, MONARCH 2, and MONARCH 3. The median duration of exposure ranged from 4.5 months in MONARCH 1 to 24 months in monarchE.

Drug Interactions and Special Populations

CYP3A Inhibitors: Avoid concomitant use of ketoconazole. Reduce the Abemaciclib dose with concomitant use of other strong and moderate CYP3A inhibitors. ( 2.2 , 7.1 ) CYP3A Inducers: Avoid concomitant use of strong and moderate CYP3A inducers. Ketoconazole Avoid concomitant use of ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold . Other Strong CYP3A Inhibitors In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Abemaciclib dose to 100 mg twice daily with concomitant use of strong CYP3A inhibitors other than ketoconazole. If a patient taking Abemaciclib discontinues a strong CYP3A inhibitor, increase the Abemaciclib dose (after 3-5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor.

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: Verzenio 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.