This site is intended only for healthcare professionals resident in India

Search

Menu

Close

Sign InLog Out
Our medicinesTherapy areasExplore ContentExplore contentEventsMaterialsVideosLet's connectLet's ConnectPfizer medical informationOnConnect

Menu

Close

Clinical Efficacy & SafetyPALOMA-2Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)PALOMA-3Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)SafetySafety OverviewPooled ARsPooled Laboratory AbnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected Safety FeaturesPALBACE® Long-term SafetyGI and Liver ToxicitiesEffect of PALBACE®  on QTc IntervalElderly PatientsVisceral Disease PatientsDose Reduction Effect on EfficacyReal-world EvidenceWhat are RWD and RWE?PALBACE® Development and RWDHow Does RWE Differ From RCT Evidence?What Is Meant by RWD and RWE?What Is the Value of RWE?Multiple Ongoing Real-world Studies at Varied Geographic LocationsEffectivenessWhat is the Flatiron Database?What Were the Key Features of P-REALITY?What Are the Characteristics of Patients in P-REALITY?P-REALITY Real-world Progression-free SurvivalP-REALITY Overall SurvivallP-REALITY StrengthsP-REALITY SummaryP-REALITY X OverviewP-REALITY X OS and rwPFSP-REALITY X Subgroup analysis OverviewP-REALITY X:OS and rwPFS in Subgroup(Lung & Liver metastasisTolerability/QoLWhat is the MADELINE Study?What Were the Key Features of the MADELINE Study?What Are the Characteristics Of Patients In MADELINE?MADELINE Physician-reported AEsMADELINE Patient-reported OutcomesMADELINE Study LimitationsMADELINE SummaryMADELINE ASIA OverviewMADELINE ASIA Patient Reported OutcomesMADELINE ASIA SafetyMADELINE ASIA Study LimitationsDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

Monitoring

One Scheduled Monitoring Provision
Support & Resources

Summary of Prescibing Information

TabletCapsuleExplore EventsExplore MaterialsExplore Videos

GI and Liver Toxicities

Overall, 1% of patients experienced Grade 3 diarrhoea, and 2.1% and 2.9% experienced Grade ≥3 ALT and AST increases, respectively, across the PALOMA trials.1

   

Scroll left to view table
Scroll left to view table

   

*PTs are listed according to MedDRA 17.1.

Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain and Stomatitis. 

 

AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GI, gastrointestinal; MedDRA, Medical Dictionary for Regulatory Activities; N, total number of patients; PALOMA, PALbociclib: Ongoing trials in the Management of breast cAncer; PT, preferred term.​​​

   

Reference:

LPD Palbace(Palbociclib) prescribing document. Pfizer Products India Private Limited. Version 7, LPDPAB062023.

   

Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
All images used are for representation purposes only

(
®)Trademark Proprietor: Pfizer Inc.USA Licensed User: Pfizer Products India Private Limited.India

    

PP-IBR-IND-0626  September 2023

Selected safety features

Real-world Evidence

With RCT data, PALBACE® RWE can help improve the understanding of outcomes in patients with HR+/HER2- mBC

Learn more


Dosing

Recommended dosing schedule and dose modifications for AEs

Learn more


Monitoring One scheduled monitoring provision Learn more
Contact Center for Health Care Professionals | Monday to Saturday 9:00 AM to 6:00 PM IST(exlcuding public holidays)

0008000503188

PfizerPro AccountPfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Sign in or RegisterSign inRegisterAccountSign Out
These pages are not intended for patients or for members of the general public. The web pages contain promotional content. For the use only of Registered Medical Practitioners or a Hospital or a Laboratory. Full prescribing information available on request. For more details on, Who is a Registered Medical Practitioner, please visit "https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf", Page No. 39, Rule 2 part (ee), last accessed on 26th April2021.

Address: The Capital,  A Wing, 1802, 18th Floor, Plot No. C-70, ‘G’ Block, Bandra Kurla Complex, Bandra East, Mumbai – 400051, India.
PP-IBR-IND-0462

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

Heading

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

ButtonButton

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Hac habitasse platea dictumst quisque sagittis purus sit amet volutpat. Lectus magna fringilla urna porttitor rhoncus. Venenatis urna cursus eget nunc scelerisque viverra. Id donec ultrices tincidunt arcu non sodales.

Sagittis aliquam malesuada bibendum arcu vitae elementum curabitur. Pellentesque elit ullamcorper dignissim cras tincidunt. Orci ac auctor augue mauris augue neque. Dui vivamus arcu felis bibendum ut tristique et egestas quis. Sed vulputate mi sit amet mauris commodo.

Nunc eget lorem dolor sed viverra ipsum. Sed ullamcorper morbi tincidunt ornare.

Copyright © 2024 Pfizer Limited, India. All rights reserved. Applicable for Pfizer Products, Product Microsites and Therapy Areas section of the website:
  • All content published herein is intended and strictly only for informational, educational, academic and/or research purposes and shall not be utilized to diagnose or treat a health problem or disease without referring to the full prescribing information for list of approved indications as contained in the product package insert
  • While due care and caution has been taken to ensure that the content herein is free from mistakes or omissions, Pfizer makes no claims, promises or guarantees about the accuracy, completeness or adequacy of the information herein
For the use only of Registered medical practitioners* or a Hospital or a Laboratory

These pages are not intended for patients or for members of the general public. The web pages contain promotional content.

 

If you select 'No', you will be redirected to Pfizer.co.in

For more details on, Who is a Registered medical practitioner*, please visit "https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf", Page No. 39, Rule 2 part (ee), last accessed on 26th April 2021.
Address: The Capital, A Wing, 1802, 18th Floor, Plot No. C-70, 'G' Block, Bandra Kurla Complex, Bandra East, Mumbai - 400051.


PP-DOL-IND-0597  01 Mar 2024
Yes No
You are now leaving PfizerPro website

​​​​​You are now leaving Pfizer Pro website and will be redirected to another website. Note that you will be governed by the Terms & Conditions and Privacy Policy of the external website. Would you like to continue?
PP-DOL-IND-0597  01 Mar 2024