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AboutAboutIBRANCE experienceMechanism of actionDosing & MonitoringDosing & MonitoringDosing and administrationMonitoringRecommended dose modifications for IBRANCEWhat you need to know about IBRANCE tabletsEfficacyEfficacyIBRANCE + aromatase inhibitorPrimary endpointSecondary endpointsUpdated analysesSubgroup analysesIBRANCE + fulvestrantPrimary endpointSecondary endpointsUpdated analysesSubgroup analysesSafety DataSafety DataIBRANCE + aromatase inhibitorAdverse reactionsDiscontinuations and dose reductionsNeutropenia and lab abnormalitiesWarnings and PrecautionsIBRANCE + fulvestrantAdverse reactionsDiscontinuations and dose reductionsNeutropenia and lab abnormalitiesWarnings and PrecautionsReal-World Evidence​​​​​​​Real-World EvidenceIntroductionRandomized controlled trialReal-world study designReal-world study patient characteristicsReal-world effectiveness dataLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkSupport & OrderSupport &
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Prescribing Information for CapsulesPrescribing Information for Tablets Indications Patient Site
Safety DataIBRANCE + fulvestrantAdverse reactions (≥10%) reported in PALOMA-3

Unless otherwise stated, PALOMA-3 data are based on the March 2015 data cut (final prespecified analysis).1

N/A=not applicable.Grading according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.Infections include all reported preferred terms (PTs) that are part of the System Organ Class Infections and infestations.Most common infections (≥1%) include: nasopharyngitis, upper respiratory tract infection, urinary tract infection, bronchitis, rhinitis, influenza, conjunctivitis, sinusitis, pneumonia, cystitis, oral herpes, respiratory tract infection, gastroenteritis, tooth infection, pharyngitis, eye infection, herpes simplex, and paronychia.Stomatitis includes: aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal discomfort, oropharyngeal pain, and stomatitis.Grade 1 events – 17%; Grade 2 events – 1%.Grade 1 events – 6%.Rash includes the following PTs: rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis, dermatitis acneiform, and toxic skin eruption.

Selected adverse events (AEs) reported in a final OS analysis (with a median follow-up of 44.8 months) of PALOMA-32

With additional follow-up, no new safety signals were observed for patients treated with IBRANCE + fulvestrant.#

  • The most common selected adverse events (≥10%, all causality)** of any grade for IBRANCE + fulvestrant vs placebo + fulvestrant were neutropenia (84% vs 4%), leukopenia (60% vs 5%), infections (55% vs 35%), fatigue (44% vs 31%), nausea (36% vs 31%), anemia (32% vs 14%), stomatitis (30% vs 14%), diarrhea (27% vs 20%), thrombocytopenia (26% vs 0%), vomiting (22% vs 16%), alopecia (19% vs 6%), rash (18% vs 6%), decreased appetite (17% vs 11%), pyrexia (14% vs 6%), and aspartate aminotransferase increased (12% vs 8%)

In an updated non-prespecified OS analysis (with a median follow-up of 73.3 months), no new safety signals were observed.3††

Based on an April 2018 data cut, with a median follow-up of 44.8 months.2Incidences of AEs reported in this updated analysis are all causality, and the AEs were selected based on their designation as Adverse Reactions (ARs, treatment-related) in PALOMA-3 in the IBRANCE Prescribing Information.2Based on August 2020 data cut (updated non-prespecified analysis), with a median follow-up of 73.3 months.3References:Data on file. Pfizer Inc., New York, NY.Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med. 2018;379(20):1926-1936.Cristofanilli M, Rugo HS, Im S-A, et al. Overall survival with palbociclib and fulvestrant in women with HR+/HER2– ABC: updated exploratory analyses of PALOMA-3, a double-blind, phase 3 randomized study. Clin Cancer Res. 2021;clincanres.0305.2022. Published online ahead of print May 12, 2022. doi:10.1158/1078-0432.CCR-22-0305IBRANCE + fulvestrantTake a look at the discontinuation rates and dose reductions from this trial View now LoadingWarnings and Precautions with IBRANCE See the detailsLoading Efficacy data for IBRANCE + fulvestrant Review the data

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Indications IBRANCE® (palbociclib) 125 mg capsules and tablets are indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (mBC) in combination with:
 
  • an aromatase inhibitor as initial endocrine-based therapy, or
  • fulvestrant in patients with disease progression following endocrine therapy
Important Safety Information Neutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever.

Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of first 2 cycles and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
 

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.
 

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g., hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis.
 

Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients to consider sperm preservation before taking IBRANCE. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants. 
 

The most common adverse reactions (≥10%) of any grade reported in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).
 

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).
 

Lab abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase (43% vs 30%). 

 

The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).
 

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%). 
 

Lab abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%). 
 

Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.
 

For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. 

Please see full Prescribing Information for IBRANCE capsules and tablets.

IndicationsIBRANCE® (palbociclib) 125 mg capsules and tablets are indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (mBC) in combination with:
  • an aromatase inhibitor as initial endocrine-based therapy, or
  • fulvestrant in patients with disease progression following endocrine therapy