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HR+/HER2- mBCPIK3CA-mutated HR+/HER2- LA/mBCHR+/HER2+ LA/mBC< Back to homepageAboutDosing & MonitoringDosing & MonitoringDosing and administration for IBRANCEMonitoringRecommended dose modificationsIBRANCE tablets and capsulesResourcesResourcesPerspectives for your patientsCoverage and accessMaterials
Prescribing Information for CapsulesPrescribing Information for Tablets Indications Patient Site
9+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-5 9+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-5 9+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-59+ years of patient experience, grounded in clinical trial data and supplemented by real-world evidence1-5
                                                                                         New indication                                                                                     IBRANCE has been approved with inavolisib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR+/HER2- advanced breast cancer.

New indication 

IBRANCE has been approved with inavolisib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR+/HER2- advanced breast cancer.

Across HR+ mBC combination regimensMake IBRANCE® (palbociclib) your CDK4/6 inhibitor of choiceMake IBRANCE® (palbociclib) your CDK4/6 inhibitor of choice
Learn more about how the indications for IBRANCE have evolved over 10+ years
 See full timelineLoadingIBRANCE, for your adult patients with:

In combination with AI or in combination with fulvestrant after ET1,2

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In combination with inavolisib and fulvestrant following recurrence on or after completing adjuvant endocrine therapy1,2

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As maintenance in combination with trastuzumab +/- pertuzumab and ET following induction treatment1,2

 View siteLoadingTitleFirst-in-class IBRANCE is approved in combinations for HR+/HER2- mBC, HR+/HER2+ LA/mBC maintenance, and PIK3CA-mutated HR+/HER2- LA/mBC.1,2 IBRANCE brochure

An overview of FDA-approved indications, including key milestones.

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Eligible, commercially insured patients may pay as little as $0 per month for their Pfizer Oncology treatment. Limits, terms, and conditions apply.* Patients may receive up to $10,600 per product in savings annually.

Learn moreLoadingReferencesAI=aromatase inhibitor; CDK4/6=cyclin-dependent kinases 4 and 6; ER+=estrogen receptor-positive; ET=endocrine therapy; FDA=Food and Drug Administration; HER2-=human epidermal growth factor receptor 2-negative; HER2+=human epidermal growth factor receptor 2-positive; HR+=hormone receptor-positive; LA=locally advanced; mBC=metastatic breast cancer; PIK3CA=phosphatidylinositol-3-kinase catalytic subunit alpha.Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico. References:IBRANCE capsules [prescribing information]. New York, NY. Pfizer Inc.; February 2015; February 2016; April 2025; June 2026. IBRANCE tablets [prescribing information]. New York, NY. Pfizer Inc.; June 2026.

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INDICATIONS HER2-Negative Metastatic Breast Cancer

IBRANCE® (palbociclib) 125 mg capsules and tablets are 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.
  • 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-authorized test, following recurrence on or after completing adjuvant endocrine therapy.
HER2-Positive Metastatic Breast Cancer

IBRANCE® (palbociclib) 125 mg capsules and tablets are indicated in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
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. In PATINA, neutropenia was the most frequently reported adverse reaction with an incidence of 78%, and Grade ≥3 neutropenia was reported in 61% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Based on laboratory findings, 93% had a decrease in neutrophil counts including 47% with Grade 3 and 3.1% with Grade 4. 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. Febrile neutropenia has been reported in 0.8% of patients exposed to IBRANCE in the PATINA study. 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% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. In PATINA, 1% of IBRANCE-treated patients had ILD/pneumonitis of any grade and no Grade 3, 4, or 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%), increased blood creatinine (96% vs 91%), decreased neutrophils (95% vs 20%), decreased hemoglobin (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%), increased blood creatinine (95% vs 82%), decreased hemoglobin (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%). Serious adverse reactions occurred in 24% of patients in INAVO120 who received IBRANCE plus inavolisib and fulvestrant. Serious adverse reactions occurring in ≥1% of patients receiving IBRANCE plus inavolisib and fulvestrant included anemia (1.9%), diarrhea (1.2%), and urinary tract infection (1.2%). Fatal adverse reactions occurred in 3.7% of patients in INAVO120 who received IBRANCE plus inavolisib and fulvestrant, including (0.6% each) acute coronary syndrome, cerebral hemorrhage, cerebrovascular accident, COVID-19 infection, and gastrointestinal hemorrhage. The most (≥20%) common adverse reactions occurring in INAVO120, including laboratory abnormalities, for IBRANCE plus inavolisib and fulvestrant vs IBRANCE plus placebo and fulvestrant were decreased neutrophils (95% vs 97%), decreased hemoglobin (88% vs 85%), increased fasting glucose (85% vs 43%), decreased platelets (84% vs 71%), decreased lymphocytes (72% vs 68%), stomatitis (51% vs 27%), diarrhea (48% vs 16%), decreased calcium (42% vs 32%), fatigue (38% vs 25%), decreased potassium (38% vs 21%), increased creatinine (38% vs 30%), increased alanine aminotransferase (34% vs 29%), alkaline phosphatase increased (31% vs 23%), nausea (28% vs 17%), decreased sodium (28% vs 19%), decreased magnesium (27% vs 21%), rash (26% vs 19%), decreased appetite (24% vs 9%), COVID-19 infection (23% vs 10%), and headache (22% vs 14%). Serious adverse reactions occurred in 25% of patients in PATINA who received IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Serious adverse reactions in ≥1% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy included infections (8%), headache and pyrexia (1.5% each), and femur fracture (1.2%). Fatal adverse reactions occurred in 1.2% of patients in PATINA who received IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy including (0.4% each) death, hepatic hemorrhage, and sepsis. The most common adverse reactions (≥20%) occurring in PATINA, including laboratory abnormalities, for IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy vs trastuzumab, with or without pertuzumab, and endocrine therapy were white blood cell decreased (94% vs 25%), neutrophil count decreased (93% vs 19%), creatinine increased (92% vs 87%), hemoglobin decreased (81% vs 47%), diarrhea (70% vs 37%), infections (64% vs 43%), platelet count decreased (59% vs 6%), stomatitis (44% vs 11%), aspartate aminotransferase increased (39% vs 25%), decreased calcium (39% vs 30%), alanine aminotransferase increased (38% vs 28%), decreased potassium (33% vs 17%), fatigue (32% vs 21%), alkaline phosphatase increased (31% vs 23%), nausea (30% vs 15%), asthenia (27% vs 21%), headache (26% vs 18%), rash (22% vs 17%), pruritus (21% vs 17%), and muscle spasms (20% vs 11%). Other Clinical Trials Experience: venous thromboembolism has been reported as an adverse reaction following administration of IBRANCE. 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. INDICATIONSHER2-Negative Metastatic Breast CancerIBRANCE® (palbociclib) 125 mg capsules and tablets are 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.
  • 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-authorized test, following recurrence on or after completing adjuvant endocrine therapy.
HER2-Positive Metastatic Breast CancerIBRANCE® (palbociclib) 125 mg capsules and tablets are indicated in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.