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Palbociclib: Drug information

Palbociclib: Drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Palbociclib: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Ibrance
Brand Names: Canada
  • Ibrance;
  • PMS-Palbociclib;
  • TARO-Palbociclib
Pharmacologic Category
  • Antineoplastic Agent, Cyclin-Dependent Kinase Inhibitor
Dosing: Adult

Dosage guidance:

Clinical considerations: Refer to aromatase inhibitor or fulvestrant monographs for respective dosing in combination with palbociclib.

Breast cancer, advanced or metastatic, hormone receptor positive, HER2 negative

Breast cancer, advanced or metastatic, hormone receptor positive, HER2 negative:

Initial endocrine-based therapy: Oral: Tablets or capsules: 125 mg once daily for 21 days, followed by 7 days off, repeat every 28 days (in combination with continuous aromatase inhibitor therapy); continue until disease progression or unacceptable toxicity (Ref). Pre/perimenopausal patients should also receive a luteinizing hormone-releasing hormone (LHRH) agonist. For males receiving palbociclib in combination with an aromatase inhibitor, also consider treatment with an LHRH agonist.

Disease progression following endocrine therapy: Oral: Tablets or capsules: 125 mg once daily for 21 days, followed by 7 days off, repeat every 28 days (in combination with fulvestrant [and an LHRH agonist or a gonadotropin-releasing hormone agonist if pre/perimenopausal]); continue until disease progression or unacceptable toxicity (Ref).

Breast cancer, locally advanced or metastatic, hormone receptor positive, HER2 negative, PIK3CA mutated

Breast cancer, locally advanced or metastatic, hormone receptor positive, HER2 negative, PIK3CA mutated (off-label combination): Oral: 125 mg once daily for 21 days, followed by 7 days off; repeat every 28 days (in combination with inavolisib and fulvestrant [and an LHRH agonist for the duration of treatment in males and pre-/perimenopausal patients]); continue until disease progression or unacceptable toxicity (Ref).

Missed/vomited doses: If a dose is vomited or missed, an additional dose should not be administered that day. Resume dosing with the next scheduled daily dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult Drug Interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Kenar D. Jhaveri, MD; Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: No dosage adjustment necessary for any degree of kidney dysfunction (Ref).

Hemodialysis, intermittent (thrice weekly): Unlikely to be significantly dialyzed (large Vd): No supplemental dose or dosage adjustment necessary (Ref).

Peritoneal dialysis: Unlikely to be significantly dialyzed (large Vd): No dosage adjustment necessary (Ref).

CRRT: No dosage adjustment necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).

Dosing: Liver Impairment: Adult

Mild or moderate impairment (Child-Pugh classes A and B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): Reduce dose to 75 mg once daily for 21 days, followed by 7 days off; repeat every 28 days.

Dosing: Adjustment for Toxicity: Adult

Note: Endocrine therapy (eg, aromatase inhibitor or fulvestrant) may also require dosage modification.

Palbociclib Dosage Modification Levels for Adverse Reactions

Dose level

Palbociclib dose

a Discontinue palbociclib if unable to tolerate 75 mg/day.

Usual (initial) dose

125 mg/day

First dose reduction

100 mg/day

Second dose reduction

75 mg/daya

Palbociclib Dosage Modifications for Adverse Reactions

Adverse reaction

Severity

Palbociclib dosage modification

a Except lymphopenia (unless associated with clinical events [eg, opportunistic infection]).

Hematologic toxicitya

Grade 1 or 2

No palbociclib dosage modification is required.

Grade 3 on day 1 of cycle

Withhold palbociclib and repeat CBC with differential within 1 week. When improved to ≤ grade 2, initiate the next cycle at the same dose.

Grade 3 on day 15 of first 2 cycles

If grade 3 on day 15, continue palbociclib at current dose to complete the cycle. Repeat CBC with differential on day 22.

If grade 4 on day 22, withhold palbociclib until improved to ≤ grade 2, then resume at next lower dose.

Consider dose reduction in future cycles if recovery from grade 3 neutropenia is prolonged (>1 week) or for recurrent grade 3 neutropenia on day 1 of subsequent cycles.

Grade 3 neutropenia with fever ≥38.5°C (≥101.3°F) and/or infection

Withhold palbociclib until improved to ≤ grade 2, then resume at next lower dose.

Grade 4

Withhold palbociclib until improved to ≤ grade 2, then resume at next lower dose.

Pulmonary toxicity

New or worsening respiratory symptoms, which may be indicative of pneumonitis

Interrupt palbociclib treatment immediately and evaluate patient.

Severe interstitial lung disease/pneumonitis

Permanently discontinue palbociclib.

Other nonhematologic toxicity

Grade 1 or 2

No dosage adjustment required.

Grade 3 or higher (if persistent despite optimal medical management):

Withhold palbociclib until symptoms improve to ≤ grade 1 or ≤ grade 2 (if toxicity is not a safety risk); after resolution, resume palbociclib at the next lower dose.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions (Significant): Considerations
Interstitial lung disease/pneumonitis

Severe, life-threatening, and/or fatal interstitial lung disease (ILD) and/or pneumonitis may occur with palbociclib (and other cyclin-dependent kinase inhibitors) (Ref). Symptoms of ILD/pneumonitis may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exam. Pulmonary toxicity may be reversible with dose interruption, appropriate treatment, and/or discontinuation (Ref).

Onset: Delayed; cases describe onset of ILD and/or pneumonitis ranging from a few months to a couple years after initiation (Ref).

Neutropenia

Neutropenia was observed in clinical studies, including grades 3 and 4 neutropenia. The median duration of ≥ grade 3 neutropenia was 7 days. Febrile neutropenia and neutropenic sepsis have also been reported. Neutropenia is quickly reversible with cessation of palbociclib (Ref).

Mechanism: Dose-related; inhibits CDK6, a key regulator of hematopoietic precursor proliferation (Ref). Inhibiting CDK6 causes cytostatic effects on the cell cycle of neutrophils (Ref).

Onset: Intermediate; median onset for any grade neutropenia is 15 days. Median onset of grade ≥3 neutropenia is 28 days (Ref).

Risk factors:

• Baseline myelosuppression (Ref)

• Recent antibiotic use (Ref)

• Nonwhite race (Ref)

• Asian ethnicity (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Percentages reported as part of combination therapy in adults.

>10%:

Dermatologic: Alopecia (18% to 33%), skin rash (17% to 18%), xeroderma (6% to 12%)

Gastrointestinal: Decreased appetite (15% to 16%), diarrhea (24% to 26%; grade 3: 1%), nausea (34% to 35%; grade 3: <1%), stomatitis (28% to 30%; grade 3: 1%), vomiting (16% to 19%; grade 3: 1%)

Hematologic & oncologic: Anemia (24% to 78%; grade 3: 3% to 6%; grade 4: <1%), leukopenia (39% to 53%; grade 3: 24% to 30%; grade 4: 1%), neutropenia (80% to 83%; grade 3: 55% to 56%; grade 4: 10% to 11%) (table 1), thrombocytopenia (16% to 23%; grade 3: 1% to 2%; grade 4: ≤1%)

Palbociclib: Adverse Reaction: Neutropenia

Drug (Palbociclib)

Placebo

Dose

Indication

Number of Patients (Palbociclib)

Number of Patients (Placebo)

Comments

All grades: 80%

All grades: 6%

125 mg/day plus letrozole (2.5 mg/day)

Estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine based therapy

444

222

Palbociclib plus letrozole; placebo plus letrozole

Grade 3: 56%

Grade 3: 1%

125 mg/day plus letrozole (2.5 mg/day)

Estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine based therapy

444

222

Palbociclib plus letrozole; placebo plus letrozole

Grade 4: 10%

Grade 4: 1%

125 mg/day plus letrozole (2.5 mg/day)

Estrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer for initial endocrine based therapy

444

222

Palbociclib plus letrozole; placebo plus letrozole

All grades: 83%

All grades: 4%

125 mg/day plus fulvestrant (500 mg)

HR-positive, HER2-negative advanced or metastatic breast cancer who have had disease progression on or after prior adjuvant or metastatic endocrine therapy

345

172

Palbociclib plus fulvestrant; placebo plus fulvestrant

Grade 3: 55%

Grade 3: 1%

125 mg/day plus fulvestrant (500 mg)

HR-positive, HER2-negative advanced or metastatic breast cancer who have had disease progression on or after prior adjuvant or metastatic endocrine therapy

345

172

Palbociclib plus fulvestrant; placebo plus fulvestrant

Grade 4: 11%

Grade 4: 0%

125 mg/day plus fulvestrant (500 mg)

HR-positive, HER2-negative advanced or metastatic breast cancer who have had disease progression on or after prior adjuvant or metastatic endocrine therapy

345

172

Palbociclib plus fulvestrant; placebo plus fulvestrant

Hepatic: Increased serum alanine aminotransferase (43%), increased serum aspartate aminotransferase (52%)

Infection: Infection (47% to 60%)

Nervous system: Asthenia (8% to 17%), fatigue (37% to 41%)

Renal: Increased serum creatinine (95% to 96%)

Miscellaneous: Fever (12% to 13%)

1% to 10%:

Gastrointestinal: Dysgeusia (7% to 10%)

Hematologic & oncologic: Febrile neutropenia (≤3%)

Ophthalmic: Blurred vision (4% to 6%), dry eye syndrome (4%), increased lacrimation (6%)

Respiratory: Epistaxis (7% to 9%)

Postmarketing:

Cardiovascular: Venous thromboembolism (Ref)

Dermatologic: Acute generalized exanthematous pustulosis (Ref), bullous rash (Ref), erythema multiforme (Ref), palmar-plantar erythrodysesthesia, Stevens-Johnson syndrome (Ref), vitiligo (Ref)

Hepatic: Hepatic injury (including hepatic encephalopathy, hepatitis, increased serum alkaline phosphatase, increased serum bilirubin, jaundice) (Ref)

Nervous system: Posterior reversible encephalopathy syndrome (Ref)

Neuromuscular & skeletal: Discoid lupus erythematous (Ref), subacute cutaneous lupus erythematous (Ref)

Respiratory: Interstitial lung disease (Ref), pneumonitis (Ref)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to palbociclib or any component of the formulation.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Ibrance: 75 mg, 100 mg, 125 mg

Tablet, Oral:

Ibrance: 75 mg, 100 mg, 125 mg [contains fd&c blue #2 (indigo carm) aluminum lake]

Generic Equivalent Available: US

No

Pricing: US

Capsules (Ibrance Oral)

75 mg (per each): $940.69

100 mg (per each): $940.69

125 mg (per each): $940.69

Tablets (Ibrance Oral)

75 mg (per each): $940.69

100 mg (per each): $940.69

125 mg (per each): $940.69

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Ibrance: 75 mg [DSC], 100 mg [DSC], 125 mg [DSC]

Tablet, Oral:

Ibrance: 75 mg, 100 mg, 125 mg [contains fd&c blue #2 (indigo carm) aluminum lake]

Generic: 75 mg, 100 mg, 125 mg

Prescribing and Access Restrictions

Palbociclib is available through specialty pharmacies. For more information, refer to https://www.pfizeroncologytogether.com

Administration: Adult

Oral: Administer at approximately the same time each day. Swallow whole, do not crush or chew; do not split tablets or open capsules prior to swallowing (do not ingest if tablets or capsules are broken, cracked, or not intact).

Tablets: Administer with or without food.

Capsules: Administer with food.

Use: Labeled Indications

Breast cancer, advanced or metastatic, hormone receptor positive, HER2 negative:

Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer (in combination with an aromatase inhibitor) in adults as initial endocrine-based therapy.

Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer (in combination with fulvestrant) in adults with disease progression following endocrine therapy.

Medication Safety Issues
Sound-alike/look-alike issues:

Palbociclib may be confused with abemaciclib, panobinostat, PAZOPanib, pexidartinib, ribociclib, trilaciclib.

Ibrance may be confused with ibrutinib.

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Metabolism/Transport Effects

Substrate of CYP3A4 (Major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP3A4 (Weak);

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

ALPRAZolam: CYP3A4 Inhibitors (Weak) may increase serum concentration of ALPRAZolam. Risk C: Monitor

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CycloSPORINE (Systemic): CYP3A4 Inhibitors (Weak) may increase serum concentration of CycloSPORINE (Systemic). Risk C: Monitor

CYP3A4 Inducers (Moderate): May decrease serum concentration of Palbociclib. Risk C: Monitor

CYP3A4 Inducers (Strong): May decrease serum concentration of Palbociclib. Risk X: Avoid

CYP3A4 Inhibitors (Moderate): May increase serum concentration of Palbociclib. Risk C: Monitor

CYP3A4 Inhibitors (Strong): May increase serum concentration of Palbociclib. Management: Avoid concurrent use of strong CYP3A4 inhibitors with palbociclib when possible. If the use of a strong CYP3A4 inhibitor cannot be avoided, decrease the palbociclib dose to 75 mg/day. Risk D: Consider Therapy Modification

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Dofetilide: CYP3A4 Inhibitors (Weak) may increase serum concentration of Dofetilide. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Finerenone: CYP3A4 Inhibitors (Weak) may increase serum concentration of Finerenone. Risk C: Monitor

Flibanserin: CYP3A4 Inhibitors (Weak) may increase serum concentration of Flibanserin. Risk C: Monitor

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Grapefruit Juice: May increase serum concentration of Palbociclib. Risk X: Avoid

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Inhibitors of the Proton Pump (PPIs and PCABs): May decrease therapeutic effects of Palbociclib. Specifically, this has been reported with the use of palbociclib capsules. Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Palbociclib. Specifically, this may occur with the use of palbociclib capsules, and to the greatest extent when taken without food. Management: Carefully evaluate potential risks and benefits of coadministration of palbociclib capsules and proton pump inhibitors or potassium-competitive acid blockers due to the risk of reduced palbociclib efficacy. Palbociclib capsules should be taken with food. Risk D: Consider Therapy Modification

Ixabepilone: CYP3A4 Inhibitors (Weak) may increase serum concentration of Ixabepilone. Risk C: Monitor

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Lemborexant: CYP3A4 Inhibitors (Weak) may increase serum concentration of Lemborexant. Management: The maximum recommended dosage of lemborexant is 5 mg, no more than once per night, when coadministered with weak CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Lomitapide: CYP3A4 Inhibitors (Weak) may increase serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be titrated up to a max adult dose of 30 mg/day. Risk D: Consider Therapy Modification

Midazolam: CYP3A4 Inhibitors (Weak) may increase serum concentration of Midazolam. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

NiMODipine: CYP3A4 Inhibitors (Weak) may increase serum concentration of NiMODipine. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Pimozide: CYP3A4 Inhibitors (Weak) may increase serum concentration of Pimozide. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Simvastatin: CYP3A4 Inhibitors (Weak) may increase serum concentration of Simvastatin. CYP3A4 Inhibitors (Weak) may increase active metabolite exposure of Simvastatin. Risk C: Monitor

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sirolimus (Conventional): CYP3A4 Inhibitors (Weak) may increase serum concentration of Sirolimus (Conventional). Risk C: Monitor

Sirolimus (Protein Bound): CYP3A4 Inhibitors (Weak) may increase serum concentration of Sirolimus (Protein Bound). Management: Reduce the dose of protein bound sirolimus to 56 mg/m2 when used concomitantly with a weak CYP3A4 inhibitor. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor

St John's Wort: May decrease serum concentration of Palbociclib. Risk X: Avoid

Tacrolimus (Systemic): CYP3A4 Inhibitors (Weak) may increase serum concentration of Tacrolimus (Systemic). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Triazolam: CYP3A4 Inhibitors (Weak) may increase serum concentration of Triazolam. Risk C: Monitor

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Ubrogepant: CYP3A4 Inhibitors (Weak) may increase serum concentration of Ubrogepant. Management: In patients taking weak CYP3A4 inhibitors, the initial and second dose (given at least 2 hours later if needed) of ubrogepant should be limited to 50 mg. Risk D: Consider Therapy Modification

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Food Interactions

Coadministration with grapefruit may increase palbociclib plasma concentrations. Management: Avoid concomitant administration with grapefruit.

Food effect: Tablets: Compared to overnight fasted conditions, AUC and Cmax increased 22% and 26%, respectively, when administered with a high-fat, high-calorie meal (~800 to 1,000 calories; with 500 to 600 calories from fat); AUC and Cmax increased 9% and 10%, respectively, when administered with a moderate-fat, standard-calorie meal (~500 to 700 calories; with 175 to 245 calories from fat).

Reproductive Considerations

Evaluate pregnancy status prior to treatment in patients who could become pregnant. Patients who could become pregnant should use effective contraception during treatment and for at least 3 weeks after the last dose. Patients with partners who could become pregnant should use effective contraception during treatment and for 3 months after the last dose.

Adverse effects to male reproductive function and fertility were observed in animal toxicology studies; males of reproductive potential may want to consider sperm preservation prior to palbociclib therapy.

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, in utero exposure to palbociclib may cause fetal harm.

Breastfeeding Considerations

It is not known if palbociclib is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment and for 3 weeks after the last palbociclib dose.

Dietary Considerations

Avoid grapefruit.

Monitoring Parameters

CBC with differential (prior to treatment initiation, every 2 weeks for first 2 cycles, then prior to each cycle, and as clinically indicated; if neutropenia is limited to grades 1 or 2 in the first 6 cycles, monitor every 3 months [prior to the beginning of a cycle] and as clinically indicated for subsequent cycles). Evaluate pregnancy status prior to treatment initiation (in patients who could become pregnant). Monitor closely for signs/symptoms of interstitial lung disease/pneumonitis (eg, hypoxia, cough, dyspnea, interstitial infiltrates on radiologic exam); exclude infectious, neoplastic, and other causes of pulmonary toxicity. Monitor for signs/symptoms of infection. Monitor adherence.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Cardiovascular monitoring: Comprehensive assessment prior to treatment including a history and physical examination, screening for cardiovascular disease risk factors such as hypertension, diabetes, dyslipidemia, obesity, and smoking (ASCO [Armenian 2017]). Consider baseline and periodic QTc monitoring in patients with QTc above the normal range or other conditions that may prolong the QTc interval (ESC [Lyon 2022]).

Mechanism of Action

Palbociclib is a reversible small molecule cyclin-dependent kinase (CDK) inhibitor that is selective for CDK 4 and 6. CDKs 4 and 6 (and cyclin D1) have a role in regulating progression through the cell cycle at the G1/S phase by regulating retinoblastoma (Rb) phosphorylation; inhibition of CDK4/6 by palbociclib reduces proliferation of breast cancer cell lines by preventing progression from the G1 to the S cell cycle phase through loss of the regulatory Rb checkpoint (Finn 2015). The combination of palbociclib with an antiestrogen provides for increased inhibition of Rb phosphorylation, downstream signaling, and tumor growth compared with each agent alone.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Tablets: Compared to overnight fasted conditions, AUC and Cmax increased 22% and 26%, respectively, when administered with a high-fat, high-calorie meal (~800 to 1,000 calories; with 500 to 600 calories from fat); AUC and Cmax increased 9% and 10%, respectively, when administered with a moderate-fat, standard-calorie meal (~500 to 700 calories; with 175 to 245 calories from fat).

Distribution: Vd (mean): 2,583 L.

Protein binding: ~85%.

Metabolism: Extensively hepatic; Major pathways: Oxidation and sulfonation, primarily by CYP3A and sulfotransferase (SULT) enzyme SULT2A1; Minor pathways: Acylation and glucuronidation.

Bioavailability: Mean absolute bioavailability: 46%.

Half-life elimination: 29 ± 5 hours.

Time to peak: Tablets: 4 to 12 hours; Capsules: 6 to 12 hours.

Excretion: Feces (~74%, primarily as metabolites); Urine (~18%; primarily as metabolites).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Total palbociclib exposure (AUCINF) is increased by 39%, 42%, and 31% with mild (CrCl 60 to <90 mL/minute), moderate (CrCl 30 to <60 mL/minute), and severe (CrCl <30 mL/minute) impairment, respectively, relative to subjects with normal renal function. Peak palbociclib exposure (Cmax) was increased by 17%, 12%, and 15% for mild, moderate, and severe impairment, respectively, relative to subjects with normal renal function.

Hepatic function impairment: Palbociclib unbound exposure (unbound AUCINF) is decreased by 17% in subjects with mild impairment (Child-Pugh class A), and increased by 34% and 77% in subjects with moderate and severe (Child-Pugh classes B and C) impairment, respectively, relative to subjects with normal hepatic function. The mean fraction of unbound (fu) palbociclib in human plasma increased incrementally in patients with worsening hepatic function. Peak palbociclib unbound exposure (unbound Cmax) increased by 7%, 38%, and 72% for mild, moderate, and severe impairment, respectively, relative to subjects with normal hepatic function.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Ibrance;
  • (AR) Argentina: Everciclex | Ibrance | Ipalxane | Lekio | Palbocil | Pariterib | Perciclib | Suvanclib | Ultraciclib | Vatilen | Vetrano | Ydesib;
  • (AT) Austria: Ibrance;
  • (AU) Australia: Ibrance;
  • (BD) Bangladesh: Cykin | Palbocent | Palbolib | Palbonix | Palboxen;
  • (BE) Belgium: Ibrance;
  • (BG) Bulgaria: Ibrance;
  • (BR) Brazil: Ibrance;
  • (CH) Switzerland: Ibrance;
  • (CL) Chile: Ibrance;
  • (CN) China: Ao pai bo | Ibrance | Qi tuo xin;
  • (CO) Colombia: Reampla;
  • (CZ) Czech Republic: Ibrance;
  • (DE) Germany: Ibrance;
  • (DO) Dominican Republic: Ibrance;
  • (EC) Ecuador: Ibrance | Palbocap | Pariterib | Perciclib;
  • (EE) Estonia: Ibrance;
  • (EG) Egypt: Ibrance;
  • (ES) Spain: Ibrance;
  • (FI) Finland: Ibrance;
  • (FR) France: Palbociclib;
  • (GB) United Kingdom: Ibrance;
  • (GR) Greece: Ibrance;
  • (HK) Hong Kong: Ibrance;
  • (HR) Croatia: Ibrance;
  • (HU) Hungary: Ibrance;
  • (IE) Ireland: Ibrance;
  • (IN) India: Adcilib | Bdpalbo | Celoclib | Cydekin | Hormoclib | Isogen | Kixta | Pabreca | Palbace | Palbinas | Palbo | Palbopro | Palborest | Palbotor | Palnat | Piciclib | Piclib | Primcyv;
  • (IT) Italy: Ibrance;
  • (JO) Jordan: Ibrance;
  • (JP) Japan: Ibrance;
  • (KE) Kenya: Ibrance;
  • (KR) Korea, Republic of: Ibrance;
  • (KW) Kuwait: Ibrance;
  • (LB) Lebanon: Ibrance;
  • (LT) Lithuania: Ibrance;
  • (LU) Luxembourg: Ibrance;
  • (LV) Latvia: Ibrance;
  • (MX) Mexico: Ibrance | Ibrulol;
  • (MY) Malaysia: Ibrance;
  • (NG) Nigeria: Ibrance;
  • (NL) Netherlands: Ibrance;
  • (NO) Norway: Ibrance;
  • (NZ) New Zealand: Ibrance;
  • (PE) Peru: Ibrance;
  • (PH) Philippines: Ibrance;
  • (PL) Poland: Ibrance;
  • (PR) Puerto Rico: Ibrance;
  • (PT) Portugal: Ibrance;
  • (QA) Qatar: Ibrance | Papillio;
  • (RO) Romania: Ibrance;
  • (RU) Russian Federation: Etulsi | Ibrance;
  • (SA) Saudi Arabia: Ibrance;
  • (SE) Sweden: Ibrance;
  • (SG) Singapore: Ibrance;
  • (SI) Slovenia: Ibrance;
  • (SK) Slovakia: Ibrance;
  • (TH) Thailand: Ibrance;
  • (TN) Tunisia: Ibrance;
  • (TR) Turkey: Reampla;
  • (TW) Taiwan: Ibrance;
  • (UA) Ukraine: Ibrance;
  • (UY) Uruguay: Ibrance;
  • (ZA) South Africa: Ibrance | Palbociclib pfizer;
  • (ZW) Zimbabwe: Ibrance
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  20. Ibrance (palbociclib) tablets [prescribing information]. New York, NY: Pfizer Labs; March 2025.
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