Ibrance (tablets)
(Palbociclib)Dosage & Administration
IBRANCE tablets are taken orally with or without food in combination with an aromatase inhibitor, fulvestrant, or inavolisib and fulvestrant. (
IBRANCE tablets are taken orally with or without food in combination with an aromatase inhibitor, fulvestrant, or inavolisib and fulvestrant.
The recommended dose of IBRANCE is a 125 mg tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE tablet may be taken with or without food
Administer the recommended dose of an aromatase inhibitor when given with IBRANCE. Please refer to the Full Prescribing Information for the aromatase inhibitor being used.
When given with IBRANCE, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant.
If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. IBRANCE tablets should be swallowed whole (do not chew, crush, or split them prior to swallowing). Tablets should not be ingested if they are broken, cracked, or otherwise not intact.
Pre/perimenopausal women treated with the combination IBRANCE plus an aromatase inhibitor or fulvestrant therapy
For men treated with combination IBRANCE plus aromatase inhibitor
The recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3.
Dose Level | Dose |
|---|---|
Recommended starting dose | 125 mg/day |
First dose reduction | 100 mg/day |
Second dose reduction | 75 mg/dayIf further dose reduction below 75 mg/day is required, discontinue. |
| Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal. | |
Monitor complete blood counts prior to the start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. | |
CTCAE Grade | Dose Modifications |
Grade 1 or 2 | No dose adjustment is required. |
Grade 3 | Day 1 of cycle :Withhold IBRANCE, repeat complete blood count monitoring within 1 week. When recovered to Grade ≤2, start the next cycle at the same dose .Day 15 of first 2 cycles :If Grade 3 on Day 15, continue IBRANCE at current dose to complete cycle and repeat complete blood count on Day 22. If Grade 4 on Day 22, see Grade 4 dose modification guidelines below. Consider dose reduction in cases of prolonged (>1 week) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles. |
Grade 3 neutropeniaAbsolute neutrophil count (ANC): Grade 1: ANC < LLN – 1500/mm3; Grade 2: ANC 1000 – <1500/mm3; Grade 3: ANC 500 – <1000/mm3; Grade 4: ANC <500/mm3.with fever ≥38.5 °C and/or infection | At any time :Withhold IBRANCE until recovery to Grade ≤2. Resume at the next lower dose . |
Grade 4 | At any time :Withhold IBRANCE until recovery to Grade ≤2. Resume at the next lower dose . |
Resume at the
CTCAE Grade | Dose Modifications |
|---|---|
| Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events. | |
Grade 1 or 2 | No dose adjustment is required. |
Grade ≥3 non-hematologic toxicity (if persisting despite optimal medical treatment) | Withhold until symptoms resolve to: |
Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis.
Refer to the Full Prescribing Information for coadministered endocrine therapy
Avoid concomitant use of strong CYP3A inhibitors and consider an alternative concomitant medication with no or minimal CYP3A inhibition. If patients must be coadministered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg once daily. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor
No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
Ibrance (Tablets) Prescribing Information
Indications and Usage ( IBRANCE is 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:
IBRANCE is indicated 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-approved test, following recurrence on or after completing adjuvant endocrine therapy.IBRANCE is a kinase inhibitor indicated:
| 4/2025 | ||||||||||||||||||||||||||||||
Dosage and Administration ( The recommended dose of IBRANCE is a 125 mg tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE tablet may be taken with or without food [see Clinical Pharmacology (12.3)] .Administer the recommended dose of an aromatase inhibitor when given with IBRANCE. Please refer to the Full Prescribing Information for the aromatase inhibitor being used. When given with IBRANCE, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant. Refer to the Full Prescribing Information for inavolisib and fulvestrant for dosing information .Advise patients to take their dose of IBRANCE at approximately the same time each day.If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. IBRANCE tablets should be swallowed whole (do not chew, crush, or split them prior to swallowing). Tablets should not be ingested if they are broken, cracked, or otherwise not intact. Pre/perimenopausal women treated with the combination IBRANCE plus an aromatase inhibitor or fulvestrant therapy or IBRANCE plus inavolisib and fulvestrant should also be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards.For men treated with combination IBRANCE plus aromatase inhibitor or IBRANCE plus inavolisib and fulvestrant therapy, consider treatment with an LHRH agonist according to current clinical practice standards.The recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3.
Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis. Refer to the Full Prescribing Information for coadministered endocrine therapy and/or inavolisib dose adjustment guidelines in the event of toxicity and other relevant safety information or contraindications.Dose Modifications for Use With Strong CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors and consider an alternative concomitant medication with no or minimal CYP3A inhibition. If patients must be coadministered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg once daily. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor [see Drug Interactions (7.1)and Clinical Pharmacology (12.3)]. Dose Modifications for Hepatic Impairment No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days [see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)]. | 4/2025 | ||||||||||||||||||||||||||||||
IBRANCE is 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.
IBRANCE tablets are taken orally with or without food in combination with an aromatase inhibitor, fulvestrant, or inavolisib and fulvestrant. (
IBRANCE tablets are taken orally with or without food in combination with an aromatase inhibitor, fulvestrant, or inavolisib and fulvestrant.
• Recommended starting dose: 125 mg once daily taken with or without food for 21 days followed by 7 days off treatment.• Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability.
The recommended dose of IBRANCE is a 125 mg tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE tablet may be taken with or without food
Administer the recommended dose of an aromatase inhibitor when given with IBRANCE. Please refer to the Full Prescribing Information for the aromatase inhibitor being used.
When given with IBRANCE, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant.
If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. IBRANCE tablets should be swallowed whole (do not chew, crush, or split them prior to swallowing). Tablets should not be ingested if they are broken, cracked, or otherwise not intact.
Pre/perimenopausal women treated with the combination IBRANCE plus an aromatase inhibitor or fulvestrant therapy
For men treated with combination IBRANCE plus aromatase inhibitor
The recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3.
Dose Level | Dose |
|---|---|
Recommended starting dose | 125 mg/day |
First dose reduction | 100 mg/day |
Second dose reduction | 75 mg/dayIf further dose reduction below 75 mg/day is required, discontinue. |
| Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal. | |
Monitor complete blood counts prior to the start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. | |
CTCAE Grade | Dose Modifications |
Grade 1 or 2 | No dose adjustment is required. |
Grade 3 | Day 1 of cycle :Withhold IBRANCE, repeat complete blood count monitoring within 1 week. When recovered to Grade ≤2, start the next cycle at the same dose .Day 15 of first 2 cycles :If Grade 3 on Day 15, continue IBRANCE at current dose to complete cycle and repeat complete blood count on Day 22. If Grade 4 on Day 22, see Grade 4 dose modification guidelines below. Consider dose reduction in cases of prolonged (>1 week) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles. |
Grade 3 neutropeniaAbsolute neutrophil count (ANC): Grade 1: ANC < LLN – 1500/mm3; Grade 2: ANC 1000 – <1500/mm3; Grade 3: ANC 500 – <1000/mm3; Grade 4: ANC <500/mm3.with fever ≥38.5 °C and/or infection | At any time :Withhold IBRANCE until recovery to Grade ≤2. Resume at the next lower dose . |
Grade 4 | At any time :Withhold IBRANCE until recovery to Grade ≤2. Resume at the next lower dose . |
CTCAE Grade | Dose Modifications |
|---|---|
| Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events. | |
Grade 1 or 2 | No dose adjustment is required. |
Grade ≥3 non-hematologic toxicity (if persisting despite optimal medical treatment) | Withhold until symptoms resolve to:
Resume at the next lower dose . |
Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis.
Refer to the Full Prescribing Information for coadministered endocrine therapy
Avoid concomitant use of strong CYP3A inhibitors and consider an alternative concomitant medication with no or minimal CYP3A inhibition. If patients must be coadministered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg once daily. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor
No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
• Recommended starting dose: 125 mg once daily taken with or without food for 21 days followed by 7 days off treatment. ()2.1 Recommended Dose and ScheduleThe recommended dose of IBRANCE is a 125 mg tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE tablet may be taken with or without food
[see Clinical Pharmacology (12.3)].Administer the recommended dose of an aromatase inhibitor when given with IBRANCE. Please refer to the Full Prescribing Information for the aromatase inhibitor being used.
When given with IBRANCE, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant.
Refer to the Full Prescribing Information for inavolisib and fulvestrant for dosing information.Advise patientsto take their dose of IBRANCE at approximately the same time each day.If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. IBRANCE tablets should be swallowed whole (do not chew, crush, or split them prior to swallowing). Tablets should not be ingested if they are broken, cracked, or otherwise not intact.
Pre/perimenopausal women treated with the combination IBRANCE plus an aromatase inhibitor or fulvestrant therapy
or IBRANCE plus inavolisib and fulvestrantshould also be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards.For men treated with combination IBRANCE plus aromatase inhibitor
or IBRANCE plus inavolisib and fulvestranttherapy, consider treatment with an LHRH agonist according to current clinical practice standards.• Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability. ()2.2 Dose ModificationThe recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3.
Table 1. Recommended Dose Modification for Adverse Reactions Dose LevelDoseRecommended starting dose
125 mg/day
First dose reduction
100 mg/day
Second dose reduction
75 mg/dayIf further dose reduction below 75 mg/day is required, discontinue.
Table 2. Dose Modification and Management – Hematologic ToxicitiesTable applies to all hematologic adverse reactions except lymphopenia (unless associated with clinical events, e.g., opportunistic infections). Grading according to CTCAE 4.0.
CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal.Monitor complete blood counts prior to the start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated.
For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, monitor complete blood counts for subsequent cycles every 3 months, prior to the beginning of a cycle and as clinically indicated.CTCAE GradeDose ModificationsGrade 1 or 2
No dose adjustment is required.
Grade 3
Day 1 of cycle:
Withhold IBRANCE, repeat complete blood count monitoring within 1 week. When recovered to Grade ≤2, start the next cycle at thesame dose.Day 15 of first 2 cycles:
If Grade 3 on Day 15, continue IBRANCE at current dose to complete cycle and repeat complete blood count on Day 22.
If Grade 4 on Day 22, see Grade 4 dose modification guidelines below.
Consider dose reduction in cases of prolonged (>1 week) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles.Grade 3 neutropeniaAbsolute neutrophil count (ANC): Grade 1: ANC < LLN – 1500/mm3; Grade 2: ANC 1000 – <1500/mm3; Grade 3: ANC 500 – <1000/mm3; Grade 4: ANC <500/mm3.with fever ≥38.5 °C and/or infection
At any time:
Withhold IBRANCE until recovery to Grade ≤2.
Resume at thenext lower dose.Grade 4
At any time:
Withhold IBRANCE until recovery to Grade ≤2.
Resume at thenext lower dose.Table 3. Dose Modification and Management – Non-Hematologic Toxicities CTCAE GradeDose ModificationsGrading according to CTCAE 4.0.
CTCAE=Common Terminology Criteria for Adverse Events.Grade 1 or 2
No dose adjustment is required.
Grade ≥3 non-hematologic toxicity (if persisting despite optimal medical treatment)
Withhold until symptoms resolve to:
• Grade ≤1;• Grade ≤2 (if not considered a safety risk for the patient)
Resume at the
next lower dose.Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD)/pneumonitis.
Refer to the Full Prescribing Information for coadministered endocrine therapy
and/or inavolisibdose adjustment guidelines in the event of toxicity and other relevant safety information or contraindications.Dose Modifications for Use With Strong CYP3A InhibitorsAvoid concomitant use of strong CYP3A inhibitors and consider an alternative concomitant medication with no or minimal CYP3A inhibition. If patients must be coadministered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg once daily. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3 to 5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor
[see Drug Interactions (7.1)and Clinical Pharmacology (12.3)].Dose Modifications for Hepatic ImpairmentNo dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh classes A and B). For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
[see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].
125 mg tablets: Oval, light purple, film-coated tablets debossed with "Pfizer" on one side and "PBC 125" on the other side.
100 mg tablets: Oval, green, film-coated tablets debossed with "Pfizer" on one side and "PBC 100" on the other side.
75 mg tablets: Round, light purple, film-coated tablets debossed with "Pfizer" on one side and "PBC 75" on the other side.
• Lactation: Advise not to breastfeed. ()8.2 LactationRisk SummaryThere is no information regarding the presence of palbociclib in human milk, its effects on milk production, or the breastfed infant. Because of the potential for serious adverse reactions in breastfed infants from IBRANCE, advise a lactating woman not to breastfeed during treatment with IBRANCE and for 3 weeks after the last dose.
None.