IBRANCE® tablets (palbociclib) 2 DOSAGE AND ADMINISTRATION

(palbociclib)

Prescribing Information

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose and Schedule

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.

2.2 Dose Modification

The recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3.

Table 1. Recommended Dose Modification for Adverse Reactions
Dose Level	Dose
* If further dose reduction below 75 mg/day is required, discontinue.
Recommended starting dose	125 mg/day
First dose reduction	100 mg/day
Second dose reduction	75 mg/day*

Table 2. Dose Modification and Management – Hematologic Toxicities*
Grading according to CTCAE 4.0. CTCAE=Common Terminology Criteria for Adverse Events; LLN=lower limit of normal.
* Table applies to all hematologic adverse reactions except lymphopenia (unless associated with clinical events, e.g., opportunistic infections). † Absolute 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.
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 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 neutropenia† 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.

Table 3. Dose Modification and Management – Non-Hematologic Toxicities
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: • 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 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)].

Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: September 2025
PATIENT INFORMATION IBRANCE® (EYE-brans) (palbociclib) Tablets
What is the most important information I should know about IBRANCE? IBRANCE may cause serious side effects, including: Low white blood cell counts (neutropenia). Low white blood cell counts are very common when taking IBRANCE and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment. If you develop low white blood cell counts during treatment with IBRANCE, your healthcare provider may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills. Lung problems (pneumonitis). IBRANCE may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including: • chest pain • cough with or without mucus • trouble breathing or shortness of breath Your healthcare provider may interrupt or stop treatment with IBRANCE completely if your symptoms are severe. See "What are the possible side effects of IBRANCE?" for more information about side effects.
What is IBRANCE? IBRANCE is a prescription medicine used: In adults to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic) in combination with: • an aromatase inhibitor as the first hormonal based therapy, or • fulvestrant in people with disease progression following hormonal therapy. In adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative and with an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene breast cancer that has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic) in combination with: • inavolisib and fulvestrant in people with disease progression during or after adjuvant hormonal therapy. It is not known if IBRANCE is safe and effective in children.
What should I tell my healthcare provider before taking IBRANCE? Before taking IBRANCE, tell your healthcare provider about all of your medical conditions, including if you: • have fever, chills, or any other signs or symptoms of infection. • have liver or kidney problems. • have any other medical conditions. • are pregnant, or plan to become pregnant. IBRANCE can harm your unborn baby. o Females who are able to become pregnant should use effective birth control during treatment and for at least 3 weeks after the last dose of IBRANCE. Your healthcare provider may ask you to take a pregnancy test before you start treatment with IBRANCE. o Males with female partners who can become pregnant should use effective birth control during treatment with IBRANCE for at least 3 months after the last dose of IBRANCE. o Talk to your healthcare provider about birth control methods that may be right for you during this time. o If you become pregnant or think you are pregnant, tell your healthcare provider right away. • are breastfeeding or plan to breastfeed. It is not known if IBRANCE passes into your breast milk. Do not breastfeed during treatment with IBRANCE and for 3 weeks after the last dose. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IBRANCE and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
How should I take IBRANCE? • Take IBRANCE exactly as your healthcare provider tells you. • IBRANCE tablets may be taken with or without food. • IBRANCE should be taken at about the same time each day. • Swallow IBRANCE tablets whole. Do not chew, crush or split IBRANCE tablets before swallowing them. • Do not take any IBRANCE tablets that are broken, cracked, or that look damaged. • Avoid grapefruit and grapefruit products during treatment with IBRANCE. Grapefruit may increase the amount of IBRANCE in your blood. • Do not change your dose or stop taking IBRANCE unless your healthcare provider tells you. • If you miss a dose of IBRANCE or vomit after taking a dose of IBRANCE, do not take another dose on that day. Take your next dose at your regular time. • When IBRANCE is used in combination with inavolisib and fulvestrant, or an aromatase inhibitor, also read the Patient Information for the prescribed products.
What are the possible side effects of IBRANCE?
IBRANCE may cause serious side effects. See "What is the most important information I should know about IBRANCE?"
The most common side effects of IBRANCE when used with either letrozole or fulvestrant include: • Low red blood cell counts and low platelet counts are common with IBRANCE. Call your healthcare provider right away if you develop any of these symptoms during treatment:
	o dizziness o shortness of breath o weakness	o bleeding or bruising more easily o nosebleeds
• infections (see "What is the most important information I should know about IBRANCE?") • tiredness • nausea • sore mouth • abnormalities in liver blood tests		• diarrhea • hair thinning or hair loss • increased blood creatinine
The most common side effects when inavolisib is added to IBRANCE plus fulvestrant include: • high blood sugar levels leading to excessive thirst and urination • sore mouth • diarrhea • decreased white blood cell counts, red blood cell counts, and platelet counts • decreased blood levels of calcium, potassium, sodium, and magnesium • increased creatine blood levels • tiredness • abnormalities in liver blood tests • nausea • rash • loss of appetite • COVID-19 infection • headache IBRANCE may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider about family planning options before starting IBRANCE if this is a concern for you. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of IBRANCE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store IBRANCE? • Store IBRANCE at 68 °F to 77 °F (20 °C to 25 °C) in the original blister pack. Keep IBRANCE and all medicines out of the reach of children.
General information about the safe and effective use of IBRANCE Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IBRANCE for a condition for which it was not prescribed. Do not give IBRANCE to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about IBRANCE that is written for health professionals.
What are the ingredients in IBRANCE? Active ingredient: palbociclib Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, succinic acid, HPMC 2910/hypromellose, titanium dioxide, triacetin, and FD&C Blue #2/Indigo Carmine Aluminum Lake. In addition, the 75 mg and 125 mg tablets contain red iron oxide and the 100 mg tablets contain yellow iron oxide. This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com. LAB-1372-7.0 For more information, go to www.pfizer.com or call 1-800-438-1985.

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