{"id":1936,"date":"2026-02-07T13:16:43","date_gmt":"2026-02-07T18:16:43","guid":{"rendered":"https:\/\/www.simplmeds.com\/ibrance\/"},"modified":"2026-02-07T13:16:43","modified_gmt":"2026-02-07T18:16:43","slug":"ibrance","status":"publish","type":"post","link":"https:\/\/staging.simplmeds.com\/?p=1936","title":{"rendered":"IBRANCE- palbociclib capsule"},"content":{"rendered":"

Description<\/h2>\n
**Description**<\/p>\n

IBRANCE capsules are taken by mouth and come in three strengths:
\n\u2022 125 mg
\n\u2022 100 mg
\n\u2022 75 mg<\/p>\n

Each capsule contains palbociclib, a medicine that works by blocking certain proteins (called kinases) that help cancer cells grow.<\/p>\n

**About the Active Ingredient:**
\n\u2022 Palbociclib appears as a yellow to orange powder
\n\u2022 It dissolves better in acidic conditions (when pH is 4 or lower)
\n\u2022 It doesn’t dissolve as well when pH is above 4<\/p>\n

**Other Ingredients:**
\nThe capsules also contain inactive ingredients that help form the capsule:
\n\u2022 Microcrystalline cellulose
\n\u2022 Lactose monohydrate
\n\u2022 Sodium starch glycolate
\n\u2022 Colloidal silicon dioxide
\n\u2022 Magnesium stearate<\/p>\n

**Capsule Shell:**
\n\u2022 Made of hard gelatin
\n\u2022 Colors range from light orange to caramel
\n\u2022 Contains coloring agents (iron oxides) and titanium dioxide
\n\u2022 Printing ink is used for labeling<\/p><\/div>\n

Indications and Usage<\/h2>\n
**What IBRANCE is used for:**<\/p>\n

IBRANCE is a cancer medicine used to treat adults with a specific type of breast cancer that has:
\n\u2022 Hormone receptors (HR-positive)
\n\u2022 No HER2 protein (HER2-negative)
\n\u2022 Spread to other parts of the body (advanced or metastatic)<\/p>\n

IBRANCE is always used together with other cancer medicines.<\/p>\n

IBRANCE can also be used with two other medicines (inavolisib and fulvestrant) for patients whose cancer:
\n\u2022 Has stopped responding to hormone therapy
\n\u2022 Has a specific gene change called PIK3CA mutation
\n\u2022 Has come back after completing hormone treatment after surgery<\/p>\n

The PIK3CA mutation must be confirmed by an FDA-approved test before starting this treatment combination.<\/p><\/div>\n

Dosage and Administration<\/h2>\n
# How to Take IBRANCE<\/p>\n

## Recommended Dose<\/p>\n

**Standard Dose:**
\n\u2022 Take one 125 mg capsule by mouth once daily
\n\u2022 Take for 21 days in a row, then stop for 7 days
\n\u2022 This makes a complete 28-day cycle
\n\u2022 Always take with food
\n\u2022 Take at the same time each day<\/p>\n

**Important Taking Instructions:**
\n\u2022 Swallow capsules whole – do not chew, crush, or open them
\n\u2022 Do not take broken or cracked capsules
\n\u2022 If you vomit or miss a dose, do not take an extra dose
\n\u2022 Just take your next dose at the regular time<\/p>\n

**Other Medications:**
\n\u2022 You will also take hormone therapy medications as prescribed
\n\u2022 Pre\/perimenopausal women may need additional hormone treatment
\n\u2022 Men may need additional hormone treatment<\/p>\n

## Dose Changes<\/p>\n

**Dose Levels:**
\n\u2022 Starting dose: 125 mg daily
\n\u2022 First reduction: 100 mg daily
\n\u2022 Second reduction: 75 mg daily
\n\u2022 If you need less than 75 mg daily, treatment will be stopped<\/p>\n

## Managing Side Effects<\/p>\n

### Blood Count Problems<\/p>\n

**Your doctor will check your blood:**
\n\u2022 Before starting treatment
\n\u2022 At the start of each cycle
\n\u2022 On day 15 of your first 2 cycles
\n\u2022 Every 3 months if blood counts stay normal<\/p>\n

**Dose changes based on blood counts:**
\n\u2022 **Mild to moderate low blood counts:** Continue same dose
\n\u2022 **Severe low blood counts:** Stop IBRANCE until blood counts improve, then restart at a lower dose
\n\u2022 **Low blood counts with fever or infection:** Stop IBRANCE until better, then restart at a lower dose<\/p>\n

### Other Side Effects<\/p>\n

\u2022 **Mild to moderate side effects:** Continue same dose
\n\u2022 **Severe side effects:** Stop IBRANCE until side effects get better, then restart at a lower dose
\n\u2022 **Severe lung problems:** Stop IBRANCE permanently<\/p>\n

## Special Situations<\/p>\n

**Taking Other Medications:**
\n\u2022 Some medications can affect how IBRANCE works
\n\u2022 If you must take certain medications, your dose may be reduced to 75 mg daily<\/p>\n

**Liver Problems:**
\n\u2022 **Mild to moderate liver problems:** No dose change needed
\n\u2022 **Severe liver problems:** Reduce dose to 75 mg daily<\/p><\/div>\n

Dosage Forms and Strengths<\/h2>\n
**Dosage Forms and Strengths**<\/p>\n

This medication comes in 3 different capsule strengths:<\/p>\n

\u2022 **125 mg capsules**
\n – Hard capsules with caramel-colored cap and body
\n – “Pfizer” printed on cap, “PBC 125” printed on body<\/p>\n

\u2022 **100 mg capsules**
\n – Hard capsules with caramel-colored cap and light orange body
\n – “Pfizer” printed on cap, “PBC 100” printed on body<\/p>\n

\u2022 **75 mg capsules**
\n – Hard capsules with light orange cap and body
\n – “Pfizer” printed on cap, “PBC 75” printed on body<\/p><\/div>\n

Contraindications<\/h2>\n
None.<\/div>\n

Warnings and Precautions<\/h2>\n
## Warnings and Precautions<\/p>\n

### 5.1 Low White Blood Cell Count (Neutropenia)<\/p>\n

Low white blood cell count is the most common side effect with IBRANCE:
\n\u2022 Happens in 8 out of 10 patients taking IBRANCE
\n\u2022 Can be serious (Grade 3 or higher) in about 2 out of 3 patients
\n\u2022 Usually starts around 15 days after beginning treatment
\n\u2022 Serious cases typically last about 7 days<\/p>\n

**What your doctor will do:**
\n\u2022 Check your blood before you start IBRANCE
\n\u2022 Check your blood at the start of each treatment cycle
\n\u2022 Check your blood on day 15 of your first 2 cycles
\n\u2022 May need to pause, lower your dose, or delay treatment if your white blood cell count gets too low<\/p>\n

**Important:** Call your doctor right away if you get a fever. Low white blood cells can lead to serious infections. One patient died from infection in clinical trials.<\/p>\n

### 5.2 Lung Problems (ILD\/Pneumonitis)<\/p>\n

IBRANCE can cause serious, life-threatening lung inflammation:
\n\u2022 Happens in about 1 out of 100 patients
\n\u2022 Can be fatal in rare cases<\/p>\n

**Watch for these symptoms:**
\n\u2022 New or worsening cough
\n\u2022 Trouble breathing
\n\u2022 Shortness of breath<\/p>\n

**Important:** Tell your doctor immediately if you have any new breathing problems. Your doctor may need to stop IBRANCE permanently if you develop serious lung problems.<\/p>\n

### 5.3 Pregnancy Risks<\/p>\n

IBRANCE can harm an unborn baby:
\n\u2022 Animal studies showed birth defects and pregnancy loss
\n\u2022 Can cause serious harm to developing babies<\/p>\n

**If you can get pregnant:**
\n\u2022 Use effective birth control during treatment
\n\u2022 Continue birth control for at least 3 weeks after your last dose
\n\u2022 Tell your doctor right away if you become pregnant<\/p><\/div>\n

Adverse Reactions<\/h2>\n
**Side Effects**<\/p>\n

This section lists the most important side effects you should know about. More detailed information about these side effects can be found in other parts of this medication guide.<\/p>\n

\u2022 Check other sections of this guide for complete information about possible side effects
\n\u2022 Talk to your doctor if you experience any concerning symptoms while taking this medication<\/p><\/div>\n

Drug Interactions<\/h2>\n
**Drug Interactions**<\/p>\n

Palbociclib affects how your body processes other medications:<\/p>\n

\u2022 Your liver breaks down palbociclib using specific enzymes (CYP3A and SULT2A1)<\/p>\n

\u2022 Palbociclib can slow down how your body processes other drugs that use the same liver enzyme (CYP3A)<\/p>\n

\u2022 This means other medications may stay in your body longer and could cause stronger side effects<\/p>\n

\u2022 Always tell your doctor about all medications, supplements, and herbal products you take<\/p><\/div>\n

Use in Specific Populations: 8 USE IN SPECIFIC POPULATIONS<\/h2>\n
# Use in Specific Populations<\/p>\n

## 8.1 Pregnancy<\/p>\n

**Risk Summary**
\nIBRANCE can harm an unborn baby. Animal studies showed the drug caused problems in developing babies when given to pregnant animals.<\/p>\n

\u2022 There is no data on pregnant women taking this drug
\n\u2022 If you are pregnant, this drug could harm your baby
\n\u2022 In the general U.S. population, 2-4% of pregnancies have major birth defects and 15-20% end in miscarriage<\/p>\n

**Animal Study Results**
\n\u2022 Pregnant rats and rabbits were given IBRANCE during pregnancy
\n\u2022 High doses caused reduced baby weight and bone problems
\n\u2022 The doses that caused problems were 4-9 times higher than human doses<\/p>\n

## 8.2 Breastfeeding<\/p>\n

\u2022 We don’t know if IBRANCE passes into breast milk
\n\u2022 Don’t breastfeed while taking IBRANCE
\n\u2022 Wait 3 weeks after your last dose before breastfeeding<\/p>\n

## 8.3 Birth Control and Fertility<\/p>\n

**Pregnancy Testing**
\n\u2022 Get a pregnancy test before starting IBRANCE if you can get pregnant<\/p>\n

**Birth Control for Women**
\n\u2022 Use effective birth control during treatment
\n\u2022 Continue birth control for 3 weeks after your last dose<\/p>\n

**Birth Control for Men**
\n\u2022 Men should use effective birth control if their partner can get pregnant
\n\u2022 Use birth control during treatment and for 3 months after the last dose<\/p>\n

**Fertility**
\n\u2022 IBRANCE may reduce fertility in men<\/p>\n

## 8.4 Children<\/p>\n

\u2022 IBRANCE is not approved for children
\n\u2022 Studies in 140 children ages 2-17 showed the drug was processed similarly to adults
\n\u2022 Side effects were similar to those seen in adults<\/p>\n

**Studies in Young Animals**
\nYoung rats given IBRANCE developed:
\n\u2022 Blood sugar problems
\n\u2022 Eye problems (cataracts)
\n\u2022 Kidney problems
\n\u2022 Tooth problems<\/p>\n

These problems were not seen in adult animals.<\/p>\n

## 8.5 Older Adults<\/p>\n

\u2022 IBRANCE works the same in older and younger patients
\n\u2022 Side effects are similar regardless of age
\n\u2022 No dose changes needed based on age alone<\/p>\n

## 8.6 Liver Problems<\/p>\n

**Dose Changes:**
\n\u2022 Mild or moderate liver problems: No dose change needed
\n\u2022 Severe liver problems: Take 75 mg daily for 21 days, then 7 days off<\/p>\n

## 8.7 Kidney Problems<\/p>\n

\u2022 No dose changes needed for any level of kidney problems
\n\u2022 This includes mild, moderate, or severe kidney disease
\n\u2022 Has not been studied in patients on dialysis<\/p><\/div>\n

Clinical Pharmacology<\/h2>\n
# How Palbociclib Works in Your Body<\/p>\n

## 12.1 How the Medicine Works<\/p>\n

Palbociclib blocks proteins called CDK4 and CDK6 that help cancer cells grow and multiply. Here’s what happens:<\/p>\n

\u2022 The medicine stops breast cancer cells from dividing and making more cancer cells
\n\u2022 It works best when combined with hormone therapy drugs (antiestrogens)
\n\u2022 Together, these medicines cause cancer cells to stop growing and eventually die
\n\u2022 The combination works better than either medicine alone
\n\u2022 Studies show it shrinks tumors more effectively when medicines are used together
\n\u2022 Normal bone marrow cells are not permanently damaged and can recover after treatment stops<\/p>\n

## 12.2 Effects on Your Heart<\/p>\n

\u2022 Palbociclib does not cause dangerous heart rhythm problems
\n\u2022 Tests showed no serious effects on heart electrical activity at the standard dose<\/p>\n

## 12.3 How Your Body Processes the Medicine<\/p>\n

**Absorption (How it gets into your blood):**
\n\u2022 Peak levels in blood occur 6-12 hours after taking it
\n\u2022 Only 46% of the dose gets absorbed into your bloodstream
\n\u2022 Steady levels in your body are reached within 8 days
\n\u2022 The medicine builds up about 2.4 times with daily use<\/p>\n

**Food Effects:**
\n\u2022 Taking with food helps the medicine work better and more consistently
\n\u2022 About 13% of people absorb very little when taking it without food
\n\u2022 Food increases absorption by 12-38% depending on the type of meal
\n\u2022 Always take with food as directed<\/p>\n

**Distribution (How it spreads in your body):**
\n\u2022 About 85% binds to proteins in your blood
\n\u2022 Spreads widely throughout your body
\n\u2022 People with liver problems may have more active drug in their blood<\/p>\n

**Breakdown (How your body breaks it down):**
\n\u2022 Your liver breaks down most of the medicine
\n\u2022 The original drug makes up 23% of what’s in your blood
\n\u2022 Most breakdown happens through two main processes: oxidation and sulfonation
\n\u2022 Only small amounts of unchanged medicine leave your body<\/p>\n

**Elimination (How it leaves your body):**
\n\u2022 Takes about 29 hours for half the medicine to leave your blood
\n\u2022 Most (74%) leaves through bowel movements
\n\u2022 About 18% leaves through urine
\n\u2022 Nearly 92% is eliminated within 15 days<\/p>\n

**Special Populations:**<\/p>\n

*Age, Gender, and Weight:*
\n\u2022 Works the same in men and women
\n\u2022 Age (22-89 years) doesn’t significantly affect how it works
\n\u2022 Body weight doesn’t significantly change how it works<\/p>\n

*Liver Problems:*
\n\u2022 Mild liver problems: 17% less active drug in blood
\n\u2022 Moderate liver problems: 34% more active drug in blood
\n\u2022 Severe liver problems: 77% more active drug in blood<\/p>\n

*Kidney Problems:*
\n\u2022 Mild to severe kidney problems: 31-42% higher drug levels
\n\u2022 Not studied in people on dialysis<\/p>\n

**Drug Interactions:**<\/p>\n

*Strong CYP3A Inhibitors (like itraconazole):*
\n\u2022 Increase palbociclib levels by 87%
\n\u2022 May need dose adjustment<\/p>\n

*Strong CYP3A Inducers (like rifampin):*
\n\u2022 Decrease palbociclib levels by 85%
\n\u2022 May make treatment less effective<\/p>\n

*Moderate CYP3A Inducers (like modafinil):*
\n\u2022 Decrease palbociclib levels by 32%<\/p>\n

*Other Medicines:*
\n\u2022 Can increase levels of some other medicines by 61%
\n\u2022 May affect how well other medicines work<\/p>\n

*Stomach Acid Reducers:*
\n\u2022 Proton pump inhibitors (PPIs) with food: minimal effect
\n\u2022 PPIs without food: significantly reduce medicine levels (62-80%)
\n\u2022 Always take with food to avoid this problem<\/p>\n

*Transport Proteins:*
\n\u2022 Low risk of affecting most drug transporters
\n\u2022 May affect some medicines that use certain transport systems<\/p><\/div>\n

Nonclinical Toxicology<\/h2>\n
**13.1 Cancer Risk, Gene Changes, and Fertility Effects**<\/p>\n

**Cancer Risk Studies**
\nScientists tested palbociclib in animals to see if it might cause cancer:
\n\u2022 In male rats given the drug for 2 years, some developed brain tumors at high doses (8 times higher than what humans take)
\n\u2022 Female rats showed no cancer risk at doses up to 5 times higher than human doses
\n\u2022 Mice given the drug for 6 months showed no increased cancer risk<\/p>\n

**Gene Changes**
\nTests showed that palbociclib:
\n\u2022 Can cause problems with cell division in lab tests
\n\u2022 Does not directly damage DNA or cause gene mutations<\/p>\n

**Effects on Fertility**<\/p>\n

**Women:**
\n\u2022 No fertility problems were found in female rats at doses up to 4 times higher than human doses
\n\u2022 No harmful effects seen on female reproductive organs<\/p>\n

**Men:**
\n\u2022 Studies in male rats and dogs showed problems with reproductive organs including:
\n – Smaller testicles and related organs
\n – Lower sperm count and movement
\n – Tissue damage in reproductive organs
\n\u2022 These effects were partly reversible when the drug was stopped
\n\u2022 Male fertility was slightly reduced in rats at high doses (20 times higher than human doses)
\n\u2022 Effects on mating ability were not seen<\/p><\/div>\n

Clinical Studies<\/h2>\n
# Clinical Studies for IBRANCE<\/p>\n

## PALOMA-2 Study: IBRANCE plus Letrozole<\/p>\n

**Who was studied:** 666 postmenopausal women with ER-positive, HER2-negative advanced breast cancer who had not received previous treatment for their advanced disease.<\/p>\n

**How the study worked:**
\n\u2022 Patients were randomly divided into two groups (2:1 ratio)
\n\u2022 Group 1: IBRANCE plus letrozole
\n\u2022 Group 2: placebo (inactive pill) plus letrozole
\n\u2022 IBRANCE dose: 125 mg daily for 21 days, then 7 days off (28-day cycle)
\n\u2022 Treatment continued until the cancer got worse or side effects became too severe<\/p>\n

**Patient characteristics:**
\n\u2022 Average age: 62 years (range 28-89)
\n\u2022 Most patients were White (78%)
\n\u2022 48% had received chemotherapy before
\n\u2022 56% had received hormone therapy before
\n\u2022 97% had cancer that had spread (metastatic)<\/p>\n

**Results:**<\/p>\n

| Outcome | IBRANCE + Letrozole | Placebo + Letrozole |
\n|———|——————-|——————-|
\n| **Time before cancer worsened** | 24.8 months | 14.5 months |
\n| **Response rate** | 55.3% | 44.4% |
\n| **Overall survival** | 53.8 months | 49.8 months |<\/p>\n

**Key finding:** IBRANCE plus letrozole delayed cancer progression by about 10 months compared to letrozole alone.<\/p>\n

—<\/p>\n

## PALOMA-3 Study: IBRANCE plus Fulvestrant<\/p>\n

**Who was studied:** 521 pre- and postmenopausal women with HR-positive, HER2-negative advanced breast cancer whose cancer had gotten worse after previous hormone therapy.<\/p>\n

**How the study worked:**
\n\u2022 Patients were randomly divided into two groups (2:1 ratio)
\n\u2022 Group 1: IBRANCE plus fulvestrant
\n\u2022 Group 2: placebo plus fulvestrant
\n\u2022 IBRANCE dose: 125 mg daily for 21 days, then 7 days off (28-day cycle)
\n\u2022 Pre\/perimenopausal women also received goserelin injections<\/p>\n

**Patient characteristics:**
\n\u2022 Average age: 57 years (range 29-88)
\n\u2022 Most patients were White (74%)
\n\u2022 80% were postmenopausal
\n\u2022 All had received previous treatment
\n\u2022 75% had received chemotherapy before<\/p>\n

**Results:**<\/p>\n

| Outcome | IBRANCE + Fulvestrant | Placebo + Fulvestrant |
\n|———|———————|———————|
\n| **Time before cancer worsened** | 9.5 months | 4.6 months |
\n| **Response rate** | 24.6% | 10.9% |
\n| **Overall survival** | 34.9 months | 28.0 months |<\/p>\n

**Key finding:** IBRANCE plus fulvestrant doubled the time before cancer got worse compared to fulvestrant alone.<\/p>\n

—<\/p>\n

## INAVO120 Study: IBRANCE plus Inavolisib and Fulvestrant<\/p>\n

**Who was studied:** 325 adults with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer whose disease got worse during or within 12 months of completing hormone therapy after surgery.<\/p>\n

**Special requirements:**
\n\u2022 Patients needed specific blood sugar levels (HbA1C <6%, fasting glucose <126 mg\/dL)\n\u2022 No diabetes requiring medication\n\u2022 Cancer must have a specific genetic change (PIK3CA mutation)\n\n**How the study worked:**\n\u2022 Patients were randomly divided into two equal groups\n\u2022 Group 1: IBRANCE + inavolisib + fulvestrant\n\u2022 Group 2: IBRANCE + placebo + fulvestrant\n\u2022 IBRANCE dose: 125 mg daily for 21 days, then 7 days off\n\u2022 Inavolisib: 9 mg daily\n\u2022 Fulvestrant: 500 mg injection on specific days\n\n**Patient characteristics:**\n\u2022 Average age: 54 years (range 27-79)\n\u2022 98% female, 39% pre\/perimenopausal\n\u2022 59% White, 38% Asian\n\u2022 64% had secondary hormone resistance\n\u2022 83% had received chemotherapy before\n\n**Results:**\n\n| Outcome | IBRANCE + Inavolisib + Fulvestrant | IBRANCE + Placebo + Fulvestrant |\n|---------|----------------------------------|--------------------------------|\n| **Time before cancer worsened** | 15.0 months | 7.3 months |\n| **Response rate** | 58% | 25% |\n| **Duration of response** | 18.4 months | 9.6 months |\n\n**Key finding:** Adding inavolisib to IBRANCE and fulvestrant more than doubled the time before cancer got worse in patients with PIK3CA mutations.<\/div>\n

How Supplied\/Storage and Handling<\/h2>\n
**How IBRANCE Comes and How to Store It**<\/p>\n

**How IBRANCE is supplied:**
\n\u2022 IBRANCE comes in different strengths and package sizes
\n\u2022 Your doctor will prescribe the right strength for you
\n\u2022 The medication comes in capsules<\/p>\n

**Storage instructions:**
\n\u2022 Store at room temperature
\n\u2022 Keep in the original container
\n\u2022 Keep away from moisture and heat
\n\u2022 Keep out of reach of children
\n\u2022 Do not use if expired<\/p><\/div>\n

Patient Counseling Information<\/h2>\n
**Important Reading Instructions**<\/p>\n

\u2022 Read the Patient Information sheet that comes with your medication
\n\u2022 This information has been approved by the FDA (Food and Drug Administration)
\n\u2022 The Patient Information sheet contains important details about your medicine
\n\u2022 Make sure to read it before you start taking your medication
\n\u2022 Keep the information sheet so you can refer to it if you have questions<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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