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Ibrance

Last reviewed on RxList: 2/1/2021
Ibrance Side Effects Center

What Is Ibrance?

Ibrance (palbociclib) is a kinase inhibitor used in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.

What Are Side Effects of Ibrance?

Common side effects of Ibrance include:

Dosage for Ibrance

The recommended dose of Ibrance is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Ibrance should be taken with food in combination with letrozole 2.5 mg once daily given continuously throughout the 28-day cycle.

What Drugs, Substances, or Supplements Interact with Ibrance?

Ibrance may interact with:

  • azole antifungals,
  • antiviral medications,
  • clarithromycin,
  • nefazodone,
  • telithromycin,
  • verapamil,
  • grapefruit or grapefruit juice,
  • phenytoin,
  • rifampin,
  • carbamazepine and St John's Wort,
  • bosentan,
  • efavirenz,
  • etravirine,
  • modafinil,
  • nafcillin,
  • midazolam,
  • alfentanil,
  • cyclosporine,
  • dihydroergotamine,
  • ergotamine,
  • everolimus,
  • fentanyl,
  • pimozide,
  • quinidine,
  • sirolimus, and
  • tacrolimus

Tell your doctor all medications and supplements you use.

Ibrance During Pregnancy and Breastfeeding

Ibrance is not recommend for use during pregnancy. It may harm a fetus. It is unknown if this drug passes into breask milk. Consult your doctor before breastfeeding.

Additional Information

Our Ibrance (palbociclib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

A lump in the breast is almost always cancer. See Answer
Ibrance Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
  • low blood cell counts--fever, chills, weakness, dizziness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
  • signs of inflammation in the lungs--new or worsening cough, painful or difficult breathing, wheezing, feeling short of breath even while resting; or
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • low blood cell counts, infections;
  • easy bruising or bleeding;
  • feeling weak or tired;
  • nausea, vomiting, diarrhea, loss of appetite;
  • mouth sores;
  • abnormal liver function tests;
  • dry skin, rash;
  • altered sense of taste;
  • nosebleed; or
  • thinning hair or hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ibrance (Palbociclib Capsules for Oral Administration)

SLIDESHOW

Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow
Ibrance Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Clinical Studies Experience

Because clinical trials are conducted under varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.

Study 1: IBRANCE Plus Letrozole

Patients With Estrogen Receptor (ER)-positive, HER2-negative Advanced Or Metastatic Breast Cancer For Initial Endocrine Based Therapy

The safety of IBRANCE (125 mg/day) plus letrozole (2.5 mg/day) versus placebo plus letrozole was evaluated in Study 1 (PALOMA-2). The data described below reflect exposure to IBRANCE in 444 out of 666 patients with ER-positive, HER2-negative advanced breast cancer who received at least 1 dose of IBRANCE plus letrozole in Study 1. The median duration of treatment for IBRANCE plus letrozole was 19.8 months while the median duration of treatment for placebo plus letrozole arm was 13.8 months.

Dose reductions due to an adverse reaction of any grade occurred in 36% of patients receiving IBRANCE plus letrozole. No dose reduction was allowed for letrozole in Study 1.

Permanent discontinuation associated with an adverse reaction occurred in 43 of 444 (9.7%) patients receiving IBRANCE plus letrozole and in 13 of 222 (5.9%) patients receiving placebo plus letrozole. Adverse reactions leading to permanent discontinuation for patients receiving IBRANCE plus letrozole included neutropenia (1.1%) and alanine aminotransferase increase (0.7%).

The most common adverse reactions (≥10%) of any grade reported in patients in the IBRANCE plus letrozole arm by descending frequency were neutropenia, infections, leukopenia, fatigue, nausea, alopecia, stomatitis, diarrhea, anemia, rash, asthenia, thrombocytopenia, vomiting, decreased appetite, dry skin, pyrexia, and dysgeusia.

The most frequently reported Grade >3 adverse reactions (≥5%) in patients receiving IBRANCE plus letrozole by descending frequency were neutropenia, leukopenia, infections, and anemia.

Adverse reactions (≥10%) reported in patients who received IBRANCE plus letrozole or placebo plus letrozole in Study 1 are listed in Table 4.

Table 4: Adverse Reactions (≥10%) in Study 1

Adverse Reaction IBRANCE plus Letrozole
(N=444)
Placebo plus Letrozole
(N=222)
All Grades % Grade 3 % Grade 4 % All Grades % Grade 3 % Grade 4 %
Infections and infestations
Infectionsa 60b 6 1 42 3 0
Blood and lymphatic system disorders
Neutropenia 80 56 10 6 1 1
Leukopenia 39 24 1 2 0 0
Anemia 24 5 <1 9 2 0
Thrombocytopenia 16 1 <1 1 0 0
Metabolism and nutrition disorders
Decreased appetite 15 1 0 9 0 0
Nervous system disorders
Dysgeusia 10 0 0 5 0 0
Gastrointestinal disorders
Stomatitisc 30 1 0 14 0 0
Nausea 35 <1 0 26 2 0
Diarrhea 26 1 0 19 1 0
Vomiting 16 1 0 17 1 0
Skin and subcutaneous tissue disorders
Alopecia 3d N/A N/A 16e N/A N/A
Rashf 18 1 0 12 1 0
Dry skin 12 0 0 6 0 0
General disorders and administration site conditions
Fatigue 37 2 0 28 1 0
Asthenia 17 2 0 12 0 0
Pyrexia 12 0 0 9 0 0
Grading according to CTCAE 4.0.
CTCAE=Common Terminology Criteria for Adverse Events; N=number of patients; N/A=not applicable;
a Infections includes all reported preferred terms (PTs) that are part of the System Organ Class Infections and infestations.
b Most common infections (≥1%) include: nasopharyngitis, upper respiratory tract infection, urinary tract infection, oral herpes, sinusitis, rhinitis, bronchitis, influenza, pneumonia, gastroenteritis, conjunctivitis, herpes zoster, pharyngitis, cellulitis, cystitis, lower respiratory tract infection, tooth infection, gingivitis, skin infection, gastroenteritis viral, respiratory tract infection, respiratory tract infection viral, and folliculitis.
c Stomatitis includes: aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oral discomfort, oropharyngeal pain, and stomatitis.
d Grade 1 events - 30%; Grade 2 events - 3%.
e Grade 1 events - 15%; Grade 2 events - 1%.
f Rash includes the following PTs: rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis, dermatitis acneiform, and toxic skin eruption.

Additional adverse reactions occurring at an overall incidence of <10.0% of patients receiving IBRANCE plus letrozole in Study 1 included alanine aminotransferase increased (9.9%), aspartate aminotransferase increased (9.7%), epistaxis (9.2%), lacrimation increased (5.6%), dry eye (4.1%), vision blurred (3.6%), and febrile neutropenia (2.5%).

Table 5: Laboratory Abnormalities in Study 1

Laboratory Abnormality IBRANCE plus Letrozole
(N=444)
Placebo plus Letrozole
(N=222)
All Grades % Grade 3 % Grade 4 % All Grades % Grade 3 % Grade 4 %
WBC decreased 97 35 1 25 1 0
Neutrophils decreased 95 56 12 20 1 1
Anemia 78 6 0 42 2 0
Platelets decreased 63 1 1 14 0 0
Aspartate aminotransferase increased 52 3 0 34 1 0
Alanine aminotransferase increased 43 2 <1 30 0 0
N=number of patients; WBC=white blood cells.

Study 2: IBRANCE Plus Fulvestrant

Patients with HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Have Had Disease Progression On Or After Prior Adjuvant Or Metastatic Endocrine Therapy

The safety of IBRANCE (125 mg/day) plus fulvestrant (500 mg) versus placebo plus fulvestrant was evaluated in Study 2 (PALOMA-3). The data described below reflect exposure to IBRANCE in 345 out of 517 patients with HR-positive, HER2-negative advanced or metastatic breast cancer who received at least 1 dose of IBRANCE plus fulvestrant in Study 2. The median duration of treatment for IBRANCE plus fulvestrant was 10.8 months while the median duration of treatment for placebo plus fulvestrant arm was 4.8 months.

Dose reductions due to an adverse reaction of any grade occurred in 36% of patients receiving IBRANCE plus fulvestrant. No dose reduction was allowed for fulvestrant in Study 2.

Permanent discontinuation associated with an adverse reaction occurred in 19 of 345 (6%) patients receiving IBRANCE plus fulvestrant, and in 6 of 172 (3%) patients receiving placebo plus fulvestrant. Adverse reactions leading to discontinuation for those patients receiving IBRANCE plus fulvestrant included fatigue (0.6%), infections (0.6%), and thrombocytopenia (0.6%).

The most common adverse reactions (≥10%) of any grade reported in patients in the IBRANCE plus fulvestrant arm by descending frequency were neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, diarrhea, thrombocytopenia, vomiting, alopecia, rash, decreased appetite, and pyrexia.

The most frequently reported Grade ≥3 adverse reactions (≥5%) in patients receiving IBRANCE plus fulvestrant in descending frequency were neutropenia and leukopenia.

Adverse reactions (≥10%) reported in patients who received IBRANCE plus fulvestrant or placebo plus fulvestrant in Study 2 are listed in Table 6.

Table 6: Adverse Reactions (≥10%) in Study 2

Adverse Reaction IBRANCE plus Fulvestrant
(N=345)
Placebo plus Fulvestrant
(N=172)
All Grades % Grade 3 % Grade 4 % All Grades % Grade 3 % Grade 4 %
Infections and infestations
Infectionsa 47b 3 1 31 3 0
Blood and lymphatic system disorders
Neutropenia 83 55 11 4 1 0
Leukopenia 53 30 1 5 1 1
Anemia 30 4 0 13 2 0
Thrombocytopenia 23 2 1 0 0 0
Metabolism and nutrition disorders
Decreased appetite 16 1 0 8 1 0
Gastrointestinal disorders
Nausea 34 0 0 28 1 0
Stomatitisc 28 1 0 13 0 0
Diarrhea 24 0 0 19 1 0
Vomiting 19 1 0 15 1 0
Skin and subcutaneous tissue disorders
Alopecia 18d N/A N/A 6e N/A N/A
Rashf 17 1 0 6 0 0
General disorders and administration site conditions
Fatigue 41 2 0 29 1 0
Pyrexia 13 <1 0 5 0 0
Grading according to CTCAE 4.0.
CTCAE=Common Terminology Criteria for Adverse Events; N=number of patients; N/A=not applicable.
a Infections includes all reported preferred terms (PTs) that are part of the System Organ Class Infections and infestations.
b Most common infections (≥1%) include: nasopharyngitis, upper respiratory infection, urinary tract infection, bronchitis, rhinitis, influenza, conjunctivitis, sinusitis, pneumonia, cystitis, oral herpes, respiratory tract infection, gastroenteritis, tooth infection, pharyngitis, eye infection, herpes simplex, and paronychia.
c Stomatitis includes: aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal discomfort, oropharyngeal pain, stomatitis.
d Grade 1 events - 17%; Grade 2 events - 1%.
e Grade 1 events - 6%.
f Rash includes: rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis, dermatitis acneiform, toxic skin eruption.

Additional adverse reactions occurring at an overall incidence of <10.0% of patients receiving IBRANCE plus fulvestrant in Study 2 included asthenia (7.5%), aspartate aminotransferase increased (7.5%), dysgeusia (6.7%), epistaxis (6.7%), lacrimation increased (6.4%), dry skin (6.1%), alanine aminotransferase increased (5.8%), vision blurred (5.8%), dry eye (3.8%), and febrile neutropenia (0.9%).

Table 7: Laboratory Abnormalities in Study 2

Laboratory Abnormality IBRANCE plus Fulvestrant
(N=345)
Placebo plus Fulvestrant
(N=172)
All Grades % Grade 3 % Grade 4 % All Grades % Grade 3 % Grade 4 %
WBC decreased 99 45 1 26 0 1
Neutrophils decreased 96 56 11 14 0 1
Anemia 78 3 0 40 2 0
Platelets decreased 62 2 1 10 0 0
Aspartate aminotransferase increased 43 4 0 48 4 0
Alanine aminotransferase increased 36 2 0 34 0 0
N=number of patients; WBC=white blood cells.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of IBRANCE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Respiratory Disorders: Interstitial lung disease (ILD)/non-infectious pneumonitis.

Male Patients With HR-Positive, HER2-Negative Advanced Or Metastatic Breast Cancer

Based on limited data from postmarketing reports and electronic health records, the safety profile for men treated with IBRANCE is consistent with the safety profile in women treated with IBRANCE.

Read the entire FDA prescribing information for Ibrance (Palbociclib Capsules for Oral Administration)

Related Resources for Ibrance

Related Health

© Ibrance Patient Information is supplied by Cerner Multum, Inc. and Ibrance Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

A lump in the breast is almost always cancer. See Answer

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