What is Ibrance and how is it used?
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 in postmenopausal women or in men; or
- fulvestrant in patients with disease progression following endocrine therapy.
What are the side effects of Ibrance?
Neutropenia was the most frequently reported adverse reaction in Study 1 (PALOMA-2) with an incidence of 80% and Study 2 (PALOMA-3) with an incidence of 83%. A Grade ≥3 decrease in neutrophil counts was reported in 66% of patients receiving Ibrance plus letrozole in Study 1 and 66% of patients receiving Ibrance plus fulvestrant in Study 2. In Study 1 and 2, the median time to first episode of any grade neutropenia was 15 days and the median duration of Grade ≥3 neutropenia was 7 days.
Monitor complete blood counts prior to starting Ibrance therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
Febrile neutropenia has been reported in 1.8% of patients exposed to Ibrance across Studies 1 and 2. One death due to neutropenic sepsis was observed in Study 2. Physicians should inform patients to promptly report any episodes of fever.
Based on findings from animal studies and its mechanism of action, Ibrance can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of palbociclib to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at maternal exposures that were ≥4 times the human clinical exposure based on area under the curve (AUC). Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Ibrance and for at least 3 weeks after the last dose.
What is the dosage of 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.
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.
Patients should be encouraged 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 capsules should be swallowed whole (do not chew, crush, or open them prior to swallowing). Capsules should not be ingested if they are broken, cracked, or otherwise not intact.
Pre/perimenopausal women treated with the combination Ibrance plus fulvestrant therapy 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 therapy, consider treatment with an LHRH agonist according to current clinical practice standards.
What drugs interact with Ibrance?
Palbociclib is primarily metabolized by CYP3A and sulfotransferase (SULT) enzyme SULT2A1. In vivo, palbociclib is a time-dependent inhibitor of CYP3A.
Effect of CYP3A Inhibitors
Coadministration of a strong CYP3A inhibitor (itraconazole) increased the plasma exposure of palbociclib in healthy subjects by 87%. Avoid concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole). Avoid grapefruit or grapefruit juice during Ibrance treatment. If coadministration of Ibrance with a strong CYP3A inhibitor cannot be avoided, reduce the dose of Ibrance.
Effect of CYP3A Inducers
Coadministration of a strong CYP3A inducer (rifampin) decreased the plasma exposure of palbociclib in healthy subjects by 85%. Avoid concomitant use of strong CYP3A inducers (e.g., phenytoin, rifampin, carbamazepine, enzalutamide, and St John's Wort).
Drugs That May Have Their Plasma Concentrations Altered by Palbociclib
Coadministration of midazolam with multiple doses of Ibrance increased the midazolam plasma exposure by 61%, in healthy subjects, compared to administration of midazolam alone. The dose of the sensitive CYP3A substrate with a narrow therapeutic index (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) may need to be reduced, as Ibrance may increase its exposure.
Is Ibrance safe to use while pregnant or breastfeeding?
Based on findings from animal studies and its mechanism of action, Ibrance can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of palbociclib to pregnant rats and rabbits during organogenesis resulted in embryo-fetal toxicity at maternal exposures that were ≥4 times the human clinical exposure based on AUC. Advise pregnant women of the potential risk to a fetus.
There 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.
Ibrance (palbociclib) is an anti-cancer agent for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with other endocrine-based drug therapy.
Multimedia: Slideshows, Images & Quizzes
Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment
Learn about breast cancer causes, symptoms, tests, recovery, and prevention. Discover the types of treatments such as surgery and...
10 Things Young Women Should Know About Breast Cancer
Is breast cancer genetic? Should I get tested for the BRCA gene? What every young women should know about breast cancer. Discover...
Breast Cancer Quiz: Symptoms & Signs
This Breast Cancer Quiz features signs, symptoms, facts, causes, common forms, terms, risk factors, statistics, and more. ...
Breast Cancer: Where It Can Spread
When breast cancer spreads, or metastasizes, it often goes to these five places: the lymph nodes, bones, liver, lungs, and brain....
Related Disease Conditions
Breast Cancer in Men
Second Source WebMD Medical Reference
How Common Is Lymphovascular Invasion in Breast Cancer?
About 30% of breast cancers metastasize to nearby blood vessels and lymph nodes, a process called lymphovascular invasion.
Male Breast Cancer
Male breast cancer accounts for 1% of all breast cancers, and most cases are found in men between the ages of 60 and 70. A man's risk of developing breast cancer is one in 1,000. Signs and symptoms include a firm mass located below the nipple and skin changes around the nipple, including puckering, redness or scaling, retraction and ulceration of the nipple. Treatment depends upon staging and the health of the patient.
Breast cancer is an invasive tumor that develops in the mammary gland. Breast cancer is detected via mammograms, breast self-examination (BSE), biopsy, and specialized testing on breast cancer tissue. Treatment of breast cancer may involve surgery, radiation, hormone therapy, chemotherapy, and targeted therapy. Breast cancer risk may be lowered by managing controllable risk factors. What you should know about breast cancer Breast cancer is the most common cancer among American women. One in every eight women in the United States develops breast cancer. There are many types of breast cancer that differ in their capability of spreading (metastasize) to other body tissues. The causes of breast cancer are unknown, although medical professionals have identified a number of risk factors. There are 11 common types of breast cancer and 4 uncommon types of breast cancer. Breast cancer early signs and symptoms include a lump in the breast or armpit, bloody nipple discharge, inverted nipple, orange-peel texture or dimpling of the breast's skin (peau d'orange), breast pain or sore nipple, swollen lymph nodes in the neck or armpit, and a change in the size or shape of the breast or nipple. Breast cancer can also be symptom free, which makes following national screening recommendations an important practice. Breast cancer is diagnosed during a physical exam, by a self-exam of the breasts, mammography, ultrasound testing, and biopsy. Treatment of breast cancer depends on the type of cancer and its stage (0-IV) and may involve surgery, radiation, or chemotherapy.
Breast Cancer Treatment by Stage
Treatment of breast cancer depends upon the stage of the cancer at the time of diagnosis. Some of the various treatments include: hormone therapy, radiation therapy, surgery, chemotherapy, HER2-targeted therapy, neoadjuvant therapy, and adjuvant therapy.
Breast Cancer During Pregnancy
Breast cancer occurs in about 1 in every 1,000 pregnant women. Treatment of breast cancer during pregnancy involves surgery, but it is very difficult to protect the baby from the dangerous effects of radiation and chemotherapy. It can be an agonizing to decide whether or not to undergo breast cancer treatment while one is pregnant.
Breast Cancer in Young Women
About 5% of cases of breast cancer occur in women under the age of 40 years old. Some risk factors for breast cancer in young women include a personal history of breast cancer or breast disease, family history of breast cancer, prior radiation therapy, and the presence of BRCA1/BRCA2 gene mutations. Breast self-exams, clinical breast exams, and screening mammograms may help detect breast cancer. Treatment may include surgery, chemotherapy, radiation, and hormone therapy.
Breast Cancer Clinical Trials
Breast cancer clinical trials are research programs designed to evaluate new medical treatments, drugs, or devices for the treatment of breast cancer. Clinical trials are designed to test the safety and efficacy of new treatments as well as assess potential side effects. Clinical trials also compare new treatment to existing treatments to determine if it's any better. There are many important questions to ask your doctor before taking part in a breast cancer clinical trial.
Treatment & Diagnosis
- Breast Cancer
- Breast Cancer Husband
- Breast Cancer: A Feisty Women's Discussion
- Breast Cancer
- Breast Cancer: Early Stage Treatments
- Breast Cancer: Clinical Trials - Today's Cutting Edge
- Breast Cancer, Metastatic: Treatment Goals and Therapy Options -- Harold J. Burstein, MD
- Breast Cancer: Early Diagnosis and Prevention
- Breast Cancer Treatments. Oct. 29, 2002.
- Breast Cancer, Taking Control: Self-Advocacy 101
- Breast Cancer Treatment Update
- Breast Cancer FAQs
- Breast Cancer Risk - Reduced With Exercise
- Herceptin Metastatic Breast Cancer Treatment
- Breastfeeding -- Protection from Breast Cancer?
- Hormone Therapy in Survivors of Breast Cancer
- Breast Cancer: Types of Breast Cancer
- Elizabeth Edwards has Breast Cancer Alert
- Exercise Improves Breast Cancer Survival
- Stress and Aggressive Breast Cancer: Cause or Effect?
- Advanced Breast Cancer in Young Women Increasing
- Angelina Jolie's Mastectomy
- Does Positive Additude Affect Breast Cancer?
- How Common and Dangerous Is Male Breast Cancer?
- How Many Breast Cancer Deaths Are there Each Year?
- Where Can Breast Cancer Spread To?
- Why Is Breast Cancer More Common in Females than Males?
- How Much Breast Cancer is Genetic?
- How Long Can Breast Cancer Patients Live?
- Who Does Breast Cancer Affect?
- How Does Breast Cancer Form?
- How Many Breast Cancer Stages Are There?
- Facts on Breast Cancer Causes, Risk Factors, and Types
- Breast Cancer Symptoms and Signs
- Breast Cancer Detection
- Breast Cancer Treatment
Medications & Supplements
Prevention & Wellness
- Breast Cancer and Menopause
- Breast Cancer Specific References
- Breast Cancer Survivors: Treatment Side Effects
- Breast Cancer Survivor's Grief: Losing Your Doctor
- Breast Cancer Survivors: After Your Mastectomy
- Breast Cancer Survivors: Nutrition, Fitness Tips
- Breast Cancer Survivors: Tips for Travel
- Breast Cancer Screening
- Breast Cancer Research: Milestones
- Breast Cancer Awareness Month
- Breast Cancer Survivors' Follow-Up Care
Health Solutions From Our Sponsors
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
All Ibrance (palbociclib) content in this article courtesy of the U.S. Food and Drug Administration.