Brand Name
Ibrance
Generic Name
Palbociclib
View Brand Information FDA approval date: February 03, 2015
Classification: Kinase Inhibitor
Form: Tablet, Capsule
What is Ibrance (Palbociclib)?
IBRANCE is indicated for the treatment of adult patients with hormone receptor -positive, human epidermal growth factor receptor 2 -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. IBRANCE is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor -positive, human epidermal growth factor receptor 2 -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.
Approved To Treat
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease
Summary: The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received p...
Molecular Analysis for Combination Therapy Choice (ComboMATCH)
Summary: This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment t...
A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination With Palbociclib, a CDK4/6 Inhibitor, in Patients With HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial
Summary: This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cel...
Related Latest Advances
Brand Information
Ibrance (palbociclib)
1DOSAGE FORMS AND STRENGTHS
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.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Neutropenia
- ILD/Pneumonitis
3.1Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Postmarketing 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
Skin and Subcutaneous Tissue Disorders: Palmar-plantar erythrodysesthesia syndrome (PPES)
4DRUG INTERACTIONS
Palbociclib is primarily metabolized by CYP3A and sulfotransferase (SULT) enzyme SULT2A1. In vivo, palbociclib is a time-dependent inhibitor of CYP3A.
4.1Drugs 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
5DESCRIPTION
IBRANCE tablets for oral administration contain 125 mg, 100 mg, or 75 mg of palbociclib, a kinase inhibitor. The molecular formula for palbociclib is C
Palbociclib is a yellow to orange powder. At or below pH 4, palbociclib behaves as a high-solubility compound. Above pH 4, the solubility of the drug substance reduces significantly.
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.
6HOW SUPPLIED/STORAGE AND HANDLING
IBRANCE is supplied in the following strengths and package configurations:
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
8PRINCIPAL DISPLAY PANEL - 75 mg Tablet Dose Pack
PROFESSIONAL SAMPLE - NOT FOR SALE
Pfizer
NDC 63539-284-07
IBRANCE
tablets
75 mg per tablet
This weekly pack contains:
Rx only
9PRINCIPAL DISPLAY PANEL - 75 mg Tablet Dose Pack Box
PROFESSIONAL SAMPLE - NOT FOR SALE
Pfizer
NDC 63539-284-03
IBRANCE
tablets
75 mg
21 tablets
Monthly Box Contains: 3 individual weekly
Rx only
Safety
10PRINCIPAL DISPLAY PANEL - 100 mg Tablet Dose Pack
PROFESSIONAL SAMPLE - NOT FOR SALE
Pfizer
NDC 63539-486-07
IBRANCE
tablets
100 mg per tablet
This weekly pack contains:
Rx only
11PRINCIPAL DISPLAY PANEL - 100 mg Tablet Dose Pack Box
PROFESSIONAL SAMPLE - NOT FOR SALE
Pfizer
NDC 63539-486-03
IBRANCE
tablets
100 mg
21 tablets
Monthly Box Contains: 3 individual weekly
Rx only
Safety
12PRINCIPAL DISPLAY PANEL - 125 mg Tablet Dose Pack
PROFESSIONAL SAMPLE - NOT FOR SALE
Pfizer
NDC 63539-688-07
IBRANCE
tablets
125 mg per tablet
This weekly pack contains:
Rx only
13PRINCIPAL DISPLAY PANEL - 125 mg Tablet Dose Pack Box
PROFESSIONAL SAMPLE - NOT FOR SALE
Pfizer
NDC 63539-688-03
IBRANCE
tablets
125 mg
21 tablets
Monthly Box Contains: 3 individual weekly
Rx only
Safety
14PRINCIPAL DISPLAY PANEL - Topper Card
Your Monthly Box
Includes 3 weekly packs of
Fill in the dates below to help track your treatment cycle.
Treatment Cycle
Week 1 Week 2 Week 3
Week 4
My Treatment Cycle Tracker
I start my Week 1
After Week 4, I will start my
PAA119239
