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.
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Brand Information
Ibrance (palbociclib)
1INDICATIONS AND USAGE
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; or
- fulvestrant in patients with disease progression following endocrine therapy.
IBRANCE is indicated in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant,
2DOSAGE FORMS AND STRENGTHS
125 mg capsules: opaque, hard gelatin capsules, size 0, with caramel cap and body, printed with white ink "Pfizer" on the cap, "PBC 125" on the body.
100 mg capsules: opaque, hard gelatin capsules, size 1, with caramel cap and light orange body, printed with white ink "Pfizer" on the cap, "PBC 100" on the body.
75 mg capsules: opaque, hard gelatin capsules, size 2, with light orange cap and body, printed with white ink "Pfizer" on the cap, "PBC 75" on the body.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Neutropenia
- ILD/Pneumonitis
4.1Clinical 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.
4.2Postmarketing 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)
5DRUG INTERACTIONS
Palbociclib is primarily metabolized by CYP3A and sulfotransferase (SULT) enzyme SULT2A1. In vivo, palbociclib is a time-dependent inhibitor of CYP3A.
5.1Drugs 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
6DESCRIPTION
IBRANCE capsules 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 with pKa of 7.4 (the secondary piperazine nitrogen) and 3.9 (the pyridine nitrogen). 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, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and hard gelatin capsule shells. The light orange, light orange/caramel, and caramel opaque capsule shells contain gelatin, red iron oxide, yellow iron oxide, and titanium dioxide; the printing ink contains shellac, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone.
7HOW SUPPLIED/STORAGE AND HANDLING
IBRANCE is supplied in the following strengths and package configurations:
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9PRINCIPAL DISPLAY PANEL - 125 mg Capsule Bottle Label
PROFESSIONAL SAMPLE - NOT FOR SALE
NDC 63539-189-11
Pfizer
Ibrance™
(palbociclib)
capsules
(palbociclib)
capsules
125 mg
For Oncology Use Only
Rx only
10PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label
PROFESSIONAL SAMPLE - NOT FOR SALE
NDC 63539-188-11
Pfizer
Ibrance®
(palbociclib)
capsules
(palbociclib)
capsules
100 mg
21 Capsules
11PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label
PROFESSIONAL SAMPLE - NOT FOR SALE
NDC 63539-187-11
Pfizer
Ibrance®
(palbociclib)
capsules
(palbociclib)
capsules
75 mg
21 Capsules
