IBRANCE is a kinase inhibitor 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:

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an aromatase inhibitor as initial endocrine-based therapy (1); or

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fulvestrant in patients with disease progression following endocrine therapy. (1)

IBRANCE capsules are taken orally with food in combination with an aromatase inhibitor or fulvestrant. (2)

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Recommended starting dose: 125 mg once daily taken with food for 21 days followed by 7 days off treatment. (2.1)

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Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability. (2.2)

Capsules: 125 mg, 100 mg, and 75 mg. (3)

None. (4)

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Neutropenia: Monitor complete blood count prior to start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated. (2.2, 5.1)

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Interstitial Lung Disease (ILD)/Pneumonitis: Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for pulmonary symptoms of ILD/pneumonitis. Interrupt IBRANCE immediately in patients with suspected ILD/pneumonitis. Permanently discontinue IBRANCE if severe ILD/pneumonitis occurs. (5.2)

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Embryo-Fetal Toxicity: IBRANCE can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (5.3, 8.1, 8.3)

Most common adverse reactions (incidence ≥10%) were neutropenia, infections, leukopenia, fatigue, nausea, stomatitis, anemia, alopecia, diarrhea, thrombocytopenia, rash, vomiting, decreased appetite, asthenia, and pyrexia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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CYP3A Inhibitors: Avoid concurrent use of IBRANCE with strong CYP3A inhibitors. If the strong inhibitor cannot be avoided, reduce the IBRANCE dose. (2.2, 7.1)

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CYP3A Inducers: Avoid concurrent use of IBRANCE with strong CYP3A inducers. (7.2)

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CYP3A Substrates: The dose of sensitive CYP3A4 substrates with narrow therapeutic indices may need to be reduced when given concurrently with IBRANCE. (7.3)

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Lactation: Advise not to breastfeed. (8.2)