Palbociclib (Ibrance) is indicated for the treatment of 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 fulvestrant in patients who have received prior therapy
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The recommended dose of Palbociclib (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.
When coadministered with Palbociclib (Ibrance), an aromatase inhibitor should be administered according to the dose schedule reported in the Product Information for that aromatase inhibitor .
When coadministered with Palbociclib (Ibrance), the recommended dose of fulvestrant is 500 mg administered intramuscularly on Days 1, 15, 29 and once monthly thereafter. Please refer to the Product Information for fulvestrant.
Palbociclib (Ibrance) is supplied as hard gelatin capsules containing 125 mg of
Palbociclib as the freebase and the following excipients
Use of Palbociclib (Ibrance) is contraindicated in patients with hypersensitivity to Palbociclib or to any of the excipients.
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